July 15, 2009

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.

Posted by Philip Dawdy at July 15, 2009 09:49 AM
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Comments

My psychiatrist told me that he basically never prescribes this stuff because it doesn't improve concentration nearly as well as stimulants, and more importantly it has the same side effect profile as tricyclic antidepressants, e.g. tachycardia, orthostatic hypotension, urinary retention, cotton mouth. So these added warnings don't surprise me. It's amazing that the pharmaceutical industry can get docs to stop prescribing tricyclics because of the horrible side effects, but still manage sell drugs with indistinguishable side effects.

Posted by: acute_mania at July 15, 2009 05:23 PM

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

The patent is probably about to expire anyway. They probably have a replacement in the works.

Posted by: Damaged at July 15, 2009 07:28 PM

Hi,

Strattera was prescribed for my 11yo because I was adamant about not wanting her on stimulants due to a family history of alcoholism and addiction.

I stopped it after two weeks because she was miserably lethargic and nauseous. Since summer break was approaching I did not follow up on alternatives, but I may consider Adderall if she still has problems this coming school year.

I'm generally opposed to psychiatric/ADHD medications for children, but I finally relented after 7 years of trying dietary and behavioral changes.

In any event, I'm glad I found your blog as it appears to be a valuable source of information for consumers.

Posted by: Brenda Mayer at July 16, 2009 07:12 PM

The patent doesn't expire until 2017. It's probably a win-win situation. By getting the information out now, Lilly won't be subject to a class action suit in the future and more hapless consumers won't be harmed.

Posted by: Tony at July 19, 2009 06:36 PM
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