Dangers of Flibanserin

Though it has been rejected twice by the FDA, Sprout Pharmaceutical has once again pushed for the approval of its drug flibanserin, also commonly referred to as Viagra for women. However, this time Sprout’s drug has been approved by the FDA despite the common risk associated with the drug.

Although the mission of the FDA, according to their website, is to ensure that drugs marketed in the U.S. are safe and effective, it is not surprising that often times, the FDA can fall short of accomplishing this due to outside forces and limited drug testing. Flibanserin is the latest example in the long list of drugs the FDA has approved even with knowledge of its negative side effects. These side effects include low blood pressure, fatigue, and fainting. In addition, dangers have been sited when the drug is used in combination with alcohol and birth control. There is also concern as the unknown effects the drug will have on pregnancy, fertility, and breast cancer.

The surprising approval comes amidst criticism citing the FDA’s failure to take female sexual dysfunction seriously. The FDA itself has acknowledge that flibanserin’s increase in sexually satisfying events among women per month by only 0.5 to 1 is questionable as a sufficient treatment to help women with low sex drives. They have also questioned whether the observed effects outweigh the safety concerns. Although it was rejected unanimously just five years ago, this year the drug has been approved by a vote of 18 to 6.

Unfortunately, in situations similar to this, it often takes a number of people being harmed before a drug is recalled or discontinued by the FDA. For example, according the website of the personal injury lawyers at Williams Kherkher, in 2010 it took 941 people suffering from instances of cardiac arrest before the FDA recalled the popular GranuFlo dialysate.

Understanding that there are risks involved with the approval of flibanserin, the FDA has added several safety restrictions to the drug. Panelists suggest that the FDA require special certification for doctors who may prescribe the drug. However, this is often ineffective in protecting patients. For example, Risperdal is only one of many drugs that the website of Williams Kherkher says has been wrongly prescribed by for unapproved, “off-label” uses.