Birth control medication is supposed to prevent an unplanned or unwanted pregnancy—not cause serious blood clots, heart attacks, strokes, or death.
Yaz, a similar but newer version of the “fourth generation” contraceptive Yasmin promises more than birth control. Approved by the Food and Drug Administration (FDA) in 2006, the pill’s maker, Bayer, declared it’s also the remedy for premenstrual dysphoric disorder. Not only will it alleviate the nasty emotional and physical symptoms of PMDD, it will also treat acne.
This multifaceted drug seems too good to be true and it is. Yaz lawsuits are streaming in from women around the U.S. claiming horrible side effects from the contraceptive pill: blood clots, deep vein thrombosis, pulmonary embolism, strokes, heart attacks, and death.
Five years prior to FDA approval, Yaz’s predecessor, Yasmin was scrutinized and cited in Europe for causing the same afflictions. The Dutch College of General Practitioners took a cautionary but staunch approach that recommended prescribing “second generation” birth control pills instead of “fourth generation” ones. The latter group contains progestin drospirenone (DRSP), a synthetic form of progestin that might be the impetus for blood clots and other life threatening maladies.
According to the federal agency, drospirenone is linked to hyperkalemia, a condition caused by exorbitant amounts of potassium in the blood. In high-risk patients this could lead to critical heart and health problems. Obviously, women who are predisposed to hyperkalemia must avoid Yaz, Yasmin, and the generic, Ocella.
As with many misleading advertising campaigns, the FDA criticized Bayer for deceptive claims and overstating Yaz’s benefits…such as for acne use.
In a 2008 letter, the agency warned Bayer that two Yaz television ads contained ‘fast moving images and background music that might be distracting to viewers’ while the side effects part was running. An example is fatal blood clot information quickly given while various images danced across the screen.
One ad featured women singing “we’re not gonna take it” while kicking, punching, and pushing balloons imprinted with words such as ‘moodiness’, ‘bloating’, and ‘irritability,’ all typical symptoms associated with PMS.
Another ad has a melodic song “Good Bye to You” with the ladies releasing the same silly balloons. Would someone watching actually believe that Yaz could relieve all the PMS symptoms scribbled on the balloons? Apparently.
“These complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life threatening,” the letter said.
Whether or not consumers buy into this type of hype, Bayer was slapped with a $20 million dollar mandate by the FDA to “remedy” their misleading information. Aside from a more truthful advertising campaign, they must receive FDA approval before airing future television spots.
Bayer must also comply with the agency on TV and print ad suggestions; and “clearly and conspicuously” disclose what the FDA has approved in its print ads regarding which symptoms Yaz can treat, according to BizJournal.
Will this make a difference? $20 million of new advertising won’t help the women presently suffering. Hopefully, our legal system will.