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FDA, Health Canada probing possible suicide link with allergy drug Singulair
WASHINGTON - U.S. and Canadian drug regulators are investigating the popular allergy medication Singulair in response to reports of mood changes, suicidal behaviour and suicide in patients.
The U.S. Food and Drug Administration said Thursday it is reviewing a handful of such patient reports and has asked Singulair's maker, Merck & Co., to dig deeper into its data for more evidence of possible links to suicide.
Meanwhile, "patients should not stop taking Singulair before talking to their doctor," the FDA said in a statement, adding that doctors should monitor patients for suicidal behaviour and mood changes.
Health Canada is also investigating a possible link between Singulair and suicidal behaviour, said spokesman Paul Duchesne, noting that consumers should see their doctors if they have concerns about taking the prescription drug.
He was unaware of any reports of suicide among Canadians taking the medication.
The FDA said it has not established a "causal relationship" between Merck's drug and suicidal behaviour. The review was prompted by three to four suicide reports it has received since last October, an agency spokeswoman said.
But Merck officials stressed that the FDA's inquiry is based on reports - not clinical studies, which are the standard tool for evaluating drug safety. The company said none of the 11,000 patients enrolled in 40 Singulair trials has committed suicide.
"We have no indication that anything about the mechanism of Singulair is consistent with these events," said George Philip, Merck director of research and product development. "But because suicide is a life-threatening event we thought it was important to provide this information in the product label."
Merck said it recently added reports of suicide to Singulair's label, which already listed suicidal thinking and behaviour as reported side-effects. The company has updated the drug's labelling four times in the past year to include information on a range of reported side-effects, which also include tremors, anxiousness and depression.
In clinical trials of asthma patients, the most common side-effects were headache, flu-like symptoms, abdominal pain and cough.
With U.S. sales of $4.3 billion last year, Singulair is used by millions of patients, according to Merck. First approved in 1998, it's part of a class of asthma and allergy drugs that includes AstraZeneca's Accolate and Critical Therapeutics's Zyflo.
Their labelling does not contain language about suicide, but the FDA said it is also reviewing reports of side-effects with those drugs.
The agency said on its website that it could take up to nine months before its scientists can draw any conclusions.
The FDA has recently begun notifying the public earlier about possible safety issues regarding drugs - a policy change that followed criticism it acted too slowly on information about the risks of Merck's painkiller Vioxx and GlaxoSmithKline's diabetes pill Avandia.
WASHINGTON - U.S. and Canadian drug regulators are investigating the popular allergy medication Singulair in response to reports of mood changes, suicidal behaviour and suicide in patients.
The U.S. Food and Drug Administration said Thursday it is reviewing a handful of such patient reports and has asked Singulair's maker, Merck & Co., to dig deeper into its data for more evidence of possible links to suicide.
Meanwhile, "patients should not stop taking Singulair before talking to their doctor," the FDA said in a statement, adding that doctors should monitor patients for suicidal behaviour and mood changes.
Health Canada is also investigating a possible link between Singulair and suicidal behaviour, said spokesman Paul Duchesne, noting that consumers should see their doctors if they have concerns about taking the prescription drug.
He was unaware of any reports of suicide among Canadians taking the medication.
The FDA said it has not established a "causal relationship" between Merck's drug and suicidal behaviour. The review was prompted by three to four suicide reports it has received since last October, an agency spokeswoman said.
But Merck officials stressed that the FDA's inquiry is based on reports - not clinical studies, which are the standard tool for evaluating drug safety. The company said none of the 11,000 patients enrolled in 40 Singulair trials has committed suicide.
"We have no indication that anything about the mechanism of Singulair is consistent with these events," said George Philip, Merck director of research and product development. "But because suicide is a life-threatening event we thought it was important to provide this information in the product label."
Merck said it recently added reports of suicide to Singulair's label, which already listed suicidal thinking and behaviour as reported side-effects. The company has updated the drug's labelling four times in the past year to include information on a range of reported side-effects, which also include tremors, anxiousness and depression.
In clinical trials of asthma patients, the most common side-effects were headache, flu-like symptoms, abdominal pain and cough.
With U.S. sales of $4.3 billion last year, Singulair is used by millions of patients, according to Merck. First approved in 1998, it's part of a class of asthma and allergy drugs that includes AstraZeneca's Accolate and Critical Therapeutics's Zyflo.
Their labelling does not contain language about suicide, but the FDA said it is also reviewing reports of side-effects with those drugs.
The agency said on its website that it could take up to nine months before its scientists can draw any conclusions.
The FDA has recently begun notifying the public earlier about possible safety issues regarding drugs - a policy change that followed criticism it acted too slowly on information about the risks of Merck's painkiller Vioxx and GlaxoSmithKline's diabetes pill Avandia.
