Yasmin and Yaz Recall for Some Batches of Pills Could Be Coming?
The FDA released a warning letter this week sent to Bayer Pharmaceuticals over Yaz and Yasmin problems at the drug makers manufacturing plant in Germany. The letter indicates that Bayer hid out-of-specification test results for key ingredients in the birth control pills and said that several batches of the drugs should have never been released to the public. In what could be a forerunner to a Yasmin and Yaz recall, the FDA has asked for detailed lists of the batches shipped to U.S. customers.
>>FDA LINK: Warning Letter About Manufacturing Problems with Yaz and Yasmin
Yaz and Yasmin are two popular birth control pills manufactured by Bayer that combine the active pharmaceutical ingredient drospirenone with ethinyl estradiol to prevent pregnancy. According to the FDA letter sent to the drug giant, several problems with the manufacturing process were identified at a plant in Germany where drospirenone was produced.
Instead of identifying batches of drugs that may be bad and preventing them from being released to the public, the FDA indicates Bayer took the results of these out-of-compliance drugs and hid them by averaging the numbers with good results. The FDA indicates that this is an “unacceptable practice” and stressed that each of the results should be treated independently.
The FDA said that at least nine batches of drugs, including batches of the progestin drosperinone used in Yas and Yasmin, were shipped to the United States when they should have never left the plant.
Although the FDA is not advising patients to stop using Yaz and Yasmin birth control, and Bayer denies that there are any quality issues with pills currently on the market, it appears that the FDA may be contemplating whether to recall Yaz and Yasmin pills made from batches of drospirenone that could be out-of-specification.
LAWSUITS OVER YAZ AND YASMIN PROBLEMS
The lawyers at Saiontz & Kirk, P.A. currently represent women throughout the United States who are pursuing a Yaz lawsuit or Yasmin lawsuit after suffering a heart attack, stroke, deep vein thrombosis, pulmonary embolism, gallbladder problems or sudden death after taking the drug.
The allegations outlined in the FDA warning letter are not the first time that Bayer has run afoul of FDA regulations to put profits before consumer safety when selling these birth control pills. Early this year, Bayer agreed to spend $20 million on a corrective Yaz advertising campaign to address false and misleading statements in earlier ads.
Lawsuits over Yaz and Yasmin allege that Bayer failed to protect the public from certain dangers associated with their birth control pill by failing to properly research their medication or warn about the potential side effects. Drospirenone is unique to Yaz, Yasmin and a generic version sold as Ocella. The progestin increases blood potassium levlels, leading to hyperkalemia, which can result in various Yasmin and Yaz health problems even when it is manufactured properly.
Even before the FDA letter was released outlining Bayer’s failure to adhere to good manufacturing practices, many lawsuits filed against the company alleged that a Yaz recall and Yasmin recall should have been issued after the company began receiving post-marketing reports of serious and potentially life-threatening injuries associated with their drug.
If you, a friend or family member have suffered a heart attack, stroke, blood clot, deep vein thrombosis, pulmonary embolism, gallbladder problems or sudden death after taking Yaz or Yasmin, request a free consultation and claim evaluation.
