http://www.nytimes.com/2007/10/05/business/05cnd-zyprexa.html?_r=1&oref=slogin&ref=business&pagewanted=print
October 5, 2007
Lilly Adds Label Warnings for Mental Illness Drug
By ALEX BERENSON
New York Times
Eli Lilly today added strong warnings to the label of Zyprexa, its best-selling
medicine for schizophrenia, citing the drug’s tendency to cause weight gain,
high blood sugar, high cholesterol and other metabolic problems.
For the first time, Zyprexa’s label now acknowledges that the drug causes high
blood sugar more than some other medicines for schizophrenia and bipolar
disorder, called atypical antipsychotics.
Lilly previously argued that Zyprexa had not been proven to cause high blood
sugar at a more frequent rate than its competitors.
Concern about Zyprexa’s side effects has been increasing since at least 2004,
and Zyprexa’s prescriptions and market share have fallen sharply over the same
period. As a result, the new warnings may have only a moderate impact among
doctors and patients, said S. Nassir Ghaemi, director of the Bipolar Disorder
Research Program at Emory University.
“The knowledge has been out there, and it’s already impacted prescribing
patterns a great deal,” Dr. Ghaemi said.
The new label will also indicate that patients who take Zyprexa may keep gaining
weight for as long as two years after starting therapy. That contradicts earlier
public statements by Lilly that weight gain on Zyprexa tends to plateau after a
few months of use. One in six patients who take Zyprexa will gain more than 33
pounds after two years of use, the label says.
Weight gain and high blood sugar are risk factors for diabetes, although Lilly
says that Zyprexa has not been proven to cause diabetes more than its
competitors.
“Obviously, we know that weight gain is a known risk factor for diabetes,” said
Marni Lemons, a Lilly spokeswoman. “However, not all patients who gain weight
develop diabetes.”
Ms. Lemons also noted that schizophrenia is a devastating and often disabling
disease and that older antipsychotic medicines also have severe side effects,
including a tendency to cause disfiguring facial tics.
The new warnings may add to the controversy surrounding Zyprexa, which is by far
Lilly’s best-selling drug. Zyprexa had global sales of more than $2.3 billion in
the first half of this year and nearly 3 million prescriptions in the United
States alone. Lilly said it had made the label changes as a part of continuing
discussions with the Food and Drug Administration.
Lilly has asked the F.D.A. to allow it to begin marketing Zyprexa for
adolescents, despite clinical trial data showing that Zyprexa causes weight gain
and metabolic problems in teenagers that can be even more severe than in adults.
Heavily marketed by drug companies, atypical antipsychotic medicines have become
one of the biggest and fastest-growing drug classes. Overall sales for the
category are projected at close to $13 billion this year, despite little
evidence that the new drugs work any better than older generic anti-psychotic
medicines that cost just pennies a pill.
The label changes come 11 years after Lilly began selling Zyprexa and more than
12 years after a large Lilly clinical trial first showed that Zyprexa might have
negative effects on weight and blood sugar.
Internal Lilly documents disclosed by The Times last December indicated that
Lilly was aware of Zyprexa’s tendency to cause weight gain and blood sugar
changes by the late 1990’s but played down the drug’s risks.
Lilly said at the time of those disclosures that the drug’s risks were already
reflected in the label. Ms. Lemons said the company had not delayed releasing
information about Zyprexa’s side effects, and had made yesterday’s label change
after a new review of clinical trials showed the drug’s potential risks.
“It’s not like this is information that we have had since 1995,” Ms. Lemons
said.
The documents disclosed by the Times in December also indicated Lilly had told
its sales representatives to encourage doctors to prescribe Zyprexa to people
who do not have schizophrenia or bipolar disorder, Zyprexa’s only approved uses.
Federal laws prohibit drug companies from so-called “off-label marketing,”
although doctors may prescribe drugs for whatever use they see fit.
Lilly has spent $1.2 billion since 2004 to settle lawsuits from 28,500 people
who claimed they developed diabetes or heart problems after taking the drug,
although Lilly says that Zyprexa has never been proven to cause diabetes. At
least 1,200 more lawsuits are still pending.
In 2004, the American Diabetes Association said that Zyprexa was more likely to
cause diabetes than other commonly prescribed antipsychotic medicines, although
the F.D.A. has never made a distinction between Zyprexa and other drugs. Even
now, Zyprexa’s label does not say it causes diabetes more than the other
medicines, only high blood sugar.
In the United States, Zyprexa’s prescriptions and market share have slid
steadily for three years. But the revenue it produces for Lilly has not fallen
because Lilly has routinely pushed through price increases on the medicine,
which can cost $8,000 for a year’s supply of a standard 20-milligram dose.
Lilly’s stock closed today at $59.48, up 52 cents.
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The information herein shall not be considered an endorsement of anyone
discontinuing psychiatric drugs. If you are stopping taking medication it is
advisable to reduce the dose gradually WITH EXTREME CAUTION, as it is difficult
to predict who will have problems withdrawing. It is worth getting as much
information and support as you can, and involving your doctor wherever possible.
You will find withdrawal information here:
http://www.mind.org.uk/Information/Booklets/Making+sense/Making+sense+of+coming+off+psychiatric+drugs.htm
FOR MORE INFORMATION ON WITHDRAWAL:: Get Peter Lehmann's book, Coming off
Psychiatric Drugs: Successful Withdrawal from Neuroleptics, Antidepressants,
Lithium, Carbamazepine and Tranquilizers. This valuable resource comes in US,
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