carly weeks From Tuesday's Globe and Mail Published Monday, Feb. 27, 2012 4:23PM EST Last updated Monday, Feb. 27, 2012 4:29PM EST Serious safety concerns over a popular oral medication used to treat multiple sclerosis have prompted Health Canada to launch a full investigation. The department made the announcement on Monday after reports of 11 deaths worldwide that have been linked to the drug fingolimod. When fingolimod, sold under the brand name Gilenya, was approved in Canada last March, it was known the drug could increase the risk of heart problems, such as a decreased or abnormal heart rate, after the first dose. But Health Canada and many other regulators around the world ruled that the benefits of the drug outweighed the risks. More related to this story None of the deaths linked to Gilenya occurred in Canada. But Health Canada has received 52 reports of adverse events linked to fingolimod since last April. At least 14 reports came from patients who experienced a decreased heart rate after taking the drug. Other reported problems include blood pressure fluctuation, fatigue and dizziness. Gilenya, marketed by Novartis, is the first oral medication approved for treatment of relapsing-remitting MS, the most common form … Continue reading →

TORONTO - Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths. There have been no reports of deaths in Canada of people taking the Novartis drug, which is sold under the brand name Gilenya. Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role. Both the U.S. Food and Drug Administration and the European Medicines Agency had earlier announced that they were undertaking reviews of Gilenya. Gilenya is used for treatment of relapsing-remitting MS to reduce the frequency of attacks and to delay physical disability; it is generally recommended when other MS treatments have not been effective or cannot be tolerated. At the time the drug was authorized, it was known that certain types of heart rhythm disturbances can be seen with Gilenya use and the Canadian labelling contains several warnings to this effect. But Health Canada says it felt the drug's benefits outweighed its risks. Of the 11 reported deaths, four involved serious heart-related events — three were heart attacks and another a disturbance of the heart rhythm. The seven other deaths are unexplained, including one … Continue reading →

Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths. There have been no reports of deaths in Canada of people taking the Novartis drug, which is sold under the brand name Gilenya. Gilenya, also called fingolimod, is taken once a day for people with the relapsing-remitting form of MS. (Novartis) Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role. Both the U.S. Food and Drug Administration and the European Medicines Agency had earlier announced that they were undertaking reviews of Gilenya. Gilenya is used for treatment of relapsing-remitting MS to reduce the frequency of attacks and to delay physical disability; it is generally recommended when other MS treatments have not been effective or cannot be tolerated. At the time the drug was authorized, it was known that certain types of heart rhythm disturbances can be seen with Gilenya use and the Canadian labelling contains several warnings to this effect. But Health Canada says it felt the drug's benefits outweighed its risks. Of the 11 reported deaths, four involved serious heart-related events — three were heart attacks … Continue reading →