The agency interviewed a couple from upstate New York whose son committed suicide as part of its investigation into side effects associated with the Merck allergy drug,The Albany Times-Union reports. And as a result of the meeting, the couple has agreed to pass along to the FDA anecdotal info they've started to receive from parents whose children began acting strangely after taking the drug.
Kate and Dave Miller have been trying to raise awareness about potential side effects of the drug since their 15-year-old son, Cody, killed himself last August. The teen had taken the med for less than three weeks to treat seasonal allergies, the paper writes. You may recall that Merck added "suicidality" to the list of Singulair's side effects last year, and the FDA recently began an investigation into side effect reports and clinical trial data.
Yesterday, the Millers had their first meeting with anyone from the FDA to discuss their son and the dozens of stories they've gotten from other parents about strange behavior by children taking Singulair, the paper reports. The closed-door, hourlong meeting included four officials from the FDA's Center for Drug Evaluation as well as New York state Senator Elizabeth Little, a Republican.
On April 23, the FDA approved changes Merck made to the package insert that mentions agitation, depression, irritability and "suicidal thinking and behavior (including suicide)." The info is also on a Singulair web site, but some pharmacists still dispense from older shipments delivered before the label changes, the Times-Union writes.
But Little wants Singulair TV ads to contain a warning that suicide is a possible side effect. Current ads say that side effects vary by age. The Millers told the FDA they want the drug to bear a "black box" label to caution that some patients can experience suicidal thoughts and mood changes. That is one possible outcome of the FDA probe, which agency officials say is expected to take nine months.