Government researchers uncover a higher incidence of
benign pituitary gland tumors…started looking at
Risperdal after noticing reports of men and children
who were producing breast milk
(June 20, 2005) - Government researchers combing
through a database of adverse drug reactions in
patients found a higher incidence of benign tumors in
the pituitary gland among patients taking Johnson &
Johnson's antipsychotic Risperdal than for similar
antipsychotic drugs.

The finding is preliminary, and doesn't prove whether
the tumors were caused by the drugs or other factors.
But it is notable because Risperdal appears different
from other antipsychotics, said Paul Seligman, who
directs the Food and Drug Administration office
responsible for postmarketing drug surveillance. "When
we see these kinds of differences among products it
raises the question of whether further detailed
analysis needs to be done," said Dr. Seligman. The
study hasn't yet been published and was presented at a
University of Pittsburgh conference last Friday.

A Johnson & Johnson spokesman said the company would
be analyzing the data to determine if further study is
required.

Risperdal is one of the most widely prescribed
antipsychotics, which are used primarily to treat
schizophrenia and bipolar disorder. It was the New
Brunswick, N.J., company's second-biggest-selling drug
with world-wide sales of $3.1 billion last year.

Risperdal jostles for market share with several other
major drugs in the so-called atypical antipsychotic
class, including Eli Lilly & Co.'s Zyprexa,
AstraZeneca PLC's Seroquel and Abilify, marketed by
Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co.
All told, such drugs had world-wide sales of $14
billion last year, according to IMS Health Inc., and
their use has expanded to include children with severe
behavioral problems, elderly people with dementia, and
people with other psychiatric disorders.

Side-effect issues have a big impact on sales in this
highly competitive class. Zyprexa's market share has
slipped six percentage points over the past year over
concerns about weight gain and diabetes; the FDA in
2003 required all the atypical antipsychotic drugs to
carry warnings about weight gain and diabetes.

The FDA researchers started looking at Risperdal after
noticing reports of men and children who were
producing breast milk. Tumors can cause the pituitary
to secrete too much of a hormone called prolactin,
whose main function is to stimulate breast milk
production during pregnancy. High prolactin levels can
also cause people to stop menstruating and develop
infertility or impotence. Patients with pituitary
tumors are usually treated with medications, and
sometimes radiation or surgery.

The researchers analyzed 2.5 million adverse events
reported by doctors, patients, and individuals since
1968. Of the 307 reports of pituitary tumors, 64, or
21%, occurred in patients taking antipsychotics.
Forty-eight reports of pituitary tumors were reported
in patients taking Risperdal, six in patients taking
Zyprexa, four associated with Pfizer Inc.'s Geodon,
and one with Seroquel. Novartis AG's Clozaril, which
is also available as a generic clozapine, had three
reports, while haloperidol, an older generic
antipsychotic, had eight reports. Abilify had zero
cases, but hasn't been on the market for as long as
the others.


Ana Szarfman, a FDA medical officer and lead author of
the study, said this kind of study can't reveal how
common the side effect is because doctors don't report
all adverse reactions to the government.

"Patients should not stop taking their medications
before talking to their doctor about all the risks and
benefits," said P. Murali Doraiswamy, a psychiatrist
at Duke University and co-author on the study. He has
consulted for several manufacturers of antipsychotic
drugs.

Source: Wall Street Journal


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