FDA approves Abilify for pediatric "bipolar"
- ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com
Will somebody stop the FDA from approving chemical weapons of destruction
aimed at America's children?
The documented, demonstrable risks of severe harm produced by the second
generation antipsychotic drugs is uncontestable.
Even leading schizophrenia researchers with financial ties to manufacturers,
such as Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia
``The major problem with second-generation antipsychotic drugs is weight
gain and diabetes. `The younger you are, the more severe and common these
Despite the severity of the risks, and despite the lack of evidence of a
therapeutic benefit, the FDA has just approved Abilify for use in children
for "bipolar" disorder, which is the "diagnosis" du jour for bad behavior.
The FDA once again, acted irresponsibly, lending the government seal of
approval without so much as a public hearing! The FDA approval of Risperdal
for children was similarly meted out.
See new Abilify label:
The FDA seems to have launched an undeclared War on America's children whose
mental and physical health are being jeopardized to increase profits and
shield companies from illegal off-label promotion of the most toxic drugs
used for non-life-threatening disease.
Congressional action is urgently to stop the catastrophic consequences.
Contact: Vera Hassner Sharav
Bristol-Myers Drug Cleared to Treat Pediatric Bipolar
By Beth Jinks
Feb. 28 (Bloomberg) -- Bristol-Myers Squibb Co.'s antipsychotic medicine
Abilify was cleared by U.S.
regulators to treat bipolar disorder in children as young as 10.
The U.S. Food and Drug Administration approved the added use for the pill,
the agency said today in new prescribing information posted on its Web site.
Abilify is already marketed for adults with bipolar disorder and major
depression, and for schizophrenia in people 13 and older.
Sales of Abilify, the New York-based company's second-best seller, climbed
29 percent to $1.66 billion last year, helped by studies showing it caused
less weight gain than competing treatments. The only other drug in the class
known as atypical antipsychotics that is approved to treat bipolar disorder
in children 10 and older is Johnson & Johnson's top-selling Risperdal, which
won U.S. clearance for that use in August.
Abilify offers a potential advantage over other atypical antipsychotics
because ``it doesn't cause to the same degree weight gain and metabolic''
disorders, said Jeffrey Lieberman, chairman of psychiatry at Columbia
University in New York, in a telephone interview yesterday.
``The major problem with second-generation antipsychotic drugs is weight
gain and diabetes,'' Lieberman said.
``The younger you are, the more severe and common these side effects.''
The number of American children diagnosed with bipolar disorder, once known
as manic depression, jumped 40-fold from 1994 to 2003, according to a study
in the Archives of General Psychiatry released in September.By 2003, the
diagnosis was applied to 1 in 100 kids, researchers found.
Bristol-Myers fell 29 cents, or 1.3 percent, to $22.91 at 4:17 p.m. in New
York Stock Exchange composite trading. The company has dropped 13 percent in
>From 2003 to 2006, U.S. prescriptions for Abilify for children 18 years andyounger soared sevenfold to more than 1 million, according to data from
Wolters Kluwer NV, a drug- tracking company. Doctors can prescribe medicines
for uses not approved by the FDA, such as using Abilify in young children,
although drugmakers can't market their products for such ``off- label''
``It wasn't well-recognized before, and in all candor there's probably an
over-diagnosis,'' Lieberman said.
``There's some fuzziness around the diagnosis which leads to some children
believed to have bipolar disorder, who don't turn out to have it when they
Doctors need to be ``very judicious in their use of these drugs,''
particularly in children, Lieberman said.
Adults with bipolar disorder often stay lodged for weeks or months in states
of deep depression, then shift to a manic phase in which they sleep little,
have intense energy, talk rapidly, and may engage in risky behavior.
Some psychiatrists say the disorder looks different in children, who may
alternate more rapidly between depression and mania, or demonstrate
moodiness, irritability and volatility. The condition has been linked to
poor school performance and substance abuse.
In November, Abilify was cleared by U.S. regulators to treat adults with
severe depression, and for use by teens with schizophrenia. The drug was
first approved in 2002 to treat adult schizophrenia, a condition that causes
distorted thinking, hallucinations and an inability to feel normal emotions.
`Evidence of Commitment'
``The approval is one of a series we've had for Abilify in a short amount of
time,'' Sonia Choi, a Bristol-Myers spokeswoman, said in a phone interview.
``This is evidence of our commitment to developing medicines to their full
Abilify is second among Bristol-Myers' products to the blood-thinner Plavix,
which had $4.76 billion in sales last year.
Antipsychotic drugs reduce levels of dopamine, a brain chemical that, in
excess, is thought to cause symptoms of psychosis and mania.
Atypical psychotics, which include Abilify, Risperdal and Eli Lilly & Co.'s
Zyprexa, first came on the market in the mid- 1990s. The products were
marketed as causing fewer of the neurological side effects that made users
of earlier medications, such as Haldol and Thorazine, tremble, doze off and
Seroquel and Geodon
Other antipsychotics include AstraZeneca Plc's Seroquel and Pfizer Inc.'s
Geodon. Bipolar disorder is often also treated with anticonvulsants,
developed to treat epileptic seizures.
Lilly's request to sell Zyprexa to treat schizophrenia and bipolar disorder
in teenagers was delayed by the FDA in April. Lilly received what the FDA
calls an approvable letter, indicating the agency needs more time to analyze
data and to determine the drug's prescribing information.
``We don't have a time frame at this point,'' Lilly spokeswoman Marni Lemons
said in a phone interview.
``We have no intention for promoting the drug for use in adolescents. We
want to add information to the label.''
J&J reported $4.7 billion in revenue from anti-psychotic medicines including
Risperdal last year, up 12 percent from 2006. The company doesn't report
separate sales figures for Risperdal.
Bristol-Myers and Tokyo-based Otsuka Pharmaceutical Co. said Nov. 15 they
had won priority FDA review of a study testing Abilify on patients 10 to 17
years old diagnosed with bipolar disorder. Priority review speeds up the
approval process, which typically takes about six months with pediatric
Otsuka discovered Abilify and retains marketing rights to the drug in Japan
and some other Asian markets.
Europe's Committee for Medicinal Products for Human Use recommended Feb. 22
that Abilify be approved to treat bipolar disorder. The drug was approved by
the European Commission as a schizophrenia treatment in Europe in 2004.
To contact the reporter on this story: Beth Jinks in New York at
Last Updated: February 28, 2008 17:36 EST
FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which
has not always been specifically authorized by the copyright owner. Such
material is made available for educational purposes, to advance
understanding of human rights, democracy, scientific, moral, ethical, and
social justice issues, etc. It is believed that this constitutes a 'fair
use' of any such copyrighted material as provided for in Title 17 U.S.C.
section 107 of the US Copyright Law. This material is distributed without
Infomail1 mailing list
to unsubscribe send a message to Infomail1-leave@...