In Singulair's new drug approval documents, scores of human subjects are reported to have withdrawn from trials because of "worsening" asthma and breathing problems. There's an asthma drug for you! Reviewers even write that one study, "demonstrates that it is better to leave patients on beclomethasone [Qvar] than to switch them to montelukast [Singulair]." Inhaled corticosteriods like Qvar, Flovent, Pulmicort and Asmanex were the standard asthma treatment until drugs like Advair and Singulair were marketed.
Approval documents include 10 blanked out pages, marked "This section was determined NOT to be releasable," and the frequent phrase, "Portions of this review were excerpted directly from the sponsor's submission," as in we didn't read it but we waved it through.
William Busse, MD, who chaired the expert panel that wrote the government's 2007 National Asthma Education and Prevention Program Guidelines despite his many Pharma financial links listed in the report, was also an investigator in the Singulair approval trials. He was issued an FDA warning letter when an inspection of his facility revealed incorrect consent forms, incorrect patient enrollments and drug inventory and labeling errors, say Singulair's new drug approval documents.
Meanwhile, more than 100 parents on the drug-rating web site askapatient.com report the symptoms the Merck/Scholastic sales piece warns about: Singulair caused hyperactivity, tantrums, depression, crying, school trouble, facial tics, strange eye movements and self-harm in their children, some as young as one. Many were put on the drug for sniffles, wheezing and early "symptoms" of asthma, in keeping with Pharma's "early treatment" push.
"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!!
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, Singulair was given a stronger warning for "neuropsychiatric" side effects. And the next year, Fox TV reported that kids on Singulair are being diagnosed with ADHD, Tourette Syndrome and serious behavioral and neurological conditions. Most are "cured" when they go off the drug. Singulair is no doubt driving other pediatric drugs sales.
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