Public Citizen Petitions FDA To Ban Oral Contraceptives Containing Desogestrel

Public Citizen’s Health Research Group filed a petition with the Food and Drug Administration (FDA) on February 6, 2007, to ban the sale of all third-generation oral contraceptives (OCs), which double the risk of potentially life-threatening blood clots compared to second-generation birth control pills.

Blood clots typically form in a patient’s legs, but they can travel to another part of the body and block blood flow. Blood clots that travel and block blood flow to the lungs are known as pulmonary thromboembolism, a condition which can be fatal.

Between November 2005 and October 2006, American women filled an estimated 7.5 million prescriptions for third-generation oral contraceptives in U.S. pharmacies. Banning third-generation oral contraceptives will potentially save hundreds of young women a year from needlessly developing blood clots and their disabling, sometimes fatal consequences.

Desogestrel-containing oral contraceptives were listed as DO NOT USE drugs in the May 1999 Worst Pills, Best Pills News  because these drugs double the risk of blood clots and do not protect women against pregnancy better than other, safer alternatives. Further, there is no acceptable evidence that these drugs provide any therapeutic advantage in relieving the adverse effects of second-generation OCs, such as unwanted hair growth (hirsutism) or acne.

The full text of the petition is available at http://www.notmypill.org/, a new Public Citizen Web site designed specifically for the third-generation OC petition campaign. Visitors to this Web site can see a brief YouTube video explaining the problem with this form of birth control. Consumers also have the opportunity to send comments on Public Citizen’s petition directly to the FDA commissioner asking that only the safest birth control options remain available on the market. Within a month of the petition being filed, over 12,000 people sent comments to the FDA in support of Public Citizen’s initiative.

Generational differences
Most oral contraceptives contain a combination of hormones – estrogens and progestins. The most commonly used estrogen in combined oral contraceptives is ethinyl estradiol. Second- and third-generation oral contraceptives differ only in their progestin component. Third-generation oral contraceptives contain desogestrel or gestodene. Gestodene is not marketed in the United States.

Second-generation oral contraceptives contain norgestrel, levonorgestrel, norethindrone, or norgestimate. Norgestimate is sometimes referred to as a third-generation product. However, many researchers consider norgestimate more like a second-generation progestin because norgestimate is partially broken down (metabolized) into a second-generation progestin. Studies showing increased risk of third-generation contraceptives are almost exclusively limited to desogestrel or gestodene.

Third-generation oral contraceptives were developed in the 1980s with the aim of producing a contraceptive that had fewer of the masculinizing adverse effects (such as hirsutism and acne) typically associated with the first- and second-generation products.

Strong FDA labels on third-generation OCs
Oral contraceptives are one of the few families of drugs that require the distribution of FDA-approved written drug information with each new and refill prescription. This information should be attached to, or found in, the package of all oral contraceptives dispensed in the United States. The following is the statement about the risk of blood clots taken directly from this FDA-approved information:

Risk of developing blood clots

Blood clots and blockage of blood vessels are one of the most serious side effects of taking oral contraceptives and can cause death or serious disability. In particular, a clot in the leg can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blockage of the vessel carrying blood to the lungs. The risks of these side effects may be greater with desogestrel-containing oral contraceptives, such as [name of third generation oral contraceptive product] (desogestrel and ethinyl estradiol) Tablets, than with certain other low-dose pills. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.

Women using oral contraceptives should consult the FDA-approved written drug information regularly for updates about potential newly recognized side effects.

All oral contraceptives sold in the U.S. carry a black box warning about the increased risk of cardiovascular side effects in smokers who use oral contraceptives. A black box warning is the strongest type of warning that the FDA can request from a manufacturer. Here is the text of the oral contraceptive black box warning:

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Lists of safer, equally effective second-generation oral contraceptives can be found in the 2005 edition of Worst Pills, Best Pills and online at worstpills.org. A list of oral contraceptives that contain desogestrel accompanies this article.

What You Can Do
If you are considering oral contraceptives, avoid the third-generation products and opt for the equally effective, safer second-generation drugs.

If you are currently using a third- generation oral contraceptive, ask your healthcare provider to change the prescription to a second-generation product.