February 2025 Part 3 Drug Safety News: Geodon; Paxlovid; Ozempic shortage ends; blood thinners and A-Fib; drug-induced high blood pressure; REMS news; podcast recommendation
Adcetris (brentuximab vedotin) for intravenous infusion
Adcetris treats adults and children with various types of lymphoma, a type of blood cancer. New clinical trials results were added to the label supporting its recent approval to treat Relapsed or Refractory Large B-Cell Lymphoma in conjunction with other drugs. Also, new clinical trials data about the risk of peripheral neuropathy was added to the Warnings and Precautions section. Peripheral neuropathy is a nerve condition characterized by numbness, tingling, or burning in extremities like the hands, fingers, and feet. Also, clinical trials data for geriatric use was added. Peripheral neuropathy is a common adverse reaction, and a table provides dosage modifications to be made until the condition improves. Adcetris was approved in 2011.
Adcetris FDA Safety Label Change
“FDA Approves Adcetris With Revlimid and Rituxan For R/R LBCL" - Cure Today website
Dayvigo (lemborexant) tablets
Insomnia treatment Dayvigo (lemborexant) label updates information for its pregnancy registry for women who are exposed to Dayvigo during pregnancy or who become pregnant while taking Dayvigo, including a new phone number and website. Dayvigo was approved in 2019.
Dayvigo FDA Safety Label Change
Dayvigo Patient Reviews - AskaPatient website
Geodon (ziprasidone) capsules or intramuscular injection
Geodon treats schizophrenia and bipolar 1 disorder in adults. The label section describing the risk of hyperprolactinemia (elevated prolactin levels) was expanded to include information about the association between hyperprolactinemia and breast cancer, adding that "published studies have shown inconsistent results when exploring the potential association between hyperprolactinemia and breast cancer." Although the FDA required that most antipsychotic drugs include the information about risk of hyperprolactinemia and breast cancer, studies show that Ziprasidone has a low propensity for prolactin elevation.
Sleep walking (or somnambulism) was added as adverse reaction in the postmarketing experience section.
A new warning section was added on the risk of serotonin syndrome, which is a potentially life-threatening condition. The risk is increased with the concomitant use of other drugs, such as MAOIs (linezolid), SSRIs, SNRIs, triptans, amphetamines, St. John's Wort and more. Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). See revised label for complete details. Geodon was approved in 2001.
Geodon FDA Safety Label Change
Geodon Patient Reviews - AskaPatient website
Paxlovid (nirmatrelvir; ritonavir) copackaged pills
Paxlovid treats mild-to-moderate cases of COVID-19 in adults who are at high risk for progression to severe COVID-19. The label was updated to provide clinical trial results for non-hospitalized patients with severe kidney disease. Lower, less frequent dose recommendations are provided for patients with moderate or severe kidney disease, as kidney impairment may increase nirmatrelvir exposure and lead to Paxlovid adverse reactions. Dialysis patients are advised to take their doses after undergoing dialysis.
Also, a new contraindicated drug is prostate cancer medication enzalutamide (Xtandi brand name). Paxlovid should not be used even after immediately stopping enzalutamide. Also, dosage instructions for all patients were modified to clarify that the doses should be taken at about the same time each day. Paxlovid was approved in 2023.
Paxlovid FDA Safety Label Change
Paxlovid has a long list of drugs that are contraindicated or may cause dangerous drug interactions. The list is available on the Paxlovid Drug Label, Table 2.
Paxlovid Patient Reviews - AskaPatient website
In other Paxlovid news, a recent study found that Paxlovid is less effective in older patients who have been vaccinated. Paxlovid did NOT significantly reduce hospitalizations in these patients. The findings were published as a research letter in JAMA.
"No large benefit from Paxlovid among COVID-vaccinated older adults" - Healio
More FDA News
Ozempic and Wegovy (semaglutide) no longer in shortage
On February 21, the FDA removed all versions of semaglutide injections (Novo Nordisk’s Wegovy and Ozempic) from the national drug shortage list. Semaglutide had officially been in shortage from 08/23/2022 to 02/21/2025. Compounding companies that provided much cheaper copies of the drug during the shortage will no longer be able to legally sell them. The compounders have been given a grace period of either 60 or 90 days to stop production, just as they were when the products tirzepatide (Eli Lilly's Mounjaro and Zepbound) were removed from the shortage list in December 2024. Wired explains how the GLP-1 industry is about to undergo massive changes.
