MSD gives statement on Singulair

Merck, Sharp and Dohme (MSD) has issued a statement relating to a continuing safety review of Singulair (monkelukast).

The company notes that the compound has been marketed for over a decade in the US, with millions of patients administered with the compound worldwide.

It adds that in October 2007 the firm has voluntarily updated its product labelling to include “suicidal thinking and behaviour”, while also including similar information in the patient product information.

MSD made these comments in response to an early communication from the US Food and Drug Administration of an ongoing safety review of the compound.

“Information from post-marketing reports is incorporated by Merck into the product label and patient product information as appropriate to help inform healthcare practitioners and patients,” the company said.

It added that the reporting of an adverse event to regulatory agencies and MSD does not mean that a post-marketing event is caused by Singulair.

MSD reports that post-marketing adverse events can be caused by medication, concomitant medications, underlying disease, genetic conditions or background events.

In January 2008, MSD said that its worldwide revenue growth was driven by the performance of Singulair, as well as the strength of Januvia Gardasil and Varivax.