The European Medicines Agency (EMA) recommended a Depo-Provera meningioma increased risk warning 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 the meningioma increased risk associated with Depo-Provera. The following … [Read more...]
Why Are There Depo-Provera Brain Tumor Warnings In Europe But Not US?
Depo-Provera brain tumor lawsuits for women who have been diagnosed with intracranial meningioma, a specific type of brain tumor, 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 any warnings about the increased risk of this … [Read more...]
Andexxa Drug Injury Lawsuits for Blood Clots, PE, DVT
Andexxa (andexanet) is a treatment currently used when the reversal of anticoagulation is needed for life-threatening or uncontrolled bleeding in patients who are using Eliquis (apixaban) or Xarelto (rivaroxaban) at the time. Andexxa drug injury lawsuits for patients who developed blood clots involving a pulmonary embolism (PE) or deep vein … [Read more...]
Ozempic Vision Loss Due to Increased Risk of NAION
Here is the most recent development concerning Ozempic 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 earlier this week had found Ozempic significantly increases the risk of type 2 … [Read more...]
Ocaliva Label Change Possible After December 2024 FDA Alert
The FDA issued an Ocaliva FDA drug safety alert in December 2024 that may result in another Ocaliva label change. This alert was for 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 recent … [Read more...]
Andexxa Clotting-Related Deaths and Andexxa Blood Clots
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee recently discussed the increased risk of Andexxa clotting-related deaths and Andexxa blood clots seen in the ANNEXA-I trial done for Andexxa, compared with a standard of care reversal agent. This Andexxa Advisory Committee considered the current drug safety profile of Andexxa in … [Read more...]
Depo-Provera Meningioma Brain Tumors Drug Injury Lawsuits
Because the current drug label for Depo-Provera Contraceptive Injection (version “Revised: 7/2024”, accessed 10/16/24) does not include any warning about an increased risk of intracranial meningioma, we are investigating possible Depo-Provera meningioma brain tumors drug injury lawsuits seeking legal compensation for women who have been diagnosed … [Read more...]
No Federal Preemption for Fosamax MDL Femur Fracture Lawsuits: September 2024 Update
The United States Court of Appeals for the Third Circuit recently issued this opinion, In re: Fosamax (alendronate sodium) Products Liability Litigation, No. 22-3412, (3d Cir. Sept. 20, 2024), ruling that there is no federal preemption for more than 500 Fosamax MDL femur fracture lawsuits that had been dismissed previously and therefore, should now … [Read more...]
Menopause Drug Veozah Liver Problems FDA Warnings
A Veozah drug label change made on August 31, 2024, added new warnings about liver toxicity and abnormal liver test results, according to a September 12, 2024, Veozah liver problems FDA Drug Safety Communication. According to the “Additional Information for Patients” section of the September 2024 FDA Veozah liver problems warnings document, … [Read more...]
Syfovre Claims: Vision Loss and Blindness: Law / Legal
Syfovre claims for vision loss and blindness involving retinal vasculitis diagnosed after a patient’s first Syfovre injection are being filed as drug injury lawsuits. The basis for these product liability Syfovre lawsuits is the drug company Apellis Pharmaceuticals failed to warn about retinal vasculitis as a side effect until it revised the … [Read more...]
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