Lupin Pharmaceuticals Recalls Two Lots of Birth Control
The company explained that the low ascorbic acid levels in Tydemy, a prescription oral contraceptive, can reduce effectiveness.
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- On July 28, 2023, Lupin Pharmaceuticals, a manufacturer based out of Baltimore, MD, voluntarily recalled two lots of Tydemy. The drug is an estrogen and progestin oral contraceptive, also known as a combined oral contraceptive (COC). Tydemy comprises drospirenone, ethinyl estradiol, and levomefolate calcium.
The drug, also sold under the brand Safyral, has been approved by the FDA for pregnancy prevention and folate supplementation.
According to the announcement, the recall applies to two lots: L200183 and L201560. The packs were distributed across the United States to wholesalers, drug chains, mail-order pharmacies, and supermarkets between June 2022 and May 2023.
Lupin noted that the medication had an out-of-specification (OOS) result during the one-year stability check. The L200183 lot, in particular, had low levels of ascorbic acid and high impurity levels.
While no adverse events have been reported as a byproduct of the impurities, the FDA explained that the effectiveness of the medications is significantly lower. Continued medication use as a primary contraceptive method may result in unexpected pregnancies.
Although the lots’ designated expiration dates are January 2024 and September 2024, the manufacturer is asking consumers to contact their healthcare providers to discuss an alternative treatment. Patients should continue taking the medication until they get an alternative medicine.
In the meantime, wholesalers, distributors, and retailers should refrain from selling the products. Any adverse events or concerns can be reported to the FDA’s MedWatch Adverse Event Reporting program. In addition, the recall notice states that recalled lots can be returned to Inmar Rx Solutions, Inc. for reimbursement.
Healthcare professionals must notify their patients about this recall to minimize the risk of unintended pregnancy. According to the CDC, in 2008, over half of all pregnancies were unintended. While the rates have declined recently, in 2011, 45% of all pregnancies were still unintended.
Access to safe and effective birth control is critical for preventing unintended pregnancies. With this medication recalled, some patients may be unable to access the appropriate medication. According to GoodRx, Yasmin and Beyaz can act as similar alternatives to Tydemy.
Providers and patients may also discuss other birth control methods, including intrauterine devices, implants, shots, patches, vaginal rings, diaphragms, sponges, spermicides, and condoms.
With the current political climate surrounding abortion access, healthcare professionals can play an essential role in pregnancy prevention.
