Monday Nov 24, 2008 (foodconsumer.org) -- The U.S. Food and Drug Administration today announced its
approval of Tapentadol hydrochloride, an immediate-release oral tablet
indicated for the relief of moderate to severe acute pain.
Tapentadol, a centrally-acting synthetic analgesic that
is manufactured by Johnson & Johnson, New Brunswick, N.J., is available in
doses of 50 mg, 75 mg, or 100 mg.
"This approval offers health care professionals an
additional choice for treating moderate to severe acute pain," said John
Jenkins, M.D., director of the office of new drugs in the FDA's Center for Drug
Evaluation and Research.
Tapentadol works in two ways, opioid (narcotic) and
non-opioid by affecting the brain and body primarily by activating opioid
receptors in the brain, spinal cord and gastrointestinal tract. The drug also
inhibits the reuptake of the brain chemical norepinephrine which possibly has
an analgesic effect.
Acute pain can be caused by many medical conditions and
can significantly interfere with a person's quality of life and general functioning.
The opioids are considered safe and effective in certain
patients but can lead to dependence, abuse, and addiction. Because of this, all
patients treated with opioids require careful monitoring by doctors for signs
of abuse and addiction, and to determine when opioid analgesics are no longer
Tapentadol does result in some side effects including
nausea, dizziness, vomiting, sleepiness, and headaches.
Serious effects that require label warnings for
Tapentadol include the risk of respiratory depression; addictive depressive
effects on the central nervous system which could occur
when taken with alcohol, other opioids, or
illicit drugs; and abuse potential.
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