Dr. Steven E. Nissen said he had no preconceived notions about drugs for attention deficit hyperactivity disorder when he was asked by the U.S. Food and Drug Administration to serve on a panel charged with creating protocols for testing such drugs.
But during a presentation, Dr. Nissen and other panel members learned of 25 reports of deaths between 1999 and 2003. Several dozen other cases of cardiovascular problems among users were reported in that period, many among people with pre-existing cardiac problems.
Dr. Nissen, a Cleveland cardiologist, felt he had enough information to take action. He suggested that stimulant medications for ADHD carry a prominent warning to pediatricians, a sign that doctors should take extra care before prescribing them.
Other panel members agreed. It voted 8-7 on Feb. 9 to recommend the warning labels for some ADHD medications. The warning does not prevent doctors from prescribing medications, but is intended to ensure that doctors know that their patients truly need the drugs and are aware of the risks.
The panel’s recommendation has reverberated around the country among doctors, parents of children who have been diagnosed with the disorder, and educators.
That’s just what Dr. Nissen, the interim director of cardiovascular medicine at the Cleveland Clinic, a renowned medical facility, wanted to happen.
“I want a public dialogue between parents and teachers and doctors,” he said in an interview last week. “People deserve to know what risks they’re taking with their medications.”
But the panel’s recommendation has also stirred a backlash, especially from psychiatrists and family physicians who prescribe medications for ADHD. They say the FDA advisory panel overstepped its charge and is making recommendations without knowing all the facts.
“It doesn’t astonish me that they wanted to weigh in,” Dr. Robert Temple, the director of the FDA’s office of medical policy, said at a press conference called after the panel’s decision. “But it wasn’t the primary matter we wanted them to weigh in on.”
The agency is not required to accept the panel’s recommendation, but officials said they would consider it.
“Every medication has a side effect,” said Dr. Lynn Wegner, a Morrisville, N.C., pediatrician who is the chairwoman of the section on developmental and behavioral pediatrics for the American Academy of Pediatrics. “The question is whether the risk is worth the reward.”
Dr. Wegner supports more study to determine whether people who have died after taking ADHD medications may have had underlying cardiac conditions. Before that’s known, it’s impossible to say just how harmful ADHD drugs may be to a wider population, she said.
Psychostimulants are the most widely used medications for the treatment of attention deficit hyperactivity disorder. In 2003, 2.5 million children ages 4 to 17 were receiving such medications for the disorder, according to the federal Centers for Disease Control and Prevention.
A federal Food and Drug Administration advisory panel has recommended that psychostimulants carry a prominent warning that they may cause sudden death or have serious complications.
SOURCES: U.S. Food and Drug Administration; National Resource Center on AD/HD
But she envisions that some doctors may just throw up their hands and stop prescribing the medications to avoid legal liability. When the news of the panel’s recommendations came out, Dr. Wegner said she had 20 messages on her answering machine within days from parents and patients who wanted to talk to her about them.
“The general pediatrician who’s busy and reads this article in The New York Times may say, ‘I don’t want to do this anymore,’ ” she said.
According to the U.S. Centers for Disease Control and Prevention, located in Atlanta, 2.5 million U.S. children ages 4 to 17 were receiving medication for ADHD, a condition characterized by inattention and impulsivity, in 2003. Psychostimulant medications, sold under brand names such as Ritalin, Concerta, and Adderall, are most often prescribed to treat the disorder. Many of the drugs have been around for decades; Ritalin was approved by the FDA in 1955.
According to the CDC, 4.4 million U.S. 4- to 17-year-olds have been diagnosed with ADHD by a health-care professional. In 2003, 7.8 percent of school-age children were reported to have an ADHD diagnosis by their parent. IMS Health, a Fairfield, Conn.-based pharmaceutical-information and -consulting company, said ADHD medications accounted for $3.6 billion in sales last year.
The medications have come under fire before, from those who say they are overprescribed and have unknown side effects. In February 2005, Canadian health authorities removed Adderall from the market over concerns about sudden deaths, but they allowed the drug to be sold six months later, in August.
Shire Pharmaceuticals, the British company that manufactures Adderall, released a statement saying that the FDA panel’s action was “unwarranted.”
Adderall “already include[s] a black-box warning in their labels for safety concerns related to amphetamine abuse or misuse,” the statement added. “The label also warns of the risk of sudden death in patients with structural cardiac abnormalities.”
Also being overlooked, the statement from Shire said, are the benefits of the medication.
Ginny Thiersch, a spokeswoman for the Landover, Md.-based group Children and Adults with Attention Deficit/Hyperactivity Disorder, or CHADD, said that the FDA panel “put the recommendation before the science.”
Now, she said, parents may be prompted to take their children off the medication without talking to their doctors, a step that Ms. Thiersch believes could have disastrous effects on such children’s classroom behavior.
Dr. Nissen, one of the first physicians to sound an alarm about Vioxx, a pain medication pulled from the market after being linked to sudden cardiac deaths, said that it’s safer for consumers to have the warnings in place, and then allow the drug companies to determine whether the warnings were unwarranted.
He said he believes that ADHD drugs are overprescribed, sometimes at the request of teachers or school administrators. Many children do benefit from ADHD drugs, he said.
“But giving it to kids with marginal symptoms, as opposed to counseling them or working with them,” Dr. Nissen said, “may not be the right thing to do.”
A version of this article appeared in the February 22, 2006 edition of Education Week as Cardiac Cases Raise Concerns Over Drugs for ADHD