New Warnings for ADHD Medication

This was in the news this morning. While none of this information is new, it will be interesting to see if fresh warning labels change people’s perception of ADHD medication. My feelings about these drugs are ambivalent. On the one hand, I’ve done a lot of research, gone to a lot of workshops, and heard a lot of experts speak about ADHD. I’ve seen firsthand the difference that proper levels of medication can make to a child’s performance in the classroom. Some children really do better when they take these medications. On the other hand, I know that the number of medicated children in the U.S. is many times greater than in other industrialized countries. The diagnosis for ADHD is very subjective. The medicines are overprescribed, and sometimes children who are simply rambunctious in the classroom are labeled ADHD. Conversely, some children who are ADD but do not display hyperactivity are missed. This happens frequently with girls. Last year, our son Haley was on Ritalin for the first time. It was unsettling to watch his behavior change while our doctor tried to find the right medication and the right dosage. While he did better in the classroom, he seemed to compensate for this by going wild at home once the medicine wore off. This year, we are home-schooling. Haley is off medication, and so far, doing fine. I’ll post an update on this as the year goes along.

In the meantime, the ADHD medication debate will not go away . . .

New warnings on ADHD drugs

By Susan Heavey Mon Aug 21, 8:26 PM ET

WASHINGTON (Reuters) – Several drugs to treat attention deficit hyperactivity disorder must include new warning information about the risk of heart problems and psychotic behavior, U.S. health officials said on Monday.

The drugs, which include GlaxoSmithKline Plc’s Dexedrine and Novartis AG’s
Ritalin, must include a warning about the possible risk of sudden death and serious heart problems,

Food and Drug Administration spokeswoman Susan Bro told Reuters.
The drugs, stimulants that can raise blood pressure, must also include warnings about the risk of behavioral problems such as aggression and mania, she said.

Bro could not confirm whether other ADHD drugs — Johnson & Johnson’s Concerta and Eli Lilly and Co.’s Strattera — also were ordered to carry the warnings.

Strattera already includes a caution about suicidal thoughts, while Shire Plc’s Adderall already carries a warning that misuse can cause heart problems.

The FDA’s decision comes months after two separate panels of outside experts offered conflicting opinions on whether the risks warranted the strongest warnings possible — a so-called black box.

FDA’s Bro could not confirm whether the heart warning was boxed. But a letter from Glaxo made public earlier on Monday advising doctors about the new warnings said the heart caution was a boxed warning.

Other non-boxed warnings about psychotic behavior, stunted growth, seizures and vision problems also were included, Glaxo’s letter said.

Holly Russell, spokeswoman for the British drugmaker, said Glaxo agreed with the FDA’s request to add the warning language and complied with the agency’s recommended wording.
Other drugmakers did not immediately return calls seeking comment.

In March, FDA advisers said new information about the risks should be added to the labels for attention deficit drugs. The outside experts stopped short of supporting a boxed warning, saying they did not want to scare off patients or their parents.

A different FDA panel in February recommended black box heart-related warnings but said it was unclear if the drugs caused heart-related complications.

Some doctors have expressed concern that new warnings could dampen use of the medicines, which the FDA has estimated see about 1 million prescriptions for adults and 2 million for children each month.

Critics say many of the prescriptions are unnecessary and that the drugs are over used.
FDA’s Bro said the agency began contacting Glaxo and Novartis about the new warning requirements in May.

That same month, Canadian health authorities publicly warned people with high blood pressure, heart disease and other medical problems to avoid taking medications for ADHD.

Rick Riordan