The European Medicines Agency (EMA) recommended a Depo-Provera warning about meningioma in September 2024. One wonders why the FDA has not followed this EMA regulatory action. Therefore, the Depo-Provera drug label in the US still does not include a warning about meningioma. The following … More
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Recent News & Case Reports
Why Are There Depo-Provera Brain Tumor Warnings In Europe But Not US?
Depo-Provera drug injury lawsuits for women who have been diagnosed with a specific type of brain tumor, intracranial meningioma, are being filed against the responsible pharmaceutical companies. A primary focus of these legal cases will be why the Depo-Provera drug label in the US does not include … More
Andexxa Blood Clot Cases Before Any AstraZeneca Drug Recall
Following a November 2024 FDA Advisory Committee meeting, drug injury lawsuits against AstraZeneca concerning Andexxa blood clot cases for patients who developed a pulmonary embolism (PE) or deep vein thrombosis (DVT) are likely to be filed. Of course, these Andexxa blood clot cases would have to … More
Ozempic Linked to Vision Loss With Increased Risk of NAION Side Effect
There is a significant development concerning semaglutide drugs like Ozempic linked to vision loss and blindness: The European Union's drug regulator said it would assess two new Danish studies that link Novo Nordisk's popular diabetes drug Ozempic to a rare eye disease. The studies published … More
Ocaliva FDA Drug Safety Warning December 2024
An Ocaliva FDA drug safety warning was issued by the FDA in December 2024 that pointed out cases of liver transplants and liver-related deaths among patients without pre-existing cirrhosis who used Ocaliva as a treatment for primary biliary cholangitis (PBC). To provide context for this most … More
Andexxa Blood Clots and Clotting-Related Deaths: FDA November 2024
The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee recently discussed the increased risk of Andexxa blood clots and clotting-related deaths seen in the ANNEXA-I trial done for Andexxa, compared with a standard of care reversal agent. This Andexxa Advisory Committee considered the … More