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Default FDA Approves Boat Accident Medicine

:-) :-) As if we need MORE snoozers on waterways (and highways):

FDA: Sleeping pills can sometimes cause 'sleep-driving'
WASHINGTON (AP) -- All sleeping pills, including the blockbusters Ambien and
Lunesta, may sometimes cause a bizarre but dangerous side effect --
sleep-driving, the Food and Drug Administration warned Wednesday.

It's like sleepwalking but behind-the-wheel: driving while not fully awake
after using a sleeping aid -- with no memory of doing so.

The FDA ordered the makers of 13 products to strengthen warnings on their
labels about two rare but serious side effects:

.. Sleep-driving, along with other less dangerous "complex sleep-related
behaviors" -- like making phone calls or fixing and eating food while still
asleep.

.. And life-threatening allergic reactions, as well as severe facial
swelling, both of which can occur the first time the pills are taken.

FDA told manufacturers to write letters to doctors to notify them of the new
warnings, and all prescription sleeping pills now will come with special
brochures called "Medication Guides" that spell out the risks for patients
in easy-to-understand language.

FDA wouldn't say exactly how many cases of sleep-driving it uncovered, or if
it knew of any car crashes, saying only that "there have been rare adverse
events reported."

"Due to the potential for embarrassment and/or legal exposure, people are
less likely to report some of the more complex sleep behaviors. Therefore,
FDA is concerned that there may be extensive under-reporting of these
events," said FDA spokeswoman Kimberly Rawlings. "It was important to alert
people about the risk of complex sleep behaviors, especially sleep-driving
because of the potential for this activity to cause harm or death to both
the patients and the community."

This entire class of medicine, known as sedative-hypnotic products, has
these rare risks, FDA said. But some drugs may cause the problems more than
others, so FDA recommended that manufacturers conduct clinical trials to
figure that out.

Copyright 2007 The Associated Press. All rights reserved.This material may
not be published, broadcast, rewritten, or redistributed.


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