Novo Nordisk Reports Compounded Wegovy Up to 33% Impure
According to court papers that were filed November 29 by Novo Nordisk representatives, samples of the compounded medications were as much as 33% impure. Others were even less potent than they claimed to be, the Danish drugmaker has alleged. This follows testing of products from Wells Pharmacy and Brooksville Pharmaceuticals.
The company is using those test results to re-file a lawsuit against Brooksville, which it first sued in July. They will also use them to build a case against Wells, whose semaglutide products were found to contain BPC-157. The FDA banned BPC-157 from use in compounded drugs this fall due to the potential for dangerous immune system reactions.
Details on the original suit can be found here:
Novo Nordisk Court Filing (July 2023)
Pre-Cut Cantaloupes Linked To Salmonella Outbreak
117 cases of salmonella in the United States have been traced to precut cantaloupes under the Malichita and Rudy brands, according to the CDC.
The CDC issued an alert on November 30 warning the public about the tainted fruit. Across the border in Canada one person has died after consuming the product. CDC representatives are extremely concerned about this outbreak because the illnesses are severe, with more than half the infected requiring hospitalization.
The agency said consumers should avoid precut cantaloupes, including that found in fruit cups. They warned consumers to wash and sanitize items and surfaces that may have come in contact with recalled fruit. Most people infected with Salmonella experience diarrhea, fever, and stomach cramps. Symptoms usually start 6 hours to 6 days following exposure.
FDA Investigates "Serious Risk" Of New Cancers Following Treatment With CAR-T Therapies
On November 28th, the FDA released a statement regarding cases of T-cell malignancies in patients treated with autologous CAR T cell immunotherapies directed by CD19 or BCMA. This included chimeric antigen receptor CAR-positive lymphoma. Clinical trials and/or postmarketing adverse event (AE) data were the notification sources.
The FDA statements noted that all currently approved genetically engineered autologous CAR T cell immunotherapies that are aimed toward CD19 and BCMA carry some risk of T-cell malignancies. T-cell cancers have developed in patients receiving treatment with multiple drugs in the same class.
Read the FDA CAR-T Therapies Statement:
FDA Issues Warning Regarding A Rare, Serious Drug Reaction To levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
On November 28th the FDA issued a drug safety communication regarding a rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).
The reaction is known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). It may begin with a rash but, can quickly progress. As a result, the agency is requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines.
The FDA warns patients and caregivers that levetiracetam or clobazam should not be stopped without speaking with the prescriber/provider. Stopping these medicines suddenly can lead to uncontrolled seizures.
For more information on this issue, including FDA advice and data summary, we encourage reading of the FDA communication below.
FDA SAFETY COMMUNICATION (November 28, 2023)
Like & Subscribe to Receive Updates & Opportunities Directly To Your Inbox!
Disclaimer: The above guide represents general informational and educational materials; always seek and follow the advice of your medical provider for any acute or chronic medical issues or questions, and follow the protocols of your program or supervising agency.
Join Clinical Quick Reference Monthly (For Free) To Learn More & Receive Emailed Updates, CEU Opportunities, Scholarship & Grant Notices, and Much More…
