FDA warns birth control pill Tydemy may have reduced effectiveness

The FDA has warned consumers that two lots of Tydemy, a prescription oral contraceptive manufactured by Lupin Pharmaceuticals, may have reduced effectiveness due to decreased levels of ascorbic acid.

Tydemy is an oestrogen/progestin oral contraceptive indicated for use by women to prevent ovulation and pregnancy.

According to the FDA, the potential reduction in its effectiveness could result in unexpected pregnancy.

The affected lots were distributed in the US from June 3, 2022, to May 31, 2023. To date, the federal agency said it had not received any reports of adverse events related to using this product.

On July 29, 2023, Lupin notified consumers about its voluntary recall of the two lots of Tydemy for patients, adding “if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy.”

The pharmaceutical company has advised patients to continue taking their medication and contact their healthcare provider for advice regarding an alternative contraceptive method.

The multinational had previously voluntarily recalled the two lots of Tydemy at the wholesale level.

FDA has encouraged healthcare professionals and patients to report any adverse events or quality problems with these or any other medications to the agency’s MedWatch Adverse Event Reporting programme.