NAION Eye Side Effect Risk Increased With Semaglutide Drugs - Two Recent Medical Studies (Posted by Tom Lamb at Drug Injury Watch) Two recent medical studies again link the eye side effect of non-arteritic anterior ischemic optic neuropathy (NAION) to semaglutide drugs, providing us with more information about Ozempic vision problems. That is significant because this is still an emerging drug safety issue, which extends to Wegovy and Rybelsus insofar as their active ingredient is semaglutide. Our first article concerning Ozempic vision problems, "Wegovy, Rybelsus, and Ozempic Eye Side Effects ..read more

Why Has This September 2024 European Medicines Agency (EMA) Action Not Been Followed by FDA in US? (Posted by Tom Lamb at Drug Injury Watch) One of the primary issues in the increasing number of Depo-Provera meningioma lawsuits will likely be why the drug label in the US still does not include a meningioma warning. Lawyers who are starting to prepare these cases for court trials in the future will probably explore the fact that the European Medicines Agency (EMA) recommended a meningioma warning for Depo-Provera (medroxyprogesterone acetate) back in September 2024. The following information ab ..read more

While European Union (EU) and United Kingdom (UK) Drug Labels Have Warned About Meningioma for Many Years (Posted by Tom Lamb at Drug Injury Watch) Drug injury lawsuits that involve the contraceptive injection Depo-Provera being linked to brain tumors in some women have been filed against the responsible pharmaceutical companies over the past several months. The basis for these legal cases is that the current US Depo-Provera drug label (version "Revised: 7/2024") does not include any warning about intracranial meningioma. We touched upon this in our October 16, 2024 article, "Side Effects of B ..read more

AstraZeneca Says "while discussions with the FDA are ongoing, Andexxa will remain on the US market." (Posted by Tom Lamb at Drug Injury Watch) In our November 21, 2024 article, "Do Andexxa Risks Outweigh Benefits Given Increased Rate of Thrombosis and Thrombosis-Related Deaths?", we previewed that discussions about this drug safety issue by an FDA Advisory Committee might lead to the withdrawal of Andexxa from the US market or, put otherwise, a possible Andexxa recall. Now that this November 2024 Andexxa FDA Advisory Committee meeting has come and gone, we get an update on the current situatio ..read more

European Drug Regulators Are Investigating Semaglutide-Related NAION Cases Presented in Two Danish Studies (Posted by Tom Lamb at Drug Injury Watch) According to this December 18, 2024, Reuters news report, "Novo Nordisk's Ozempic faces EU review for potential eye disease connection", 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 earlier this week ha ..read more

New Cases of Liver Transplants And Liver-Related Deaths Among Patients Who Did Not Have Cirrhosis (Posted by Tom Lamb at Drug Injury Watch) In a December 12, 2024, Drug Safety Communication the FDA said it had recently found cases of Ocaliva liver injury among patients who did not yet have cirrhosis, or scarring of the liver, including reports of liver transplants and liver-related deaths. From that December 2024 FDA document, "Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis", we get this contextual inform ..read more

Issue to be Considered by FDA Advisory Committee on November 21, 2024, and Discussion May Lead to Andexxa Drug Recall (Posted by Tom Lamb at Drug Injury Watch) At its November 21, 2024 meeting, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will discuss whether Andexxa risks outweigh benefits. From the October 2024 FDA Briefing Document for that Andexxa Advisory Committee meeting comes this Draft Discussion Question: ANNEXA-I demonstrated an increased incidence of thrombosis (15.1% versus 6.9%) and thrombosis-related deaths at Day 30 (2.5% versus 0.9%) in the [Andexxa (andex ..read more

Intracranial Meningioma Risks Are Increased When Depo-Provera Was Used for More Than One Year (Posted by Tom Lamb at Drug Injury Watch) A medical journal article published in March 2024 reported that Depo-Provera (medroxyprogesterone acetate) increased the risk of intracranial meningioma by 5.6 times if Depo-Provera was used as birth control for longer than a year. The contraceptive injection Depo-Provera being linked to brain tumors in some women is a still emerging drug safety issue that has recently resulted in some drug injury lawsuits seeking legal compensation being filed against the res ..read more

Federal Appeals Court Rejects Merck's Legal Defense of Federal Preemption in September 2024 (Posted by Tom Lamb at Drug Injury Watch) A federal appeals court ruled in September 2024 that more than 500 plaintiffs should have their Fosamax femur fracture drug injury lawsuits reinstated and sent back to the current judge presiding over the federal court Fosamax MDL litigation. Specifically, the United States Court of Appeals for the Third Circuit issued this opinion, In re: Fosamax (alendronate sodium) Products Liability Litigation, No. 22-3412, (3d Cir. Sept. 20, 2024). As a result of that Septe ..read more

August 2024 Veozah Drug Label Change Adds Warnings About Liver Toxicity and Abnormal Liver Tests (Posted by Tom Lamb at Drug Injury Watch) On September 12, 2024, the FDA announced a warning about the rare occurrence of serious liver injury when a woman is using Veozah for hot flashes due to menopause. This Veozah liver injury FDA Drug Safety Communication instructed patients and doctors to stop Veozah if signs and symptoms of liver injury occur. In more detail, from the "Additional Information for Patients" section of that September 2024 FDA Veozah liver injury document: Stop taking Veozah imm ..read more