FDA Reviewing Stronger Warning Labels Regarding Blood Clots on Yaz Labels
The Associated Press as well as ABC Nighty News Have Recently Published Articles Highlighting the FDA's Desire to Add Additional Safety Warnings to Yaz Labels:
"Federal health regulators are leaning toward adding new information about the risk of blood clots to the labels of widely prescribed birth control pills such as Yaz, in light of growing evidence suggesting the newer contraceptive drugs may be riskier than older drugs. In documents released Tuesday, the Food and Drug Administration said there is conflicting evidence about the risk from several studies, but the information should appear in labeling used by doctors and patients. "We believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility," state the briefing documents from FDA scientists.On Thursday,the FDA will ask outside experts to weigh in on the issue and whether some women should not take the drugs.
Yaz and several other pills contain a manmade hormone called drospirenone which was heavily marketed as carrying fewer side effects than earlier drugs.But over the last two years several large, independent studies have suggested the rate of blood clots with drugs with the hormone is slightly higher than with other drugs. The most recent analysis by the FDA looked at the medical records of 800,000 U.S. women and found that the risk of a blood clot with drospirenone-containing pills was higher than other hormone-based contraceptives. The overall rate of events was very low however, with an estimated 10 in 10,000 women on the newer drugs experiencing a blood clot, compared with 6 in 10,000 women on older contraceptives per year.
Studies conducted by German drugmaker Bayer, which markets Yaz and related pill Yasmin, found no increased risk of blood clots. Sorting out the blood clot risk of birth control drugs is especially difficult because all hormone-based drugs increase the risk of clotting. Further complicating the issue is that clots can be caused by factors such as smoking, obesity or family history.
Introduced in 2001, Yasmin was the first birth control pill to use a new form of progestin called drospirenone, which appeared to have fewer side effects. The reformulated version of the drug, Yaz, was approved in 2006 with new claims on the label that it decreased acne and a severe type of mood disorder. With the slogan, "beyond birth control," Bayer's advertisements pitched Yaz to women in their 20's as an alternative to older generations of contraceptives. One advertisements featured young women singing the Twisted Sister anthem, "We're Not Gonna Take It," while popping balloons labeled "moodiness," ''bloating" and "acne."Within two years, Yaz had grown into the best-selling birth control pill in the U.S. with peak sales of $781 million in 2009, according to data from IMS Health. But sales plummeted more than 50 percent the following year after the company was forced to run corrective TV and magazine advertisements. The FDA said the company's commercials suggested Yaz could treat premenstrual syndrome. In fact, the drug has only been shown to decrease incidence of a much more serious mood disorder called premenstrual dysphoric disorder. Additionally, the FDA said Bayer's commercials used distracting music and visuals to downplay the drug's list of side effects.
Some company executives apparently encouraged these exaggerated claims, ABC News has learned. Internal documents obtained by ABC News show their reactions: "[T]his is outstanding!!! can we get good morning america to do the same segment!!!???!! (tee hee)," one executive wrote about the Dallas segment that called Yaz a miracle pill for PMS.
But the Food and Drug Administration wasn't amused. In 2008, the FDA said Yaz was not shown to be effective for common PMS, just a rare and serious form of menstrual symptoms, and that Yaz's success with acne was "misleadingly overstate(d)."
State authorities also accused Bayer of deceptive advertising. But by then, millions of women had already opted for Yaz. Studies funded by Bayer found no difference in risk, while all four of the most recent independent studies found increased risk.
Dr. Susan Jick, author of one of those independent studies involving almost a million women added that when she sent her study to Bayer, she was surprised that they never responded or asked to work with her.
"The studies that have found increased risks are not in the best interest of the company," Jick said.
Columbia University medical ethicist David Rothman added that, in general, "We have got to look at drug studies published by the company producing the products with a lot of suspicion. They have too much skin in the game."
Internal Bayer documents obtained by ABC News raise questions about some of the company's research. According to one report, Bayer apparently kept the name of one of two employees off a company-sponsored study because, according to an internal email, "there is a negative value to having a corporate author on the paper."
"It's really nefarious, a basic violation of scientific integrity, when the person who did the research doesn't even appear on the paper," Rothman said.
Thousands of women are now suing Bayer, but the company continues to deny any wrongdoing. Citing those lawsuits, Bayer refused to be interviewed for this story and instead sent ABC News a statement saying Yaz is as safe as any other birth control pill when used correctly."