Tunderbar
Thu, Mar-15-07, 17:17
http://www.playfuls.com/news_005485_Sleep_Drugs_Not_As_Innocu-
ous_As_You8217d_Think.html
Prescription sleeping pills can have some odd side-effects
such as driving while asleep or allergic reactions.
The Food and Drug Administration has called for new cautions
on 13 prescription sedative-hypnotic medications approved to
treat insomnia and other sleep disorders. Its concerns were
not serious enough to withdraw the drugs though.
While many of the drugs can be used safely, the data collected
since their approval poses some question marks, according to
Dr. Steven Galson, head of FDA's Center for Drug Evaluation
and Research.
"After reviewing the available post-marketing adverse event
information for these products, FDA concluded that labeling
changes are necessary to inform health care providers and
consumers about risks," he said.
What exactly are the risks? Engaging in various activities
such as driving while asleep ("sleep driving") without any
recollection afterward, the FDA said. Patients taking the
drugs were also found to make phone calls, have sex, eat and
cook while asleep.
Severe allergic reaction known as anaphylaxis and severe
facial swelling called angioedema can also occur, even with
the first dose.
Among the medications the FDA considers should sport new
warnings are Sepracor Inc.'s Lunesta and Sanofi-Aventis's
Ambien as well as drugs made by Abbott Laboratories, Takeda
Pharmaceuticals Co. Ltd. and Tyco International Ltd.'s Tyco
Healthcare, the agency said.
Some good news would be that the odd side-effects, though
existent, are quite rare, according to Dr. Russell Katz, head
of FDA's neurology division. He added it was likely such
incidents were underreported by consumers and doctors.
"There may be things patients can do to reduce the risk of
these complex behaviors," said Katz. "Namely, refrain from
alcohol and other drugs that depress the nervous system."
The manufacturers have agreed to add stronger warnings on
their product labels, said Katz, except for one which he did
not identify.
The FDA also recommended that manufacturers of sleep drugs
conduct trials to see how often the risks affect patients
taking their particular product. "Although all
sedative-hypnotic products have these risks, there may be
differences among products in how often they occur," the
agency said.
****
File this in the No-shit-sherlock file.
TC
ous_As_You8217d_Think.html
Prescription sleeping pills can have some odd side-effects
such as driving while asleep or allergic reactions.
The Food and Drug Administration has called for new cautions
on 13 prescription sedative-hypnotic medications approved to
treat insomnia and other sleep disorders. Its concerns were
not serious enough to withdraw the drugs though.
While many of the drugs can be used safely, the data collected
since their approval poses some question marks, according to
Dr. Steven Galson, head of FDA's Center for Drug Evaluation
and Research.
"After reviewing the available post-marketing adverse event
information for these products, FDA concluded that labeling
changes are necessary to inform health care providers and
consumers about risks," he said.
What exactly are the risks? Engaging in various activities
such as driving while asleep ("sleep driving") without any
recollection afterward, the FDA said. Patients taking the
drugs were also found to make phone calls, have sex, eat and
cook while asleep.
Severe allergic reaction known as anaphylaxis and severe
facial swelling called angioedema can also occur, even with
the first dose.
Among the medications the FDA considers should sport new
warnings are Sepracor Inc.'s Lunesta and Sanofi-Aventis's
Ambien as well as drugs made by Abbott Laboratories, Takeda
Pharmaceuticals Co. Ltd. and Tyco International Ltd.'s Tyco
Healthcare, the agency said.
Some good news would be that the odd side-effects, though
existent, are quite rare, according to Dr. Russell Katz, head
of FDA's neurology division. He added it was likely such
incidents were underreported by consumers and doctors.
"There may be things patients can do to reduce the risk of
these complex behaviors," said Katz. "Namely, refrain from
alcohol and other drugs that depress the nervous system."
The manufacturers have agreed to add stronger warnings on
their product labels, said Katz, except for one which he did
not identify.
The FDA also recommended that manufacturers of sleep drugs
conduct trials to see how often the risks affect patients
taking their particular product. "Although all
sedative-hypnotic products have these risks, there may be
differences among products in how often they occur," the
agency said.
****
File this in the No-shit-sherlock file.
TC