An upstate New York couple's campaign to warn the public about the potential psychological side effects of a popular asthma and allergy medicine reached a milestone, with drugmaker Merck & Co., recently agreeing to add a warning about 'neuropsychiatric events' to prescribing information for Singulair. The two-paragraph notice that agitation, anxiety, hallucinations, suicide and other such behaviors 'have been reported in . . . patients taking Singulair' now will be included in a 19-page document generally consulted by doctors and pharmacists who prescribe and dispense the drug. The change, which was formally announced by the FDA in August, dovetails with separate information for patients noting that users of the medicine have reported 'behavior and mood-related changes.' The move was applauded by Kate and Dave Miller of Queensbury, N.Y., who have lobbied the FDA and Merck to examine and spread awareness of the possible psychological side effects of the drug since 2007, when their 15-year-old son, Cody, committed suicide after using the medicine for 17 days to treat seasonal allergies. 'This is an acknowledgment that these people are reporting (problems),' said Kate Miller, a hair salon owner. If similar information had been widely disseminated before, Miller said, she would have been able to weigh the risks and benefits of Cody taking the medicine 'for a stuffy nose.' She added: 'Our son would still be alive.' The new precautionary information falls short of the Millers' goal of the government requiring the drug to bear a 'black box' label -- the FDA's most serious warning -- cautioning that some patients can experience suicidal thoughts and mood changes while on the drug. The updated prescribing information stems from a Food and Drug Administration review of reports filed about the experiences of patients who have taken the medicine since it was approved in 1998. Although the FDA in January said its preliminary investigation of the drug's clinical trials found no link between Singulair and suicidal behavior, the agency continued analyzing data from reports that patients and doctors filed with the government's voluntary drug monitoring system. As a result, the FDA directed Merck to include the precautionary information, which the FDA said appears from the reports to be 'drug-induced.' The Millers pressed the issue personally during a meeting in Washington last year with FDA officials coordinated by then-Rep. Kirsten Gillibrand, D-N.Y. Gillibrand, now senator, said she was 'pleased' by the change. 'This is important to ensure the safety of this prescription drug,' Gillibrand said, 'but more remains to be done.' The Millers say their experience with Singulair revealed the flaws in the government's reliance on a voluntary system for patients and doctors to report the 'adverse events' they experience while on prescription drugs. And, they say, it shows the need for more thorough scrutiny of the potential psychological effects of drugs during clinical trials. Merck has consistently stood by the safety of Singulair, which it says is a 'medicine that has been prescribed to tens of millions of patients with asthma and allergic rhinitis since its approval more than 11 years ago.' In a statement released after the FDA directed the manufacturers of Singulair and similar drugs to include the precaution, Merck noted its cooperation with the FDA and previous labeling changes. The company had added 'suicidality' to the list of side effects in 2007. Kate Miller said the updated prescribing information improves the odds that when patients on the medicine tell their doctors about new psychological symptoms, the physicians will consider them as a possible side effect of the drug, rather than just treating the conditions separately. 'I've never been running through the streets saying take it off the market,' Miller said. 'But it is a dangerous drug to some people. And that needs to be said.' Miller said the family's push to spread awareness about Singulair 'gives purpose to our life.' 'When a child -- or anyone -- dies from suicide, their death defines their life,' she said. But 'our son's life had such meaning. He was a child that was going to go places. 'We don't want him remembered just for this,' she added. 'We want to make change. We want this to not happen to (others). It definitely gives purpose to us. . . . We definitely feel like we made a difference.' (Jennifer A. Dlouhy can be reached at 202-263-6400 or at the e-mail address jdlouhy(a)hearstdc.com) 