The NFA received an overwhelming reaction to its recent press release on a study published in the American Journal of Medicine, that ULTRACET (tramadol hydrochloride/ acetaminophen) has been found to effectively reduce pain in people with fibromyalgia. We received many questions regarding this drug and thought it would be of interest to our readers if we shared the answers to these questions in the form of a newsletter article.

For more information on ULTRACET please visit:

www.ultracet.com/using/pi.html

www.ultracet.com/using/about.html

www.docguide.com/dg.nsf/PrintPrint/ADAD235951D105D085256AAE0068F632

www.immunesupport.com/library/showarticle.cfm/id/3086

or call the Customer Communications Center at: (800) 682-6532.

Questions:

Q: Who makes Ultracet and has it been approved by the FDA?

A: Ultracet was developed by Ortho-McNeil and it does have FDA approval.

Q: Is it available in Canada or the UK?

A: Ultracet is not currently available outside of the United States.

Q: Can you only take Ultracet for five days?

A: Although Ultracet has been approved for short term use in the treatment of acute pain, a physician can approve flexible dosing, as the drug reportedly provides long-lasting pain relief.

Q: Can you explain the use of Ultracet and how it may help people with FM pain?

A: According to Ortho-McNeil: "ULTRACET is a unique pain medication that combines tramadol, a leading prescription pain reliever, and acetaminophen, the most commonly recommended over-the-counter analgesic in the U.S. ULTRACET provides powerful relief from many kinds of acute pain, including joint pain, strains and sprains, post-operative recuperation, joint pain flares and muscle aches."

"ULTRACET provides effective pain relief in two important ways. First, laboratory studies suggest that ULTRACET reduces the amount of pain you feel by acting directly on the parts of the brain where pain is perceived and on the spinal cord where pain signals are transmitted. Second, it reduces the size of the pain signal passed from one nerve to another."

Q: What makes Ultracet different from other pain medications?

A: According to Ortho-McNeil: "ULTRACET is different from aspirin and nonsteroidal anti-inflammatory drugs (also known as NSAIDs) such as ibuprofen, naproxen, Celebrex®, or Vioxx®. ULTRACET offers effective pain relief with fewer prostaglandin-related side-effects that interfere with other treatments. That means it may be a good choice if you are at risk of stomach ulcers, because ULTRACET has not been associated with ulcers or stomach bleeding in medical studies. In addition, ULTRACET does not impair kidney function or interact with many blood pressure medications. And if you are at risk of kidney problems, ULTRACET does not affect the hormone-like system that helps keep your kidneys working normally. However, your physician may need to adjust your dose of ULTRACET if your kidney function is below normal."

Q: What are the side effects?

A: "All medicines, including ULTRACET, can cause side effects. People who experienced side effects with ULTRACET in medical studies usually did so at the beginning of treatment. The most frequently reported side effects were constipation, sleepiness, and sweating. You should speak with your doctor about any side effects you experience while taking ULTRACET. ULTRACET may impair your ability to drive a car or operate machinery."

Q: Can Ultracet be dangerous?

A: "If you have a history of severe, life-threatening allergic (anaphylactoid) reactions to codeine and other opioids, you may be at increased risk and, therefore, should not take ULTRACET pain medication."

Q: Can you take Ultracet if you are taking antidepressants?

A: Although there are no counter indicated medications you should talk to your doctor about the following:

"There are certain medications that should be used with caution while taking ULTRACET. These include tranquilizers, sleeping pills, antidepressants, and opioid pain medicines. Some people who have taken tramadol, one of the components of ULTRACET, have reported seizures. The risk of seizures is increased with doses of tramadol above the recommended range. Tramadol increases the seizure risk in people taking certain medications (e.g., tricyclic antidepressants, SSRIs, opioids)."

A: "Cases of abuse and dependence on tramadol (one of the components of ULTRACET) have been reported. ULTRACET should not be used in people who are opioid-dependent. Since ULTRACET can reinitiate physical dependence, it is not recommended if you have a tendency to abuse drugs, a history of drug dependence, or chronically use opioids."