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 needed.

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.