May 28, 2023: Five new drug approvals; FDA flags ADHD drugs with safety updates; Antibiotics research; Pancreatic cancer study; Brain-Computer technology; Allergy drug side effect
Drug Approvals
The U.S. Food and Drug Administration (FDA) approved Pfizer's Paxlovid (co-packaged nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19. Examples of high risk adults are patients over 65, those who are immunocompromised, those with cancer, asthma, diabetes or heart disease. Since April 2022, Paxlovid has been available under Emergency Use Authorization.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults
On Ask a Patient, the most commonly reported side effects of Paxlovid include metallic taste, dizziness, and headache (click to read related reviews).
Pfizer lists 38 drugs that should NOT be taken with Paxlovid because of serious or life-threatening interactions: https://www.paxlovid.com/#significant-drug-2
The FDA expanded its approval of AbbVie's once-a-day Rinvoq (upadacitinib) to include treatment for adults with moderate to severe Crohn’s disease who have had an inadequate response to tumor necrosis factor (TNF) blockers. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhea and abdominal pain. Rinvoq was originally approved in August 2019 to treat moderate to severe rheumatoid arthritis in patients who have have an inadequate response or intolerance to one or more TNF blockers. It is also approved for six other inflammation-related conditions, including eczema.
The drug has a boxed warning for risk of serious infections, malignancies, cardiovascular events, and mortality. The most common side effects are upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache.
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-treatment-moderately-severely-active-crohns-disease
In addition, Rinvoq's label was updated to incude clinical trials results, new warnings, precautions and adverse reactions:
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2285
Check out patient reviews of Rinvoq.
The FDA approved Bausch & Lomb's Miebo eye drops to treat dry eye disease. The company says it is the first and only FDA-approved DED treatment that targets tear evaporation. Drops are to be used four times daily.
https://www.optometrytimes.com/view/fda-approved-bausch-lomb-novaliq-candidate-nov03-for-signs-and-symptoms-of-dry-eye-disease
The FDA approved Krystal Biotech's Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy for the treatment of a rare skin disease called dystrophic epidermolysis bullosa (DEB), also known as "butterfly disease." Patients with the disease are often called “butterfly children” because their skin is as fragile as a butterfly’s wings. The skin rips and blisters easily, leading to open wounds that are prone to skin infections and fibrosis. About 9,000 to 10,000 people worldwide suffer from DEB, including about 3,000 in the U.S. The gel medication, approved for age 6 months and up, provides the patient’s skin cells an intact and healthy copy of the faulty gene causing the disorder, COL7A1, thereby helping the wounds to heal. The herpes virus is used because of its natural ability to evade the immune system. However, it does not infect patients with herpes virus, as the virus is engineered to eliminate its ability to replicate in normal cells.
https://medcitynews.com/2023/05/fda-approval-skin-disorder-rare-disease-gene-therapy/
The FDA approved Xacduro (sulbactam and durlobactam injection) to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by the bacteria Acinetobacter baumannii-calcoaceticus complex. The most common adverse reaction with Xacduro was liver function test abnormalities. Other potential side effects are hypersensitivity reactions and Clostridioides, difficile-associated diarrhea. (See related story below on use of A.I. to find new antibiotic treatments to combat Acinetobacter.)
https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria
Drug Safety Announcements
The FDA released a drug safety communication to bring attention to the problem of patients sharing their ADHD drugs, the misuse of prescription stimulants, and the addictive potential of the drugs that can lead to overdose and death. The FDA is requiring updates to Boxed Warnings on the labels across the entire class of these medicines, which include drugs containing amphetamine (Adderall, Adderall XR) and methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR), and other stimulants like Vyvanse, Dexedrine, Desoxyn, and Focalin.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updating-warnings-improve-safe-use-prescription-stimulants-used-treat-adhd-and-other-conditions
PDF of Revised Label Changes
The FDA updated the drug safety label for asthma (age 5 and up) and COPD drug Breo Ellipta (fluticasone furoate) to add more information about the risk of stunted growth in children and teens, along with several other changes to its label. The revised label instructs health care providers to monitor the growth of pediatric patients receiving BREO ELLIPTA routinely and to titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms. https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=63#
Read patient experiences with Breo Ellipta.
