Nov. 16, 2006 – A large number of people suffer from different sort of pains either acute to moderate to severe pain and almost 50 million Americans suffer from chronic pain. FDA has also approved Ultram in September 2005 based upon a safety and clinical data after undergoing clinical trials.
Seizures have been reported in patients receiving tramadol. The risk of seizure is increased with doses of tramadol above the recommended range and in patients taking certain medications such as tricyclic antidepressants, selective serotonin reuptake inhibitors, or opioids. Administration of tramadol may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, other drugs that reduce the seizure threshold, or in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections).
“Chronic pain affects a large segment of the U.S. population, with an estimated 45 percent of all Americans seeking care for persistent pain at least once during their lifetime,” according to Dr. Fernandes
The development of a once-daily formulation of tramadol is indicative of how an innovative drug-delivery technology can overcome the most difficult formulation enhancement challenges,” said Douglas.
Tramadol, like other opioids used in analgesia, can be abused. ULTRAM should not be used in patients who are suicidal or addiction-prone, or taken with alcohol-containing beverages.
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