Health Canada warns birth control pill has high risk of clots
OTTAWA, December 6, 2011 (LifeSiteNews.com) - In June Health Canada announced that it would be reviewing the safety of the contraceptive pills Yaz and Yasmin over concerns users may experience a two to three times greater risk of developing blood clots, compared to those who use other brands of contraceptive pills.
The results of the review, released December 5, state that “drospirenone-containing oral contraceptives (marketed under the brand names Yasmin and Yaz) … may be associated with a risk of blood clots that is 1.5 to 3 times higher than other birth control pills.”
Health Canada explained that it considered several recent observational studies evaluating the risk of blood clots with drospirenone-containing oral contraceptives versus other oral contraceptives.
“Overall, the body of current evidence suggests that the risk of blood clots is 1.5 to 3 times higher with oral contraceptives that contain drospirenone relative to those that contain levonorgestrel, a different hormone.”
“To put this into perspective, if the estimated risk of developing a blood clot among women taking a levonorgestrel-containing birth control pill is 1 in 10,000 women per year, as some studies have estimated, then the risk in women taking a drospirenone birth control pill is about 1.5 to 3 women in 10,000 per year,” Health Canada says.
“The drug labels for Yasmin and Yaz have been updated to include information on the studies and the recommendation that, when prescribing an oral contraceptive, health professionals consider the risks and benefits of drospirenone-containing oral contraceptives for a specific patient in light of her risk for developing blood clots, and relative to the risks and benefits of other birth control pills on the market.”
Bayer Pharmaceuticals, the company that manufactures all four of the brand name drugs that contain drospirenone (Yaz, Yasmin, Beyaz, and Safyral) reported that Yaz and Yasmin alone earned Bayer $505 million in the first half of 2011, which makes it the third highest earning drug for the company.
Health Canada downplays the danger of oral contraceptives stating, “Blood clots are a rare but well known side effect associated with all birth control pills. The risks of blood clots are higher with pregnancy and childbirth than with oral contraceptives,” and “Overall the risk of blood clots with any oral contraceptive (including Yasmin and Yaz) is very small.”
However, Bayer is facing almost 10,000 Yaz-related lawsuits in the U.S. from women who say the drug manufacturer misrepresented the dangers associated with using the birth control pills – side effects including stroke, cardiac arrest, blood clots, and gallbladder problems.
As Bayer reported in their stockholder newsletter, the company is currently facing a “number of lawsuits pending in the United States and served upon Bayer” numbering “about 9,300 as of July 16, 2011.” Bayer notes that, “Plaintiffs allege that they have suffered personal injuries, some of them fatal, from the use of Bayer’s oral contraceptive products Yasmin™ and / or YAZ™.”
One of the “fatal personal injuries” involves an 18-year-old New Jersey college student, Michelle Pfleger, who died of cardiac arrest after taking Yaz for acne treatment. A blood clot had lodged in her lungs resulting in her sudden death on her way to classes on September 24, 2010. Her mother Joan Cummins filed suit against Bayer on May 10.
In Canada a group of women initiated a class-action lawsuit against Bayer in 2010 claiming that the contraceptive pill manufacturer does not adequately inform users of the potential serious health risks associated with its oral contraceptives.
The lawsuit alleges that Bayer downplayed the serious side effects of the pills, failed to conduct proper research before releasing them onto the market, and failed adequately to warn patients and doctors about the increased health risk associated with use of Yasmin and Yaz.
Matthew Baer, legal counsel at the firm of Siskinds LLP, which is representing the group, told the media that he has evidence about the health risks of Yasmin and Yaz that has been linked to over 25,000 reported cases of adverse effects and several deaths.
One of the litigants in the suit, Christine Lovelace of Halifax, related that after she began taking Yaz she developed strange symptoms that culminated in a transient ischemic attack, or mini-stroke.
“I went paralyzed all down my left side and I lost my ability to communicate. It was terrifying,” she told CTV.
She said the symptoms disappeared after she stopped taking the drug; however she still suffers from nerve damage to her left hand and foot.
“We believe that through this lawsuit Bayer will be required to explain to Canadian consumers what it knew about the risks associated with using Yasmin and Yaz and when it first became aware of those risks,” said Matthew Baer. “In this case, as with all of these types of cases, we are concerned about whether Canadians were adequately warned of the risks associated with using the products in question.”
Siskinds LLP is advising Canadians who have experienced adverse events from Yasmin and/or Yaz to visit their website or to call 1-800-461-6166 ext 2341. A video explaining the lawsuit and information on financial compensation of potential class members who are victims of Yasmin or Yaz is also available on the website.