The FDA's Bureaucracy vs. Common Sense

Like many Americans, I read everything I can get my hands on about the new studies and warnings on drugs like Ritalin.

Why does everything have to be so hard? Why can’t common sense prevail? You know things are not always perfect. Yet every time we get competent, logical performance from a medical advisory board, the bureaucratic leadership of the FDA always has to, shall we say, make things more bureaucratic! More meetings spend more money and waste more time. They are always making sure that they are covering their bases (I was going to say something else).

Case in point: The recommendations by an advisory medical panel of the FDA which urged manufacturers to place stronger labels on drugs like Ritalin, warning doctors and parents about potential heart risks such as strokes and serious arrhythmias in children and adults.

A study released this week reported 25 sudden deaths among people taking stimulants. There are millions of health records linking stimulants with risks of strokes and heart rhythm irregularity. But does the FDA take this recommendation? NO! An FDA official said, "We don't think anything different needs to be done right now. We are not going to act on the committee's recommendation anytime soon. We need to study this further.”

It was like the FDA calling the medical panel hyperactive!

Over four million patients, mostly children, take these drugs to treat attention deficit disorder or hyperactivity (which, by the way, is probably over diagnosed by teachers and healthcare professionals – but that’s another story). So now, we wait. We wait for the FDA to gather more data, have more discussion. And wait for the pharmaceutical industry reaction before a simple label that could save somebody’s life is placed on a box.

Here are some of your emails on the subject:

“With the recent ‘black box’ warning on ADHD drugs, such as Ritalin, I am concerned about the affects of the drug Strattera, which my 16-year-old son takes for ADHD. Are the effects the same as the more common ADHA drugs used by younger children? Also, he took a generic form of Ritalin for a few years, before switching to Strattera. Are the Ritalin concerns long lasting, after the drug has been stopped?” — Annjlee (Normal, IL)

Dr. Manny's answer: The two medicines act differently in the body, so the side effects are different. As for the long lasting effects of Ritalin, it appears that there are no long-lasting affects after the medication has been stopped.

“Should a child be given a brain scan before they are labeled with either ADHD or ADD?” — Jo Ann

Dr. Manny's answer: In my opinion, ADD and ADHD are over diagnosed. So, be careful. A trained child psychologist and/or pediatric neurologist should make the diagnosis. Also, brain scans are typically not utilized in the management or diagnosis of ADD unless there are neurological symptoms that the pediatrician feels further workup is necessary.

P.S. Don't forget to watch FOX News Channel. And please feel free to write to me at DRMANNY@FOXNEWS.COM and tell me what you think. Ask a question, share a thought, share a remedy — We'll try to answer all of your mail online or on the air.

Dr. Manny Alvarez serves as Fox News Channel's senior managing health editor. He also serves as chairman of the department of obstetrics/gynecology and reproductive science at Hackensack University Medical Center in New Jersey. For more information on Dr. Manny's work, visit