Wednesday, May, 22, 2013

Yaz Side Effects Blog & News

Tuesday, October 27, 2009 - 11:08

According to a recent decision by the Judicial Panel on Multi District Litigation, the United States District Court for the Southern District of Illinois will oversee and hear all drug defect cases brought to federal court involving the prescription birth control drugs Yaz, Yasmin, and any other contraceptive medications using the key drug drospirenone. The case, Multi District Litigation No. 2100, reflects state-to-state allegations by women using the prescription birth control drugs that the makers of Yaz, Yasmin, and other related drugs are liable for wrongful marketing and sales practices, resulting in products liability litigation.

Transferee Judge David R. Herndon of Southern Illinois will oversee all federal litigation involving claims against Yaz and related drugs. The decision to turn the MDL over to the Southern Illinois judge was announced on October 1, only seven days after the initial hearing to consolidate all cases into a MDL. This is significant in that it shows an urgency to develop clear and concise determination in the causes of injury and death, as well as the judicially-imposed responsibility of Bayer and other manufacturing companies.

The drugs Yaz, Yasmin, Ocella, and other related contraceptives have been linked to a variety of side effects, from mild cases of headaches and vomiting to serious instances of blood clots, strokes, and heart attacks. Originally prescribed for use in birth control, premenstrual pains, and mild acne, these drugs containing drospirenone cause an increase of estrogen and potassium in the bloodstream, and these factors contribute to complications that can lead to pulmonary embolisms, deep vein thrombosis, and the aforementioned strokes and heart attacks.

Within a week of the decision to accept all cases against Bayer and other related prescription drug manufacturers as MDL-2100, Bayer admitted that as many as 129 lawsuits had been served involving Yaz and Yasmin. As the cases will now cross only the desk of Judge Herndon, it is estimated that thousands of cases will be involved in this MDL in the coming months.

On average, Bayer earns $1.8 billion worldwide for the sales of Yazmin, and while cases and allegations continue to pile up, the prescription contraceptive is still readily available and continues to be the most used oral contraceptive in the United States. Bayer contends that many of the side effects that are involved in current lawsuits and allegations are stated clearly within all product warning labels.

Thursday, October 15, 2009 - 12:16

Bayer Healthcare Pharmaceuticals is pulling a 60-second ad for birth-control pill Yaz. The move comes after the U.S. Food and Drug Administration expressed concerns that two ads for the drug go too far in suggesting the drug could help overcome PMS and acne.

The FDA criticized this Yaz ad, 'Balloons,' which is still in rotation.

The FDA issued a warning letter to the company about the ads, created by Y&R. One of the ads had already been taken off the air.

The warning letter said that while Yaz had been approved as a contraceptive and a treatment for PMDD (premenstrual dysphoric disorder) and in some cases for acne, the TV ads could be viewed as suggesting the drug also remedied PMS and broader conditions of acne.

No clear distinction
The FDA cited the failure of an ad called "Not Going to Take It" to sufficiently distinguish between PMDD and PMS. The drug treats PMDD but isn't approved to treat PMS. The letter said the pictures of what it called euphoric, playful women singing "We're not gonna take it" as they kick, punch and push words describing symptoms such as "irritability," "moodiness," "bloating" and "feeling anxious" suggested that Yaz would treat PMS.

The FDA had similar criticism of a comparable ad still in rotation. It also said the acne relief mentioned in the ad overstates the drug's effect.

Bayer, in a statement today, said it will respond to the FDA's letter and work with the agency with regard to the other promotional materials in the campaign.