The Ozempic Shortage is Over - Wired
Ozempic Patient Reviews - AskaPatient website
New Drug Approved for TGCT
Deciphera Pharmaceuticals ' Romvimza (vimsetinib) capsules were approved for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for whom surgery as a treatment is not advised. TGCT is a rare, benign tumor that can develop in joints anywhere in the body. They most commonly occur in the fingers, thumbs, ankles or feet, knees, wrists, or elbows, and are more common in females and adults age 30 to 50. Romvimza was granted expedited approval and has several postmarketing studies requirements, including completion of an ongoing 104-week rat carcinogenicity study.
FDA Press Release
Read more about TGCT at Cleveland Clinic
FDA REMS (Risk Evaluation and Mitigation Strategy) Update
REMS (Risk Evaluation and Mitigation Strategy) is a drug safety program that the U.S. Food and Drug Administration (FDA) requires for certain medicines with serious safety concerns, such as drugs that may cause birth defects or pose extreme risk to a patient if not taken strictly according to instructions. Often this involves training for the healthcare provider so that the patient will receive specific counseling about the drug. There are 71 active REMS programs, but many of the programs cover multiple drugs. For example, the opioid analgesics category covers over 300 individual drugs.
An FDA public dashboard for REMS is searchable, but the documents for the safety programs are still not available at the FDA site. At Ask a Patient website, you can find links to the actual documents from our list of active REMS (drug safety programs) that link to non-FDA sites when possible. Opioid analgesics, Prolia for osteoporosis, cystic acne drugs (isotretinoin), antipsychotics Zyprexa Relprevv and clozapine, narcolepsy drugs Xyrem and Xywav, and Spravato (esketimine) and many more are on the list.
Links to FDA REMS documents (at Ask a Patient website)
Examples of REMS:
Opioid Analgesics REMS
Zyprexa Relprevv
Drugs Causing High Blood Pressure
Did you know that certain types of antidepressants can cause high blood pressure? A new MedShadow article describes how Kyle, a woman taking the antidepressant Effexor, developed and dealt with this surprising side effect. Kyle was prescribed venlafaxine, an SNRI-type of antidepressant (Effexor brand name) to help ease her uncomfortable menopause symptoms. She started on a 75 mg dose, then increased it to 150 mg a day. After about a year, she experienced a scary hypertensive crisis that required a trip to the emergency room. Read the full story, with information about the types of antidepressants that may cause high blood pressure or orthostatic hypotension.
”Effexor’s Link To Dangerous Spikes In Blood Pressure” - MedShadow.org
Effexor XR (venlafaxine) Patient Ratings and Reviews - more than 100 have reported experiencing high blood pressure or hypertesion with venlafaxine at AskaPatient website.
The People's Pharmacy's Joe Graedon provides information about common drugs that might cause high blood pressure, including NSAIDS, prednisone, and more.
”Everyday Medications That Raise Blood Pressure: NSAIDs or Acetaminophen?” - People’s Pharmacy website
Blood Thinners and A-Fib Research
A University of Bath study suggests that older people with atrial fibrillation (AF) can inadvertently be put at risk by not taking blood thinners (anticoagulants) such as apixaban. Many doctors don't like to prescribe these drugs in patients over the age of 65 because of the risk of bleeding. However, the new study found that contrary to popular medical belief, stopping anticoagulants for patients age 75 and over does not change the risk of major bleeds, and triples the risk of stroke and heart attacks. The authors state that the study is believed to be the first to measure patient outcomes when anticoagulant medication is stopped. The study was published in the journal Heart.
University of Bath Press Announcement
Patient Reviews of Apixaban (Eliquis) by patients age 65 and up.
Podcast Recommendation: Understanding Mom-and-Pop Pharmacies’ Struggles
Dave Dayen and Matt Stoller’s "Organized Money" podcast series looks at the phenomenon of U.S. monopolies that have emerged in different industries. This episode, “The Revolt of the Pharmacist,” focuses on the challenges faced by independent pharmacies. Many pharmacies have found it impossible to stay in business because of the three pharmacy benefit managers that control most of the drug transactions in the U.S. If you don't understand what pharmacy benefit managers (PBMs) do, this episode provides some insight.
"What would you do if you owned an independent pharmacy and you discovered that the only way to actually make money would be to stop filling most of the prescriptions that came in? This is what our guest Benjamin Jolley sees every day. As a third-generation independent pharmacist in Salt Lake City, Utah, he’s watched as a small handful of middlemen have taken control over a giant amount of pharmaceutical transactions. Listen to his story. How did we get here?"
Thank you for reading this edition of Ask a Patient Health News: Drugs and Treatments Safety Updates. Did you miss the last two editions? Check them out here:
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