Two brands of birth control pills prescribed to roughly two million women in 2009 are being named in a national class action lawsuit alleging serious health side-effects.
Yasmin and Yaz, both Bayer-manufactured drugs, were approved by Health Canada in 2004 and 2008 respectively.
Since their debut on the market, Yaz and Yasmin have been promoted as a contraceptive that can help control acne as well as the symptoms of premenstrual syndrome.
But in recent months, women across Canada have been coming forward to report side effects from the drugs that range from strokes to blood clots, deep vein thrombosis, pulmonary embolisms and gallbladder stones.
On April 7, 2010, Alberta women joined the nationwide group seeking compensation for the drugs’ side-effects.
A statement of claim filed in Calgary Court of Queen’s Bench seeks damage for any women in the province who have taken Yaz or Yasmin.
Regina-based lawyer Tony Merchant said his firm has already been contacted by about 700 claimants, including the families of seven young women who died.
“The seven deaths are all similar in that they were all young women who were healthy,” Merchant said.
“One woman who died was 28, the rest were 14 to 19 years. Of the 400 who do have problems, many have lost their gall bladder. All of them have continual blood pressure problems or blood clots related to blood pressure effects.”
About 90 of the 700 claimants who have come forward nationwide are from Alberta, and Merchant estimates that if liability can be proven, total damages will be in the multi-million dollar range.
The Canadian lawsuit’s statement of claim alleges that Bayer failed to adequately warn patients and doctors about the increased risk of serious adverse injuries associated with use of Yasmin and Yaz as compared to other oral contraceptives.
In a 2010 Leader Post article, Dr. Shurjeel Choudhri, the company’s senior vice-president and head of medical and scientific affairs, said the risks of blood clots with Yaz and Yasmin are no different than those for any other oral contraceptives.
The risk of a blood clot while on any birth control pills is about nine per 10,000 women versus about half that for women those who don’t use the pill.
“Bayer has very thoroughly evaluated the safety of these two oral contraceptives,” said Choudhri. “We’ve done two, large, well-designed prospective studies that involved over 120,000 women.”
“These are newer oral contraceptives and our detection techniques for blood clots and our awareness of blood clots has gone up in recent years,” he said.
In response to a 2010 CTV report, Bayer contended its oral contraceptives “have been and continue to be extensively studied worldwide and are safe and effective when used according to the product labeling.”
As for the lawsuits, Bayer said it is “in the process of gathering information on these cases, but the complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours. Bayer will defend itself vigorously against these lawsuits.”
The Society of Obstetricians and Gynaecologists of Canada advises all women currently using oral contraceptives not to suddenly stop taking them and continue using them as prescribed, unless they experience complications.