The FDA Center for Veterinary Medicine granted full approval to Pegasus Laboratories’ KBroVet (potassium bromide chewable tablets), a prescription treatment for the control of seizures in dogs with idiopathic epilepsy, or recurring seizures with no known cause. Pegasus’ KBroVet website notes that idiopathic epilepsy is the most common chronic neurologic disorder in dogs. Dog owners must work closely with their veterinarians to monitor clinical signs of bromide intoxication, which can happen when high levels of bromide overwhelm the nervous system. The medication, which is taken daily, has been available under conditional approval since 2021.

FDA Press Release: FDA Grants Full Approval for Drug to Control Seizures in Dogs With Idiopathic Epilepsy

Drug Information for KBroVet The 15-page guide posted at the FDA website provides supporting clinical data, dosage instructions, and more.

While any dog breed can develop idiopathic epilepsy, Schnauzers, Collies, Basset Hounds, Cocker Spaniels, Labrador Retrievers, and Golden Retrievers are diagnosed more frequently. Read more about idiopathic epilepsy in dogs at Whole Dog Journal: “Managing Idiopathic Epilepsy”

New Drug Treats Lymphoma in Dogs

The FDA Center for Veterinary Medicine granted full approval for Anivive Lifesciences’ Laverdia (verdinexor) tablets to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system. Laverdia prevents certain proteins from leaving the nucleus of cancer cells, thereby allowing these proteins to control the growth and prevent the spread of cancerous cells in dogs. The medication has been available under conditional approval since 2021. Owners of dogs with lymphoma administer Laverdia orally while at home, following a veterinarian prescription and the safety directions detailed in the product’s client information sheet. Laverdia is given twice per week immediately after eating, with at least 72 hours between doses. The most common adverse effects are anorexia, weight loss, vomiting, diarrhea, and lethargy.

Medical gloves safe for use with chemotherapy drugs should always be worn when handling Laverdia and when cleaning up after a dog undergoing treatment and for three days following the last treatment. The FDA states that canine lymphoma affects fewer than 80,000 dogs in the U.S. each year.

FDA Press Release: FDA Grants Full Approval of First Oral Treatment for Lymphoma in Dogs

Minoxidil Warning for Pet Owners

If you have a dog or cat and also use minoxidil (including Rogaine brand name) as a hair loss treatment, be careful not to let your pets ingest the medication or come in contact with surfaces that may have been exposed, such as skin, towels, clothes, and bedding. The FDA recently posted updates to minoxidil labels to include a new pet-related warning after recent research has shown a link between minoxidil and toxicosis, with about 14% of hospitalized cats dying from the exposure

A medical literature review study led by Department of Dermatology and Skin Science, University of British Columbia, Vancouver was published in The Journal of the American Academy of Dermatology in August 2025: “Minoxidil toxicosis in cats and dogs: A scoping review and call to action.”

The study notes that symptoms, which include poor feeding and shortness of breath, may set in as early 30 minutes after exposure. Treatments mentioned in the study included supplemental oxygen, warming pads, intravenous fluids, diuretics, vasopressors, thoracocentesis (procedure to remove fluid or air from around the lungs), and beta blockers.

Longevity Pill for Dogs: Huge Clinical Trial to Begin

Veterinary drug research company Loyal announced that the FDA’s Center for Veterinary Medicine has accepted the Target Animal Safety (TAS) section of its “Expanded Conditional Approval” application for LOY-002, an investigational medication that aims to extend the lifespan of dogs. There are three components to the FDA’s “Expanded Conditional Approval (XCA)” process, and so far Loyal says it has met two of them: safety and efficacy.

Now it is working on the manufacturing component and beginning a clinical trial (called the STAY study) necessary for eventual full approval of LOY-002. Loyal says that the medication works by addressing the “metabolic dysfunction that all dogs experience as they age, delaying the start of many diseases that reduce quality of life for senior dogs.” So far, effectiveness data has not been released.

The STAY study is a double-blinded, four-year long placebo-controlled study with 1,300 dogs enrolled across 70 veterinary clinics nationwide. According to Forbes, this is the largest animal clinical trial ever conducted. LOY-002 is administered orally and is intended for dogs age 10 or older weighing at least 14 pounds. Loyal is also working on a separate injectable drug for very large dogs.

Loyal Press Release: One step closer to a longevity drug: LOY-002 hits key FDA milestone

Forbes: A Longer Leash on Life: Inside the Dog Longevity Startup Loyal
Profiles the founder of Loyal, 30-year-olld Celine Halioua who has raised more than $135 million in equity and has for years been focused on finding a marketable drug to improve longevity in dogs.

Other Longevity Research: Whole Dog Journal: “Rapamycin: the new anti-aging pill for dogs?”

Thank you for reading this special post about pet medications. Would you like to read more about pet medications news in the future? Please comment or click the “like” button on this page.

Today’s newsletter is a brief Thanksgiving edition, highlighting a recent drug pricing announcement from the Center for Medicare Services (CMS). We will return in two weeks with our regular edition containing drug safety news and more.

Newly negotiated, much lower prices for 15 drugs will go into effect in January 2027 for patients with Medicare insurance. CMS says the negotiated prices will save taxpayers roughly $12 billion a year compared with this year’s prices. For example, the cost to Medicare for Novartis’ Ozempic will drop from $959 a month per patient to $274 per month. In 2024, 2.3 million Medicare patients age 65 and up took Ozempic. Here are some more examples of monthly price reductions:

• Trelegy Elipta, for asthma and COPD: $654 to $175 (GSK)

• Breo Elipta, for asthma and COPD: $397 to $67 (GSK)

• Linzess, for chronic constipation: $539 to $136 (AbbVie)

• Xtandi, for prostate cancer: $13,480 to $7004 (Astellas)

These new prices are the list price Medicare will pay, representing an upper level cap for patients; patient out-of-pocket prices might be lower, depending on their specific “Part D” (Medicare medications) plan. For example, if a Medicare patient who has met his deductible is required to pay 25% of the drug cost as a co-pay, with current prices Ozempic would be 25% of $959 or $235. With the new pricing in 2027 and the same 25% co-pay, it would be just $68 a month. Some of the drugs will be new options for Medicare patients, since all Part D plans will be required to offer access to the drugs. Check here for the complete list of the 15 drugs, old and new prices, and number of Medicare patients taking each of the drugs:

