Public Citizen- an advocacy group for the protection of consumer health has come out strongly against the FDA.
According to them the fact that third generation oral contraceptives have twice the risk of potentially fatal blood clots, a side effect of the synthetic hormone used in it, than second generation birth control pills, was known to the FDA, yet it has allowed the sale of these drugs for the last 12 years.
"While the use of any type of combined oral contraceptive holds an increased risk of venous thrombosis (blood clots), third-generation birth-control pills double that risk without preventing pregnancy any more effectively than older pills do" states Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
All contraceptive pills carry a very low risk of blood clots (due to venous thrombosis) that, even more rarely, can travel to the lungs and kill. It is a side effect of the pills' hormones, estrogen and progestin.
Second-generation birth-control pills contain norgestrel, levonorgestrel or norethindrone while third generation pills contain a synthetic type of progestin called desogestrel.
Third-generation birth-control pills were developed in the 1980s in an attempt to create an oral contraceptive that caused fewer side effects than earlier versions such as acne and unwanted hair.
In December 1995, three independent studies concluded that third-generation pills were about twice as likely as second-generation versions to cause blood clots. This was followed by other studies with similar results.
Accordingly users who may be subject to these potentially fatal blood clots are 30 in 100,000 as against 15 in 100,000 in those taking second-generation pills.
Yet says Vanessa Cullins, of Planned Parenthood, an organization which is opposing Public Citizens petition, ``Desogestrel pills should not be taken off the market; they are safe and very effective.
"It is true that birth-control pills raise the incidence of blood clots over not using them, yet you have to put it into context. For women who aren't using any form of hormonal birth control and who aren't pregnant, the risk is four out of 100,000. For all birth-control pills, the risk is 10 to 30 in 100,000, while in pregnancy the risk of blood clots is 60 in 100,000.
``What we are talking about is a slight rate of increase in a very rare event. For some women desogestrel is a better choice than other drugs'', she concludes.
Yet, Public Citizen argues that since studies have shown third generation pills do not have any added advantage over second generation pills, why continue with a pill that has double the risk of blood clots?