An FDA committee has recommended that information about the risk of hallucinations in children be added to the labels of attention deficit hyperactivity disorder (ADHD) drugs.
They did not, however, argue in favor of a "black box" warning, the strongest type of warning that can be affixed to a medication, for either hallucinations or cardiovascular risks, out of concerns that doing so would scare patients away from the drugs.
This conflicts with an earlier panel's recommendation that the cardiovascular risks be given a black box warning. The FDA is likely to follow the more recent panel's advice.
The recent panel also did not recommend adding a suicide risk warning to the labels, although one such drug, Strattera, does already carry a black box warning about suicide risk.
They did recommend that the FDA create a medication guide explaining the possibilities of increased aggressive behavior, heart attack, stroke, and potential sudden death.
Looks like there's going to be no black box warning for either the hallucinatory or cardiovascular risks of ADHD drugs despite evidence supporting this labelling. That's the bad news.
The good news is that it really doesn't matter as black box warnings aren't particularly effective. They tend to be a tactic drug companies and the FDA use to say they warned the doctors and the public before they finally pull the drug off the market.
This interim measure allows the drug company to earn significantly more profits. Unfortunately, many are harmed or killed because their physicians did not believe or heed the warnings.
Many of the drugs used to treat ADHD are not only potentially hazardous, but they are unnecessary if your child is treated appropriately. And, just because the FDA is leaning toward putting a warning on the label, however watered down, doesn't mean it will happen anytime soon either. Any updates on prescription labels may not appear for several years.
Interestingly, I just learned that the medical director of the physician's group at Northwestern Hospital in Chicago just put her son on krill oil and in 40 days noticed remarkable improvement. The results were so dramatic that she invited the major supplier of krill oil to come out to Chicago and speak to the physician group at Northwestern this week.
If you have a child with ADHD I would strongly recommend reviewing the interview we did with Dr. Lendon Smith shortly before he passed away.
If you or a loved one is suffering from ADHD, please remember there are plenty of safe, effective alternatives for treating this condition without the need for a toxic, hallucinogenic drug. Some particularly effective methods include: