The drug is Singulair. The bottle says it's for allergies and asthma. What it doesn't say is the Food and Drug Administration is investigating it for possibly causing behavioral changes and even suicidal thoughts.

Trevor Williams is your typical 4-year-old boy. But he was anything but typical a few months ago when he was taking Singulair for his asthma and allergies.

“If you didn't do it the way he wanted, he was screaming and kicking for 20 to 30 minutes at a time,” said his mother, Emily Williams.

That's how it started but Williams says Trevor’s behavioral changes quickly escalated.

“One night he took a string off Nebulizer and wanted to tie it around his bear’s neck; he wanted to kill his bear because it was bad,” she said.

And then there was the moment that his behavior went from difficult to frightening.

“He said, ‘I'm just going to kill myself so I don't have to see you anymore,’” said Williams. “That's the day I told my husband, ‘Something is wrong.’”

Williams went online to see if perhaps the behavior was linked to Singulair, and came across a Web site with complaint after complaint about side effects similar to Trevor's. What's more, she learned the FDA is investigating a possible link between the use of Singulair and behavioral changes and suicidal thoughts.

Among the many side effects listed on the prescription are stomach pain, cramps, unusual weakness and upset stomachs, but Williams never saw behavioral changes or thoughts of depression on the list.

“It says irritability but nothing as far as violence and everything,” she said.

Since the FDA began its investigation, Merck, the drug's manufacturer, says it has been "informing doctors and patients of this new information in several ways." That includes updating singulair.com and merck.com, but not the prescription packaging, to include "suicidal thinking and behavior."

On the patient information sheets included with Singulair prescriptions from two different pharmacies, neither lists behavioral changes or suicidal thoughts. One says patients or guardians should check with the manufacturer each time a prescription is filled but that doesn’t seem like something that most people would do.

“We could all be more vigilant in that respect,” said Terry Barks, a pharmacist at St. John's Hospital’s drug information center.

Barks says manufacturers, doctors, pharmacists and, yes, even patients need to do a better job of investigating the prescriptions that they take.

“People need to take more personal responsibility and professionals need to be more diligent about reporting adverse effects,” said Barks.

Williams wants the FDA to take it one step further.

“I just wish they would stop prescribing it until they find out what's going on,” she said.

While the FDA and Merck are both still investigating, leaders of the American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma & Immunology (ACAAI) says no data indicates a link between Singulair and suicide.

   By the way, the best way for patients to keep up to date with changes to their medications is to go to FDA.gov to sign up for e-mail notifications.

Merck is committed to patient safety, and has acted responsibly to give doctors and patients information to help them make informed decisions about their treatment choices.

Since voluntarily updating the Singulair worldwide product label in October 2007 to include "suicidal thinking and behavior", Merck has been informing doctors and patients of this new information in several ways, including:
--Tens of thousands of doctors have been contacted by our sales representatives.
--Singulair.com and merck.com have been updated.
--Our print ads have new information for patients attached to them.
--National and state pharmacy associations have been notified.

In addition, we analyzed our clinical studies and have given the FDA the results of that analysis. Information at this analysis can be found on merck.com.

We are now analyzing our clinical studies using a method recently developed by outside experts and will give this information to the FDA as part of their review (which, due to the complexity of the issue, was expected to take nine months according to the agency's prior statement). We will publish these results in a peer-reviewed journal as part of our commitment to broadly sharing with the medical/ scientific community any new scientific insights in this evolving area of medical interest.

Patients and parents should talk with their doctors if they have questions about Singulair. Millions of patients have been prescribed Singulair in the U.S. and around the world over the last 10 years. Singulair is an important therapeutic option, and people with asthma need treatments that are effective and generally well-tolerated.
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Singulair is indicated for the prevention and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, for the relief of symptoms of seasonal allergic rhinitis (SAR) in adults and children two years and older, and for the relief of symptoms of perennial allergic rhinitis (PAR) in adults and children six months and older.

The use of Singulair for chronic treatment of asthma may not eliminate the need for inhaled or oral corticosteroids. While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, Singulair should not be abruptly substituted for inhaled or oral corticosteroids. Patients should be advised to take Singulair daily as prescribed for chronic treatment of asthma even when they have no symptoms, as well as during periods of worsening asthma, and to contact their physician if their asthma is not well controlled.