Sometimes, it takes millions to convince the world of something. Other times, it could all be pushed over the edge by just a single instance. The latter is the case when discussing the decision of the Food and Drug Administration to finally legally require pharmaceutical companies to issue warning labels on their birth control patches. While there have been patients and doctors who have tried to get this to happen over the years, all it took was one case of a very real risk of death to finally get the FDA to do what many feel it should have done from the very start.
The issue stems from the risk of some of the synthetic compounds that hormone-based birth control methods release into the body can cause blood clots. These blood clots, specifically known as venous thromboembolisms (VTEs), can be dangerous to people due to the damage they can do if they manage to travel to the lungs. These clots, an exceedingly rare side effect of birth control hormones, have been known to cause highly fatal pulmonary embolisms. As previously mentioned, VTEs are among the rarest – if not the rarest – of the possible side effects of the pill and the patch. For many years, the risk was considered to be so low and insignificant for the pill that it was largely ignored by the world. However, for those many years, the same believed to be a false assumption for the patch.
The old suspicion of the birth control patch releasing hormones more directly into the body, thereby increasing the risks of side effects, has only recently been confirmed. The blood clots in question, in particular, have been a cause of much concern over the years. Women's groups and concerned medical professionals have noted the possible effects of the increased hormones and the higher risk of VTEs in the patches and have been trying to convince the FDA to issue orders so that an appropriate warning can be issued. However, the FDA has managed to uphold its initial ruling that the risks for the patch are as low as those for the pill, up until recently. Along with one prominent incident, a scientific study also served as the final confirmation needed for the FDA to finally take notice. Some of the more extreme elements applauded the FDA order, but believes it would be more prudent to have the birth control patches banned from the US market.
In their defense, pharmaceutical companies stated that the risks of using the patch are being drastically overplayed. They claim that the patches do not pose an increased risk for healthy females; at least, not any more than what the pill would. However, they did openly admit that certain lifestyle, genetic, and health factors could come into play to increase the risks of side effects, including the formation of VTEs. According to a number of pharmaceutical companies, these factors can include things such as smoking, alcoholism, a history of substance abuse, hormonal imbalances, and genetic abnormalities that affect the blood. They also mentioned that patients need not use the patches, and that there were plenty of birth control alternatives available to them.