Atorvastatin, or generic Lipitor, was recalled November 9
The FDA changed its guidance after a conference call with pharmacies and other groups
"We need to fix our process a little bit," says FDA official
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The Food and Drug Administration advised patients Friday to keep taking a popular cholesterol drug even though it might contain specks of glass, reversing advice it gave just a day ago.
Millions of people take Ranbaxy Pharmaceutical’s generic Lipitor, or atorvastatin, and many have been calling pharmacies confused about whether to take the drugs they have in their medicine cabinets.
Ranbaxy initiated a recall November 9 and told pharmacies to stop dispensing the drug, but gave no advice to consumers about what to do with what was in their medicine cabinets.
Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the agency would review how it handles communication to the public during recalls.
“It took us some time to figure out what was going on,” she said. “We need to fix our process a little bit.”
Between 3 million and 4 million people take Ranbaxy’s atorvastatin, according to Ross Muken, senior managing director at ISI Group. The company has more than a 40% share of the generic Lipitor market.
The FDA made no public statements on the recall until Thursday, when the agency said concerned patients should stop taking their medicine if their pharmacist confirmed it was from a recalled lot.
After a conference call Friday afternoon with pharmacies and other groups, the agency decided to change their guidance.
“Yesterday’s statement was poorly phrased,” Woodcock said Friday. “It made people think they should stop taking their medicine.”
The glass particles are “the size of a grain of sand,” she added.
The pills “aren’t of the quality we would expect of a drug, but they aren’t risky, either,” Woodcock said.
Ranbaxy has stopped making atorvastatin while they investigate how the glass got into the drug, according to the FDA.