CMS: Fact Sheet with Drugs and Prices for 2027

CMS Press Release (November 25, 2025) : “CMS Delivers Savings for Seniors on 15 Major Drugs for Cancer and Chronic Disease”

Lower Prices for 10 Drugs in January 2026

While you’ll have to wait another year for the lower prices on Ozempic, Linzess, and other drugs mentioned above, you only have to wait about a month for reduced prices on ten others, listed below. In August 2024, CMS announced the first ten drugs with newly negotiated lower prices. These new prices, listed below, will take effect in January 2026 and represent a monthly (30 day) price:

• Eliquis, for blood clots: price reduced from $521 to $231 (Bristol Meyers Squibb)

• Entresto, for heart failure $628.00 to $295.00 (Novartis)

• Enbrel, for rheumatoid arthritis: $7,106 to $2,355 (Immunex)

• Farxiga for Type 2 diabetes: $556.00 to $178 (AstraZeneca)

• Imbruvica, for blood cancer: $14,934 to $9319 (Pharmacycles)

• Januvia, for Type 2 diabetes: $527 to $113 (Merck)

• Jardiance, for diabetes: $573 to $197 (Boehringer Ingelheim)

• Novolog insulin pens (various) for Type 2 diabetes: $495 to $119 (Novartis)

• Stelara, for rheumatoid arthritis and ulcerative colitis: $13,836.00 to $4,695.00 (Jannsen)

• Xarelto for blood clots: $517 to $197 (Janssen)
  
  The new prices are the list price Medicare will pay, representing an upper level cap for patients; patient out-of-pocket prices might be lower, depending upon a person’s prescription (Part D) plan. All Medicare patients will have access to the drugs. In 2025, patients had an out-of-pocket cap of $2,000 for medications; this will rise to $2,100 in 2026. Like last year, Medicare patients in 2026 won’t have to worry about the “donut hole,” a situation where prior to 2025, some patients had to pay thousands of dollars out-of-pocket until they reached a “catastrophic limit” of over $6,000. Check this CMS fact sheet for total expenditures by brand name drug, number of patients taking, and more:

Fact sheet on 2026 Negotiated Lower Drug Prices (CMS)

Did you miss our last newsletter? Read it here:

After comparing Caplyta’s “old” (June 2023) drug label with the newly revised label (November 2025), it is notable that the Tardive Dyskinesia Warning Section was scaled back, even though movement-related side effects were more prevalent compared with placebo in the trials for the new indication. We won’t get into the clinical trial effectiveness results here (which were favorable), as we are only looking at the adverse events warning changes.

Background

Caplyta (lumateperone, 42mg) was first approved in 2019 as an “atypical antipsychotic” treatment for schizophrenia. It later received approval for bipolar disorder in adults and also as an add-on treatment for bipolar-related depression to be used either alone or along with lithium (a mood stabilizer) or valproate (an anticonvulsant). The drug was developed by Intracellular Therapies, but was purchased by Johnson & Johnson (J&J) in early 2025 for $14.6 billion.

New Indication for Caplyta: Major Depression

On November 5, 2025, Caplyta received expanded FDA approval as a treatment for major depressive disorder (MDD) in adults, to be used along with an antidepressant. Adults who don’t respond to an antidepressant alone (any type) may now be prescribed the antipsychotic as an adjunctive treatment. Fierce Pharma notes that this new indication will “super-size the market for Caplyta, as MDD affects about 22 million adults each year, according to J&J. . .which is anticipating Caplyta will eventually bring in $5 billion in annual sales.”

The clinical trial studies that supported its approval (Study 501 (NCT04985942 and Study 502 (NCT05061706) for major depressive disorder were six weeks long and compared Caplyta/Antidepressant with a Placebo/Antidepressant combination. The third study (called Study 503 with the code NCT0561719) was only open to patients who had actually completed one of the first two studies. That study was open label (all patients took Caplyta plus an antidepressant) and looked at long-term (six months) efficacy and safety. Data for that long-term trial is not yet included in the drug label.

Caplyta’s revised drug label, which includes a Patient Medication Guide, adds that the most common side effects reported in the MDD study were dizziness, drowsiness, and sedation. Importantly, the “Patient Medication Guide” warning about Tardive Dyskinesia was kept intact, and remained the same as the 2023 version.

Movement Disorder Risks

However, with no apparent connection to the new MDD indication or research, the main label content (section 5.5) on the risk of “Tardive Dyskinesia” (TD) was revised. Although second-generation antipsychotics like Caplyta generally have less movement-related side effects like tremors, muscle spasms, gait disturbances, and tardive dyskinesia than first-generation drugs, the risk still exists. Also, Caplyta is so new that long-term side effect risks are still unknown.

The “Tardive Dyskinesia” risk section is noticeably shorter (about half the length) compared with the previous version. It removes the definition of the condition (“Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs”), and moves the warning about the relationship between long-term use and the increased likelihood of it being an irreversible condition into a paragraph about increased risk of TD in elderly women. The new label also removes the paragraph cautioning that prescribing should happen in a manner that is “most likely to reduce the risk of tardive dyskinesia.” Together, these revisions seem to weaken the strength of the warnings about TD.

The revisions to the TD warning section are surprising, considering that the MDD clinical trial had a higher prevalence of extrapyramidal (movement-related) side effects for Caplyta + antidepressant vs. placebo + antidepressant than did the trials for other indications (bipolar-related depression and schizophrenia). For the MDD study, the clinical trial adverse events summary states:

“In the 6-week, adjunctive MDD trials, the frequency of reported EPS-related adverse reactions (tremor, bradykinesia, muscle spasms, gait disturbance, tongue spasm, muscle tightness and dyskinesia), excluding akathisia and restlessness, was 5% for CAPLYTA-treated patients and 0.8% for placebo-treated patients.”

