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A Queensbury couple is blaming their teenage son's suicide on the allergy drug Singulair. The drug's manufacturer says they've been alerting doctors and pharmacists to the potential for danger, but a NewsChannel 13 investigation reveals the drug maker's notification program, at least in the Capital District, is weak and ineffective, putting allergy sufferers at risk.
Cody Miller was an active 15 year old who took his life on August 4, 2007, just 17 days after starting Singulair for his fall allergies.
Usually he took Allegra but during his back to school physical, his pediatrician made the change. Singulair was FDA approved for treating asthma in February 1998 and in 2003 got the green light to treat seasonal allergy symptoms.
Millions of people have taken the drug.
"He was very sure of the drug and very comforting on the phone saying, you know this is perfectly, he's going to be better off with this drug, you know. So I filled the prescription," said Kate Miller.
Since Cody was their only child, Kate says she was very attentive to his well being. She checked the Merck website and the information sheet she got from the pharmacist on Singulair and found no red flags, so they were stumped when Cody started acting out of character.
"Second week he started having some issues with not sleeping well, and then sleeping like long periods of time, and leg aches and just kind of agitated behavior," said Miller.
"He only had three days of really falling, negative emotional meltdown really emotional .. yeah, like just shaky, sweating profusely, actually just, you know, thought well God, you need some sleep, you know, something wrong, unrealistic fears," said Miller.
On the last day of his life Cody went upstairs to take a shower before dinner. When he failed to answer his mother's call, Kate checked on him.
"So I went upstairs and I found my son," said Miller.
Cody had hanged himself. At the hospital, the Doctors asked about any drugs he was taking. Kate kept saying, nothing but Singulair.
On October 2, 2007, two months after Cody's death, Merck updated the warning for Singulair to include suicidal thoughts and actions.
Company spokesman Ronald Rogers tells me the company received some post marketing events and changed the package insert, patient brochures and ads.
Rogers assured NewsChannel 13 that drug reps were instructed to share the information with clients, but none of the doctors or pharmacists we checked with was aware of the update.
Cohoes pharmacist John McDonald says he would have liked a heads up.
McDonald sells more than 50 bottles of Singulair a month and yet the inserts in his newest stock date back to April 2007, before Merck changed the listing of side effects.
McDonald checked a special website for pharmacists and didn't even find a hint of potential for suicide.
"Well it's frustrating to be honest with you, it's very frustrating," said McDonald.
Pharmacists at CVS and Rite Aid stores we checked with were also unfamiliar with the update, as were a couple of pediatric groups.
The president-elect of the Albany County Medical Society, who is an allergy specialist, said he didn't have an inkling of the potential for trouble.
"I hadn't gotten any messages regarding this and I've talked to some of my colleagues and they were totally unaware of it," said Dr. David Shulan.
And his newest drug samples were still packing old inserts without the latest information.
"And this is what's meant for the patients," added Shulan.
The Singulair website carries the updated side effects, but you have to search it out in the patient information PDF on the fourth of five pages.
If you check with the FDA, you'll find nothing. As they told us, they haven't updated their website on Singulair since 2001.
While the Merck spokesman couldn't give NewsChannel 13 a count of cases that lead to the update, he said a warning does not reflect a conclusion. He said an adverse event can be caused by many things including, genetics, disease, or a background event.
For the Millers, there was only one event, the death of their son.
"Something has to be done. Somebody you know, go in the right direction, because as a parent, as a consumer of a drug you should know all the risks and the benefits and then you can make your own decision," said Miller.
Anytime you experience a change in health or behavior after starting a new drug, tell your doctor, don't stop the medication.
If you have a bad reaction to a drug, you can post it on the FDA website.
There is also a consumer website you can check to see if anyone else has had an adverse reaction.
We've set up links on our website.
On Thursday, February 28, 2008, the FDA opens two days of hearings on risk communications.
Issues like this may be addressed and Merck says they are always looking for ways to improve their communication.
The company says, in this case, they believe the level of communication is appropriate for the level of the label change.
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