EDITORIAL – Prescriptions require warnings

A number of reports have come out indicating that medications for attention deficit… A number of reports have come out indicating that medications for attention deficit hyperactivity disorder – ADHD – seem to be causing some serious problems in the people who take them. Heart attacks, hallucinations, mania and psychosis are all documented effects of popular drugs like Ritalin, Adderall and Strattera, as well as their generic versions.

What’s the Food and Drug Administration to do? Children given placebos during clinical trials had zero instances of these complications. The side effects stopped for most children who were on the medications once they went off of them; they sometimes resumed as soon as the medications were restarted. More than 90 studies have been done.

So far, no one can figure out exactly why these things are happening or conclusively pin these effects on the drugs. Even so, it sure looks like there is a clear case of cause and effect here.

The FDA’s advisory committee recommended adding black-box warnings to these drugs. The most serious warnings a medication can bear, the warnings would alert doctors, patients and parents to these disturbing possible side effects. Still, the FDA has not decided what it is going to do and whether or not it will require the that warnings be added.

This isn’t a difficult decision, but it is an important one. The FDA has a responsibility to protect people and keep them informed. As McNeil Consumer and Specialty Pharmaceuticals, a branch of Johnson ‘ Johnson that manufactures the active ingredient in Ritalin, said in a briefing document, it is normal to weigh the “therapeutic benefits and potential risks” of medications. How can people accurately weigh these things if they are not informed of the risks?

The company, not surprisingly, went on to stress the importance of weighing the risk of untreated ADHD, which is a separate issue all together. There are doubtless many, many children and adults who suffer from ADD and ADHD, and for whom medication is the only effective treatment. For these people, it may well be worth taking these risks – but they still need to know exactly what risks they are taking.

There are also many children who are needlessly prescribed drugs, when what they really need is something else: time, discipline, a modified diet or just space to be energetic. In these borderline cases, a strict warning like this may help deter parents from placing their children on unnecessary medications.

The FDA needs to publish these warnings immediately. Moreover, those who are currently on the medications need to be informed of these newly discovered risks, so that they can decide for themselves how they want to react.