Compare this with the EPS (movement related) types of adverse events occurring in the trials for the other approved indications:

• For the schizophrenia trials, the frequency of EPS-related reactions was 6.7% for the CAPLYTA-treated patients and 6.3% for placebo-treated patients.
  (Could it be that some of the schizophrenia patients participating in the Caplyta trial had already developed TD from previous years of medication, so that the difference in the prevalence of this adverse effect between the tested drug and placebo was not as great as in the MDD trial, which likely included patients who had never taken an antipsychotic before?)

• For the monotherapy bipolar depression trials, the frequency of reported EPS-related reactions was 1.3% for CAPLYTA-treated patients and 1.1% for placebo-treated patients.
  (These results suggest that the antidepressant-Calypta combo may be more likely to result in the EPS-related reactions than the antidepressant or Caplyta alone (see below).

• For the adjunctive bipolar depression trials (where lithium or valproate was also used) the frequency of reported EPS-related reactions was 4% for CAPLYTA-treated patients and 2.3% for placebo-treated patients.

  (Because the difference was less than 2%, that adverse reaction was not included in the clinical trial adverse event comparison table. Also, the result suggests that the antidepressant-Calypta combo may be more likely to result in the EPS-related reactions than the antidepressant or Caplyta alone.)

The below chart is from the most recent drug label, providing clinical trials adverse reactions for the MDD trials. Note the “Tremor” adverse reaction of four percent for patients taking Caplyta:

A Takeaway

While this drug has been “on a roll” and much celebrated in the media, safety concerns exist. The additional approval means that a huge new patient population, most likely without prior antipsychotic experience, will soon be taking this drug. Based on the MDD clinical trials results, it seems like a new “movement-related” warning should have been added to the Patient Medication Guide for the MDD indication.

Even if the longer terms trials show that the movement related disorders go away eventually or are not serious, it should be disclosed that the effect can happen early in treatment. Many patients don’t look at the clinical trial results and won’t know about this new risk unless their doctor has thoroughly read the drug label and shares the information with a patient considering taking the new medication.

In addition, while we don’t know whether the FDA questioned what appears to be a weakening of the warnings section on Tardive Dyskinesia, it would be helpful if the drug sponsor’s reasoning for all significant labeling changes were required to be included in the publicly accessible FDA letters to drug sponsors. For now at least, the television/video ads include the same warnings about TD that existed before the label update. However, the other types of movement disorders that occurred during the MDD trials are not mentioned in the commercials that promote the drug as an add-on for treating depression.

Sources and More Reading

Caplyta Drug Label Safety Update (November 2025) and links to current and previous drug labels.

Cleveland Clinic: “Antipsychotic Medications”

Psychiatric Times: Interview with Principal Investigator (Intra-Cellular Therapies) for Caplyta

Fierce Pharma “JJS Caplyta Supersizes Its Reach with Lucrative Expansion for Major Depressive Disorder”

FDA: “FDA Changes to an Approved Drug” and “Frequently Asked Questions about Labeling for Prescription Medications”

Clinical Trials are linked within this article.

Ratings for Caplyta: Patient Opinions About Caplyta (Please add yours!)

March 24, 2026 update: The FDA plans to update its guidance on natural thyroid medications by August 2026. Patients do not have to worry about losing access to the medications for now. Check out this summary of the good news:

Sticking Out Our Necks Hormonal Health News with Mary Shomon

GOOD NEWS ON NATURAL THYROID!

As those of us in the hypothyroidism community who take natural desiccated thyroid (NDT) medications know, this past year has been a total rollercoaster. In August 2025, the FDA issued a surprise “crackdown” and deadline change that signaled a summer 2026 end of availability for NDT drugs Armour Thyroid and NP Thyroid. For patients who have already fail…

Read more

20 days ago · 14 likes · 3 comments · Mary Shomon / "Thyroid Mary"

The FDA announced it is looking at taking action against companies selling “unapproved” animal-based thyroid drugs, but not right away. Additionally, FDA Commissioner Martin Makary stated that he hopes to approve a biological thyroid drug. Right now, none of the natural thyroid medications being marketed are approved as drugs by the FDA, although they are available from compounding pharmacies. The FDA says that “these unapproved animal-derived thyroid medications are not eligible for compounding because these products are regulated as biological products under the Public Health Service Act.”

In the meantime, many patients are concerned they will lose access to a medication that works for them for their low thyroid (hypothyroidism) symptoms. The FDA says that the concentrations in the natural products are not consistent and the source materials (dried or “desiccated” thyroid gland, usually from a pig) may have impurities. Examples of these products include Armour Thyroid, NP Thyroid, Nature Thyroid, and more.

FDA Press Release (August 2025 and updated on March 16, 2026): FDA Actions Address Unapproved Thyroid Medications

On our website, on average, many patients with low thyroid or Hashimoto’s disease are satisfied with products like Armour Thyroid, the natural (porcine) version of thyroid hormone. They find it works better than synthetic versions like levothyroxine or liothyronine sodium. Check out patient testimonials for Armour Thyroid.

Did you know that desiccated thyroid has been used as a treatment for more than a hundred years, far longer than levothyroxine? This fact is brought out in a recent podcast, which we featured in a recent post : “Recommended Podcast: Why is the FDA Planning to Ban Natural Desiccated Thyroid?” The podcast features an endocrinologist as well as patient advocate and Substack writer Mary Shoman.

Link to the Podcast (from November 15, 2025) at People’s Pharmacy or on Apple Podcast

More Reading:
Medscape: FDA Warns of Future Action on Animal-Derived Thyroid Drugs

Related Recalls:

In a related item about thyroid meds, more than 150,000 bottles of Accord’s generic levothyroxine tablets are under recall because of potency problems (subpotent: they have less than the labeled concentration of medication):
FDA Recall Announcement

Accord initiated a separate recall of Levothyroxine Sodium Tablets (Synthroid generic), which was announced in October 2025. Accord Healthcare is recalling 54,432 bottles of Levothyroxine Sodium Tablets, 88 mcg (90-count bottles), due to subpotency discovered during long-term stability testing. The tablets were manufactured by Intas Pharmaceuticals Limited in Selaqui, India. Levothyroxine is generic for Synthroid and treats hypothyroidism.
FDA Recall Announcement

Some Substack newsletters focus on the topic of low-thyroid conditions and treatments that are covering the FDA news and worth checking out include (hormones.substack.com) linked at the top of this article. Also:

The Invisible Hypothyroidism Newsletter

💊 Thyroid Medication Ban | Issue 211

Read more

8 months ago · 6 likes · 1 comment · Rachel Hill

Note that The Thyroid Clinic (below) is U.K.-focused but the stories and news may be of interest to all:

The Thyroid Clinic

Patient Stories Series

The early years…

Read more

8 months ago · 3 likes · The Thyroid Clinic

The regular Ask a Patient Health News Drug Safety Newsletter is on break this week, and will return on Sunday, July 27.

