Publication: Health Tips Sleep drug product labels to change | |
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HEALTH TIPS - Friday, March 16, 2007
"News That Keeps You Healthy"
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Sleep drug product labels to change
WASHINGTON, -- The U.S. Food and Drug Administration
has ordered manufacturers of drugs used to help
people sleep to strengthen warnings about potential risks.
The FDA said all manufacturers of sedative-hypnotic drug
products -- a class of drugs used to induce or maintain
sleep -- must strengthen their product labeling to include
stronger language about such risks as severe allergic react-
ions and complex sleep-related behaviors. Those behaviors
include sleep-driving, which is defined as driving while not
fully awake after ingestion of a sedative-hypnotic product,
with no memory of the event. "There are a number of pre-
scription sleep aids available that are well-tolerated and
effective for many people," said Dr. Steven Galson, director
of the FDA's Center for Drug Evaluation and Research.
"However, after reviewing the available post-marketing
adverse event information for these products, FDA concluded
that labeling changes are necessary to inform healthcare
providers and consumers about risks." The FDA also ordered
the pharmaceutical companies to notify healthcare providers
about the new warnings. The medications of concern to the
FDA are: Ambien/Ambien CR, Butisol Sodium, Carbrital,
Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom,
Restoril, Rozerem, Seconal and Sonata.
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Scientists identify 'autism gene'
NEW HAVEN, Conn., -- U.S. scientists say an international
research consortium has identified a gene and
a region of a chromosome that might lead to autism in
children. Yale School of Medicine autism experts Ami Klin
and Dr. Fred Volkmar said the discovery is based on the
world's largest autism genome scan conducted by the more
than 120 scientists from 19 nations who formed the Autism
Genome Project. The researchers speculate there may be five
or six major genes and as many as 30 other genes involved
in autism. If a child has more of those genes, there is a
higher chance of being born with autism or a more severe
form of the disease. Autism is a complex brain disorder that
inhibits a person's ability to communicate and develop
social relationships, and is often accompanied by extreme
behavioral challenges. The study and its findings are
described in the March issue of the journal Nature Genetics.
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U.S. court rules against medical marijuana
SAN FRANCISCO,-- The 9th U.S. Circuit Court of Appeals ruled
Wednesday that an individual's right to medical marijuana
does not supersede the Controlled Substances Act. Presiding
over the San Francisco court, U.S. Circuit Court of Appeals
Judge Harry Pregerson voted against plaintiff Angel Raich's
claim on Wednesday, saying a medical need does not allow an
individual to violate the law, the Oakland (Calif.) Tribune
said. "Nothing in the common law or our cases suggests that
the existence of a necessity defense empowers this court to
enjoin the enforcement of the Controlled Substances Act as
to one defendant," he said. The legal case began in October
2002 when Raich and Diane Monson attempted to safeguard
their medical marijuana use by suing the government. Raich's
attorney told the paper that the case may soon be headed to
the U.S. Supreme Court, where they would ask for a review of
the appeal court's decision.
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