GlaxoSmithKline and Shire add to ADHD drug warnings
22 August 2006 00:00 in Pharmaceutical Company Product News
GlaxoSmithKline (GSK) and Shire, two of the UK's largest pharmaceutical companies, have created additional warnings for drugs containing dextroamphetamine sulphate.
Dextroamphetamine sulphate is used in the treatment of attention deficit-hyperactivity disorder and is found GSK's Dexedrine, as well as Shire's Adderall XR, its best-selling drug.
The companies have warned that sudden death can occur with the use of the drugs in patients with pre-existing structural cardiac abnormalities or other serious heart defects.
The new warning comes in response to a request from the Food and Drug Administraion, (FDA) for drug manufacturers to provide additional information about the use of stimulants in patients with heart defects.
Commenting on the FDA's request, Steven Nissen, president of the American College of Cardiology, told Bloomberg: "It's a very strong warning [and] it's appropriately worded."
"It basically lets physicians and patients know that these drugs do have serious cardiovascular side effects," he added.
The FDA's request also affects other drug manufacturers like Novartis, which produces Ritalin.
Last week, Shire ended litigation proceedings against Barr Laboratories after the American company attempted to market generic versions of Adderall XR. Barr admitted its patent infringement and agreed to purchase a licence to market the immediate-release form of Adderall.
The companies also entered into a collaboration regarding transvaginal ring technology, giving Shire exclusive rights to market the products in the UK and other European countries. © Adfero Ltd
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