If you have ever taken any kind of medication, you have likely noticed the list of potential risks and side effects. For example most antibiotics have a do not drink alcohol while on this medication warning. A common warning for birth control is a raised risk of blood clots particularly in women over 35 or women who smoke. The manufacturers of prescription medications are supposed to keep track of any potential side effects during trial periods and let the FDA know what they are so the FDA can weight them against the benefits of the medication. If approved the medications then come with warnings about the potential effects. Having risks will not necessarily preclude a medication from getting FDA approval but it is a possibility.
Bayer, the company that produces YAZ and Yasmin, a family of birth control pills that use drospirenone (a synthetic progestin) reported similar levels of blood clot risk to previous types of birth control pills when submitting data for the drugs to be approved. Newer reports are actually showing that medications containing drospirenone may actually have a 1.5 times higher risk of blood clots compared to birth control pills that use different hormones. This has led many to speculate that Bayer may have intentionally provided false information about the safety of the YAZ family of pills. There are currently over 10000 pending lawsuits over it.
Bayer is also accused of falsely advertising the benefits of YAZ and what it has been approved to treat. In the U.S. doctors may prescribe a medication for uses other than what it has initially been approved by the FDA for, however the manufacturer may not advertise for anything other than the approved uses. YAZ was approved by the FDA to treat a severe form of PMS (Pre-Menstrual Syndrome) known as PMDD (Pre-Menstrual Dysphoric Disorder) and moderate acne. In their commercials however, YAZ is advertised to treat PMS and mild acne. This led to an inquiry by the FDA and Bayer having to create a new series of advertisements clarifying what the approved uses for YAZ are.
In spite of all this controversy there is no disputing over the effectiveness of YAZ as a birth control method. The FDA does not seem to be considering removing its approval of YAZ and other drospirenone containg pills, but they are meeting on December 8th to decide if the warning labels that go with it should be altered to include warnings about the higher blood clot risk. This is not a new idea; Ortho Evra- the birth control patch, already has a warning label for its increased blood clot risk.
Even with the raised risk, the chances of experiencing a blood clot for women under 35 who are none smokers is still relatively low so many doctors say they will continue to prescribe YAZ and other drospirenone containing birth control prescriptions because it is more effective than older types and comes with fewer mild side effects. For many women the raised risk of blood clots it worth getting rid of severe PMS symptoms. What do you think, is not getting pregnant worth a slightly higher risk of clotting or would you ask your doctor for a different prescription if they recommended YAZ?