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Medical professionals hailed Strattera as a breakthrough when it appeared in 2002. The medication generically known as atomoxetine was the first non-stimulant the FDA approved to treat attention deficit hyperactivity disorder (ADHD) in adults and children. However, discrepancies in trial studies manufacturer Eli Lilly performed in the U.S. and Europe resulted in the FDA, in 2004, requesting a label about potential liver damage and serious psychiatric conditions.
Trial Studies
Falling in the norepinephrine reuptake inhibitor category, Strattera had originally been developed as an antidepressant. Manufacturer Eli Lilly claims it conducted six trials over two and a half years, with results supposedly showing effectiveness in children, adolescents, and adults. The FDA approved it in response.
Before the drug entered the European market, however, preliminary studies were conducted, with less auspicious results emerging. In one, 10 of 20 participants disappeared, 25 percent stopped because of harmful effects, and only one individual completed the study to its end.
For a second study, 100 children were involved, but participants’ parents allege Eli Lilly withheld important information about adverse psychiatric side effects.
Side Effects and Warnings
From 2002 and 2005, the FDA received 350 reports of psychosis or mania, 900 reports of aggressive or violent behavior, and 400 reports of suicidal behavior. The British MHRA received another 766 reports about heart disorders. However, these figures are estimated to be just one to 10 percent of all affected. Along with these conditions, Strattera has been associated with:
- Weight loss
- Impaired motor skills
- Increased blood pressure or heart rate
- Liver damage
By 2004, 41 cases of raised liver enzymes resulted in the FDA issuing a warning about potential severe liver damage that progresses to failure and death. The warning further specifies that patients who develop jaundice should discontinue usage.
By 2005, the FDA issued a warning to Eli Lilly about its advertisements, which allegedly minimized Strattera’s risks and implied doctors could prescribe the drug to treat schizophrenia, autism, traumatic brain injuries, dyslexia, cannabis abuse, co-morbid alcohol abuse, Parkinson’s disease, and insomnia.
Further, a study of 2,200 children, with 851 given a placebo and 1,357 the medication, found that five taking Strattera had suicidal thoughts during a period of six to 18 weeks. In response, the FDA announced it would investigate all ADHD medications in response to reports concerning psychiatric side effects.
Strattera continues to be available on the market, and was prescribed to 3.3 million people, including 2 million children, from 2002 to 2008.
Legal Action
While Eli Lilly lost a patent lawsuit, no multi-district or mass tort litigation has yet been filed in the U.S. However, lawyers like Trantolo & Trantolo have been taking on and directing claims concerning its side effects, advertisement practices, and the manufacturer’s less-than-forthright approach during clinical trials. If you or a loved one experienced liver damage or suicidal thoughts not long after being prescribed Strattera, have Trantolo & Trantolo’s Connecticut lawyers evaluate your claim.
