(August 21, 2006) -- GlaxoSmithKline Plc and Shire Plc said they strengthened warnings that their attention-deficit drugs may cause psychological side effects and misuse may lead to sudden death from heart attacks and strokes.

Glaxo, the world's second-largest drugmaker, said today that it added the warnings to prescribing information on its Dexedrine treatment last month. Shire said it also added the warnings for its Adderall XR, the top-selling treatment for attention deficit hyperactivity disorder.

The Food and Drug Administration in May asked makers of similar central nervous system stimulants to add the warnings, said FDA spokeswoman Kimberly Rawlings in an e-mail. Five million Americans use ADHD drugs, 3.3 million of them under the age of 19, according to Medco Health Solutions Inc., a manager of drug benefits for employers and insurance companies. The changes follow recommendations from two FDA advisory committees.

``It's a very strong warning,'' said Steven Nissen, president of the American College of Cardiology and chairman of cardiology at the Cleveland Clinic, who served on a February advisory committee that recommended warnings, in a telephone interview. ``It's appropriately worded. It basically lets physicians and patients know that these drugs do have serious cardiovascular side effects.''

Side Effects

The warnings list side effects including suppression of growth, psychosis, bipolar illness, aggression and ``serious'' cardiovascular side effects. The FDA posted a Glaxo letter to doctors and the revised prescribing information on its Web site today. The letter doesn't name other manufacturers.

Other products covered by the warnings may include those containing methylphenidate, used for more than 50 years, such as Novartis AG's Ritalin and generic copies. Novartis spokeswoman Gina Moran in East Hanover, New Jersey, didn't immediately respond to a phone message.

FDA spokeswoman Rawlings was unable to say specifically which drugs would be required to have the new warning.

London-based Glaxo's American depositary receipts rose 4 cents to $54.48 at 4:01 p.m. in New York Stock Exchange composite trading. One ADR is equivalent to two common shares. American depositary receipts of Shire, based in Basingstoke, U.K., climbed 25 cents to $50.16 at 5:20 p.m. New York time in Nasdaq Stock Market composite trading. Each ADR represents three common shares.

Advisory Committees

The February advisory committee urged the FDA to require its strictest form of warning, highlighted in boldface type and outlined with a black box, to all ADHD drugs because of the risk of heart attack, stroke and sudden death. In March a separate committee recommended additional warnings of the psychological side effects.

Growth in the number of children on the drugs slowed in 2005 to less than 1 percent from 11 percent in 2004 and 16 percent in 2003, according to data compiled by Franklin Lakes, New Jersey- based Medco.

Shire changed its labeling after the FDA approved the warnings July 31, spokesman Matthew Cabrey in Wayne, Pennsylvania, said in an interview.

Doctors wrote 195,000 prescriptions last year for Glaxo's Dexedrine, accounting for less than 1 percent of all prescriptions for ADHD, Glaxo spokeswoman Holly Russell said in a telephone interview. Dexedrine has been available since before 1950 and generic versions came available in 2002, Russell said.

Snakes, Alligators

Since 2000, the FDA has received more than 500 reports of psychosis in children 10 and younger who took ADHD drugs, the FDA staff said in a March report. In one case, a 7-year-old boy on Adderall reported seeing people sitting in a rocking chair and people coming into the house and stealing Christmas presents. A 5-year-old boy reported seeing snakes and polka-dot alligators.

Some lawmakers, including Senator Charles Grassley, an Iowa Republican, criticized the FDA's handling last year of safety risks associated with drugs for ADHD. The FDA came under increasing scrutiny after the Canadian health agency pulled Adderall XR from the market in February 2005 when 20 people taking the drug died. Health Canada returned the drug to the market in August and in May strengthened the warnings.

More on this story: FDA Calls for New Warnings On ADHD Drugs

Last updated: 08/06

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