FDA responds to ADHD medication study results
ROCKVILLE, Md. The Food and Drug Administration has said that results of a study it funded with the National Institute of Mental Health should not prompt parents of children with attention-deficit hyperactivity disorder to halt their children’s stimulant medication regimens, and parents should instead discuss concerns with prescribers.
The study, led by Columbia University researcher Madelyn Gould and published in the American Journal of Psychiatry, indicated a possible link between the medications and sudden cardiac death in children. Still, the FDA said that due to limitations in the study, the data did not change its stance on the risks and benefits of the medications.
“The FDA continues to review drug safety information for stimulant medications used to treat ADHD so that we can give healthcare professionals and families the most up-to-date drug safety information available,” FDA Center for Drug Evaluation and Research director Janet Woodcock said.
The study’s investigators compared the use of stimulant medications in 564 healthy children from across the country who died suddenly, “most likely” due to sudden cardiac disturbance, with the use of stimulant medications in 564 children who died as passengers in auto accidents. Of 564 children who died suddenly, 10 were reported to be taking a stimulant medication at the time, compared with two of the 564 who died in auto accidents.
The agency said limitations in the study included a low frequency of stimulant use reported in the study and control groups; a “significant” time lag between the dates when the deaths occurred and collection of the data; the difference in circumstance of death have explained differences in families’ or caregivers’ abilities to recall information relating to medication use at the time of death; and sudden unexplained death in a child would be more likely to trigger an inquiry into the cause of death than death due to blunt force trauma from an auto accident.
Maryland offers free prescription card to residents
ANNAPOLIS, Md. Maryland earlier this week launched a new statewide discount drug card program, called the Maryland Rx Card. The program, free to all Maryland residents, will provide savings of up to 75% on prescription drugs, though savings should average roughly 30%.
The program has no restrictions to membership, including no income requirements and no age limitations, and will be accepted at more than 50,000 pharmacy locations across the country.
Novo Nordisk discusses diabetes costs, patient motivation at conference
WASHINGTON The cost of diabetes to the country and the lag in patient motivation to take action to offset it were the major themes at a conference sponsored recently by a drug maker focused on the disease.
Danish drug maker Novo Nordisk convened the conference in Washington, bringing in such speakers as American Diabetes Association CEO Larry Hausner.
Without intervention at the national and patient level, the company said, the country runs the risk of having 50 million people living with the disease by 2025.
“The growing prevalence of diabetes is having a profound effect on the health of current and future generations, as well as our national economy,” Hausner said. “We must awaken the public’s consciousness of diabetes and ensure our leaders in Congress recognize healthcare reform as their opportunity to transform the lives of all people affected by this devastating disease.”