ADD drug, pulled in Canada, stays on market in USA
February 11, 2005
USA TODAY

A day after Canadian officials came to an opposite conclusion, FDA regulators said Thursday that there is insufficient evidence to pull an attention deficit disorder (ADD) drug from the market.

The drug, called Adderall and Adderall XR, has been linked to 20 reports of sudden death worldwide, most in children, according to Health Canada. None of the deaths were in Canada.

The Food and Drug Administration says 12 of those reported deaths were in the USA and occurred from 1999 to 2003, a period when 30 million prescriptions were written for the stimulant drug.

Most patients taking the drug are children being treated for hyperactivity, although reports have surfaced of abuse by people who want to stay awake.

Shares of Shire Pharmaceuticals, the British company that makes the drug, fell 10.8% to close at $31.80.

'We are surprised by this action from Health Canada. Shire remains confident in the safety and efficacy of Adderall XR,' said Shire CEO Matthew Emmens in a statement on the firm's Web site.

The news follows several other high-profile drug safety issues in recent months, including the worldwide withdrawal of painkiller Vioxx after a study showed a sharply increased risk of heart attack and stroke.

The 12 deaths out of 30 million prescriptions do not exceed what the FDA says it would expect to occur in a group that size. And the FDA said other factors also had to be considered: Five of the deaths occurred in patients with underlying heart defects. Another involved a child subjected to high temperatures, vigorous exercise and dehydration, said Robert Temple, an associate director for medical policy at the FDA.

The deaths occurred in children who took the drug for as little as one day and as long as eight years.

'We looked at these data about six months ago, and we just don't think you can conclude the drugs are doing anything,' Temple said. 'If the evidence isn't good enough to make a case that there's a real risk, it's not a service to people to take the drug away.'

In August, the FDA added a warning to Adderall's label, saying people with underlying heart defects had an increased risk of sudden death.

Adderall, an amphetamine, is in one of three classes of drugs used to treat ADD. Another class, also stimulants, is methylphenidate products, such as Ritalin or Concerta. The third is non-stimulant Strattera.

Seven deaths over five years have been reported among patients using the methylphenidate products, the FDA says.

Doctors and other medical experts cautioned patients not to suddenly stop taking Adderall and to talk with their doctors about their concerns.