In recent months, the news media have been filled with reports suggesting that AD/HD medications, as well as certain antidepressants taken by many children with AD/HD, can cause significant health hazards, including sudden death.

Are these reports accurate? Are these medications jeopardizing your health or that of your child? Should you switch meds - or stop using them altogether? Good questions. But where do you go for answers? You probably aren't too eager to trust the pharmaceutical companies, and your doctor may lack the time to address all of your concerns. And, unfortunately, the mainstream media aren't always very good at putting scientific findings into context.

Let me try to help. In this column, I'll tell you the story about recent medication scares and explain how to make informed decisions.

2005 News

In early 2005, Health Canada, the Canadian drug regulatory agency, banned the sale of Adderall XR (amphetamine). The decision was made after studies conducted in the U.S. revealed that 12 children had died suddenly while on Adderall or Adderall XR. After reviewing these studies, our FDA decided to leave Adderall XR on the market in the U.S., noting that the rate of sudden death was no higher among children who were taking Adderall XR than among the general population of children.

Among the 12 fatalities reported by Health Canada, five involved youngsters who had structural heart defects - which are known to raise the risk for sudden death. Several of the remaining seven cases involved children who had another risk factor, such as a family history of ventricular tachycardia (rapid heartbeat). One case was reported more than three years after the fact, which makes the report less reliable. In another case, the child's blood was found to contain toxic levels of amphetamine, suggesting an overdose. The duration of treatment among the 12 who died varied from one day to eight years.

Given the shaky evidence of danger posed by Adderall XR, I think the FDA did the right thing. Apparently, Health Canada thinks so, too. Last August, the agency reversed its decision and allowed Adderall XR back on the market.

The FDA's review of Adderall safety is available at fda.gov (search for "Adderall"). The same Web site has information regarding recent reports of cardiovascular problems among children taking Concerta, a long-acting version of methylphenidate (Ritalin). The FDA has ordered additional research on the matter, but has indicated that there was no need for immediate action. For the latest, click on "drug advisory," then "Concerta."

Strattera and SSRIs

In September, the FDA issued a warning of increased risk of suicidal thoughts among adolescents who take the drug Strattera (atomoxetine). Following the release of the advisory, Strattera's manufacturer, Eli Lilly & Co., announced that it would put a "black box" warning on the drug's label. I think this was an overreaction to the evidence. Of the 1,357 youngsters studied who were taking Strattera, only five reported having suicidal thoughts. If you or your child is doing well on Strattera, there's probably no reason to stop taking it. Your physician should know how to monitor for depression and for suicidal thoughts.

In recent years, there have also been reports of increased incidence of suicidal thoughts among adolescents who take a highly effective class of antidepressants known as selective serotonin-reuptake inhibitors, or SSRIs. The FDA urged physicians and parents to monitor youngsters who take SSRIs, and ordered the drugs' manufacturers to add a black box warning to the labels. As a result of these actions, many parents requested that their children be taken off their SSRIs.

Another overreaction. Remember, depressed people, in general, are more likely to think about suicide. In fact, studies show that more than 40 percent of depressed adolescents think about hurting themselves. The studies cited in many media reports included data only from youngsters who were asked if they had suicidal thoughts. Other studies, in which data were included from general participants (not just those who were specifically asked to share their thoughts about suicide) found that taking an SSRI is associated with a slight reduction in suicidal thoughts.

Do youngsters taking SSRIs have increased risk or not? The truth remains unclear. Yes, physicians should advise parents of this concern. But parents must realize that such concerns may be based on incomplete data.

For a review of the scientific literature on SSRIs, go to parentsmedguide.org.

How to evaluate media reports

Medical studies you read about in the media are just that: studies. A single study rarely means much. All the evidence needs to be considered before reaching a conclusion about the safety of a particular medication. That's something that reporters often fail to do. Follow the reports of the FDA to learn the facts around any of the agency's decisions. Base your decisions on more than what you read or hear in the mainstream media.

I continue to prescribe all these medications with confidence. Yes, I am aware of potential problems, and I share my concerns with my patients and their families. But I also remind them that even aspirin has potentially troublesome side effects.