Dec 20, 2005 01:42
A $700-million class action lawsuit has been filed against the makers of Depo-Provera, a birth control injection prescribed to more than 600,000 Canadians last year. The lawsuit alleges that women who have taken the contraceptive have developed osteoporosis.
Depo-Provera is made by international drug conglomerate Pfizer Canada, also responsible for popular prescription drugs Viagra, Zoloft and Celebrex. The injection, which often halts menstruation, was tested in the 1980s and approved in Canada in 1997. Two million prescriptions for the drug have been written in Canada in the past four years.
One year ago, Pfizer warned Canadian and American officials the drug could lead to bone density loss. The United States issues a warning shortly afterwards saying the drug should not be used as a contraceptive. Health Canada issued similar statements in November, 2004, and June and July this year.
"The data indicate that women who use Depo-Provera may lose significant (bone mineral density)," states the July Health Canada warning. "The data also indicate that bone loss is greater with increasing duration of use and may not be completely reversible."
The lawsuit is one of three that has been filed in Canada.
Pfizer Canada responded to the claims in a press release, saying it plans to "vigorously defend" the lawsuit. (See below for the full statement.)
It says the suit is "without merit" because the drug has been "safely used by millions of women around the world for decades" and that "all medicines have benefits and risks."
PFIZER CANADA STATEMENT REGARDING DEPO-PROVERA CLASS ACTION
Pfizer Canada said today it plans to vigorously defend a class action lawsuit filed against the company in Ontario Superior Court in relation to Depo-Provera (medroxyprogesterone acetate suspension for injection).
Pfizer Canada believes the action is without merit. Depo-Provera is an important treatment option for Canadian physicians and patients and has been used safely by millions of women around the world for decades.
All medicines have benefits and risks. It is important that patients discuss with their physicians and understand the benefits and risks before taking any medication. Since the approval of Depo-Provera, as additional clinical and safety information has become known, Pfizer has worked collaboratively with Health Canada to determine appropriate actions, including updating the product monograph and prescribing information, distributing letters to healthcare professionals, and issuing public advisories, to ensure that Canadian physicians and patients have the information required to make appropriate treatment decisions.
Pfizer is committed to the safety of Canadian patients and works closely with Health Canada to ensure that the most up-to-date safety information for all of our products is included in the product monographs and prescribing information and that this information is communicated to physicians and patients.