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Singulair possibly linked to suicide
Kate Stickelmaier, Daily Vidette Senior Staff
Issue date: 4/7/08 Section: News
The Food and Drug Administration (FDA) and Merck & Co, Inc are evaluating the possibility of a link between the company's popular drug, Singulair, and suicide.
According to Susan Cruzan, an agency spokesperson, "the FDA is reviewing reports of behavior or mood changes, suicidal thoughts and behavior… and reports of three suicides among the millions of patients who take the drug."
Merck, the manufacturer of the asthma and allergy medication, added information regarding these "least common" side effects to the drug's label in October 2007, according to Cruzan.
The FDA "has requested that Merck evaluate Singulair study data for more information about suicidality and suicide," according to the agency's Early Communication created March 27.
"An early communication means that [the] FDA is conducting an evaluation of an issue, adverse event reports or other data…to determine whether there is an association with use of the drug," Cruzan said.
The communication also states that it may take up to nine months before any conclusions can be drawn due to the complexities of the analyses.
"Patients should not stop taking Singulair before talking to their doctors…," Patrick Moraleda, Student Health Services pharmacy supervisor, said. "Healthcare providers should monitor changes in mood."
Over the past year, Merck has also updated the prescribing information and patient information for Singulair to include tremor (March 2007), depression (April 2007) and anxiousness (February 2008).
"Merck plans to highlight the changing information," Moraleda said. "I believe this is still the implementation stage."
According to the communication, Merck plans to address the recent changes in prescribing information through face-to-face interactions with prescribers to provide them with patient information leaflets about Singulair.
The FDA is also reviewing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo and Zyflo CR.
Since the drug was first FDA approved in 1998, millions of patients in the U.S take Singulair as its sales were $4.3 billion last year.
According to Susan Cruzan, an agency spokesperson, "the FDA is reviewing reports of behavior or mood changes, suicidal thoughts and behavior… and reports of three suicides among the millions of patients who take the drug."
Merck, the manufacturer of the asthma and allergy medication, added information regarding these "least common" side effects to the drug's label in October 2007, according to Cruzan.
The FDA "has requested that Merck evaluate Singulair study data for more information about suicidality and suicide," according to the agency's Early Communication created March 27.
"An early communication means that [the] FDA is conducting an evaluation of an issue, adverse event reports or other data…to determine whether there is an association with use of the drug," Cruzan said.
The communication also states that it may take up to nine months before any conclusions can be drawn due to the complexities of the analyses.
"Patients should not stop taking Singulair before talking to their doctors…," Patrick Moraleda, Student Health Services pharmacy supervisor, said. "Healthcare providers should monitor changes in mood."
Over the past year, Merck has also updated the prescribing information and patient information for Singulair to include tremor (March 2007), depression (April 2007) and anxiousness (February 2008).
"Merck plans to highlight the changing information," Moraleda said. "I believe this is still the implementation stage."
According to the communication, Merck plans to address the recent changes in prescribing information through face-to-face interactions with prescribers to provide them with patient information leaflets about Singulair.
The FDA is also reviewing reports it has received of behavior/mood changes, suicidality and suicide in patients who took Accolate, Zyflo and Zyflo CR.
Since the drug was first FDA approved in 1998, millions of patients in the U.S take Singulair as its sales were $4.3 billion last year.
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