The Therapeutic Goods Administration (TGA) has issued a new safety advisory for Strattera, the non-stimulant drug once touted as a safe alternative to ADHD stimulants. Strattera already carries warnings for serious adverse events including suicidal ideation and potential fatal liver damage. The TGA has now added a warning about ‘clinically significant increases in heart rate and blood pressure’. (The new warning is available at http://www.tga.gov.au/safety/alerts-medicine-atomoxetine-111102.htm)
The safety advisory warns ‘Atomoxetine [Strattera] is contraindicated in patients with symptomatic cardiovascular diseases, moderate to severe hypertension or severe cardiovascular disorders, whose condition would be expected to deteriorate if they experienced increases in blood pressure or in heart rate that could be clinically important’. It follows new data obtained from clinical trials sponsored by the manufacturer Eli Lilly, which has now been required to write to Australian health professionals to warn them of the risk.
Strattera made a splash when it was first released on the market in the US in 2002 as a non-addictive alternative to amphetamine based stimulants. However, it didn’t take long before the gloss wore off. Just two years later, the US Food and Drug Administration was warning of the risk of potentially fatal liver damage and the following year, about an increased risk of suicidal ideation in children and adolescents being treated with the drug.
From early 2004, when the failed antidepressant first came on the Australian market as an ADHD drug, until November 2010 there were one hundred and thirteen voluntary adverse event reports made to the TGA. These included over fifty reports of self harm or suicidal ideation. It is impossible to know the true number of actual events, as the voluntary nature of the reporting system means only a fraction of incidents gets reported. (For further details of Strattera’s history of misery see http://speedupsitstill.com/strattera)