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Feb. 10 (Bloomberg) -- U.S. drug safety reports linking an attention deficit drug to 20 deaths aren't enough for the Food and Drug Administration to follow Canada in taking the product off the market, the agency's director of medical policy said today.
Health Canada ordered the withdrawal yesterday of Adderall XR, made by Shire Pharmaceuticals Group Plc, based on its review of adverse-event reports previously given to the U.S. agency by the Basingstoke, England-based company. The drug is prescribed for children and adults with attention deficit hyperactivity disorder.
``The cases are not convincing evidence the drug is clearly responsible for these deaths,'' said Robert Temple, director of the FDA's office of medical policy, in an interview.
The drug, Shire's biggest product, will remain available in the U.S., its largest market, Temple said. House and Senate committees have been probing the FDA's monitoring of drug safety since antidepressants were linked to increased risk of suicide in children and Merck & Co. withdrew its Vioxx painkiller after a company study tied it to heart risks.
The FDA is deciding whether to conduct its own study of the Shire drug's safety and will closely monitor adverse-event reports, Temple said. In the U.S. about 2 million children have attention deficit hyperactivity disorder, according to the National Institutes of Health.
Shares of Shire, the U.K.'s third-biggest drugmaker, fell the most in a more than a year today. The company's stock dropped 64.5 pence to 577.5 pence at the close of trading in London. The 10 percent drop was the steepest since January 2003.
FDA Discouraged Withdrawal?
``Information conveyed to my staff suggests that during a recent Adderall meeting, one or more FDA employees requested that the Canadian government refrain from suspending the use of Adderall XR because there was concern that FDA could not handle another `drug safety crisis,''' Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, said today in a letter to acting FDA Commissioner Lester Crawford.
Grassley requested details of meetings with Canadian officials concerning Adderall and related records and documents. A phone message left after normal business hours for FDA spokesman Brad Stone for comment on Grassley's letter wasn't immediately returned.
Health Canada ordered the drug to be withdrawn after Shire declined a request to take it off the market voluntarily, said Robert Peterson, head of the agency's therapeutic products division, on a conference call today with reporters. Canadian authorities will further examine details of the safety reports before deciding whether to allow sales to resume, Peterson said.
Adderall XR, the drug's extended-release version, had third- quarter sales of $140 million, more than 40 percent of Shire's revenue for the period. Adderall is an amphetamine, a class of drugs that stimulate the central nervous system.
Shire ``is confident in the safety of Adderall XR,'' and disagrees with Health Canada's conclusions, Shire spokesman Matthew Cabrey said in a telephone interview. About 37 million prescriptions have been dispensed over 10 years, and more than 1 million people have taken Shire's two forms of Adderall, he said.
The Shire drug competes with Novartis AG's Ritalin, Johnson & Johnson's Concerta, and Eli Lilly & Co.'s Strattera, which carries the FDA's strongest-possible warning for risk of liver damage.
Reports of deaths among children and adults using Adderall XR led the FDA in August to add a warning to the drug's label citing a risk of sudden death and serious heart problems.
Both agencies' decisions were based on information the company gave the FDA through the agency's adverse-event reporting system. The reports linked the drug to the deaths of 14 children and six adults from 1999 to 2003.
``Our conclusion now isn't any different from our conclusion when we looked at them last time,'' the FDA's Temple said. ``What we found was that the data were not convincing.''
Among the deaths, five patients had structural heart abnormalities, one was a child with Type-1 diabetes, another was a child who had exercised to the point of severe dehydration and heat exhaustion, and an eighth showed toxic levels of amphetamine, according to a public health advisory posted in the FDA Web site.
``This highlights that all medicines have their problems,'' said Mark Stein, a professor of psychiatry and pediatrics at the University of Chicago. ``It's really important that children be evaluated first to make sure they don't have any cardiac abnormalities or anything else that would put them at high risk.''
The rate of deaths may not be significantly higher than among those who don't use Adderall, Temple said. There have been seven reports to the FDA of sudden deaths among patients using Ritalin or Concerta, he said.
``It's not a favor to the community to react to everything that comes out,'' Temple said. ``The decision to put a child on a chronic drug should be made with full understanding that drugs are not risk-free. You have to weigh all the benefits against the possibility the drug could do something bad.''
Adderall's label in the U.S. already carries the strongest FDA warning, highlighted in a black box, that amphetamines ``have a high potential for abuse'' and ``should be prescribed or dispensed sparingly.'' Separate warnings on the label caution against use during pregnancy or while breast feeding.
The FDA's ``ability to inform people doesn't work,'' Representative Bart Stupak, a Michigan Democrat, said in an interview today. Stupak has been a critic of the FDA for several years after his son committed suicide in 2000 while taking the acne drug Accutane, made by Roche Holding AG. ``If you're going to keep this thing on the market, have a signed informed-consent for the patient, and make it mandatory,'' Stupak said.
The House Energy and Commerce Committee will hold a hearing in March to review how the FDA has regulated Accutane and other drugs, Stupak said.
To contact the reporters on this story:
Geraldine Ryerson-Cruz in Washington at firstname.lastname@example.org;
Juliann Walsh in Princeton at email@example.com.
To contact the editor responsible for this story:
Robert Simison at firstname.lastname@example.org
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