Business of Medicine News Alerts

 
 
  • Alert French Regulators Suspend Pioglitazone Citing Cancer Risk The decision to yank the drug was made after a study requested by the drug regulatory authority, AFSSAPS, confirmed a small increase in bladder cancer among patients treated with the diabetes drug.
  • Alert FDA Restricts Use of Simvastatin 80 mg In the SEARCH trial--the basis for the FDA review--52 patients taking the 80-mg dose developed myopathy compared with one patient treated with the 20-mg dose. In addition, 22 patients treated with the high dose of simvastatin developed rhabdomyolysis compared with none treated with the 20-mg dose.
  • Alert Japan Halts Prevenar, ActHIB Vaccines After Four Children Die Japan's health ministry has halted the use of vaccines made by Pfizer Inc and Sanofi-Aventis SA to prevent meningitis and pneumonia following the deaths of four children.
  • Alert Topiramate Linked to Birth Defects New human data show that the prevalence of cleft lips and palates in infants born to women taking topiramate was roughly 3 times higher than that for women taking other antiepileptic drugs.
  • Alert Lots of Jantoven, other agents recalled Upsher-Smith has expanded its recall from one lot to 16 lots of its Jantoven brand of warfarin sodium and has added lots of amlodipine and other drugs.
  • Alert Tylenol Products Recalled The products were made at facility where cleaning procedures were insufficient or not adequately documented.
  • Alert Dronedarone Linked to Liver Damage, Transplants, Says Sanofi Sanofi Aventis has sent out a letter to US healthcare professionals alerting them to an association between severe hepatic injury, including two liver transplants, and use of its anti-arrhythmic drug, dronedarone (Multaq). The company says it will also change the prescribing information for the product, although it stresses no causal association has yet been established. The FDA has also issued a
  • Alert Abbott Withdraws Sibutramine From Market The US FDA asked the manufacturer to pull the weight-loss medication from the market after clinical trial data pointed to a 16% increase in the risk for serious cardiovascular events.
  • Alert FDA Restricts Rosiglitazone, But EMA Suspends It After months of deliberations, the FDA has opted to allow Avandia to stay on the market, but only with severe restrictions. It also opted to stop the TIDE trial, pending a rereview of the RECORD trial. In contrast, the EMA has ordered the suspension of all rosiglitazone-containing products
  • Alert FDA Warns Physicians About Using Unapproved IUDs Defenders of using unapproved IUDs say physicians lose money when they implant costlier FDA-approved versions.
  • Alert Alcon Laboratories Recalls Vitreoretinal Surgery System Alcon Laboratories will rectify hardware and software problems with the Alcon Constellation Vision System that could lead to eye injuries, including blindness.
  • Alert FDA Warns Abbott Diabetes Care About Its Glucose Meters One glucose meter in the Abbott line is still experiencing a "supply interruption" in the United States, and now the manufacturer had been warned of improper quality control practices.
  • Alert FDA Issues Requirements for Recall of Baxter Infusion Pumps The FDA has issued a final order for Baxter to recall all Colleague infusion pumps currently in use in the United States and to provide refunds or replacement pumps to customers at no cost.
  • Alert FDA Adds Boxed Warning to Leflunomide for Severe Liver Injury More cases of this adverse event prompted the agency to strengthen an existing warning on the label for the rheumatoid arthritis drug.
  • Alert Use Fibrin Sprayers Correctly to Avoid Embolisms, Warns FDA The agency has received reports of gas or air embolisms after the administration of hemostatic drugs and biological products with sprayers pressurized by gas and air.
  • Alert Tylenol Recall Grows Again The recall of Tylenol and other over-the-counter medicines has grown once again, with Tylenol maker McNeil PCC Inc.
  • Alert FDA Issues Second Warning Against Treating Leg Cramps With Quinine Treating such cramps with quinine is an off-label use with potentially serious adverse effects, the agency says.
  • Alert Recall of LIFEPAK 20/20e The recall affects approximately 43 000 devices distributed worldwide over a five-year period starting in September 2002.
  • Alert MRSA/SA Test Recalled Because of Rare False-Negative Results Patients with MRSA infections may receive incorrect treatment or delayed care due to false negatives, according to the FDA.
  • Alert Coumadin Samples Recalled in US BMS has voluntarily recalled a number of blister packs of Coumadin 1 mg provided as samples in the US, because they may not contain the right amount of an additive, isopropanol. There is little clinical risk from this situation, the company says.
 
 
 
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