Shire Pharmaceuticals' top-selling Adderall XR drug for attention deficit hyperactivity disorder (ADHD) needs to carry stronger warnings about the risk of side effects says the US FDA regulators.
It has asked the drug company to make clear to the public about the side effects of the drug such as hallucinations and paranoia.
This can occur in some patients with no identifiable risk factors. The FDA had prepared a report about a seven-year-old boy who, after taking ADHD drugs imagined seeing people sitting in a rocking chair and people coming into the house and stealing Christmas presents. Another such incident is that of a five-year-old boy who said he saw snakes and polka-dot alligators.
The spokesman for Shire said that it was too early to speculate on the outcome of next week's meeting. He said that any type of enhanced warning should be based on scientific data. But there is not enough data at the moment to warrant enhanced warnings.
The FDA's Drug Safety and Risk Management Advisory Committee talked about the heart risks due to the usage of ADHD drugs. The FDA advisory panel said that the ADHD drugs namely the Shire's Adderall and Novartis's Ritalin, should carry black box warnings highlighting the risk of heart attacks.
Thomas Laughren, director of the Division of Pyschiatry Products at the FDA, said that as of now nothing has to be changed and the labeling right now is adequate.