Loryna, New Generic form of Yaz, Named in FDA Blood Clot Review

Last month, the U.S. Food & Drug Administration (FDA) approved Loryna, a generic version of the Yaz birth control. The FDA Loryna approval came just weeks before the agency issued a Drug Safety Communication regarding a possible increased risk of blood clots with birth control pills like Yaz and Loryna.

Loryna is made by Sandoz and is the second generic version of Yaz to be approved by the FDA. The other, Gianvi made by Teva Pharmaceuticals, was approved in 2010. Loryna is indicated for the prevention of pregnancy as well as for the treatment of moderate acne and premenstrual dysphoric disorder (PMDD) in women at least 14 years of age only if the patient desires an oral contraceptive for birth control.

Like Yaz, Loryna is made with a type of progestin called drospirenone. According to the FDA, drospirenone can cause a complication called hyperkalemia, which occurs when there is too much potassium in the blood. Because of this potential risk, Loryna should not be taken by high risk patients, such as those with renal insufficiency, hepatic dysfunction and adrenal insufficiency. Women who use contraceptives made with drospirenone should undergo periodic blood testing to monitor their potassium levels.

Just weeks after Loryna was approved, the FDA announced that it and other contraceptives made with drospirenone were being monitored because of fears they might increase a woman’s risk of developing a blood clot more than birth control pills made with a different type of progestin. In addition to Loryna, the FDA is monitoring Yaz, Yasmin, Beyaz, Safyra, Ocella, Syeda, and Zarah.

The FDA issued its Drug Safety Communication after The British Medical Journal reported a two- to three-fold greater risk of venous thromboembolic events (VTEs) – including life threatening deep vein thrombosis (DVT) and pulmonary embolism (PE) – in women using oral contraceptives containing drospirenone rather than a progestin called levonorgestrel. Previous studies examining the risk of blood clots and drospirenone contraceptives have had conflicting results, according to the FDA.

Drospirenone birth control pills, including Yaz, Yasmin and their generic counterparts, have been named in thousands of lawsuits claiming the drugs caused users to suffer dangerous side effects, including blood clots, heart attacks, and strokes. Many of those lawsuits have been consolidated in a multidistrict litigation in federal court in the Southern District in Illinois.

This entry was posted in Loryna, Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.