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Paul Kiesel
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Will the FDA Recall Birth Control Products Yasmin & Ocella?

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From The Record:

After a birth control pill spent months in the spotlight during commercials aimed at correcting misrepresentations about it, the pill is now at the center of a St. Clair County lawsuit.

Kerry Sims filed a lawsuit Aug. 18 against Bayer and Walgreens, alleging her ingestion of the birth control pill Yasmin, which is also known as Yaz, caused her to experience a blood clot in her lung and infection surrounding the clot.

The suit comes after a commercial warning of some fallacies about the pill repeatedly ran on television for months.

"You may have seen some Yaz commercials recently that were not clear," the ad says. "The FDA wants us to correct a few points in those ads."

It goes on to say Yaz is used to treat the less serious premenstrual dysphoric disorder and moderate acne, not the more serious premenstrual syndrome or mild acne as Bayer once advertised.

But the $20 million Bayer spent on the commercial is not enough for Sims, who says the company failed to warn her about the pill’s dangers before she started taking it.

"Plaintiff Kerry Sims reasonably relied upon Defendants’ representations to her and/or her healthcare providers that Yaz/Yasmin was safer than other types of oral contraceptives for human consumption and/or use and that Defendants’ labeling, advertisements and promotions fully described all known risks of the product," Sims’s suit states.

However, such representations were misleading, Sims claims.

In fact, from 2004 through 2008, Yaz has reportedly caused more than 50 deaths, which occurred in some women as young as 17, the complaint says.

"These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, and stroke in women in their child bearing years," the suit states.

The pill’s danger possibly stems from Bayer’s use of drospirenone, a new type of progestin only used in Yaz and its generic counterpart, Ocella, according to the complaint. The drospierenone causes increased levels of potassium in the blood, which can lead to a condition called hyperkalemia if potassium levels become too high, Sims claims.

In turn, hyperkalemia can cause heart rhythm disturbances, which can then cause the slowing of blood to the heart, allowing for the formation of blood clots. Those clots can lead to heart attacks or can break off and travel to the lungs, causing pulmonary embolism, which is the condition Sims suffered from. In another scenario, the blood clot can travel to the brain where it can cause a stroke, according to the complaint.

Click here for the rest of the article.

2 Comments

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  1. Mary B. says:
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    “It goes on to say Yaz is used to treat the less serious premenstrual dysphoric disorder and moderate acne, not the more serious premenstrual syndrome or mild acne as Bayer once advertised.”

    This information is not only incorrect medically, but it is also a misinterpretation of the Yaz commercials being discussed.

    These commercials CLEARLY state that Yaz is approved for the treatment of the MORE serious PMDD, not the LESS serious PMS.

  2. GJELblogger says:
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    Additionally, yaz and yasmin are not the same drug. the amount of Ethinylestradiol they contain are different.