Today we’re sharing an update on two recently approved Alzheimer drugs, Kisunla (approved in July 2024) and Leqembi (approved in January 2023) both of which have been approved to treat early stages (mild cognitive impairment or mild dementia stage) of Alzheimer disease. Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. The drug works by slowing the progression of the disease by reducing the number of amyloid plaques (thought to be a contributing factor to Alzheimer’s) in the brain.

Kisunla’s boxed warning was modified to add that the severe side effect of ARIA (Amyloid Related Imaging Abnormalities) can be fatal. ARIA-E (for edema/effusion) often includes temporary swelling in areas of the brain. It usually occurs early in treatment and is asymptomatic, although serious and life-threatening events like seizures can occur. Kisunla also received approval for a new dosing regimen that clinical trials show have a reduced incidence of the ARIA side effects compared with the previous dosing guidelines.
https://www.fiercepharma.com/pharma/eli-lilly-kisunla-wins-fda-nod-new-dosing-fewer-brain-side-effects-alzheimers-disease

Link to revised Kisunla Drug Label

Leqembi’s cost effectiveness is being challenged by regulators in Japan, who say that at annual cost of 2.98 million yen ($20,300), the price must fall sharply to justify public reimbursement. In the U.S., the cost of the drug is $26,500 and is only partially covered by Medicare.
https://www.thepharmaletter.com/biotechnology/leqembi-costeffectiveness-questioned-in-japan-as-pricing-debate-intensifies

Leqembi Adverse Events Interactive Dashboard

Since Alzheimer’s treatment Leqembi’s (lecanemab) approval in January 2023, sponsor Eisai estimates that around 13,500 U.S. patients have taken it. How has it gone since then, in terms of severe side effects? So far, 1,877 adverse event case reports have been received by the FDA, mainly for patients in the U.S. and Japan. Although (72%) of the reported events were considered “non-serious,” a total of 57 patients died and 311 were hospitalized. Read more about Leqembi and explore the data with our new interactive dashboard. This tool is best used on a desktop computer or larger screen, like a tablet. Please share any suggestions for the tool in the comments below on through our Contact Us page.
https://www.askapatient.com/research/leqembi-interactive-dashboard-adverse-events.asp

Did you miss our last newsletter? Read it here:

Visit our website at www.askapatient.com for drug ratings and reviews submitted by patients. Please share the publication or click the “heart” button below to help this newsletter reach more readers!

The FDA final decision will be delayed for at least six months, until after the public comment period ends in May 2025. (Perhaps this FDA delay is by design, as a delay will also give manufacturers a chance to change their production formulas.)

FDA Announcement on phenylephrine (November 7, 2024)
The public can comment on the proposal, and FDA will review the public comments before finalizing a decision.

Risk of elevated blood pressure

Because phenylephrine can raise blood pressure (in fact, it's used for that purpose in some formulations), people trying to avoid that risk should make sure to read the ingredients listed on the product package (the Drug Facts label) to avoid buying OTC oral meds with phenylephrine. Phenylephrine-containing products are still on the shelves, especially in the multi-ingredient cold and allergy category.

An FDA information guide discusses oral phenylephrine and over-the-counter medications, how to check a drug label, and how to find alternative products for nasal congestion for colds and allergies.

Many phenylephrine meds are not affected by the proposal

The drug ingredient phenylephrine hydrochloride is not going away; it will still be found in over-the-counter nasal decongestant sprays and a variety of other treatment types. Here are some examples of phenylephrine-containing drugs that might come as a surprise to some consumers:

1.      It is used in over-the-counter eye drops to treat irritation and redness.

2.      It is used in over-the-counter hemorrhoid topical creams and suppositories, such as Preparation H.

3.      As a prescription drug, ophthalmic solutions are used by medical practitioners in to dilate a patient's eyes.

4.      As a prescription drug, it is administered by injection (I.V.) by medical practitioners to treat hypotension (low pressure, often caused by anesthesia or septic shock.)

Should phenylephrine be removed from prescription-only oral decongestants too?

In its press announcement, the FDA doesn't mention whether it is also considering removing oral phenylephrine from prescription-only drug products.

Read our September 2023 article about placebo decongestant outrage:

https://news.askapatient.com/i/137129671/common-otc-ingredient-in-cold-medicine-deemed-no-better-than-placebo

Looking for the November Drug Safety Update? Part 2 will be sent later today. Check out Part 1 here:

https://www.askapatient.com/news/tirf-pain-meds-fentanyl-discontinued.asp

In May 2024, the United States Congress requested a Department of Justice (DOJ) investigation into a suspected doping cover-up involving an incident, which occurred about six months before the 2021 summer Olympics in Tokyo, where 23 Chinese swimmers tested positive for a banned heart drug called trimetazidine (TMZ). (The summer games were postponed from 2020 to 2021 because of the Covid pandemic.)

The Chinese anti-doping agency (CHINADA) found traces of TMZ in the hotel kitchen where athletes were staying at the time of the positive drug tests. After a review of the cases, the World Anti-Doping Agency (WADA) accepted China's finding that the positive test results were caused by food contamination at the hotel. At least three of the Chinese swimmers went on to win medals. The U.S. Olympics officials believe these swimmers should not have been allowed to compete in either the 2021 or 2024 Olympics.

