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After Billions Are Made, Risks from Asthma Drug Emerge

World sales of Merck’s blockbuster asthma drug, Singulair, were about $5 billion a year until last year when its patent expired in the United States. But the drug also has a darkening cloud over it. The Australian medicine watchdog has received 58 reports of adverse psychiatric events in children and teenagers taking Singulair since 2000 and reports have also surfaced in the US.

Singulair, a leukotriene receptor antagonist or LTRA, is one of several “add-on” asthma drugs that were debuted in the last decade. Patients are supposed to add the new, “asthma controller” drugs to their regular rescue inhalers and inhaled corticosteroids not replace them. Ka-ching.

In the US, Singulair was heavily marketed for minor childhood allergies, in addition to asthma, and sold in a cherry-flavored chewable formulation. Merck had marketing partnerships with Scholastic, a leading educational publishing group, and the American Academy of Pediatrics, reported the US’ Fox News.

Sales pieces from the Scholastic/ Merck partnership cajoled parents, “When your child breathes in an asthma trigger, such as pollen from trees or weeds, the body releases leukotrienes (loo-ko-TRY-eens)” which Singulair blocks. But they also told parents their children could experience, “hallucinations (seeing things that are not there), irritability, restlessness, sleepwalking, suicidal thoughts and actions (including suicide), trembling, and trouble sleeping,” on the drug. At least they wouldn’t be sniffling.

In 2009, after 15-year-old Cody Miller of Queensbury, NY was given Singulair for hay fever and took his own life 17 days later, the US Food and Drug Administration (FDA) gave Singulair a stronger warning for “neuropsychiatric” side effects. The next year, Fox TV, a leading US television network, reported that children on Singulair are being diagnosed with ADHD, Tourette Syndrome and serious behavioral and neurological conditions caused by the drugs. Most are “cured” when they go off the drug but some are not and are then given other damaging pediatric behavioral drugs.

Over 100 parents on the popular US drug-rating web site askapatient.com, corroborate the evidence, reporting that Singulair caused hyperactivity, tantrums, depression, crying, school trouble, facial tics, strange eye movements and self-harm in their children, some as young as one year old. Many of the children were prescribed Singulair for sniffles and wheezing which were called early symptoms of asthma, commensurate with Pharma’s “early treatment” business model.

“Last night was a complete meltdown over every single thing that could have possibly been a minor annoyance, such as not being able to squeeze enough toothpaste out of the tube, which culminated in a 30-minute screaming and crying bonanza,” writes the mother of a 7-year-old who has been on Singulair for six months. “I was reading stories to her tonight, and she must have popped her jaw open at least 40 times over the course of two books (mouth open wide like a yawn in fast-forward). I was keeping an eye on her, and a few times I asked her why she kept doing that and she said she didn’t know, and she thought maybe her mouth was ‘itchy.'”

“Do NOT recommend this drug to other parents,” writes another mother. “4 year olds that suddenly talk about killing themselves are influenced by a DRUG!!”

Even adults are put on Singulair for minor reasons with major consequences. “I was perfectly healthy prior to taking this drug,” reports a 53-year-old woman about Singulair on the askapatient web site.  “Doc noticed I had a little wheeze and prescribed Singulair. I began to have the dreams, insomnia and depression after the first few days,” which led to “suicidal thoughts,” she says.

Like many of Big Pharma’s blockbuster drugs, Singulair made billions by selling “diseases”–in this case childhood allergies and asthma. And like many blockbuster drugs, the true dangers have only emerged since the drug went off patent and the profit potential was gone.

Watch Martha on a Huffington Live discussing the pharmaceutical industry.

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

More articles by:

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

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