What if your young son or daughter suddenly developed extreme behavior and emotional problems and even acted suicidal? What if your doctor misdiagnosed and mistreated the symptoms because neither you or your doctor knew they were from the Singulair the child was taking? For more than five years, hundreds of parents whose children suffered frightening side effects from Singulair and drug safety activists have asked the FDA to acknowledge the problem. Finally, the FDA and medical community are validating the concerns.
In September, the FDA's Pediatric Advisory Committee called for clearer warnings of neuropsychiatric side effects on Singulair's labels and for a "dear doctor" letter to be sent to health care professionals.
Leading the awareness campaign in the United States about Singulair dangers to children is Parents United for Pharmaceutical Safety and Accountability, founded by Jenna Markle, whose own son suffered from Singulair's side effects. The group's goals include raising awareness, better information and distribution channels about risks to consumers and professionals and opposing Merck's attempt to sell the drug over-the-counter.
Reports of the harmful pediatric side effects of Singulair, which were first covered nationally by Fox News in 2009, have a chilling sameness. Toddlers who were put on the drug for sniffles or wheezing, develop unprecedented tantrums, fear and self-harm. Many parents report bed-wetting and repetitive motions/tics in their children from the drug. A parent posting a report this week on the Parents United website notes how "helpless" her tantrum-prone son is while he is "in the midst of a meltdown." He has been on Singulair for three years, she says.
"I asked our new pediatrician (we moved) and she said for sure take him off singulair, she hasn't prescribed it in years because of that effect. I felt sick to my stomach and took him off immediately. It's been four days of great behavior until tonight, tantrum came and that look in his eye was back. I'm hopeful he's made improvements and that it'll take sometime for it to get back to the norm as well as learned behavior, but how long," she writes.
In October, a parent on askapatient reports her daughter "developed horrendously grotesque mouth contortions and hard eye blinking," on Singulair. "It was disturbing and alarming to watch. We thought she had tourets syndrome (sic). We did not make the connection until we ran out of meds and didn't refill the script for almost 2 months over the summer. Her tics went away. Most recently, our daughter's allergies flared up again and so on Monday we began giving her the montelukast again. Today, she started with the nodding and blinking tics once again. It has to be this medication."
Hundreds of similar reports of Singulair's effects on children have appeared on askapatient.com, the Parent United website and elsewhere online.
Luckily, the Parents United website offers a little reassurance about the symptoms. "With the exception of the children that we lost, our children experienced a remission of symptoms when they stopped taking Singulair," says the site.
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