Health Canada raises red flag on birth control patch

- Brock Press

01/30/08 - The Evra birth control patch may be more convenient than the pill for many Canadian women, but while new evidence suggests it may also be more dangerous, doctors are urging calm.
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 the birth control technology arrived on the Canadian market in 2004.
Two of the 17 patients reported to Health Canada died as a result of the complications.
One of the deaths was a 16-year-old. Most of the adverse reactions Health Canada received, totalling 93, 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 is no conclusive evidence linking the patch with increased health risks compared to other contraception methods.
Janssen-Ortho defended Evra, stating that 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 that Evra is safe and effective when used according to approved prescribing information.
New labeling requirements were issued by Health Canada in 2006, warning women of the product's higher risk of blood clots when compared with other contraceptive methods such as the pill.
Dr. Michael Kovacs, an expert on blood clots at Ontario's Schulich School of Medicine and Dentistry, explained that complications can happen at any age and it was likely related to the fact that there are simply more young woman on birth control than older women which skewed the results.
"Young women have a very high chance of being on birth control ... [health problems are] attributed because of that," Kovacs said.
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 three 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, five in 10,000 per year," Kovacs said.
Some women, though, 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," Lent said.
Kovacs agreed, "Women should discuss with their family doctor or gynecologist about the best method of birth control".