FDA Issues Warning About Ineffectiveness of Thousands of Tydemy Birth Control Pills

The Food and Drug Administration (FDA) has issued an alert regarding the potential ineffectiveness of thousands of Tydemy brand birth control pills. Manufacturer Lupin Pharmaceuticals conducted tests that revealed two batches of these contraceptive tablets might have reduced efficacy.

The Tydemy pills, a combination prescription contraceptive containing estrogen and progestin, are subject to recall for specific lot numbers, which can be found on the FDA’s official website. Distribution of the affected batches occurred between June 2022 and May 2023, reaching various pharmacies and supermarkets nationwide.

Approximately 4,179 boxes, equivalent to around 350,000 tablets, have been recalled due to this issue, as reported by the FDA. Individuals using birth control from the recalled lots are advised to continue taking their current medication while promptly consulting their healthcare provider for guidance on alternative contraceptive methods.

Lupin Pharmaceuticals is urging patients to maintain their medication regimen and seek advice from their healthcare provider for alternative contraceptive options, as stated by the FDA. The company has voluntarily initiated the recall at the wholesale level.

The Reduced Effectiveness Issue Explained: Standard pharmaceutical practices involve stability testing to ensure the viability of medications up to their expiration dates. Lupin Pharmaceuticals found that the Tydemy batches in question exhibited lower levels of an inactive ingredient, ascorbic acid, beyond the 12-month mark, along with the presence of an excessive “known impurity.” This discrepancy may compromise the product’s effectiveness, potentially leading to unintended pregnancies.

No reports of adverse events related to the recalled lots have been received by Lupin Pharmaceuticals so far. In the event of any concerns or issues, both doctors and patients are encouraged to report them to the FDA via online channels or fax.

The root cause behind this “out of specification” problem remains unclear, and it’s uncertain if additional batches are affected. Despite being recognized as the “third-largest pharmaceutical company in the U.S. by prescriptions,” Lupin Pharmaceuticals has previously faced recalls, including one involving blood pressure medication Quinapril due to impurities. An inspection conducted at a Lupin facility revealed shortcomings, such as inadequate investigation into “out of specification” test results and insufficient actions taken to prevent recurrence, according to FDA inspectors.

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