Scary side effects lead to warning labels, wariness

I 'M STARTING to wonder if the FDA is failing us, or if things that we never used to hear about are now being more widely reported.

I think the FDA has a lot of 'splainin' to do (this will mean something only to those of you old enough to remember Lucy and Ricky Ricardo--OK, so I'm old).

Last week, Eli Lilly announced that it would be adding a "black box warning" to labeling on its ADHD drug, Strattera. The warning states that the drug may increase suicidal thoughts in children, especially in the first weeks or months of treatment, or when there is a dosage change.

Eli Lilly said it provided the FDA with results from Strattera clinical trials of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Strattera attempted suicide (by overdosing on Strattera, no less) but survived, company and FDA officials said.

This black box warning is very similar to the one added to all anti-depressants last year, because several of them also cause a small but significant increase in suicidal thoughts and behaviors in children and teens. I guess this news is not surprising, since the molecular structure of Strattera is similar to anti-depressant drugs such as Prozac.

Then, while writing this, I came upon a "breaking news" e-mail from the American Academy of Pediatrics, dated Oct. 1. Apparently, there have been five reports of teens developing Guillain-Barre Syndrome within 2-4 weeks of receiving the new Menactra vaccine. This is the vaccine for meningococcal meningitis for youths ages 11 and up, about which I wrote in a recent column.

The demand for the vaccine has been so high that already there is a shortage, so we haven't been giving as much of it lately. Maybe that's a good thing. It's not yet known whether the association is causative or coincidental. More than 2.5 million doses of Menactra have been distributed to date, so the rate of GBS is similar to what would have been expected to occur by coincidence. However, the timing of the GBS cases is concerning.

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