Now, at the 2024 summer games in Paris, Chinese swimmers have been closely scrutinized, with each of its 31 swimmers having been tested at least 10 times so far by World Aquatics. About 11 of the 23 swimmers from the December 2020 incident are also competing this summer in Paris. Hard feelings between WADA and the U.S. Olympic Committee led to WADA putting conditions on the U.S.’ s hosting of the 2028 Olympics, causing more friction.

Today, July 30, WADA responded to the latest U.S. allegations regarding athletes testing positive for banned substances:

"The politicization of anti-doping continues with this latest attempt by the media in the United States to imply wrongdoing on the part of WADA and the broader anti-doping community. As we have seen over recent months, WADA has been unfairly caught in the middle of geopolitical tensions between superpowers but has no mandate to participate in that.

Anger Lingers Over Positive Doping Tests for Chinese Swimmers (New York Times)
What's the swimming doping scandal all about? (Reuters)

Rules about Drugs and Supplements at the Olympics

Rules about what drugs or substances you can or can't take as an Olympic athlete have changed over time. For example, alcohol and even caffeine were at one time verboten. Today, an athlete will not be banned for consuming a few cups of coffee before a competition or a beer the night before. At the 2016 Olympics, many of the prescription drugs banned then also are on the banned list today, but the rules seem to have been stricter eight years ago, based on what experts were saying at the time.

For example, amphetamines (stimulants like Adderall or Ritalin) were banned in 2016, but if athletes had ADHD, they were usually not allowed to take the medications, even if they had been prescribed by a doctor.  NYU Langone Medical Center sports doctor Dr. Dennis Cardone  told ABC in 2016 that "a medical waiver is available but it's uncommon for an ADHD medical waiver to be approved."

In 2024, many athletes receive "therapeutic use exemptions" (TUEs) to take prescription stimulants or other banned prescription drugs. Gymnast Simone Biles has a TUE for Ritalin (methylphenidate) and says she also now takes an anxiety medication. Interestingly, in China, Japan, Singapore, and other countries, stimulants like amphetamine-containing Adderall and Ritalin are illegal, so athletes from those countries are not allowed to take the same stimulant drugs that other competitors are allowed to take.

WADA maintains the international list of banned drugs and substances. Some substances are banned across the board (all the time) and some are banned for competition only.

Permitted dietary supplements often used by athletes include protein supplements, multivitamins, vitamins, iron and other minerals, caffeine, and the substance creatine. Creatine is naturally stored in the muscles; when taken as a supplement it can boost muscle mass and performance. A survey on opinions about supplements' effectiveness finds that 60% of respondents find protein-centric products to be extremely effective while fat-burning supplements are found to be extremely effective by just 40% of those polled. Check out all the survey results here:
https://www.singlecare.com/blog/fitness-supplements/

Mental Health at the Olympics

In response to growing concern about mental health among athletes, teams from across the globe are sending more mental health care providers to the Olympics. Here are some of the ways mental health needs are being met in Paris:

More than 170 registered mental health professionals or qualified safeguarding experts from more than 90 countries were registered to be in Paris for the Olympic games. Counseling hotlines are available 24/7 with over 70 languages available for any athlete who is in crisis or would like to talk to a counselor. This service will be available to every athlete for four years after the games end. Sports psychologists are equipped to help athletes who may suffer with the let-down or depression that often occurs once the competition is over.

On the first floor of the Olympic Village fitness center, a "Mind Zone" (Athlete 365 Mind Zone) area provides a dedicated space for mental health and well-being. It includes soft light, areas for VR guided meditation, sleeping pods, and yoga spaces.

Biles, Osaka and Phelps spoke up about mental health. Has anything changed for the Paris Olympics? (AP News)

For Olympic athletes, first come the games, then come the post-Olympics blues (Scientific American)

Covid Protocols: What happens if an athlete catches Covid?

The protocols for Covid-19 illness are no longer strict and isolation is not mandatory for those infected, but mask wearing and distancing from other athletes is encouraged by some teams. Treatment depends on symptoms and diagnosis. In the days leading up to the Paris Olympics, at least eight athletes tested positive for Covid, including five members of the women's Australian water polo team. The U.S. Team follows CDC protocols, which now treats Covid the same as other respiratory illnesseses.
Covid protocols: What happens if an athlete tests positive? (USA Today)

Covid Vaccinations

Covid vaccinations are not required for U.S. or international athletes to participate in the Paris games, but the U.S. did require its athletes to be vaccinated against Covid-19 in order to participate in the 2022 Winter Olympics in Beijing. At Beijing, the International Olympic Committee (IOC) did not mandate vaccines, but unvaccinated athletes had to undergo a 21-day quarantine upon arrival.

“Discover the history of this tribe of colorful red characters based on the famous Phrygian cap - a symbol of freedom” at the official Olympics website:
https://olympics.com/en/paris-2024/the-games/the-brand/mascots

Anesthesiologists Originally Said, All Patients Should Stop

The American Society of Anesthesiologists (ASA) recommended in June 2023 that all patients, regardless of whether or not they have type 2 diabetes, should stop taking GLP-1 weekly-administered drugs (such as Ozempic) the week prior to an elective procedure or the day before if they are taking a daily dosage form of a GLP-1 (such as Rybelsus). They said this will help empty the stomach before surgery to avoid respiratory complications during surgery. Now, they share the recommendations of the other medical societies that do not call for stopping the medication. Joint Guidance: https://www.asahq.org/about-asa/newsroom/news-releases/2024/10/new-multi-society-glp-1-guidance

Gastroenterologists Say No, Not All Patients Need to Stop (for endoscopic procedures)

In November 2023, in response to the ASA guidance, the American Gastroenterological Association (AGA) recommended that it does not support all patients stopping GLP-1 drugs (like Ozempic) prior to elective endoscopy procedures.  Instead, "AGA suggests doctors individualize the approach to each patient on a GLP-1 receptor agonist prior to a procedure."  They also recommend "in lieu of stopping GLP-1 RAs, patients can also be placed on a liquid diet one day prior to their procedure."

