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WASHINGTON, D.C. - Just because a federal panel has recommended stronger warnings for antidepressants prescribed to children doesn't mean changes are imminent, says one member of Congress.
All drugs used to treat depressed children should carry a "black box" warning of the antidepressants' link to increased suicidal thoughts and actions, the advisers ruled Tuesday.
But U.S. Rep. Bart Stupak, D-Menominee, said the Food and Drug Administration likely "It's only a recommendation, and we have seen in the past that the FDA doesn't follow recommendations," said Stupak, whose district includes Cheboygan County.
The "black box" warning, among the strongest in the FDA's arsenal, should reach doctors no matter how they get drug information and would extend to drug advertising directed at patients.
The panel made the ruling Tuesday after hearing testimony Monday about antidepressants' powers and perils from doctors, researchers and relatives of patients who killed themselves after taking such medication. The panel spent the bulk of Tuesday deliberating before issuing its recommendation, according to The Associated Press.
That message, however, might never reach parents of children whose doctors prescribe antidepressants.
That's because Stupak knows from experience that the FDA doesn't rush warnings into place on such advice.
"I think they'll ignore the recommendation," Stupak said from his Capitol Hill office. "They will enter into negotiations."
Just like the FDA did with Accutane.
Stupak says Accutane, a potent acne drug, is tied to the 2000 death of his son, Bart Stupak Jr., at the family's Menominee home.
In February of this year a similar panel ruled that Accutane should carry label warnings. Since then, the FDA has been negotiating what to do with the recommendation.
As with antidepressants, Accutane has been tied to teen suicides and suicidal thoughts. Britain has banned prescriptions of antidepressants to minors.
The black box option is more strident than the bold-letter warnings the same federal advisers suggested be added to antidepressant labels this March. Antidepressant prescription rates to children were unchanged by the earlier warning, the AP reports.
Unlike the earlier red flag, advisers said this new warning should make clear that antidepressants have been linked to two to three more children per 100 having heightened suicidal thoughts and behaviors.
Stupak said that unless the warnings are issued to parents along with the prescription, the parents could never know that there are dangers inherent with the antidepressants.
"I'm still waiting to see what labeling they are going to do," Stupak explained. "Does that mean small print in the little piece of paper that comes with the prescription? Is it just a notice to health care professionals and not the consumers? In order for consumers to know the dangers, it has to be a warning on the packaging label. Otherwise, labeling means only the professional gets the information."
Stupak said independent studies have proven that there is a link between antidepressants and teen suicide.
"The British study is clear. It shows there is two times more suicide ideation," Stupak stated. "The Columbia study shows the percentage is 1.8 times."
He said American teens are under more stress than those in Britain, and that the FDA should take action now.
"We should err on the side of caution," he noted. "Britain did it right. Why can't we?"
Another hearing of the House Oversight and Investigation Subcommittee taking testimony on the warnings is slated for Sept. 24.
"Here we go again," Stupak said. "My question is what ... is your mission? If this drug doesn't meet the test, why screw around with it?"
While Stupak said he plans to put pressure on the FDA to issue a packaging warning, the negotiations likely will not begin until next year.
"They won't do anything until next March," Stupak predicted.
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