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...]
Diffuse Pleural Mesothelioma: A Challenge in Early Diagnosis
Abstract: We present the clinical case of a 58-year-old female patient, a smoker with occupational exposure to respiratory toxins, who was admitted to our clinic following evaluation in an emergency department, where she was diagnosed with a moderate right pleural effusion. Upon admission, the patient exhibited respiratory symptoms, including … [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...]
Treatment of Malignant Pleural Mesothelioma: American Society of Clinical Oncology Clinical Practice Guideline
Introduction The purpose of this guideline is to provide recommendations for the management of patients with malignant pleural mesothelioma (MPM), an aggressive tumor with a poor prognosis. In the United States, about 3,000 new cases are diagnosed each year. The median overall survival of patients with advanced surgically unresectable disease is … [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...]
Immunotherapy for Treatment of Pleural Mesothelioma: Current and Emerging Therapeutic Strategies
Pleural mesothelioma is a rare malignancy associated with asbestos exposure and very poor prognosis, with a 5-year overall survival of 12%. Outcomes may vary according to stage at time of diagnosis and histologic subtype. Most recently, clinical trials utilizing dual checkpoint inhibitor regimens and chemotherapy in combination with immune … [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...]
FDA Approves Pembrolizumab Plus Chemo for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
The FDA has approved [ Keytruda (pembrolizumab) ] plus pemetrexed and platinum chemotherapy in the frontline treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. Data from the phase 2/3 KEYNOTE-483 study (NCT02784171) showed that [ Keytruda (pembrolizumab) ] plus chemotherapy (n = 222) significantly … [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...]
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