Drug Safety Updates: April 2024 Part 2 Labeling changes for Entresto, Dupixent, CAR-T therapies; Dangers of “Gas Station Heroin”(tianeptine supplements); counterfeit Botox and Ozempic
Drug Safety Label Changes: Entresto and Dupixent
Heart failure drug Entresto (sacubitril; valsartan) had a safety label update to include results of geriatric and pediatric trials.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1374
Eczema drug Dupixent (dupilumab) had a safety label update to include clinical trials results, including pediatric clinical trial results. The drug is approved for patients over the age of one.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1709
FDA Safety Communication on CAR-T Immunotherapy
The FDA announced that after investigating reports that CAR-T immunotherapy, a type of cell-based gene therapy, may cause secondary cancers, including lymphoma, the FDA found that the risk warranted changes to the drug labels. CAR-T therapies include Abecma (idecabtagene vicleucel), Breyanzi (lisocabtagene maraleucel) Carvykti (ciltacabtagene autoleucel) Kymriah (tisagenlecleucel) Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel). These treatments, all approved within the last six years, treat various blood cancers.
In January, FDA notified companies of changes to the boxed warning and required related updates to other sections of the label. Patients and clinical trial participants receiving treatment with these products should be monitored life-long for secondary malignancies.
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-boxed-warning-t-cell-malignancies-following-treatment-bcma-directed-or-cd19-directed
“Gas Station Heroin” Product Warning and Recall
Despite a voluntary recall initiated in January 2024, the FDA continues to receive adverse event reports related to Neptune‘s Fix products, including interactions with other medications, seizures, loss of consciousness and death. In January, the FDA sent a letter to convenience stores, gas stations and other organizations urging retailers to stop selling Neptune’s Fix and any other tianeptine-containing products.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/neptune-resources-llc-issues-voluntary-nationwide-recall-neptunes-fix
According to a CDC report, Neptune’s Fix was the most commonly used product among tianeptine exposures reported to the New Jersey Poison Control Center during the second half of 2023, with twenty cases of tianeptine ingestion associated with severe clinical effects during June–November 2023, representing a sharp increase from the poison center’s baseline of two or fewer exposure calls per year. Reported complications related to unregulated tianeptine products included low blood pressure, seizure and heart rhythm irregularities such as tachycardia, according to the report. At least one person went into cardiac arrest.
Tianeptine, classified as an atypical tricyclic antidepressant, is prescribed in Europe, Asia and Latin America to treat major depressive disorder or anxiety or irritable bowel disease, but it is not approved in the U.S. Some countries have restricted how tianeptine is prescribed or dispensed, or revised the drug label to warn of possible addiction. It produces a euphoric high and carries a significant risk of overdose. Furthermore, its short half-life can lead to rapid withdrawal, increasing its potential for addiction and misuse.
In the U.S., tianeptine-containing products are often sold as health supplements in convenience stores and gas stations, hence the name "gas station heroin." Products may also be branded as “Zaza” and “Tianna Red.” Some people have turned to tianeptine as an opioid alternative, or to self-treat anxiety or depression. Medical journals and reports to the FDA suggest that adverse events may occur when tianeptine is taken at doses higher than the doses prescribed in the countries where the drug has been approved.
https://www.cdc.gov/mmwr/volumes/73/wr/mm7304a5.htm
In New Jersey, a 48-year old Atlantic county man is suing the maker of Neptune’s Fix elixir, claiming that after consuming the product, he lost consciousness and suffered organ damage, and that he was hospitalized for two weeks.
https://www.nj.com/atlantic/2024/04/neptunes-fix-drink-sold-at-nj-shop-gave-me-seizures-organ-failure-man-says-in-suit.html
Super Chill, another distributor of Neptune’s products, is also initiating a recall. Product images and more information here:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-neptunes-fix-or-any-tianeptine-product-due-serious-risks
Counterfeit Botox Warning
The Centers for Disease Control and Prevention (CDC) is investigating a multi-state outbreak of a botulism-like illness related to counterfeit Botox (botulinum toxin) injections. As of April 18, 2024, a total of 22 people ranging in age from 25 to 59 (all female) from 11 states have reported harmful reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas. 20 of the 22 report receiving the injections for cosmetic purposes. Nine people have been hospitalized. States reporting these reactions include California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, Texas, and Washington.
Symptoms of the illness include blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness and difficulty lifting one’s head following injection of the product. The CDC explains that an antitoxin is the most common way to treat botulism.
https://www.cdc.gov/botulism/outbreaks/harmful-reactions-botox-injections.html
The FDA has images of the counterfeit products, including boxes and vials. This wll help the user determine that the product is from Allergan/AbbVie, the maker of Botox.
https://www.fda.gov/drugs/drug-safety-and-availability/counterfeit-version-botox-found-multiple-states
Counterfeit Ozempic Warning
BrandShield, a reputation monitoring site for various industries, works with the Pharmaceutical Security Institute (PSI) to protect pharmaceutical brands. BrandShield told Reuters that last year, they took down more than 250 websites selling fake versions of popular weight-loss and diabetes drugs in the GLP-1 class.
https://www.reuters.com/business/healthcare-pharmaceuticals/more-than-250-websites-selling-fake-weight-loss-drugs-reported-by-anti-2024-04-15/
The FDA has posted photos of authentic and fake Ozempic needles and packaging lot numbers. Counterfeit or tampered medicinal products may be reported to the FDA local consumer complaint coordinator.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chai
