Now, though, 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. And the changes have upset Mike Ferguson, a Republican congressman from New Jersey, who was involved in efforts to ensure the guides were distributed. (This is the new guide).
"I'm disappointed," he tells Pharmalot. "These were directed especially at parents, who should have as much information as possible before they give their children powerful medications. These changes dilute the message. I can appreciate the desire to communicate to a broader population, but they should have created specially marked sections. This is a step backwards. And perhaps we need to have another hearing on the topic."
In an e-mail, an FDA spokeswoman wrote that there were concerns that "the original medication guide was too long and...might actually discourage appropriate prescribing and use of the medications...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."
One parent, who has been embroiled in the antidepressant controversy, is also upset. "The original guide reflected more scientific info and language that clearly was aimed at getting a parent's attention," says Lisa Van Syckel, a New Jersey resident and self-styled activist. "This is watered down and so doesn't serve as the kind of attention grabber that the other guide did. The FDA ought to pay more attention to what parents say."
For her part, the FDA spokesman adds that outside groups, such as the American Psychiatric Association or PhRMA, "did not have any role in the development of these guides." [UPDATE: At hearings last June, the APA testified that the earlier Med Guides may scare docs and patients away from using the drugs].
Which Med Guide should be distributed?
- Old Med Guide (96%, 265 Votes)
- New Med Guide (4%, 10 Votes)
Total Voters: 275