Will the FDA issue a recall for Lipitor Side Effects in 2014?
Written by Stephen Fields on October 29, 2013
Two recalls of atorvastatin, the generic form of Lipitor, have been issued in the last four years, affecting thousands of customers. Now, in addition to these safety concerns, some consumers are asking whether there will be a Lipitor recall in 2014: this time, the concern is that using Lipitor could lead to an increased risk of type 2 diabetes, particularly for women.
2010 Lipitor Recall
The FDA announced in 2010 that Pfizer had voluntarily recalled 191,000 bottles of Lipitor. The recall came after numerous consumer reports of an “uncharacteristic odor” coming from the bottles that Lipitor was packaged in. Pfizer stated that the odor was unlikely to cause health problems, but instructed patients to contact their doctors or pharmacists with their concerns.
Generic Lipitor 2012 Recall
In 2012, a recall was issued for 41 lots of atorvastatin produced by the Indian pharmaceutical company Ranbaxy. The voluntary recall centered around possible contamination of 10, 20, and 40 mg Lipitor tablets with tiny particles of glass. The FDA instructed consumers concerned about the recall to contact their pharmacists to find out whether their medication had been affected. If they had received recalled medication, they were told to immediately stop taking the atorvastatin, and to talk to their pharmacist or doctor about getting replacement medication.
Ranbaxy Generic Lipitor Recall 2014
In 2014, Ranbaxy Laboratories, Inc. issued another recall on their generic version of Lipitor due to a potential dosage problems. More than 64,000 bottles of 10 mg tablets of atorvastatin were recalled because of the possibility that some of the bottles may contain 20 mg tablets.
The new recall was related to the 2012 Lipitor recall for glass particles. Ranbaxy told customers in a letter to customers that a pharmacist had discovered a 20 mg tablet in a bottle that was supposed to have only 10 mg tablets. After further review, Ranbaxy identified two additional lots that may have been affected with mixed doses.
Will there be a 2014 Lipitor and Diabetes recall?
As increasing evidence points to a link between Lipitor and diabetes in women (one 2012 study found that the drug could increase the risk of diabetes by 50% in postmenopausal women), some have wondered whether the FDA will issue a recall.
Despite recent studies that indicate a potential Lipitor-diabetes link, it does not appear that the drug will be recalled over diabetes concerns.
Generally, drug recalls are issued by pharmaceutical companies themselves. This was the case in the 2010, 2012 and 2014 atorvastatin recalls. In response to claims of a diabetes risk, Pfizer has thus far stood behind its medication. In June, the company issued a press release, stating that “an extensive series of published clinical data shows the safety and efficacy of Lipitor.” Pfizer does not seem poised to issue a recall.
Occasionally, the FDA will step in to issue a recall if a drug company will not. However, it seems unlikely that such an action will be taken this year in the case of Lipitor. The FDA has already required a change in the way that statin manufacturers label their drugs; labels must now alert consumers that these medications could increase blood sugar. For now, this seems to be as much action as the agency will take.
Although Lipitor has not been recalled, some women are still pursuing Lipitor diabetes lawsuit claims against Pfizer. This cholesterol-lowering medication, they argue, caused them to develop diabetes, a lifelong disease that requires daily management.
If you have developed diabetes after using Lipitor, you may be eligible to file a claim against the manufacturer of this drug. Contact our law firm to receive free legal advice and information about claim filing deadlines in your state. Please do not hesitate—call 1-888-210-9968 today.