YAZ/Yasmine News for June 2011: Did Alleged Off-Label Use for Acne Result in Death?

Hat Tip to Pharmalot.com:

There are  contraceptive pills known as Yaz and Yasmin, and a recently filed wrongful death lawsuit claims that the pills were used off label to treat a young woman's acne problem. The product labeling on Yaz does indeed say that states that the pill may be prescribed to treat moderate acne for young ladies who are at least 14, provided that  the patient wished to have an oral contraceptive for birth control. Both drugs contain drospirenone, and her patient records referred to Yasmin and Yaz simultaneously.

After she began her course of treatment, she was admitted to a North Carolina hospital and then later died of bilateral pulmonary emboli.

Read more about this case at Pharmalot, whose link is: http://www.pharmalot.com/2011/06/bayer-off-label-promotion-of-yasmin-birth-control-pill-killed-our-daughter-lawsuit/

In late May, 2011, the FDA issued this news:

FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone

he U.S. Food and Drug Administration (FDA) is informing the public about new information^1,2 that is being assessed as part of FDA's ongoing safety review of birth control pills that contain drospirenone. This review will further evaluate the risk of blood clots in women who use these products. 

Facts about Drospirenone

Used in combination with an estrogen in oral contraceptives.  Brand names of drospirenone-containing products include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral. In addition to prevention of pregnancy, some birth control pills containing drospirenone are also approved to treat symptoms of premenstrual dysphoric disorder (PMDD), to treat moderate acne, and to raise folate levels, in women who choose to use an oral contraceptive for birth control.

Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy.


Two recently published studies reported a greater risk of blood clots for women taking birth control pills containing drospirenone as compared to the risk in women taking birth control pills containing another progestin known as levonorgestrel.

Previously published studies have also addressed the risk of blood clots in women using birth control pills containing drospirenone. These studies had conflicting findings--two postmarketing studies required by the FDA or European regulatory agencies did not report any difference in the risk of blood clots between drospirenone-containing products and products containing levonorgestrel or other progestins. Two other publications in 2009, however, reported that the risk of blood clots is higher in women using drospirenone-containing products than in women who use levonorgestrel-containing products.

^{More here:} 

http://www.fda.gov/Drugs/DrugSafety/ucm257164.htm