FDA investigates suicide link with Singulair

The US Food and Drug Adminsitratio is investigating a possible association between Merck & Co's Singulair (montelukast) and suicide. The leukotriene receptor antagonist is the number-one prescribed product in the US respiratory market. The once-a-day oral drug for chronic asthma and the relief of symptoms of allergic rhinitis, earned $1.2 billion in the fourth quarter of 2007, a 20% year-on-year rise (Marketletter February 4).

Over the past year, US drug major Merck has updated the prescribing information and patient information for Singulair to include several post-marketing adverse events: tremor, depression, suicidality and, most recently, anxiousness. In February, it discussed with the agency how best to communicate these labeling changes to prescribers and patients. The firm plans to highlight the recent changes in face-to-face interactions with prescribers and provide them with patient information leaflets.