The FDA has decided that it is going to ask that more warning information be added to birth control pills like Yaz. The desire of the regulators is to ensure that full warnings are provided about Yaz and its potential to cause blood clots that can lead other potentially fatal conditions.
The FDA had previously announced that with conflicting reports about just how dangerous Yaz is as it pertains to blood clots, there is a large need for the warning label clarification. In fact, FDA scientists said, “We believe that, because of the consistency in recent reports of an increased risk, product labeling should reflect that very real possibility,” Canada’s CBC News reported.
These blood clot dangers forced the FDA to launch an investigation into Yaz oral contraceptives after Bayer allegedly tried to hide the blood clots risks from them. The commissioner of the FDA, David Kessler, stated that the reports that Bayer sent them did not include a draft opinion from Bayer’s own researchers that showed Yasmin’s increased likelihood of causing blood clots over other birth control pills.
“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said. “The company also promoted the oral contraceptive for unapproved uses, particularly for treatment premenstrual syndrome.”
The FDA also has announced plans to block a move to remove the age limitations on patients looking to buy the “Plan B” contraception. At the moment, consumers cannot purchase the Plan B contraceptives unless they are at least 17 years old. However, the FDA does want to have the Plan B pills placed next to condoms in the drugstores, but Kathleen Sebelius, Human Services Secretary, intervened and prevented it.
Yaz has been a problem for Bayer for the past couple of years, once it got out that the pills came with serious adverse side effects. Some of those side effects include gallbladder disease and blood clots that can lead to heart attacks, strokes, pulmonary embolisms and deep vein thrombosis.