Some Say it Depends on Why You're Taking Ozempic

Taking Ozempic for Type 2 Diabetes: No (in most cases)

Authors of a recent study in Anaesthesia (a U.K. publication) reviewed the medical literature for studies that looked at the connection between GLP-1 drugs associated with delayed gastric emptying (like Ozempic) and the risk of pulmonary aspiration  during the "peri-operative" time period (before. during, or after surgery). Since it is important to maintain consistent blood sugar levels, many experts advise not to stop the drug prior to surgery unless an endocrinologist has prescribed an alternative treatment plan.

Taking Ozempic for Weight Loss Only: Yes

The authors of the Anaesthesia study found that anesthesiologists recommend stopping the drug for at least three "half-lives" before a procedure if the patient is only taking the drug for obesity. This would be about 3 weeks in advance of surgery for a patient taking semaglutide (Ozempic brand name), because Ozempic has about a 7-day "half-life."

A drug "half-life" refers to how long it takes for about 50% of the drug concentration to remain in your body. After three drug half-lives, only about 12% of the drug still remains in your body. Not all GLP-1 drugs have such a long half-life as Ozempic. For example, Victoza (liraglutide) has a half-life of only 13 hours, so it would only have to be discontinued 39 hours before surgery under these guidelines. (Table 3 in the article lists common GLP-1 drugs' half-lives and withhold times.)

New Research Supports Continuing GLP-1 Meds Before Surgery

Stanford researchers suggest that a less conservative approach might be appropriate for both type 2 diabetes and obesity patients. They found that, despite the fact that some GLP-1 patients have solid contents in their stomach while under full anesthesia, these patients do just as well as those not taking the GLP-1 medications.

The Stanford study, published as a research letter in JAMA, states that the rates of postoperative respiratory complications for GLP-1 users vs. non-users were similar (3.5% for those taking one of the drugs and 4% for those who had not been prescribed the drugs). The authors argue that patients may not need to go off the medications before surgery. Caveat: The authors note that their findings "do not apply to patients using GLP-1 receptor agonists under light or moderate sedation without an anesthesiologist or other advanced airway practitioner."

Pre-Surgery Fasting

Regardless of medication decisions, all of the experts recommend similar pre-procedure fasting instructions, such as fasting for 8-12 hours. AGA also recommends that patients taking GLP-1 drugs limit their diet to clear liquids the day before their procedure.

References:

American Society of Anesthesiologists Multi-Society Guidance Press Release:
https://www.asahq.org/about-asa/newsroom/news-releases/2024/10/new-multi-society-glp-1-guidance

ASA (American Society of Anesthesiologists) Press Release: https://www.asahq.org/about-asa/newsroom/news-releases/2023/06/american-society-of-anesthesiologists-consensus-based-guidance-on-preoperative

Aspiration Risks of Ozempic: https://www.peoplespharmacy.com/articles/if-you-need-surgery-while-on-ozempic-or-wegovy-be-very-careful

AGA (American Gastroenterological Association) Press Release https://gastro.org/press-releases/continue-glp1-drugs-before-endoscopy/

David A. Milder, Tamara Y. Milder, Sophie S. Liang, Peter C.A. Kam . Glucagon-like peptide-1 receptor agonists: a narrative review of clinical pharmacology and implications for peri-operative practice, Anaesthesia, May 2024. 10.1111/anae.16306
(a U.K. publication, authors of the study are from Australia)
https://associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/full/10.1111/anae.16306

Stanford Press Release: https://fsi.stanford.edu/news/some-good-news-diabetics-facing-surgery-while-taking-ozempic

JAMA article: Dixit AA, Bateman BT, Hawn MT, Odden MC, Sun EC. Preoperative GLP-1 Receptor Agonist Use and Risk of Postoperative Respiratory Complications. JAMA. 2024;331(19):1672–1673. doi:10.1001/jama.2024.5003
https://jamanetwork.com/journals/jama/article-abstract/2817853?guestAccessKey=0234613c-2e74-444c-ac25-4f9e82f9b24b

Did you know that National Prescription Drug Takeback Day was last Saturday, April 27? If you missed it, you don’t have to wait another year: it’s not too late to dispose of your unwanted/expired drugs. To help protect our waterways and drinking water, avoid flushing* your meds down the sink or toilet unless the patient label instructs you to do so. Here are three better options:

1. More than 16,500 pharmacies, hospitals, and businesses, and even some police departments have year-round drop boxes where you can dispose of your unused prescription (including opioids like oxycodone) and over-the-counter meds. Find a year-round drop-off location here:
   https://apps.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e1s1

2. If the drug is NOT a controlled drug (like an opioid), is unopened (still sealed), does not require refrigeration, and has at least 5 months left before it expires, consider donating it to an organization like Sirum that will send the drug to a community pharmacy or clinic that will dispense the medication free to someone who can’t afford it. Think about that drug you paid a hefty $50 or $100 or more co-pay for – but no longer take and doesn’t expire for almost another year. While pharmacies and nursing facilities can sign up for the service and provide meds in bulk, individuals can also donate by filling out a form. Donors are asked to pay $10 for the prepaid shipping packages which Sirum will send you to use to mail your medications.
   https://sirum.org/individuals/

3. You may also dispose of unwanted meds in the regular trash by following these FDA-recommended steps: Remove the pills, tablets, capsules (do not crush), or liquids from the container and mix it with an “undesirable” substance like used coffee grounds or kitty litter. Place the mixture in a sealable bag, empty can, or other container to prevent the drug from leaking out of the garbage bag. Before throwing out your empty medicine containers and bottles, remove or scratch out identifying information from the labeling.  
   https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know

*Note:  to keep everyone in your home safe from accidental or intentional ingestion, the FDA recommends flushing drugs that contain opioids, which include any drug that contains the word buprenorphine, hydrocodone, meperidine, methadone, oxycodone, and tapentadol. Non-opioids recommended to flush include sodium oxybate and others. While this recommendation is questioned by some environmental groups, the FDA says the risk of harm outweighs potential risk to the environment.

If you wear contact lenses (even the disposable kind), please make sure that you DO NOT flush them down the toilet or down the sink, as they also will pollute waterways and endanger aquatic life. Simply throw them into the trash instead.
https://www.mentalfloss.com/article/555129/why-you-should-never-flush-your-contacts-down-drain

For some Earth Day thoughts on pharmaceuticals and the environment, check out this post by "Beyond Bio” author.

