Category: Drug Safety Alerts
-
Teva’s Budeprion XL Will Get Another Safety And Efficacy Review By FDA
FDA To Collaborate With Complaining Patients On Study Of Reported Problems With This Generic Version Of Antidepressant Wellbutrin XL (Posted by Tom Lamb at DrugInjuryWatch.com) By means of a September 23, 2008 Wall Street…
-
Association Between Long Term Fosamax Use And Femoral Stress Fracture Is Challenged
September 2008 ASBMR Meeting: Dr. Abrahamsen Asserts Atypical Fractures Of Femur Are Not Triggered By Fosamax (Posted by Tom Lamb at DrugInjuryWatch.com) In late June 2008 we learned that one type of femoral stress…
-
New Reports Of Vytorin And Zetia Causing Liver Failure And Liver Disease
2008 Medical Journal Articles Describe Two Cases; Authors Suggest Liver Testing At Start Of Therapy And When Titrating Dosage Is Necessary (Posted by Tom Lamb at DrugInjuryWatch.com) In December 2007 we told you about an…
-
FDA Warns Sandoz About Possible Quality-Control Problems At Its North Carolina Generic Drug Manufacturing Facility
Inspection Found Sandoz Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills (Posted by Tom Lamb at DrugInjuryWatch.com) There is yet another apparent quality-control problem…
-
August 2008: Byetta Associated With Hemorrhagic Pancreatitis And Necrotizing Pancreatitis
FDA Has Learned Of Six Such Cases Since October 2007 "Dear Doctor" Letter About Acute Pancreatitis In Patients Taking Byetta (Posted by Tom Lamb at DrugInjuryWatch.com) On August 18, 2008 the FDA issued a…
-
August 2008 Actavis Recall Of All Drugs Manufactured At Its Little Falls, NJ Plant
FDA Inspection “revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices” (Posted by Tom Lamb at DrugInjuryWatch.com) All of a sudden it seems that the sky is falling…
-
EU Drug Watchdog Wants Avelox Use Limited Mainly Due To Liver Toxicity Concerns
Risk Of Adverse Hepatic Reactions, Including Fatal Liver Injury, Is Cited by European Regulators At July 2008 Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) The Committee for Medicinal Products for Human Use (CHMP), a…
-
Neurology Journal: Johnson & Johnson’s Drug Topamax May Increase Risk of Birth Defects
Beware If Taking This Seizure Medicine Alone Or With Other Epilepsy Drugs During Pregnancy (Posted by Tom Lamb at DrugInjuryWatch.com) The July 22, 2008 issue of Neurology, the medical journal of the American Academy…
-
Will There Be An Avelox – Liver Toxicity Warning Letter From Bayer Coming Soon In The U.S., Or Not?
In July 2008 FDA Said Avelox, With Other Antibiotics In Fluoroquinolone Class, Would Add A “Black-Box” Warning For Tendinitis And Tendon Ruptures (Posted by Tom Lamb at DrugInjuryWatch.com) On July 8, 2008 the FDA…