Problem with Yaz Generic Label Acknowledged by Teva

Teva Pharmaceuticals has admitted that it made false statements on the label of Gianvi, a generic clone of Bayer’s Yaz birth control pill. 

As part of a false advertising lawsuit brought by Bayer, Teva Pharmaceuticals told a federal judge on June 16 that it incorrectly claimed that Gianvi used Bayer stabilization technology to improve the drug’s shelf life. Bayer sued the company in U.S. District Court in the Northern District of Illinois, asking Judge Virginia Kendall for a temporary restraining order against the company.

In Yaz, the active ingredients are surrounded by a beta-cyclodextrin (betadex) clathrate, which works as a molecular cage that extends the pills’ shelf life. Teva Pharmaceuticals’ early Gianvi prescribing information indicated that its pills were also using this technology, but that was not the case.

Judge Kendall dismissed Bayer’s temporary restraining order request after Teva agreed to correct the mistake by sending out weekly e-mail and faxes to doctors for the next three months alerting them to the label problems with Yaz generic. In addition to correcting the label, Teva has agreed not to send out any more packages of Gianvi with the incorrect prescribing information.

The legal skirmish is part of a larger ongoing battle between the two pharmaceutical giants over Teva’s release of Gianvi, which was announced several weeks ago and immediately sparked a lawsuit over the generic Yaz birth control pill from Bayer. Officials for Bayer allege that Teva is violating a contract between the two companies that prohibited the generic drug maker from launching Yaz generic until at least July 2011. Teva officials, however, say that the contract allowed them to sell the birth control pill early under certain conditions.

Yaz (ethinyl estradiol and droperinone) is a birth control pill manufactured by Bayer, which contains a fourth-generation progestin that is only found in Yaz, it’s precursor, Yasmin, and Ocella, a generic Yasmin version. While Ocella is also distributed by Teva, Bayer still manufactures the pill under a prior agreement between the drug makers. 

Bayer currently faces more than 1,100 Yaz lawsuits, Yasmin lawsuits and generic Ocella lawsuits filed throughout the United States on behalf of women who allege that the drug maker failed to adequately research their birth control pill or warn about the risk of serious and potentially life-threatening injuries, such as stroke, heart attack, pulmonary embolism, deep vein thrombosis, gallbladder disease and other complications.

Drospirenone has been cited as the likely cause of an increased risk of blood clots and other serious health problems with Yaz and Yasmin. Many of the complaints filed against the drug maker allege that a recall of Yaz and Yasmin should have been issued after post-marketing reports suggested that the birth control pills carry a higher risk than some other oral contraceptives.