Sunday, December 2, 2012

Blog 13 FDA Reversal

The Food and Drug Administration have advised all patients on Friday to continue taking a widespread cholesterol drug even though there had been concerns that the drug might contain specks of glass, retreating advice it gave just a day earlier.  Millions of people are taking Ranbaxy Pharmaceutical's generic Lipitor, or atorvastatin, and numerous have been calling the pharmacies because they were confused about whether or not to take the drugs in which they have in their medicine cabinets.  Ranbaxy originated a recall on November 9 and told all the pharmacies to stop distributing the drug, but gave no feedback to the clients about what to do with what was in their medicine cabinets.  Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, thought the agency would review how it handles communication to the public during recalls.  It took them some time to think out what was going on. They realised that they needed to fix their processes a little bit.  Between 3 million and 4 million people have taken Ranbaxy's atorvastatin, according to Ross Muken, who is the senior managing director at ISI Group. The company has greater than a 40% share of the generic Lipitor market.  The FDA made no public declarations on the recall until Thursday, when the agency said anxious patients should stop taking their medicine if their pharmacist established it was from a recalled lot.  After a conference call Friday afternoon with pharmacies and other groups, the agency decided to change their direction.  It caused people to believe that they should stop taking their medicine.  The glass particles are as small as a grain of sand, she added. Ranbaxy has stopped making atorvastatin while they investigate how the glass got into the drug, according to the FDA.

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