Shire: Additional studies of Adderall better than 'black box' warning on cardiovascular risks

By E. Janene Geiss

Philadelphia, Feb. 10 - Shire plc said Friday that the interests of physicians and patients would be better served by further study of attention deficit hyperactivity disorder drugs and their possible relationship to serious cardiovascular adverse events - and not a "black box warning" on the label of all stimulant medicines used to treat the disorder as recommended at Thursday's meeting of the Food and Drug Administration Drug Safety and Risk Management Advisory Committee.

The company said it is supportive of the goals of the meeting but wanted to put several of the issues discussed into perspective, according to a company news release.

The overall purpose of the meeting was to review the cardiovascular safety issues associated with medicines used to treat attention deficit hyperactivity disorder (ADHD), officials said.

Data regarding the reported incidence rates of serious cardiovascular adverse events - both in patients taking ADHD medicines and those not taking ADHD medicines - were reviewed. Importantly, the reported incidence rates were similar in both groups, officials said.

The company said the advisory committee recognized the reported incidence rates of the rare serious cardiovascular adverse events are generally within the rates that would be expected from the untreated general population, but the group still recommended to the FDA that it include risk information about cardiovascular events in a "black box warning" for all stimulant medicines used to treat ADHD.

"While we fully support full disclosure and adequate warning, Shire believes that the interests of physicians and patients would be better served by further study to determine whether there is, in fact, a relationship between these medicines and cardiovascular events. Obtaining this information is crucial prior to taking what would be an unprecedented action to include something in a black box that is not supported by sufficient data," the company said in the release.

The company said that Adderall XR and Adderall already include a "black box warning" in their labels for safety concerns related to amphetamine abuse or misuse.

The label also warns of the risk of sudden death in patients with structural cardiac abnormalities, officials said.

"We stand behind this labeling and believe that further action is unwarranted," the company said in the release.

The company also said the benefits of treatment should not be overlooked. As several participants at the meeting pointed out, ADHD is a serious condition, and if left untreated the disorder can result in serious consequences.

Stimulant medicines such as amphetamines and methylphenidate are highly effective in treating patients with ADHD and have been used for more than 50 years, officials said.

ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than typically observed in individuals at a comparable age and maturity level.

Shire is a Basingtoke, England, specialty pharmaceutical company that focuses on meeting the needs of the specialist physician with a focus on central nervous system and gastrointestinal disorders, general products and human genetic therapies.

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