Beyond Bio

Side Effects May Include...

Somewhere downstream of Amsterdam, trouble was brewing in the water. The cocaine from last night’s party was kicking in. They were young, they were high, and about to make decisions that they would regret for the rest of their lives… They also happened to be…

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2 years ago · 1 like · R. Wulf

Acupuncture is a form of Eastern Medicine that involves stimulating the nervous system using small hairlike needles, heat, or pressure.

It is one of the oldest continuing forms of medicine and is estimated to be at least 2,000 years old. Mostly practiced in Asian countries, there are surviving documents from as early as the thirteenth century mapping acupuncture points on the human body. More recent evidence shows that acupuncture may be older than we could ever have imagined. A 5,300 year old mummified early human discovered in the Italian Alps, nicknamed Otzi the Iceman by archaeologists, was found to have intact tattoo marks along key acupuncture channels (constellations of acupuncture points). This suggests that acupuncture may have been used as early as the Copper Ice Age, more than doubling its timeline.

In western cultures, acupuncture was once believed to be a placebo treatment laced with superstition, but the treatments are now becoming accepted worldwide. In fact, today the World Health Organization recognizes acupuncture as an effective treatment for 31 common disorders from pain relief to turning a breech baby.

A Visit to a Modern-day Acupuncture Office

It was a cold cloudy day in late December as I was walking through a busy crosswalk towards a nondescript office building in Arlington, Virginia. I was here to meet Rebecca Reynolds, a licensed acupuncturist and nurse practitioner just a few miles outside of Washington D.C. The reception area inside could have passed for any doctor’s clinic, but something told me a visit with Becky, as her friends call her, would be anything but ordinary. On her plain wooden door is an image of a cute wooly mammoth with a spear sticking out of his rear end.  A thought bubble coming out of his head says: “That’s odd, my neck suddenly feels better…” The caption below reads: “Early Acupuncture.”

Inside the small office is a paper-covered patient table not unlike what’s equipped for a regular physical. In the corner is an iPod hooked up to a speaker – “For playing music to get patients into a relaxed state,” she tells me. Around the office are some cups and boxes with what I can only guess is acupuncture equipment. The light clutter gives it a homier feel, kind of like an art studio. I glance upward and I see that the standard-issue ceiling light has been covered with a translucent blue and white gel pane.  To someone lying on the table, it would look like the office ceiling opened up to a blue sky.

Every acupuncturist is a little different. In fact, there are several schools of thought when it comes to acupuncture technique. All incorporate traditional Asian philosophies such as the idea of 8 Principles (Yin/Yang, Heat/cold, Excess/Deficiency , Interior/exterior) or the Five Elements (Fire/Earth/Metal/Water/Wood), while in addition to traditional approaches other newer techniques may be taught such as electro-stimulation or neuro-acupuncture. “I use the Becky Method”, Reynolds tells me with a wink. “I do a little of everything. I work with whatever works best for the situation.”

Having worked for years in the Office of Medical Services in the US State Department  as a Foreign Service Medical Provider to US diplomats overseas, Reynolds first discovered the true potential of acupuncture when based at a hospital in Sri Lanka in the 1980’s.

Reynolds recalls a particular case of a patient who had fallen from a tree, fracturing the head of his humerus (the large bone in the upper arm). As was the custom, the patient immediately received acupuncture treatments in tandem with western treatments provided at this Sri Lankan Clinic. “It was miraculous,” said Reynolds. “We took him in for x-rays, and three days later, the fracture looked just as if it were several weeks in healing.” Somehow, the acupuncture treatments stimulated his bones to recalcify the fracture at a rapid pace.

 “That’s one of the things I [treat with acupuncture],” Reynolds added. “Helping people who are having surgery, pre- and post-operatively so they will have a better surgical outcome and a less complicated recovery with less bruising, etc.”

How it Works

While there are 360 classical acupuncture points, there are many other extra points that can be used, some in  places you wouldn’t expect. On the ear alone, there are 120 points. According to the Cleveland Clinic, ears have very sensitive connections to the rest of the nervous system, which makes them ideal target points for acupuncture.

Reynolds uses “ear seeds” on of some her patients. Ear seeds are small stickers with a cow basil seed in the center, other types of materials can be used for ear seed like silver, gold, stainless steel. When placed on an ear point, it applies a light pressure. Patients can wear the ear seeds for up to a few days to help extend the treatment of appetite control or pain control. For people who don’t like the feel or look of the cow basil seeds, Reynolds has a supply of gold plated ear seeds with small decorative rhinestones on the outer side; it gives the look of tiny diamond in the ear. 

The practice of acupuncture focuses on the flow of energy, or “Qi,” and blood throughout the body. According to traditional Asian belief systems, illness and/or physical pain stems from an imbalance in the energy, Qi throughout the body. Acupuncture is a way of getting energy /Qi where it is needed, or draining it from places where it exists in excess.  

What may be surprising is that the scientific findings for the workings of acupuncture may not be so different.

Acupuncture points align with points on the body where nerve cells are particularly reachable. Nerve cells are the direct communication points to the brain. These cells are responsible for your sense of pain and other sensations such as temperature, texture, and even for your body’s fight or flight response during times of stress. How do these cells communicate with the brain? Through a chain network of electrical signaling from nerve cell to nerve cell. An electrical path that could be described as “energy” not unlike the idea of Qi.  These pathways can be tricked by stimulating other nerve cells, interfering with current active pathways in the case of pain, or connecting new pathways.

Studies by the Harvard Medical School have discovered certain subsets of nerves located at traditional acupuncture points. These nerves can signal the body to perform certain tasks such as releasing anti-inflammatory chemicals called cytokines. Other acupuncture points trigger the release of dopamine (the “happy” hormone responsible for relieving stress)

Placebo Effect or Not?

Whenever we’re dealing with treatment that focuses on the brain, not the pain, it’s easy to wonder if acupuncture is a very convincing form of the placebo effect. But evidence shows that acupuncture interacts with the whole nervous system, not just the brain.

