Skip to main content
Part of complete coverage on

FDA reversal: Keep taking recalled cholesterol drug

By Elizabeth Cohen, Senior Medical Correspondent
updated 5:26 PM EST, Fri November 30, 2012
Ranbaxy Pharmaceuticals issued a recall November 9 of a generic form of Lipitor that might contain specks of glass.
Ranbaxy Pharmaceuticals issued a recall November 9 of a generic form of Lipitor that might contain specks of glass.
STORY HIGHLIGHTS
  • 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

Editor's note: The Empowered Patient is a regular feature from CNN senior medical correspondent Elizabeth Cohen that helps put you in the driver's seat when it comes to health care.

(CNN) -- 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.

Elizabeth Cohen
Elizabeth Cohen

"It took us some time to figure out what was going on," she said. "We need to fix our process a little bit."

FDA: Stop taking recalled cholesterol drug

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.

Recall leaves glass-specked drug in hands of patients

ADVERTISEMENT
Part of complete coverage on
Senior Medical Correspondent Elizabeth Cohen helps put you in the driver's seat when it comes to health care with her column, Empowered Patient.
updated 5:04 PM EST, Wed December 12, 2012
In a battle over healthier school lunches that pitted the Obama administration against school children, chalk up a point for the kids.
updated 5:26 PM EST, Fri November 30, 2012
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.
updated 5:08 PM EST, Wed November 21, 2012
Women are being "overdiagnosed" with breast cancer, according to a new study in the New England Journal of Medicine.
updated 5:25 PM EST, Mon November 5, 2012
When you're a patient, you trust you're in good hands, but even the best doctor or nurse can make a mistake on you or someone you love.
updated 10:45 AM EST, Thu November 8, 2012
Egg freezing technology has improved so much that egg banks have started websites where patients can order and ship frozen eggs.
ADVERTISEMENT