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article imageFDA delays generic Lipitor recall announcement 3 weeks

By Greta McClain     Dec 2, 2012 in Health
Ranbaxy Pharmaceutical's, a division of Ranbaxy Inc, issued a voluntary recall of atorvastatin, a generic form of the cholesterol lowering drug Lipitor.
The company issued the recall on November 9th after they found glass particles the size of a "fine grain of sand" in some of the pills. Ranbaxy shut down all production of the drug while they investigated the incident and notified the U.S. Food and Drug Administration (FDA) of the issue. In a statement on the company's website they say:
"The recall is being conducted at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the U.S. FDA."
On Thursday, November 29th, the FDA issued a press release alerting the public of the potential danger, saying:
"The probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out. Because of the size of the particles which may be present in the affected lots it is unlikely to cause a significant safety concern. However, the possibility of adverse experiences arising primarily due to physical irritation cannot be ruled out. As of this date, Ranbaxy has not received any reports of adverse events related to this recall."
The recall involves 41 affected lots of the 10 mg, 20 mg and 40 mg of atorvastatin. A full list of the products recalled can be found here.
ABC News is reporting that the FDA advised those concerned about the drug to consult their pharmacist and confirm whether their prescription was part of the recall. If they received a product that was recalled, the FDA said consumers should stop taking the product and consult their doctor or pharmacist about obtaining an "alternate product".
On Friday, a day after the FDA advised consumers to stop taking the drug, they reversed course, telling patients to continue to take the drug even though it may contain specks of glass. In a revised statement the FDA claims that "adverse health problems related to the recalled atorvastatin is extremely low."
The reversal has caused confusion among patients taking the drug, with millions calling pharmacies asking whether they should take the drugs they have in their medicine cabinets. Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, called Thursday's FDA statement "poorly phrased" and said it "made people think they should stop taking their medicine". She told CNN the pills involved in the recall "aren't of the quality we would expect of a drug, but they aren't risky, either."
This is not the first time Ranbaxy has had problems with their products. The FDA banned the company from importing about 30 drugs in 2008 after it found manufacturing deficiencies at two of the company's facilities in India. Later that same year, the company was accused of falsifying data it used in drug applications. According to Reuters, the company agreed to hire a third party to review its facilities, implement data integrity procedures for its marketing applications, and ensure the company meets good manufacturing practices.
In January, a federal court ordered a decree baring the company from manufacturing drugs at its most troubled facilities, a move federal authorities called “unprecedented in scope.”
Due to past safety concerns, some are wondering why the FDA waited a full 20 days before alerting the public of potential dangers. Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told CNN the agency would review how it handles communication to the public during recalls, adding:
"It took us some time to figure out what was going on. We need to fix our process a little bit."
Digital Journal sent an email to FDA Generic Drugs and Adverse Event press officer, Sarah Clark-Lynn, Thursday evening. Clark-Lynn was asked if the FDA considered traces of glass safe for consumers to ingest, as well as asking for further explanation of the delay in alerting the public. That inquiry has gone unanswered as of this publication.
More about generic Lipitor, Ranbaxy Pharmaceuticals, atorvastatin calcium, Fda, US Food and Drug Administration
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