| Jan Drew 2006-08-27, 2:26 am |
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http://www.bloomberg.com/apps/news?...UZd0Xs&refer=uk
Glaxo, Shire Strengthen Risk Warnings on ADHD Drugs (Update1)
By Shannon Pettypiece and Justin Blum
Aug. 21 (Bloomberg) -- GlaxoSmithKline Plc and Shire Plc said they
strengthened warnings that their attention-deficit drugs may cause
psychological side effects and misuse may lead to sudden death from heart
attacks and strokes.
Glaxo, the world's second-largest drugmaker, said today that it added the
warnings to prescribing information on its Dexedrine treatment last month.
Shire said it also added the warnings for its Adderall XR, the top-selling
treatment for attention deficit hyperactivity disorder.
The Food and Drug Administration in May asked makers of similar drugs,
called central nervous system stimulants, to add the warnings based on
recommendations from two advisory committees, said Glaxo spokeswoman Holly
Russell. Other products covered by the warnings would include those
containing methylphenidate, used for more than 50 years, such as Novartis
AG's Ritalin and generic copies.
``It's a very strong warning,'' said Steven Nissen, president of the
American college of Cardiology and chairman of cardiology at the Cleveland
Clinic, who served on a February advisory committee that recommended the
warning, in a telephone interview. ``It's appropriately worded. It basically
lets physicians and patients know that these drugs do have serious
cardiovascular side effects.''
The warnings list side effects including suppression of growth, psychosis,
bipolar illness, aggression and ``serious'' cardiovascular side effects. The
FDA posted a Glaxo letter to doctors and the revised prescribing information
on its Web site today. The letter doesn't name other manufacturers.
Advisory Committees
The February advisory committee urged the FDA to require its strictest form
of warning, highlighted in boldface type and outlined with a black box, to
all ADHD drugs because of the risk of heart attack, stroke and sudden death.
In March a separate committee recommended additional warnings of the
psychological side effects.
Basingstoke, U.K.-based Shire changed its labeling after the FDA approved
the warnings July 31, spokesman Matthew Cabrey in Wayne, Pennsylvania, said
in an interview.
Doctors wrote 195,000 prescriptions last year for London- based Glaxo's
Dexedrine, accounting for less than 1 percent of all prescriptions for ADHD,
spokeswoman Russell said in a telephone interview. Dexedrine has been
available since before 1950 and generic versions came available in 2002,
Russell said.
Novartis spokeswoman Gina Moran in East Hanover, New Jersey, wasn't
immediately available for comment.
``FDA sent out letters on May 22, 2006, directing sponsors to strengthen the
wording in the warnings section with regard to serious cardiovascular events
and psychiatric events,'' FDA spokeswoman Kimberly Rawlings said in an
e-mailed response to a request for comment.
``We decided that the possible cardiovascular and psychiatric risks would be
best addressed by new warning language, but did not justify a black box,''
Rawlings said. ``To date, all sponsors of stimulant medications have replied
and the responses are currently under review.''
To contact the reporters on this story: Shannon Pettypiece in Washington at
at spettypiece@bloomberg.net ; Justin Blum in Washington at at
jblum4@bloomberg.net .
Last Updated: August 21, 2006 17:15 EDT
http://www.bloomberg.com/apps/news?...pI&refer=europe
Glaxo, Shire Strengthen Risk Warnings on ADHD Drugs (Update2)
By Shannon Pettypiece and Justin Blum
Aug. 21 (Bloomberg) -- GlaxoSmithKline Plc and Shire Plc said they
strengthened warnings that their attention-deficit drugs may cause
psychological side effects and misuse may lead to sudden death from heart
attacks and strokes.
Glaxo, the world's second-largest drugmaker, said today that it added the
warnings to prescribing information on its Dexedrine treatment last month.
Shire said it also added the warnings for its Adderall XR, the top-selling
treatment for attention deficit hyperactivity disorder.
The Food and Drug Administration in May asked makers of similar central
nervous system stimulants to add the warnings, said FDA spokeswoman Kimberly
Rawlings in an e-mail. Five million Americans use ADHD drugs, 3.3 million of
them under the age of 19, according to Medco Health Solutions Inc., a
manager of drug benefits for employers and insurance companies. The changes
follow recommendations from two FDA advisory committees.
``It's a very strong warning,'' said Steven Nissen, president of the
American college of Cardiology and chairman of cardiology at the Cleveland
Clinic, who served on a February advisory committee that recommended
warnings, in a telephone interview. ``It's appropriately worded. It
basically lets physicians and patients know that these drugs do have serious
cardiovascular side effects.''
Side Effects
The warnings list side effects including suppression of growth, psychosis,
bipolar illness, aggression and ``serious'' cardiovascular side effects. The
FDA posted a Glaxo letter to doctors and the revised prescribing information
on its Web site today. The letter doesn't name other manufacturers.
Other products covered by the warnings may include those containing
methylphenidate, used for more than 50 years, such as Novartis AG's Ritalin
and generic copies. Novartis spokeswoman Gina Moran in East Hanover, New
Jersey, didn't immediately respond to a phone message.
FDA spokeswoman Rawlings was unable to say specifically which drugs would be
required to have the new warning.
London-based Glaxo's American depositary receipts rose 4 cents to $54.48 at
4:01 p.m. in New York Stock Exchange composite trading. One ADR is
equivalent to two common shares. American depositary receipts of Shire,
based in Basingstoke, U.K., climbed 25 cents to $50.16 at 5:20 p.m. New York
time in Nasdaq Stock Market composite trading. Each ADR represents three
common shares.
Advisory Committees
The February advisory committee urged the FDA to require its strictest form
of warning, highlighted in boldface type and outlined with a black box, to
all ADHD drugs because of the risk of heart attack, stroke and sudden death.
In March a separate committee recommended additional warnings of the
psychological side effects.
Growth in the number of children on the drugs slowed in 2005 to less than 1
percent from 11 percent in 2004 and 16 percent in 2003, according to data
compiled by Franklin Lakes, New Jersey- based Medco.
Shire changed its labeling after the FDA approved the warnings July 31,
spokesman Matthew Cabrey in Wayne, Pennsylvania, said in an interview.
Doctors wrote 195,000 prescriptions last year for Glaxo's Dexedrine,
accounting for less than 1 percent of all prescriptions for ADHD, Glaxo
spokeswoman Holly Russell said in a telephone interview. Dexedrine has been
available since before 1950 and generic versions came available in 2002,
Russell said.
Snakes, Alligators
Since 2000, the FDA has received more than 500 reports of psychosis in
children 10 and younger who took ADHD drugs, the FDA staff said in a March
report. In one case, a 7-year-old boy on Adderall reported seeing people
sitting in a rocking chair and people coming into the house and stealing
Christmas presents. A 5-year-old boy reported seeing snakes and polka-dot
alligators.
Some lawmakers, including Senator Charles Grassley, an Iowa Republican,
criticized the FDA's handling last year of safety risks associated with
drugs for ADHD. The FDA came under increasing scrutiny after the Canadian
health agency pulled Adderall XR from the market in February 2005 when 20
people taking the drug died. Health Canada returned the drug to the market
in August and in May strengthened the warnings.
To contact the reporters on this story: Shannon Pettypiece in Washington at
at spettypiece@bloomberg.net ; Justin Blum in Washington at at
jblum4@bloomberg.net .
Last Updated: August 21, 2006 18:24 EDT
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