Rare side-effect warnings for Strattera
pharmafile | February 8, 2005 | News story | Sales and Marketing |Â Â Â
UK health professionals have been warned about rare but serious liver problems observed in Lilly's Strattera.
The drug has been licensed for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents since July 2004, but new evidence suggests it can cause hepatic disorders including severe acute hepatitis, but that the incidence is less than 1 in 50,000 patients.
Prof Gordon Duff, chairman of the Committee on Safety of Medicines said: "This is an important drug in the treatment of ADHD in children, and it has been widely and effectively used in the US and increasingly in the UK. It is therefore important that we take a balanced approach to this new advice. Parents should not be dissuaded from having their children treated with this medicine, but it is right that they should be aware of possible, but rare side-effects."
A total of 67 adverse reaction reports have been made through the UK's Yellow Card Scheme, including three reports of hepatic disorders, from an overall number of 10,000 patients who have been prescribed the drug.
An estimated 2.3 million patients have taken Strattera worldwide, with 41 reports of hepatic disorders recorded including two cases of severe acute hepatitis.
The MHRA has advised prescribers that the reactions have not formed an identifiable pattern, and has ruled therefore that routine liver function monitoring is unlikely to help and is not recommended. It advises that the drug should be discontinued in patients with jaundice or laboratory evidence of hepatic injury, and should not be restarted.
A question and answer information sheet has been put together especially for parents of children taking the drug, the MHRA making good its pledge to increase communication with the public and patients following sustained criticism of its record.
Methylphenidate is the standard treatment for ADHD, and is best known by the brand name Ritalin (Novartis) but is also available as Jannsen-Cilag's Concerta XL and Celltech's Equasym. Methylphenidate gives a stimulant 'buzz' to non-ADHD users and is thus open to abuse, a problem Lilly overcame in the development of Strattera.
Methylphenidate products are also recognised to cause liver problems in a few rare cases and already carry the appropriate warnings.
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