July, 20 2018

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Canada Pulls ADHD Drug

WASHINGTON -(Dow Jones)- Health Canada said late Tuesday it has instructed that Adderall, a drug used to treat Attention Deficit Hyperactivity Disorder ( ADHD) in children and adults be pulled from the Canadian market over concerns the drug caused 20 deaths.

The Food and Drug Administration said it is in close contact with Canadian health authorities over its decision to suspend sales of the drug. However, the FDA said Tuesday it "does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada's analyses of adverse event reports and FDA's own knowledge and assessment of the reports received by the agency."

Adderall is marketed in Canada by Shire BioChem, a unit of Shire Pharmaceuticals PLC (SHPGY).

In a statement, Health Canada said the decision to request that Shire pull Adderall was based on a safety review provided by the company. It indicated that there were 20 international reports of sudden death in patients taking Adderall R, the immediate release form of the drug, and Adderall XR, the extended release version. "These deaths were not associated with overdose, misuse or abuse. Fourteen deaths occurred in children, and six deaths in adults. There were 12 reports of stroke, two of which occurred in children," Health Canada said.

Both Adderall R and Adderall XR are sold in the U.S. and Adderall XR is sold in Canada.

In a statement, Shire said although it is complying with the Canadian request, "the company strongly disagrees with the conclusions drawn by Health Canada and is considering appropriate responsive action."

The company said it remains confident in the safety and effectiveness of Adderall for the treatment of ADHD when used in accordance with the approved labeling.

Shire said the interpretation of the same data by the FDA led to a revised label for Adderall XR last September, which states that the drug should not be used in children or adults with structural cardiac abnormalities.

The FDA said it would provide issue information sheets for consumers concerned about Adderall and Health Canada's decision to suspend sales of the drug. The FDA said it would also provide up-to-date information about Adderall's safety profile on its website at www.fda.gov.

In information posted to its Web site, the FDA said sudden unexplained death has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR.

"In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall," the FDA said. But, the FDA also said, it cannot, at this time, "conclude that recommended doses of Adderall can cause sudden unexplained death."

The FDA said patients using Adderall, or parents of children on the drug, who have questions about the drug should consult their physicians before making any alterations to their therapy.

Adderall is a central nervous system stimulant, or an amphetamine. The medication is used to treat attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older and in adults.

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