Strattera Gets Warnings For Severe Liver Injury, High Blood Pressure

The FDA today issued a new set of warnings for the non-stimulant ADHD drug Strattera, made by Eli Lilly. I’ll just quote the FDA’s new language:

“Severe Liver Injury

“Reported cases of liver injury occurred within 120 days of initiation of atomoxetine [Strattera] in the majority of cases and some patients presented with markedly elevated liver enzymes [>20 X upper limit of normal (ULN)], and jaundice with significantly elevated bilirubin levels (>2 X ULN), followed by recovery upon atomoxetine discontinuation.

“Effects on Blood Pressure and Heart Rate

“Orthostatic hypotension and syncope have been reported in patients taking Strattera. Strattera should be used with caution in any condition that may predispose patients to hypotension, or conditions associated with abrupt heart rate or blood pressure changes.”

The FDA also approved updated language for the drug’s adverse reactions labeling, including warnings that the drug can cause lethargy, hypoaesthesia (loss of skin sensitivity), paraesthesia (tingling), sensory disturbances, urinary hesitation and urinary retention.

None of which can be good news for Lilly and its drug.

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