The U.S. Food and Drug Administration (FDA) just issued a warning letter to a drug maker for faulty birth control pills.
In yet another birth control scare, Warner Chilcott, maker of Ovcon birth controls pills, was warned by the federal regulator via a letter dated March 8, said FiercePharma. According to the agency, for five years, Ovcon’s potency has been questionable, creating a pregnancy risk to women.
Last year, the FDA conducted an inspection of Warner Chilcott’s Fajardo, Puerto Rico manufacturing plant. From 2006 to the June 2011 recall, said the FDA, “7 of 9 lots of Ovcon (Norethindrone (NE) 1 mg and Ethinyl Estradiol (EE)) 50 mcg tablets, laced on stability, failed to meet the assay test specification for Ethinyl Estradiol (EE) at different stability testing intervals.”
This may result in the Ovcon pills not lasting until their expiration date, said the FDA letter, wrote FiercePharma.
Warner Chilcott told the agency that it did not take steps to resolve the matter because it feels that a different stability condition test was a more accurate indicator, said FiercePharma. The FDA told Warner that it must ensure Ovcon passes both tests. Warner said that new packaging should help resolve the problem; however, the FDA pointed out that a batch in the new packaging failed a test.
The FDA also warned that Warner’s “quality control unit has failed to exercise its responsibility to assure that your product meets its predetermined specifications throughout its shelf life.” Warner has 15 days to provide the agency with the steps it will take to resolve the matter. The FDA Warning Letter can be accessed at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm295690.htm
This news follows two other reports of faulty birth control pills that led to recalls. We previously wrote that another 8 million birth control pills were involved in a new recall implemented over a packaging error. In that case, Glenmark Generics Inc. recalled seven lots of Norgestimate and Ethinyl Estradiol Tablets USP because some of the packaging blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and rendering the lot number and expiry date visible only on the outer pouch.
As we’d written, this packaging error could render the daily regimen for these oral contraceptives incorrect, leaving women with inadequate contraception, and at risk for unintended pregnancy.
We also previously wrote that Pfizer recalled 1 million birth control pill packages and could be facing lawsuits. A packaging problem was also to blame in that case. According to experts familiar with the matter, women who become pregnant after taking the defective birth control pills could sue Pfizer for their unwanted pregnancies, and could sue big. The issue is the same in the Glenmark recall and Warner debacle.