Couple Plead Case Against Allergy Drug
FDA officials will collect personal stories of people experiencing unusual side effects while taking the allergy drug Singulair, a move that follows a meeting Friday with a Queensbury couple who blame the medication for prompting their son's suicide.
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 medication for less than three weeks to treat seasonal allergies.
The drugmaker, Merck & Co., added "suicidality" to the list of Singulair's side effects last year, and the FDA last month launched an investigation into the drug.
But Friday was the Millers' 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 the medication.
The closed-door, hourlong meeting was arranged by Rep. Kirsten Gillibrand, D-Greenport, and included four officials from the FDA's Center for Drug Evaluation as well as New York state Sen. Elizabeth Little, R-Queensbury.
Afterward, Gillibrand described the meeting as "productive."
Gillibrand said: "We were able to give enormous amounts of information to the FDA." And the Millers "were able to give a lot of detail about the information that they have learned because of their advocacy."
Since going public with their story, the Millers have received dozens of e-mails and phone calls from parents who say their children began acting strangely after taking the drug. A handful also committed suicide.
Still others reported that when their children stopped taking the drug, their odd behavior -- such as anxiety and sleeping problems -- abated.
As a result of the meeting, the Millers will pass along all anecdotal information they receive directly to the FDA.
Gillibrand said one of the FDA officials took particular interest in how the children's behavior changed after stopping the drug and plans to continue working with the Millers to get information from other parents who have had similar experiences.
As part of its investigation, the FDA has already directed Merck to go through records from the drug's clinical trials, and the agency is examining adverse-effect reports that people have filed with the government after bad experiences with the medication.
Kate Miller stressed that the family knows nothing will bring back her only child, but "our reason for being here is an awareness campaign."
Although Merck has added "suicidal thoughts and actions" to documentation of possible reactions inserted with drug packaging and put the information on a Web site about Singulair, some pharmacists still dispense from older shipments of the medication delivered before the warning label changes.
On April 23, the FDA approved changes Merck made to the documentation accompanying the drug to expand on the list of "adverse reactions" that have been reported since the medication was put on the market.
Now, the list includes "psychiatric disorders," including agitation, depression, irritability and "suicidal thinking and behavior (including suicide)."
Little said she would like to see TV ads for the drug contain a warning that one of the possible side effects is suicide. Current advertisements say that side effects vary by age.
The Millers told the FDA they want the medication to bear a "black box" label -- the FDA's most serious warning -- to caution that some patients can experience suicidal thoughts and mood changes. That is one possible outcome of the FDA probe, which agency officials Friday said is expected to take nine months.
Gillibrand said she would consider assembling legislation to improve the way the FDA communicates warnings to doctors. She emphasized that "we're not trying to take a drug off the market" that could be valuable for millions, but rather spread the word among patients that there are associated risks.
Singulair was approved by the FDA in 1998 to prevent and treat asthma. But it also has been used to treat seasonal allergies.
Merck has said that more than 2 million people take the drug.