Heightened blood clot risk of certain birth control pills gets FDA's attention

Several scientific studies have shown that birth control pills Yaz and Yasmin increase the risk of blood clots. Yaz and Yasmin contain the synthetic hormone drospireinone, which is believed to cause dangerous, potentially deadly, blood clots, which can cause strokes, heart attacks, and pulmonary embolisms.  

Due to the known increased risk of blood clots with these birth control pills, the FDA has decided to address the issue to determine whether stronger warning labels should be required. Lawyers suing Bayer on behalf of patients injured by the drug have offered to share evidence they have uncovered in the litigation with the FDA. Turns out that documents produced in the Yaz/Yasmin litigation against Bayer suggest that Bayer withheld data from the FDA about the blood clot risks of their drugs. 

At least one document suggests that Bayer knew the reports of blood clots with Yasmin were significantly higher than those for three other oral contraceptives. Unfortunately for patients, Bayer pointed the FDA to another study, which it said was more definitive and did not show an increased risk of blood clots.

One of the experts retained in the litigation is Dr. David Kessler, a former FDA commissioner. He opined, "Based on the information I have reviewed, and it is my opinion, that Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin." 
Unfortunately, the FDA refused to accept the plaintiffs documents, citing that the deadline had passed.

One has to wonder if Bayer had provided the FDA with all of the information it had about the increased risk of blood clots, whether these newer generation birth control pills would have been approved. Of course, Bayer had a vested interest in getting the drug approved for sale, regardless of the known risk to women.

This is an example of "same song. second verse," wherein Big Pharma pushes the FDA to get a drug approved, witholds critical data about the true risks associated with the drug, makes millions off the drug, and only after countless people have been seriously injured or died will the FDA take action.

Oftentimes, dedicated trial lawyers who file lawsuits and expose the real truth about these drugs and the pharmaceutical companies that push them are able to get the drugs pulled off the market.

To learn more about prescription drug safety and the pharmaceutical industry, you can download a free copy of my book Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know.