Post-menopausal women taking a popular osteoporosis drug are at increased danger of dying from a stroke if they have heart disease or are at high risk of a heart attack, Health Canada warns.
In a large-scale trial of 10,000 post-menopausal women with heart problems in 26 countries, the drug raloxifene, marketed as Evista, increased the risk of stroke death from 1.5 per thousand women to 2.2, it said yesterday.
The drug received widespread publicity last month after a second trial found that for post-menopausal women at high risk of getting breast cancer, it reduced the risk without the serious side effects of tamoxifen.
But the stroke risk prompted Health Canada and the drug maker, Eli Lilly, to post the new warning and advise patients taking Evista to consult their doctors.
In 1999, another drug trial found that it increased the risk of developing life-threatening blood clots in the legs or lungs by seven women in every 10,000 taking the drug.
More than 42 million prescriptions for Evista have been filled around the world to protect against bone fractures since it was first approved in 1997.
“It’s confusing, but you have to be wary about using new drugs,” said Joel Lexchin, a healthy policy professor at York University.
“New drugs often have unexpected side effects associated with them and we need to be cautious about recommendations for their use early on unless you’re looking at a disease where the mortality rate is so high that something is better than nothing.”
Drug companies rely on so-called blockbuster medications that can earn $1 billion or more worldwide and are always searching for new uses for the same drug, which is where the side effects show up, he said. “That’s what you’re seeing with Evista.”
Alan Cassels of the University of Victoria’s school of health information said warnings about side effects are never included in the product information patients receive with the drugs.
“It drives me nuts,” he said. “That’s information women need to know. Health Canada has been dragging its feet for years on making it mandatory. Women are not getting good information.”
But David Juurlink, a drug safety specialist at Sunnybrook and Women’s College Health Sciences Centre, said the new stroke risk is small and women shouldn’t overreact.
The drug trial looked at multiple bad outcomes and the only one where there was an increase was in stroke-related deaths, he said.
But women who are at very high risk of stroke or who have had mini strokes should talk to their doctor.
Eli Lilly is continuing to evaluate the data with health regulatory bodies and worked rapidly to communicate the early results, a spokeswoman said.
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