To illustrate this, Reynolds showed me a video of Tilly, a pug receiving acupuncture treatments after being paralyzed in a car accident. The amazing thing is that the acupuncture treatments were actually reopening nerve pathways that had been blocked, eventually helping her to regain control of her legs.

There are several other theories about why acupuncture is so effective. Some evidence suggests that acupuncture aids in stimulating blood circulation, which could alter concentrations of cholesterol and triglycerides in certain areas of the body. Other studies have focused on how acupuncture can stimulate the production of natural painkillers, create more efficient electrochemical pathways, and interfere with pain signal pathways.  Perhaps it is a combination of several of these reasons. When it comes to acupuncture, there’s still a lot to learn.

Q & A

Here’s an adapted interview with Reynolds for those considering acupuncture treatment:

Q: What’s the most important thing to remember about acupuncture?

A: Acupuncture is not a “pill.” It is not a quick fix: to know if acupuncture is going to help you and your problems you should plan of getting a number of treatments consistently, much like physical therapy. With modern medicine, 1+1 always equals 2. In acupuncture, 1+1 can equal 2, or it can equal 5, or 10, but if it doesn’t help in 10-12 treatments then another type of therapy is needed.

Q: Can my insurance cover acupuncture?

A: Many insurance plans do cover the cost of acupuncture for pain treatment. Check with your insurance provider about facilities that will work with your plan. Other acupuncture offices may deal only in direct payments from clients, but all patients should ask for  a receipt with a procedure codes (CPTs) and diagnostic codes (ICDs) so that it can be submitted for reimbursement to the patient’s insurance company or used for tax purposes. Also, flexible health saving programs reimburse at 100%; these flexible saving accounts always want a receipt as well.

Q: How much does acupuncture cost?

A: It depends on the practice, and your location. Reynolds charges $140-$170 for initial treatments and $95-$125 for follow-up treatments without insurance. Other acupuncturists may charge more. Community or group acupuncture costs less but you are in a room with number of other people, sometimes 8 or more patients. 

Q: How long do the effects of acupuncture last?

A: That depends on a number of factors related to your specific body and pain severity. For some, one pain treatment may completely resolve the pain. But for others it may take up to 1-4 weeks. Please keep in mind that many folks come in for treatment of issues other than pain, including anxiety, allergies and so on. For folks with chronic conditions, they will come in for a balancing maintenance treatment that might be every 2 weeks to 2-4 months according to how they are feeling. For example, someone with seasonal affective disorder will need to be seen more in the fall and winter.

Q: Are there any side effects of having acupuncture?

A: Almost none; on rare occasions you may get a small bruise. You may feel more relaxed. I advise my patients to drink plenty of water after a treatment and not to overschedule themselves. After your first treatment it’s also not unusual to have a softer stool. One unexpected side effect is patients may see an increase in fertility levels after undergoing regular acupuncture treatments. I had a patient being treated for anxiety. She and her husband had been unable to conceive for years. It turned out the anxiety was the block, and once we dealt with that, she had a healthy baby boy. For that reason, I also encourage my patients to use birth control if pregnancy is not desired.

Q: Does acupuncture hurt?

A: No. When done properly, it should not hurt. Acupuncture needles are much smaller than vaccination needles, only about a hair’s width. The needle is sometimes felt going in; after the needle is applied you shouldn’t be able to feel it. Some people might have a sensation of heaviness or pulsing at times.

Q: I am terrified of needles, are there other ways to experience the benefits of acupuncture?

A: Acupressure is similar in theory but does not actually puncture the skin.  Many people use both in tandem. Cupping is another alternative medicine that uses suction pressure over acupuncture points. If you’re unsure about acupuncture, acupressure or cupping might be a way to dip your toes in the water.

Q: Can I just google the acupuncture points and do acupuncture on myself?

A: Acupuncture is a very precise form of medicine, and acupuncturists must go through extensive training in order to be licensed to practice. (It’s just like becoming a doctor or a nurse in that way). Do not try it at home.

Q: Can acupuncture points be used to decrease numbness?

A: Yes. It can be used to reduce neuropathy.

Q: Do you specialize in treating certain parts of the body or certain ailments?

A: I’ve treated patients with a variety of different ailments. I’ve had patients come in for chronic pain relief, pre- and post-surgical procedures, sinus infections, fertility treatments, turning breech babies, and mental health conditions like anxiety and depression to name a few. I’ve treated kids, adults, and senior citizens. Even given two patients with the same ailment, each treatment is unique because each person is unique. But acupuncturists do specialize, some work with fertility or pain. 

Q: What exactly goes into ‘The Becky Method’ of acupuncture?

A: The “Becky Method” is actually a combination of Traditional Chinese Medicine (TCM) as well as Five Element (5-E), Japanese, Meridian, Tan, and Neuro-Acupuncture techniques, plus a holistic approach to the patient’s needs and concerns. “A treatment might include Dry Needling (a method of needling used by some physical therapist), Sotai, Gua Sha, cupping, moxibustion, electro-stimulation or traditional acupuncture; every treatment is unique and individualized for each patient and his/her presenting conditions.”

About

Rebecca Reynolds has practiced acupuncture in the Washington D.C. area since 2015. She graduated from the Middle Way Acupuncture Institute in Mt. Vernon, Washington and served on the executive board of the Virginia Acupuncture Society 2015-2017. She holds 2 master’s degrees, one in nursing and the other in acupuncture, and spent over thirty years working as a health care provider domestically and overseas.  She is a Master Senior Fitness Instructor and teaches senior stretching at Ft Meyer with other volunteer fitness instructors. For more information, visit her website: www.a-a-acupuncture.com

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Learn more about topics mentioned in this article:

https://www.who.int/publications/i/item/978-92-4-001688-0

https://hms.harvard.edu/news/exploring-science-acupuncture

https://www.hopkinsmedicine.org/health/wellness-and-prevention/acupuncture

https://www.smithsonianmag.com/smart-news/what-otzi-icemans-tattoos-reveal-about-copper-age-medical-practices-180970244/

https://health.clevelandclinic.org/ear-seeds