(PRWEB) December 13, 2011
The US Food and Drug Administration (FDA) advisory committee voted 21-5 on Thursday that labeling on Bayer’s popular Yaz and similar birth control pills is inadequate and should be revised to better reflect the higher risk of blood clots associated with these drugs, compared with older oral contraceptives. Ennis & Ennis, P.A. explains the panelists want the label to make clearer the potential risk of blood clots in the legs and lungs from taking the pills, and that clots can be fatal. Currently the label only informs women about the conflicting studies on the blood clot risks. Attorney Holly Ennis with Ennis & Ennis, P.A. comments, “I was really hoping the committee members would look at the consumer’s best interests and remove Yaz and these types of birth control pills from the market entirely, especially considering that there are so many other birth control pill options available to women that do not carry the increased risk of blood clots. I only hope that the new label truly prevents young women from unnecessary suffering because it is too little too late for my clients.”
The panel members went on to vote 15-11 that the drugs’ benefits as a contraceptive outweigh the risks. This vote was a bit more controversial due to conflicting data. Seven independent studies have revealed that drospirenone, the artificial hormone found within Yaz and Yasmin, increases the risk of developing potentially fatal blood clots. However, Bayer claims that their studies do not reveal that increased risk. Interestingly, one of the seven independent studies was performed by the FDA and that study revealed an almost 75% increased risk of developing blood clots when compared to older generation birth control pills.
Despite this overwhelming evidence of seven independent studies, however, some physicians turned a blind eye to the information presented. Dr. Michele Curtis, an obstetrician and gynecologist at the University of Texas-Houston Medical School, said the week’s moves would not change her opinion on birth control or what she prescribes to her patients. “I don’t think any of the stories this week should change somebody’s opinion of the risk that combined contraceptives pose,” she said, pointing out that the blood clot risks of the new generation of pills was known before the FDA’s meetings. “All I want to know is whether it’ll do more harm than good,” Curtis said.
According to NPR, Bayer’s strongest witness was Dr. Andrea Lukes, a North Carolina gynecologist who said her patients on contraceptives such as Yaz or Yasmin often have less bloating, acne and breast tenderness. “In my experience,” Lukes said, “patients who begin Yaz or Yasmin are less likely to change and are happier with this pill… drospirenone pills provide an important and unique role for contraception.” After hearing that, Dr. Naomi Tepper of Emory University voted for the proposition that drospirenone contraceptives’ benefits outweigh their risks because she was afraid that a no-vote “would mean pulling them from the market. And if there are women who believe this pill benefits them, that has to be taken into consideration.” Also somewhat conflicted was Sean Hennessy of the University of Pennsylvania who commented, “I voted yes, but it was a difficult vote. I think the drug probably ought to be rarely used.”
Meanwhile, others looked at their patient’s best interests and understood that there are safer options available to their patients that do not carry the increased risk of dangerous blood clots. “I can see no real group of patients that this drug benefited over existing alternatives,” Mark Woods of New York University School of Medicine told the AP. “Without any clear benefit, and given the potentially catastrophic risk, I voted no.”
Holly Ennis is a Florida attorney who concentrates her practice in representing clients nationwide again pharmaceutical companies and medical device companies. She has represented clients who have suffered adverse side effects from Yaz, Yasmin, Vioxx, Fosamax, Avandia, and Zyprexa, as well as clients who have been affected by the Depuy Hip Implant recall. Holly Ennis can be reached at hckennis(at)ennislaw(dot)com or 1-800-856-6405. To learn more about Holly, visit http://www.ennislaw.com.
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