Blood clots, deaths linked to Evra

Health Canada documents 16 blood clots and two deaths since 2004

Tuesday, April 7th, 2009

The Evra birth control patch may be more convenient than the pill for many Canadian women, but new evidence suggests it may also be more dangerous.

The January issue of Health Canada’s Canadian Adverse Reaction Newsletter documented 16 cases of blood clots and one heart attack in Evra patch users since its arrival on the Canadian market in 2004. Two of the 17 patients reported to Health Canada died as a result.

One documented case of death was that of a 16-year-old, and most of the 93 total adverse reactions Health Canada received were from women in their teens, 20s or early 30s.

The Evra patch, manufactured by Janssen-Ortho Inc., is a prescription-only contraception patch that adheres to the skin, delivering hormones into a woman’s body to prevent pregnancy.

According to IMS Health Canada, a market research company, between January and November 2007, 274,617 Evra prescriptions were dispensed from retail pharmacies.

So far, there has been no conclusive evidence linking the patch with an increased risk of health problems versus other contraception methods.

In a statement, Janssen-Ortho defended Evra stating all forms of birth control pose increased risks of serious conditions like blood clots.

“The risk of serious adverse events is small in healthy women, but increases significantly if associated with the presence of other risk factors such as obesity or cigarette smoking,” it said.

It added Evra is safe and effective when used according to approved prescribing information.

New labeling requirements, warning women of the patch’s higher risk of blood clots versus the pill, were issued by Health Canada in 2006.

Dr. Michael Kovacs, an expert on blood clots at the Schulich School of Medicine and Dentistry, explained problems can happen at any age.

“Young women have a very high chance of being on birth control ... [health problems are] attributed because of that,” Kovacs said.

Dr. Kovacs said for persons of university age, the background risk per year of blood clots is one in 10,000. With oral contraceptives, this risk may increase to 3 in 10,000 " still a relatively small number.

“If the Evra patch has an increased risk ... which no one knows for sure, the absolute risk would be, at most, 5 in 10,000 per year,” Dr. Kovacs added.

Some women are concerned by Health Canada’s red flags about the Evra patch.

“I don’t think I’d feel comfortable taking that,” Stephanie Shewchuk, a third-year Western kinesiology student said. “You know [pills] are more reliable.”

Dr. Barbara Lent, associate professor in the department of family medicine at Schulich, said hormonal contraception in its various forms is a safe and effective option for the majority of young women.

“We all need to pay attention to these concerning cases, but not overreact until we have better information,” Dr. Lent added.

Dr. Kovacs agreed, “Women should discuss with their family doctor or gynecologist about the best method of birth control.”

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