Last week, a flap emerged over the Medication Guide that drugmakers are required to have distributed with their antidepressants. The guide issued in 2005, shortly after the FDA first required Black Box warnings on the pills, was filled with tips and suggestions for parents and guardians - behavior that can be interpreted as worrisome; a reference to clinical study results, and specific info on when a doctor visit is a good idea. The words ‘child’ and ‘children’ are mentioned a total of 31 times.

Now, a revised version is circulating and, while similar to the 2005 guide, the language is different. The new two-page guide offers a more generalized alert for children, teenagers and young adults - the populations for which Black Box warnings were issued. Some of the specifics found in the earlier guide are missing or condensed, and the emphasis that was initially placed on children is no longer there. This is the old guide and this is the new guide.

At the time, an FDA spokeswoman told us that, while “the original version focused more on kids under 18, the new data showed us that suicidality signals extended into young adults ages 18 to 24. The way the newer medication guide was written reflects a need to broaden the focus into all audiences. The content was restructured, but actually the advice to clinicians, patients, parents and caregivers is the same.”

The differences drew a sharp response from Mike Ferguson, a Republican congressman from New Jersey, who accused the agency of taking a step “backwards” and putting children at risk. So yesterday, he sent a letter to the FDA and demanded the agency scrap the new med guide and ensure the older version is distributed. The new med guides, he writes, dilute the power and clarity of (the warnings contained in the old med guides), and as such, deny parents information that is vital to the safety of their children.” Whether they will follow his wishes, however, remains to be seen.