An attention deficit hyperactivity disorder drug that was forced off the market last February by Canadian Health officials is being reinstated, the drug's maker, Shire Pharmaceuticals, announced Wednesday.
Adderall XR will be reinstated on the Canadian market effective this Friday, but it will take a bit longer before the drug is available again across the country, company spokesperson Matt Cabrey said in an interview.
The reversal of the federal regulator's decision comes after a panel of experts — called a new drug committee — reviewed the safety data on the drug. Shire triggered the review by in effect appealing Health Canada's decision to remove the drug from the market.
"The NDC (new drug committee) came to the conclusion that there was not enough evidence of an increased harm from Adderall compared to other therapies available," said Health Canada spokesperson Jirina Vlk.
"The benefits of treating ADHD has to be balanced with the known harms of this class of drugs."
Health Canada pulled Adderall XR, a once-a-day treatment for ADHD, off the market on Feb. 9 after learning from the company of 20 cases of sudden death and 12 of stroke in people using the drug. None of those cases occurred in Canada.
Fourteen of the sudden deaths and two of the strokes were in children. A number of the cases involved children with structural heart defects.
Steve - see our following March entry and we'll you decide what's going on here.
ADHD drug Adderral pulled in Canada -
The popular drug, which has been linked to 20 sudden deaths worldwide, mostly in children, was taken off the Canadian market Wednesday, sparking questions about whether kids in the USA should be using it.
The Food and Drug Administration issued a public health advisory on its Web site saying that the rate of sudden death for children on Adderall XR is no higher than for those not on the drug. But children with heart defects could be at higher risk.
Parents are making decisions about stimulants such as Adderall XR with few facts, says Julie Magno Zito, an epidemiologist at the University of Maryland. There are no good long-term studies of such medicines, she says. Rare side effects of a drug won't surface in short studies unless they include a huge number of kids, such as in a national HMO, and that kind of study hasn't been done on Adderall XR, Zito says.
About 700,000 children in the USA take Adderall XR, a timed-release stimulant, and 300,000 use Adderall, a version that often needs to be taken more than once a day, according to Shire Pharmaceuticals Group PLC, maker of the drug.
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