Consumer Group Petitions FDA To Ban Some Contraceptive Pills

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Main Category: Women's Health / Gynecology
Also Included In: Cardiovascular / Cardiology;  Pharma Industry / Biotech Industry;  Pregnancy / Obstetrics
Article Date: 07 Feb 2007 - 0:00 PDT

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US consumer group Public Citizen is petitioning the Food and Drug Administration (FDA) to ban certain types of contraceptive pills. The group wants contraceptive pills containing the hormone desogestrel, known as third generation pills, taken off the market because they have an increased risk of blood clots, they say.

The women's reproductive health and family planning group Planned Parenthood Federation of America opposes the move by Public Citizen saying it was misleading and using out of date information to justify their claims.

Filing the petition yesterday, Public Citizen said that American women took 7.5 million prescriptions for oral contraceptives containing desogestrel during the year ending in October 2006. They say that banning these pills could prevent hundreds of women form getting blood clots in their veins, or venous thrombosis, which can sometimes block blood flow leading to disability, and can even be fatal because the clots can travel to the lungs and cause pulmonary embolism.

They estimate that desogestrel causes clots in 3 out of every 10,000 women who take the pills.

As well as sending a petition to the FDA, Public Citizen has started an online campaign on safe birth control pills highlighting what they see as the danger of third generation oral pills. They have launched a video on YouTube which includes a place where people can sign up to the petition.

Desogestrel is a type of progestin, a synthetic hormone similar in biological action to naturally occuring progesterone. Combination oral birth control pills have synthetic versions of estrogen and progestin. The third generation ones use desogestrel as the progestin component, while the earlier versions use norgestrel, levonorgestrel or norethindrone.

Desogestrel avoids certain side effects found with the earlier contraceptive pills such as acne and increased hair growth.

According to Dr Sidney Wolfe, Director of Public Citizen's Health Division, the government should take the third generation oral birth control pills off the market because they offer no unique benefit over the older and safer pills.

Dr Wolfe said that "While the use of any type of combined oral contraceptive holds an increased risk of venous thrombosis, third-generation birth control pills double that risk without preventing pregnancy any more effectively than older pills do."

According to Public Citizen, the oral birth control pills that contain desogestrel are: Desogestrel and Ethinyl Estradiol (Duramed/Barr and Watson Pharmaceuticals), Desogestrel and Ethinyl (Duramed/Barr), Desogen (Organon), Velivet (Duramed), Kariva (Duramed/Barr), Mircette (Duramed/Barr), Apri-28 (Duramed/Barr), Ortho-Cept (Ortho-McNeil), Reclipsen (Watson) and Cyclessa (Organon).

Planned Parenthood's Vice President of Medical Affairs, Vanessa Cullins, agreed that compared to not taking them, the pills do carry a slight risk of blood clots. But she said you have to see it context. The risk of blood clots in women who are not pregnant and not on any form of oral contraceptive is already 4 out of every 100,000. Taking any form of oral contraceptive increases that risk to between 10 and 30 in 100,000. Desogestrel is linked to a slight increase in an already very rare event, she said.

When the UK health authorities drew attention to the risk of blood clots from taking oral contraceptives in the mid 1990s this was followed by a sharp increase in the rate of pregnancies and abortions, she added.

Click here to go to Public Citizen website

Click here to go to Planned Parenthood website

Written by: Catharine Paddock
Writer: Medical News Today


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