In addition to antidepressants, eczema medicines (Elidel and Protopic), and asthma medicines (Advair and Serevent), it looks like stimulant medications that are used to treat ADHD, including Ritalin, Concerta, Adderall, and Focalin, may also soon get a black box warning. Strattera, a non-stimulant that is used to treat ADHD already has its own black box warning.
The FDA's Drug Safety & Risk Management Advisory Committee recently recommended that ADHD stimulant drugs receive a black box warning on their labels to discuss their possible risk of causing high blood pressure, stroke, and sudden death.
It is important to note that this recommendation does not mean that the FDA will add the black box warning and that there is no proven link between case reports of cardiac problems and ADHD drugs.
Black Box WarningsThe need for warnings on medicines is clear, as several drugs have recently been withdrawn from the market because of known side effects. Many experts question if adding warnings to medicines even when the link to side effects hasn't been proven, as in the case of antidepressants, eczema medicines, and ADHD medicines, will be as effective.
With so many warnings out there, won't people just start ignoring the warnings?
That is definitely one possible problem with all of the recent warnings. Many doctors and parents may simply get so used to the warnings that they don't even consider them when deciding if a child should take a medicine.
Although being silent and ignoring obvious safety hazards would be a mistake, scaring people about rare and theoretical risks, espeically when the benefits of the medicines outweigh those risks doesn't do anyone any good.
Adding to the controversy, with the new warnings, many experts come out against them, as in the case of Elidel and Protopic, which are used to treat kids with eczema. Althought the FDA added a black box warning to them recently, the American Academy of Dermatology issued a statement in response to the FDA warning, saying that they disagree with the FDA and that they believe that current research doesn't prove that Elidel and Protopic are dangerous when used properly.
ADHD Black Box WarningThere is no general ADHD black box warning yet. The FDA will now have to review the recommendations of the Drug Safety & Risk Management Advisory Committee, which voted 8 to 7 for the black box warning, with one abstention, and make a decision on whether to actually add the black box warning.
And when considering whether or not to keep your kids on ADHD medicines, keep in mind what Dr. Laurence Greenhill had to say, when he testified in front of an FDA committee on behalf of The American Academy of Child and Adolescent Psychiatry and the American Psychiatric Association:
Stimulant medications offer many benefits to a wide range of children, and have proven to be safe over a half-century of use.There also seems to be some politics behind the new recommendation for the black box warning. Reading between the lines, you get the feeling that some panel members feel that ADHD is being overdiagnosed and that stimulant medicines are being overused. Could a black box warning be their way of reining in the use of ADHD drugs, like Adderall and Ritalin?