Tuesday, November 22, 2011

Georgia November 21, 2011 Yaz News

FdaImage via WikipediaAs the litigation moves along in the cases involving the Yaz birth control products, there is this news from recent discovery responses:

Bayer may have considering marketing the birth- control pills for unapproved uses  according to company e-mails.

Bayer reps discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of  premenstrual syndrome. Salespeople for Bayer unit Berlex Laboratories Inc., acquired in the 2006 purchase of Schering AG, received an e-mail that year from a company official citing a Woman’s Day magazine article about Yaz.

From the email: “This article is a nice way of using YAZ for PMS treatment instead of just focusing on the specific” class of women battling premenstrual dysphoric disorder, the most severe form of PMS, wrote Matt Sample, a Berlex sales consultant, according to a copy of the e-mail produced as evidence.

The FDA approved Yaz only for the most severe form of PMS. Yaz is approved to treat Treat premenstrual dysphoric disorder (PMDD).

Premenstrual dysphoric disorder—PMDD—is the most severe form of PMS. That is, the only actual difference between the two syndromes is the severity of their symptoms. Even that is not always clear, since there are severe cases of PMS that do not happen to meet the criteria for PMDD.

One characteristic that can distinguish PMDD from PMS is the intensity of the emotional or psychological symptoms. In PMS, physical symptoms or emotional symptoms can be the primary cause of concern. The related cardinal feature of premenstrual dysphoric disorder is the degree to which it interferes with work and relationships. Of course, severe (or even moderate) PMS can have a tremendous impact on a woman's enjoyment of life and her productivity at work and at home. Source

The FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. The FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report.


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