http://www.washingtonpost.com/ac2/wp-dyn/A16214-2004Mar22?language=printer
> > THE WASHINGTON POST
> > New Warning Urged On Antidepressants
> > Alert Would Address Suicidal Tendencies
> >
> > By Shankar Vedantam
> > Washington Post Staff Writer
> > Tuesday, March 23, 2004; Page A03
> >
> >
> > The Food and Drug Administration urged drugmakers yesterday to put new
> > warning labels on popular antidepressant medications, including Paxil,
> > Zoloft and Luvox, alerting doctors and consumers to watch for suicidal
> > tendencies, hostility and agitation in patients taking the drugs.
> >
> > The agency's action focuses on 10 antidepressant drugs in all and
follows
> a
> > warning by the British government last year advising physicians not to
> > prescribe most widely used antidepressants to children. Last month,
> families
> > of American adolescents who killed themselves while taking the
medications
> > implored the FDA to take comparable steps, and an expert advisory
> committee
> > urged greater vigilance in the use of the medications in children with
> > depression.
> >
> > The agency said it does not know whether the medications -- which
include
> > several drugs known as selective serotonin reuptake inhibitors, or
> SSRIs --
> > are responsible for reported side effects such as inner restlessness,
> > agitation and suicidal thoughts in some people. Officials said they are
> > drawing greater attention to known cautionary information while a team
of
> > outside researchers completes a comprehensive analysis of the possible
> > risks.
> >
> > Patients taking the drugs who experience behavioral side effects should
> > contact their physicians, said Russell Katz, director of
> > neuropharmacological drug products at the FDA. If the symptoms are new
or
> > severe, he added, doctors should consider lowering the dose or stopping
> the
> > drug.
> >
> > Yesterday's move by the agency calls for warning-label changes for
adults
> as
> > well as children, and for patients who are depressed as well as those
who
> > use the drugs for unrelated problems.
> >
> > "The advice applies across the board whether the drugs are used for any
> > indication -- psychiatric or not," Katz said.
> >
> > Critics of the medications called yesterday's move a victory and
demanded
> > that the FDA go further. Although Prozac is the only one of this class
of
> > drugs that has been specifically approved to treat depression in
children,
> > doctors are writing tens of thousands of prescriptions for many of the
> > others, based on their clinical judgment that the drugs are safe and
> > effective.
> >
> > "Doctors are going to be on the line not to prescribe them as if they
were
> > pacifiers," said Vera Hassner Sharav, president of the Alliance for
Human
> > Research Protection, a patient advocacy group based in New York.
> >
> > Many critics complain that a majority of studies of the drugs in
children
> > found that the medications did no better than dummy pills in treating
> > depression, but that these studies have been hidden from doctors and the
> > public. The companies say the studies are proprietary.
> >
> > Sharav and other critics charge that the FDA and the American
psychiatric
> > establishment, which has broadly supported the efficacy of the drugs,
have
> > been unduly influenced by the pharmaceutical industry. Dozens of
lawsuits
> > against the medications have been filed around the country.
> >
> > Many psychiatrists say the medications save lives and warn that
> discouraging
> > patients from taking them could lead to greater numbers of suicides.
They
> > insist that suicidal tendencies or attempts among patients taking the
> drugs
> > are the result of underlying disorders, not the medications.
> >
> > Rates of suicide among adolescents have generally declined as
> antidepressant
> > use has surged in recent years, said Thomas P. Laughren, FDA team leader
> for
> > psychiatric drug products. While no one knows whether the two trends are
> > linked, he said at a news conference yesterday, such data framed the
> context
> > in which the FDA acted.
> >
> > The drugs affected by yesterday's announcement are Prozac, Zoloft,
Paxil,
> > Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.
> >
> > C 2004 The Washington Post Company
>