Earlier this week The Washington Times wrote an article about Yaz and Yasmin. Comfortably couched in the middle is this snippet:
“The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all contraceptives, including ours,” Ms. Talarico [of Bayer] said.
The FDA agrees.
“The safety profiles for Yasmin and other combined hormonal contraceptive products containing estrogen . . . are similar,” [FDA] spokeswoman Karen Riley said.
The gist of the article is that young and otherwise healthy woman are suffering blood clots, and suing Bayer because they believe YAZ and Yasmin birth control pills are the cause. It goes through Bayer’s problems, including the FDA-mandated $20 million corrective ad campaign, and the quality control problems besieging Bayer’s manufacturing plant.
But, this excerpt is out of context. It is hard to know what it means. On the one hand, it may acknowledge what we all know—the range of possible side effects of YAZ and Yasmin are the same as for most other birth control pills. That is a fact. Plaintiff’s YAZ lawsuits are alleging that YAZ and Yasmin have an increased risk of those “side effects,” however. Note here that “side effects” can include death.
Then, the comment by the FDA spokesperson is especially confusing—the safety profiles are similar. What does the FDA base that on? What studies are they citing? The science behind this is, at the very least, contested regarding whether YAZ is more dangerous than other birth control pills. And, the studies are continuing, so it seems irresponsible (and atypical) for the FDA to take a position, different from their usual conservative stance. Perhaps the FDA is simply acknowledging that all birth control pills have similar “side effects.” But, it sounds suspiciously like they are claiming they all have the same degree of safety (i.e., are likely to cause “side effects” with the same frequency).
At this point, the trend of the studies is to prove otherwise.