An APA request that medication guides mandated by the Food and Drug
Administration (FDA) list benefits of the medications, as well as the risks,
was among the many views agency officials heard during public hearings in June
on the pamphlets that accompany many psychotropic and other medications at the
time they are dispensed.
The hearings in Washington, D.C., stemmed from an FDA decision to assess
the effectiveness of and consider changes to the medication guides it has
required pharmaceutical manufacturers to provide since 1998 for drugs that the
FDA determines pose a "serious and signifi-cant public health
concern." The guides are intended to educate consumers about the
medications' side effects and prevent serious adverse events.
It was initially estimated that the guides would be needed for about 1
million prescriptions annually, but that number has expanded to about 300
million prescriptions a year, covering 240 products.
Physicians in general and psychiatrists in particular have raised concerns
that the guides' emphasis on the potential side effects of medications has
dissuaded many patients from taking the medications. In the case of
psychotropics, that aversion could lead to greater risks from untreated mental
illness, APA has pointed out.
Darrel Regier, M.D., director of the American Psychiatric Institute for
Research and Education and APA's Division of Research, testified that
science-based guides can help patients better understand their prescribed
medication, but information should be balanced to counter sensational media
reports of medication dangers. The FDA, he said, should adopt standards that
include the benefits of the drugs, in addition to potential side effects.
"The risks when the disorder is left untreated far outweigh the risks
of treatment," Regier said about depression medication.
Psychiatrists have urged the FDA to expand on a precedent-setting addition
that the agency is requiring to the black box on antidepressant labeling
warning about the suicidal risks of untreated depression, as well as the risks
of the medication. No statement about the dangers of untreated depression in
youth under age 18 appears in the current labeling, in effect since 2005.
Manufacturers of antidepressants were asked to submit their updated labeling
to the FDA last month (Psychiatric News, June 1).
David Fassler, M.D., a Vermont-based child and adolescent psychiatrist and
an APA trustee-at-large, testified on behalf of the American Academy of Child
and Adolescent Psychiatry (AACAP). He said that the black-box warnings have
led to a big drop in antidepressant use among youth corresponding with an
increase in youth suicides, according to recent data.
"While it is premature to draw definitive conclusions about
causality, the implication is disturbing," Fassler said.
The "disturbingly one-sided" guides emphasize risks and
downplay benefits, while not providing adequate information to parents, he
said. Fassler pointed out the benefits of well-designed guides and noted that
APA and AACAP have developed an online supplemental guide to answer 14 common
questions parents have about antidepressants.
Robert Temple, M.D., director of the Office of Medical Policy at the FDA's
Center for Drug Evaluation and Research, questioned the feasibility of
describing benefits in the guides because many psychotropics have never been
researched to show comparative rates of suicidal behavior.
Although Fassler and other psychiatrists agreed that more research is
needed on commonly used drugs to quantify their benefits, he noted some
benefits that have already been shown, for example a 50 percent decrease in
the suicide rate in teens taking lithium.
A factor complicating the labeling effort is that many of the benefits of
medications are derived through broadly accepted uses that are off-label. The
widely accepted suicide-prevention effect of lithium, for example, is an
off-label use for depression treatment because none of its manufacturers has
sought a labeling change to add an antidepressant indication.
Members of the FDA committee were urged to consider changes that could
indicate the possibility of benefits beyond the specific approved uses for
After testimony from psychiatrists, patient advocates, and pharmacist
groups urging consumer-friendly redesigns, panel members voiced support for
inclusion of a highlights section about the drug, followed by more details and
a Web site consumers could visit for more information.
Many speakers also urged testing any redesigns of the densely worded guides
on a broad spectrum of consumers to ensure that the language is accessible and
intelligible to even below-average readers. However, FDA panel members said
the urgency of the redesign would likely disallow much testing before
distribution. Consumer testing could come after distribution, as part of
future changes, Temple said.
Other common requests from speakers at the FDA hearings were that consumers
have the option to receive the guides in electronic form and that federal
officials standardize the format and length of the guides, which can be up to
30 pages long.
Although many representatives from pharmacies and drug makers urged the
creation of a single guide to cover entire classes of drugs, others did not
favor that idea. Carol Watkins, M.D., a psychiatrist and member of the board
of directors of the Greater Baltimore chapter of Children and Adults With
Attention-Deficit Disorder, said she prefers medication-specific guides
because small differences between the drugs matter.
For example, "Some [medications have labeling that says] not to
divide them, and others say to sprinkle them over food, and those details can
make a big difference to patients," Watkins said.
FDA information on the medication guides is posted at<www.fda.gov/cder/Offices/ODS/medication_guides.htm>.
The APA and AACAP antidepressants guide is posted at<www.parentsmedguide.org>.▪