Public Citizen Wants Yasmin Birth Control Banned

Washington, DCA birth control pill that is classed as a third-generation contraceptive is the cause of concern for health advocates concerned with the potential for the Yasmin pill to foster blood clots. Yasmin, manufactured by Bayer and also sold as a generic, has been placed on a 'do not use' list published by Public Citizen, who petitioned the US Food and Drug Administration (FDA) in 2007 to ban Yaz birth control.

US Recall News, on December 11th of last year reported that Yasmin had been under heavy scrutiny for potential links to serious adverse reactions including heart attack, stroke and blood clots.

However it was a year earlier, on February 6th 2007 that Public Citizen petitioned the FDA to ban the increasingly popular third-generation Yasmin birth control product entirely.

The public advocacy group had numerous reasons to support their stance.

For one, Public Citizen claimed that oral contraceptives containing desogestrel just about doubled the risk of developing blood clots (venous thrombosis), representing 30 cases for every 100,000 women each year as compared with 15 cases for every 100,000 users for second-generation oral contraceptives (OCs).

Public Citizen maintained in its petition that the banning of third-generation contraceptives such as Yaz birth control would save hundreds of women each year from the sometimes-fatal adverse effects.

The advocacy group, in a letter signed by a handful of Public Citizen luminaries including Dr. Sydney Wolfe, referenced one study that found 2 percent of patients with a first-recognized venous thromboembolism (blood clot) who were younger than 40 years of age, "died in hospital, most of them probably from a pulmonary embolism."

The petition is reproduced in full, on the official web site of the US Food and Drug Administration.

According to the Public Citizen petition, third-generation oral contraceptives such as the Yasmin pill were developed in the 1980s and differed from their second-generation cousins with regard to progestin component. The former contain desogestrel in the US, and proved popular due to a diminished androgenic effect inherent with second-generation products. Users of third-generation OCs noted diminished incidents of facial acne and the growth of unwanted hair.

Since Yasmin birth control was introduced to the US market in 2001, sales have continued to climb. US Recall News notes that revenue from the product reached nearly $500 million in 2007.

What's more, the potential adverse effects associated with the Yasmin pill are not unlike other birth control products, according to US Recall News. Side effects include, but are not limited to myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, hypertension, tender breasts, mood swings, depression, weight gain and edema.

The active ingredients for Yasmin, the estrogen ethinyl estradiol and the progestin drospirenone, can work against the body's normal mechanism for regulating salt and water balance, a situation that can lead to potentially serious heart and health problems in some high risk patients.

Contributors to the US Recall News site have some heartbreaking stories to share. One newlywed named Megan wrote that she had been taking Yasmin birth control for a year before she stopped in an effort to start a family. Two years ago she stopped in an effort to try to conceive, but has not achieved a natural menstrual cycle since stopping. Last June Megan was given progesterone in an effort to re-engage her menstrual cycles, however a year has passed and still no sign of one. Megan says her co-workers are envious that she doesn't have to put up with having a regular period, but given the fact Megan and her new husband are trying to start a family, the loss of opportunity is devastating.

Then there is Kelly, who wrote on June 16th, "My daughter was on Yasmin for two months and she is 18. She had a pulmonary in both lungs. Alot of IVs, breathing treatments, sick at her stomach (and) sharp stabbing pains in her back. She (was) in very good health before she took these pills. Never smoked ever, and did not drink. She has to do a lung doc. (sic) every week, blood tests and has to take blood thinners for a long time. PLEASE USE SOMETHING ELSE. IT'S NOT WORTH THE CHANCE!" (Large caps from the author)

And then there is Robert Robinson whom, on December 24th of last year offered up two short, but compelling sentences. "My wife died of a DVT in 2007 most likely caused by taking Yasmin. I miss her more then (sic) anything else in the world."

Public Citizen made the point in its petition to the FDA that the use of any combined oral contraceptives has "long been associated with an increased risk of venous thrombosis." However, in its petition Public Citizen references three independent studies published in December 1995 that all conclude third-generation OCs presented twice the risk of venous thrombosis (blood clots) when compared with second-generation products.

Public Citizen wants Yasmin gone. So far, the FDA has yet to comply.

Public Citizen has always advocated that it is important for women to have choices in their quest for responsible and reasonable birth control. However, a woman's health and ultimate survival should not be adversely threatened, as Yasmin birth control is allegedly thought to do. Yaz birth control, on the market since 2001, may contribute improvements with regard to the presence of acne and unwanted hair. However, the risk of blood clot and other serious adverse reactions to the Yasmin pill may not be worth the risk.