Antibiotics Research
Researchers at McMaster University and Massachusetts Institute of Technology tested a new artificial intelligence (AI) method for finding drug candidates that would work against the most problematic species of bacteria - Acinetobacter baumannii. To find a new antibiotic, researchers took thousands of known drugs and manually tested them on Acinetobacter baumannii to see which could slow it down or kill it. This information was fed into the AI so it could learn the chemical features of drugs that could attack the problematic bacterium. The AI was then unleashed on a list of 6,680 compounds whose effectiveness was unknown. The AI produced a "shortlist" of about 240 drugs, which were then tested in the lab. Out of nine potential drugs, the most promising is an antibiotic called abaucin. The study was published in Nature Chemical Biology.
https://news.mit.edu/2023/using-ai-scientists-combat-drug-resistant-infections-0525
Cancer Research
Pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer, has a mortality rate of 88 percent and is the third leading cause of death from cancer in the U.S. Memorial Sloan Kettering Cancer Center researchers treated pancreatic cancer patients with mRNA vaccines tailored to each person’s specific cancer. Half of pancreatic cancer patients who received a personalized mRNA cancer vaccine after surgery did not have a recurrence of the tumor a year and a half later. The study involved 16 patients and was published in Nature.
https://www.technologynetworks.com/biopharma/news/personalized-mrna-vaccine-could-be-used-to-treat-pancreatic-cancer-373937
Brain-Computer Interface (BCI) Advances
Scientists continue to fine tune their brain-computer interface (BCI) technology, bringing potential solutions for those with paralysis closer to reality. Here are some recent examples:
Twelve years ago, a cycling accident left 28-year old Gert-Jan Oskam with paralyzed legs and partially paralyzed arms, after his spinal cord was damaged in his neck. Now 40, Oskam is back on his feet and walking, thanks to a device called a "brain-spine interface," that creates a ‘digital bridge’ between his brain and the nerves below his injury. When Oskam thinks about walking, the skull implants' signal is wirelessly transmitted and decoded by a computer that Oskam wears in a backpack, which then transmits the information to the spinal pulse generator. The technology was developed at the Swiss Federal Institute of Technology in Lausanne by Grégoire Courtine and colleagues.
https://www.nature.com/articles/d41586-023-01728-0
Check this article in Techspot for a video clip of Oskam walking using the technology.
Neuralink, Elon Musks’ high profile company in the emerging BCI industry, announced that it has received FDA approval to move forward with a human clinical trial for its own brain-computer system called "Link." Founded in 2016, Neuralink aims to commercialize BCIs in wide-ranging medical and therapeutic applications — from stroke and spinal cord injury (SCI) rehabilitation, to neural prosthetic controls, to the capacity "to rewind memories or download them into robots," said Musk in 2020.
https://www.engadget.com/neuralink-receives-fda-clearance-to-begin-human-trials-of-its-brain-computer-interface-001504243.html
Watch this 3.5 minute video of a link-implanted macaque playing Pong with a joystick and also by just by using his mind. Experiments on monkeys led to accusations from the non-profit organization Physicians Committee for Responsible Medicine (PCRM) of animal abuse. U.S. lawmakers are now urging regulators to investigate how Neuralink oversees animal testing and whether the make-up of a panel overseeing these tests contributed to botched and rushed experiments.
Paradromics, another BCI company, is a step ahead of Neuralink, having already received Breakthrough Device designation from the FDA for its Connexus Direct Data Interface. This designation gives them special access and advice from the FDA, helping them along the pathway to device approval. Pandromic's device requires invasive brain surgery, but CEO Matt Angle said the quality of the neural signals it can measure will allow patients to communicate at a faster and more natural rate than they could with a less invasive BCI, like the one being developed by Paradromics competitor Synchron, yet another company in the industry – this one is backed by Amazon owner Jeff Bezos and Microsoft founder Bill Gates.
https://www.cnbc.com/2023/05/18/brain-implant-company-paradromics-one-step-closer-to-fda-approval.html
Pharmacist Tip: Stopping Allergy Drugs After Long-Term Use May Cause Itching
After hearing from many readers about their experiences with unbearable itching when they stopped taking antihistamines like cetirizine, The People's Pharmacy's Joe and Terry Graedon contacted the FDA multiple times and urged them to investigate. Eventually, the agency ackowledged the reaction of “withdrawal itching” (pruritus) with both cetirizine (Zyrtec) and levocetirizine (Xyzal) in the journal Therapeutic Advances in Drug Safety (July 5, 2019). The Graedons argue that the drug labels should require some mention of the potential adverse reaction after stopping either cetirizine or levocetirizine, but so far, no such warning is provided.
https://www.peoplespharmacy.com/articles/unbearable-itching-after-stopping-antihistamines-like-xyzal-or-zyrtec
Ask a Patient website has also received multiple reports of patients experiencing withdrawal itching. Here are examples of patients reporting extreme itching after stopping Zyrtec (cetirizine):
https://www.askapatient.com/viewrating.asp?drug=19835&name=ZYRTEC&SideEffect=itching
Visit us at AskaPatient.com for drug ratings and reviews provided by patients along with more news and health information. Note to readers: Ask a Patient® Health News (regular edition) will be sent on Tuesday, May 30. If you are not already subscribed to this separate newsletter, sign up today.