The Food and Drug Administration (FDA) has issued a warning regarding the reduced effectiveness of two batches of the prescription birth control Tydemy. The FDA stated that the two lots of Tydemy may have decreased levels of ascorbic acid, which could result in the contraceptive being less effective and potentially lead to unexpected pregnancy. The affected lots, identified as L200183 and L201560, were distributed in the United States between June 3, 2022, and May 31, 2023. Lupin Pharmaceuticals, the manufacturer of Tydemy, voluntarily recalled the two batches in late July. The company advised patients to continue taking the medication but also instructed them to immediately contact a healthcare professional for advice on alternative treatment options.
According to Lupin Pharmaceuticals, the recall was initiated because a significant reduction in the amount of inactive content, specifically ascorbic acid, could potentially impact the effectiveness of the product and result in unexpected pregnancy. The company emphasized that it had not received any reports of adverse events related to the recalled batches. Lupin Pharmaceuticals is notifying customers, wholesalers, distributors, drug chains, mail order pharmacies, and supermarkets about the recall and arranging for the return of all the affected product lots. Consumers and retailers with questions are directed to contact Inmar Rx Solutions, Inc. at (866) 480-8206, and consumers can also return their products to Inmar Rx Solutions, Inc. for reimbursement.
Tydemy is a popular brand of oral contraceptive that contains a combination of the hormones estrogen and progestin, which are naturally produced by a woman's body. These hormones override the signals from the brain to the ovaries, suppressing the ovulation process. Approximately 14% of women between the ages of 15 and 29 in the United States use oral contraception pills, according to the FDA.
The recall of Tydemy comes after testing by Lupin Pharmaceuticals revealed decreased levels of ascorbic acid and high levels of a known impurity in the two affected lots. The FDA noted that it has not received any reports of adverse events related to the use of Tydemy. The recall affects a total of 4,179 boxes, which amounts to approximately 350,000 tablets that may be less effective at preventing pregnancy. The FDA advised patients who are currently taking the recalled lots of Tydemy to continue taking their pills but to seek an alternative contraceptive method from their healthcare provider.
The reason for the reduced effectiveness of the recalled Tydemy batches is related to stability testing conducted by drugmakers to ensure that medications remain effective until their expiration dates. Lupin Pharmaceuticals stated that the affected batches of Tydemy did not meet the required levels of ascorbic acid after 12 months and contained a higher level of a known impurity. The company did not provide further details on the cause of these deviations or whether additional batches may be affected.
Lupin Pharmaceuticals has faced previous recalls, including one for the blood pressure medication Quinapril due to impurities. In a recent inspection of one of the company's facilities, the FDA identified several shortcomings, including inadequate investigation of deviations and failure to address the root causes of out-of-specification test results. The FDA encourages doctors and patients who have experienced issues with Tydemy or any other medication to report them online or by fax.
The recall of Tydemy highlights the importance of ensuring the effectiveness and safety of prescription medications. Patients are advised to closely follow recalls and warnings issued by regulatory agencies and promptly contact their healthcare providers for guidance on alternative treatment options.
