Two articles raise concerns about attention deficit drugs. Both articles are posted below in their entirety in order to assure public awareness of these concerns. The drugs include Ritalin, Concerta, Methylin, Metadate, Adderall and Adderall XR. The drugs may be linked to an increased risk of death and injury.
Special warnings on attention deficit drugs urged
WASHINGTON — Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they may be linked to an increased risk of death and injury, federal health advisers said Thursday.
A Food and Drug Administration advisory panel voted in favor of the “black box” warning after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote of the Drug Safety and Risk Management advisory committee was 8-7, with one abstention. One committee member, Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, said it would be “inappropriate, unethical behavior” not to disclose that there was uncertainty about the safety of the drugs.
The FDA is not required to follow the recommendations of its advisory committees but typically does.
“The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way,” director of the FDA’s Office of Medical Policy, told reporters after the meeting.
Doctors prescribe the drugs to about 2 million children and 1 million adults a month.
Drugs that would have to carry the warning labels are methylphenidates, which are sold as Ritalin, Concerta, Methylin and Metadate. The labels for Adderall and Adderall XR, both amphetamines, have included the warnings since 2004.
U.S. reports deaths of patients taking drugs for ADHD
February 9, 2006
By Lisa Richwine
WASHINGTON (Reuters) – U.S. regulators were told of 24 deaths among patients who took Shire Pharmaceuticals Group Plc’s attention deficit drug Adderall (amphetamine, dextroamphetamine) through 2003, according to a report released on Wednesday.
Another 16 deaths were reported through 2003 in patients who took methylphenidates, said the report prepared by Food and Drug Administration staff. Ten deaths were reported among other drugs in the amphetamine class, it said.
The report from April 2004, which disclosed all the deaths, did not say the drugs were responsible for the fatalities but urged close monitoring of possible cardiac problems in children who took them.
An FDA advisory panel will meet on Thursday to discuss how best to study the safety of the medications. FDA staff also will provide updated figures on health problems that have been reported in people who took the drugs, the report said.
Shire spokesman Matthew Cabrey said data has not shown any correlation between Adderall and the sudden deaths reported among children. He said the company supports the FDA’s review of the matter.