Status of the Yaz Recall
Even though there have been numerous studies on the severe side effects of Yaz, a recall still has not been issued. Though this drug has not been the focus of a recall, people who have been closely monitoring drugs safety are deeply worried about Yaz as compared to other similar oral contraceptives. These watchdogs have called for a strict evaluation about Yaz, the manufacturer and federal regulators.
On top of this, Bayer’s relation with the U.S Food and Drug Administration or FDA advisory committee has been doubted. It was revealed that members of the FDA advisory committee have been working with Bayer, which explains, for some people, why no recall has been issued.
Reasons for Yaz Recall
Yaz consumers developing severe medical conditions have come out a few months after the release of this drug in the market. Though there have been studies from funded industries which demonstrated that Yaz had not contributed to any of these medical conditions, private researchers have decided to take the initiative and investigate more about the said drug.
According to the U.S Food and Drug Administration, their study have showed that the risk of developing blood clots is raised by 74% for women taking oral contraceptives with drospirenone, an ingredient found in Yaz. Therefore, people asked for a recall for the drug. However, this was refuted by Bayer, the manufacturer of Yaz, stating that there were no other risks aside from the common side effects of oral contraceptive pills, thus, a drug recall was not necessary.
The issue with synthetic progesterone
Numerous women around the globe have switched to Yaz. With a promising ad as the best-yet birth control pill with several benefits, such as, losing weight, prevent acne and premenstrual mood swings, Yaz had no problem topping the sales market for oral contraceptives during its release in 2006.
Most oral contraceptives in the market contain synthetic estrogen and progesterone. While it is true that Yaz does have a synthetic estrogen similar to other birth control pills, its synthetic progesterone, drospirenone,is the questionable element.
In fact, drospirenone was associated to pulmonary embolism, higher risk of blood clots, strokes, heart attack, high potassium levels and even gallbladder diseases.
FDA Advisory Committee’s Conclusion on the Recall of Yaz
Though consumer watchdogs have been voicing out a Yaz recall, the Food and Drug Administration have not made an absolute decision about the argument, instead, they have assembled an advisory committee to take a closer look into this oral contraceptive pill. Advisory committees are often composed of independent specialists in a specific medical filed. This was a common approach of the FDA to help provide suggestions.
The research then came out with a result of: (Panel votes)
15 to 11 in favor of keeping this oral contraceptive pill available on the market and 21 to 5 for a drug change label.
A few days after, a nonprofit group called Project On Government Oversight (POGO) highly doubted this result along with the panel’s disapproval of including a warning label on Yaz to make consumers aware that there would be a risk of developing blood clots.
POGO’s executive director Danielle Brian pointed out that the joint committee’s conclusion should be disregarded because of the industry ties of 4 of the advisory committee members with Bayer.
Yaz victims still waiting for Yaz Recall
Though issues about Bayer’s relation to the FDA have been exposed, the unfortunate victims of Yaz are still waiting for changes. No Yaz recall has been made so far and Yaz still remains available on the market, only now with a 4 sentence label implying that there is a risk of developing blood clots when using oral contraceptives in general. An absolute action on the conflicts of interests is still awaited for the FDA.
As of October 2012, Bayer has received as much as 11,300 Yaz claims filed by patients who suffered from Yaz-related injuries and has paid $750 million to settle thousands from those lawsuits. These patients have used a legal system to assist them for these injuries.
If you are a victim of Yaz, fill out our case evaluation form to learn if you qualify for compensation now.