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Drug Warnings Could Protect Students, Too

February 13, 2006

Eleanor Davidson, a doctor who treats students at Case Western Reserve University, in Cleveland, has long been wary of prescribing stimulants, like Ritalin and Adderall, to students with cardiovascular problems in an effort to treat attention deficit hyperactivity disorder.  

“Last week, I saw a student with borderline high blood pressure who wondered if he was a good candidate for ADHD drugs,” she said Friday. “Under those circumstances, I would not want to put a young adult on these medications.” Instead, she prescribed Wellbutrin, a drug that is often used to treat depression, but is also sometimes effective in treating ADHD.

Members of a federal advisory panel had those sorts of concerns in mind when they voted Thursday to recommend that U.S. Food and Drug Administration regulators should require manufacturers of stimulants to place prominent “black box” warnings on drug labels and offer guides detailing risks, such as heart attacks, strokes and death. Since the vote, several health experts have said that the stricter standards might curb the use and abuse of such stimulants in the college-age population.

“In young adults, there may be underlying cardiovascular abnormalities that could be exacerbated if they take these drugs,” Arthur Levin, director of the Center for Medical Consumers in New York City, and member of the advisory panel, said Friday. “This applies whether a student is using the drugs legally or illicitly.

“For students who exercise a lot or for those who live an unhealthy lifestyle,” added Levin, “there’s an increased risk -- although small in younger populations -- of heart attacks and strokes [when using the drugs].”

Davidson, while favoring stricter warnings, said that the personalities of college students must be taken into account when prescribing drugs to them. “I don’t think that scaring students works,” she said. “I don’t think that lectures work, either.”

Instead, Davidson said she finds it more useful to help students understand how a drug works for them.  When prescribing stimulants, she often notes that they provide more energy, but can also lead to exhaustion, if abused. “An athlete or a dancer doesn’t want to be exhausted,” she said.  

Matthew Cabrey, a spokesman for Shire Pharmaceuticals, said Friday that he could not provide exact figures on the number of students, aged 18 to 24, who now take Adderall XR, the company’s most prescribed drug. He did note that since the FDA gave approval for the drug to be prescribed to people aged 18 and older in 2004, the number of adults taking the drug has dramatically increased. Nationwide, almost four million patients are currently prescribed drugs to treat ADHD.

FDA officials told several news outlets that the vote by the committee, composed largely of drug safety specialists, was somewhat unexpected. Another committee, made up of pediatricians and psychiatrists, is expected to discuss possible recommendations -- and how they might pertain to younger people -- in March. The FDA could ultimately decide not to act on either committee’s recommendations, since they are advisory in nature.

Bryan Goodman, a spokesman for Children and Adults with Attention-Deficit/Hyperactivity Disorder, said his group wouldn’t want to see any student who truly needs to be on ADHD drugs stop taking them because of the committee’s recommendation. He added that the risks from taking such drugs are low. A review by the FDA of reports of sudden death or cardiovascular incidents in patients taking ADHD medications found 25 reports of death, mostly among youth, between 1999 and 2005, and 54 incidents of serious cardiovascular problems.

Still, even pharmaceutical companies have noted that abuse of the drugs appears to be increasing in the college student population, especially as more kids who grew up being treated for ADHD are reaching college age.

“We are aware of increased reports about perceived misuse of stimulants among high school and college students,” said Cabrey. In an effort to combat the problem, Shire Pharmaceuticals provided the American College Health Association with a grant to develop a monograph titled "Use and Misuse of Stimulants: A Guide for School Health Professionals," and related Web materials that are intended to educate college health care providers about stimulant use and misuse. The project is currently in the development phase.

In the meantime, Levin said he’s hopeful that the FDA will act on the committee’s recommendation. “It’s not a perfect solution,” he said. “But with increased warnings on any drug, the number of prescriptions tend to go down.  I’d also expect that illicit abuse of stimulants by college students would go down, too.” 

 

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