Best Read Articles on Safety Issues and Recalls in 2021
News about counterfeit versions of Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) and Descovy (emtricitabine, tenofovir alafemamide) and the pause in the REMS program for clozapine were among the best read articles of 2021.
Apotex to Import Generic of Chantix from Canada
This is being done in coordination with the FDA to address the shortage created by the recall of Chantix. UPDATE: Pfizer has expanded its recall of Chantix from nine lots to 12 lots.
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Counterfeit Versions of Biktarvy and Descovy Found in Pharmacies
The bottles have a counterfeit foil seal or label and contain an incorrect number of tablets.
FDA’s New Warning Includes Xeljanz and other JAK Inhibitors
The FDA’s review of the JAK inhibitor class concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with these arthritis and ulcerative colitis medicines.
FDA Pauses Clozapine REMS Program
New requirements resulted in long call wait times, which has led to patient access issues.
Piqray’s Safety Label is Updated
Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.
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FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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