2008 Woodie Awards
Controversial pills stay on shelves
Allison Stice
Issue date: 2/20/07 Section: News
Though a prominent consumer advocacy group is urgently calling for certain types of birth control pills to be pulled off the market, University Health Center officials said they will continue carrying the popular pills, which studies have found to contain a hormone that doubles the risk for blood clots.
The group, called Public Citizen, filed a petition with the FDA Feb. 6 calling for a ban on all third-generation birth control pills containing the hormone, called desogestrel. The health center carries several third-generation pills, including Desogen, Mircette and Cyclessa, which contain desogestrel.
Health center physician Shelley Parr describes the third-generation pills as "quite popular," with Ortho Tri-Cyclen Lo remaining the most in demand due to its cheaper cost.
"Years ago when these pills first came out, the medical community was worried, but over time, we have not seen a significant increased risk in patients anecdotally," Parr said.
Third-generation oral contraceptives offer no greater protection against pregnancy than older pills, but patients choose them because of other benefits, Parr said.
"Some of the side effects are more desirable," she said. "They're better for acne, decrease testosterone and they also have a longer half-life, which means they're more forgiving if a patient skips a pill."
But for some students, the benefits simply aren't worth the danger of blood clots.
"I don't see how the effectiveness could be worth the increase in risk," said freshman letters and sciences major Amanda McCarty.
Newer oral contraceptives differ from older ones in their progestin, or hormonal, component. According to the petition, desogestrel is a progestin that is too risky to be sold. In addition to causing a greater disruption of normal menstrual patterns, including stopping periods altogether in half of all users, the hormone is responsible for 30 clots per 100,000 users, as opposed to 15 per 100,000 in older formulas, according to Trent and West Midlands Regional Medicines Information Services, which maintains a website on medical news.
An FDA spokeswoman said the FDA is reviewing the petition, which cites information from 35 different studies conducted since 1995 by universities, doctors and health organizations.
Blood clots, also referred to as venous thrombosis, are a risk associated with all oral contraceptives. Clots manifest themselves in the lower limbs, though they can also occur in veins of the brain, upper limbs and abdomen. They can be identified by pain, swelling and redness in the area. The danger comes when the clot dislodges from the vein and travels to the lungs or other important organs, blocking crucial blood flow.
"With technology and what we now know about women's health, I would think newer pills would be safer," said freshman letters and sciences major Dana Halpern.
Even when the damage from clots isn't fatal, one-half to one-third of all patients develop post-thrombotic syndrome - a chronic illness of ulceration, redness, swelling and pain, according to the petition.
"It's likely that women who get blood clots have a genetic predisposition to clotting," Parr said.
The health center currently offers a $185 blood test that looks for a genetic mutation that causes a natural inclination toward clotting.
However, results from a study of fatal pulmonary embolism in New Zealand women show that in a series of deaths from clots, physicians could not have foreseen the risk.
Because 7.5 million prescriptions for contraceptives containing desogestrel were filed last year, the petition states that by pulling third-generation pills from the market, the lives of thousands of young women could be saved. The advocacy group released a video on YouTube to warn younger users about the dangers of the newer pills.
Patients who have suffered from blood clot-related illnesses due to desogestrel may be eligible for a class action lawsuit.
Contact reporter Allison Stice at sticedbk@gmail.com.
The group, called Public Citizen, filed a petition with the FDA Feb. 6 calling for a ban on all third-generation birth control pills containing the hormone, called desogestrel. The health center carries several third-generation pills, including Desogen, Mircette and Cyclessa, which contain desogestrel.
Health center physician Shelley Parr describes the third-generation pills as "quite popular," with Ortho Tri-Cyclen Lo remaining the most in demand due to its cheaper cost.
"Years ago when these pills first came out, the medical community was worried, but over time, we have not seen a significant increased risk in patients anecdotally," Parr said.
Third-generation oral contraceptives offer no greater protection against pregnancy than older pills, but patients choose them because of other benefits, Parr said.
"Some of the side effects are more desirable," she said. "They're better for acne, decrease testosterone and they also have a longer half-life, which means they're more forgiving if a patient skips a pill."
But for some students, the benefits simply aren't worth the danger of blood clots.
"I don't see how the effectiveness could be worth the increase in risk," said freshman letters and sciences major Amanda McCarty.
Newer oral contraceptives differ from older ones in their progestin, or hormonal, component. According to the petition, desogestrel is a progestin that is too risky to be sold. In addition to causing a greater disruption of normal menstrual patterns, including stopping periods altogether in half of all users, the hormone is responsible for 30 clots per 100,000 users, as opposed to 15 per 100,000 in older formulas, according to Trent and West Midlands Regional Medicines Information Services, which maintains a website on medical news.
An FDA spokeswoman said the FDA is reviewing the petition, which cites information from 35 different studies conducted since 1995 by universities, doctors and health organizations.
Blood clots, also referred to as venous thrombosis, are a risk associated with all oral contraceptives. Clots manifest themselves in the lower limbs, though they can also occur in veins of the brain, upper limbs and abdomen. They can be identified by pain, swelling and redness in the area. The danger comes when the clot dislodges from the vein and travels to the lungs or other important organs, blocking crucial blood flow.
"With technology and what we now know about women's health, I would think newer pills would be safer," said freshman letters and sciences major Dana Halpern.
Even when the damage from clots isn't fatal, one-half to one-third of all patients develop post-thrombotic syndrome - a chronic illness of ulceration, redness, swelling and pain, according to the petition.
"It's likely that women who get blood clots have a genetic predisposition to clotting," Parr said.
The health center currently offers a $185 blood test that looks for a genetic mutation that causes a natural inclination toward clotting.
However, results from a study of fatal pulmonary embolism in New Zealand women show that in a series of deaths from clots, physicians could not have foreseen the risk.
Because 7.5 million prescriptions for contraceptives containing desogestrel were filed last year, the petition states that by pulling third-generation pills from the market, the lives of thousands of young women could be saved. The advocacy group released a video on YouTube to warn younger users about the dangers of the newer pills.
Patients who have suffered from blood clot-related illnesses due to desogestrel may be eligible for a class action lawsuit.
Contact reporter Allison Stice at sticedbk@gmail.com.
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