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Ctions and Cases of Misuse of Ultram or Tramadol Numerous reports of side reactions and possibility of medicine misuse caused FDA to revise the recommended prescription dosage of Ultram (tramadol), a medicine used in pain treatment. FDA has also sent a letter to medicine doctors including information about the drug’s safety. Since March 3, 1995 when the medicine was admitted to the market there were 115 reports of substantial abuse, withdrawal symptoms, dependence and intentional overdose by people who used the medicine. What’s more, in post marketing surveillance there were also reported 83 cases of seizure in those patients who were taking Ultram together with other medicines like selective serotonin uptake inhibitors (Prozac, or fluoxetine) or tricyclic antidepressants (Read the article) December 21st 2006 Posted to Tramadol Drug Uses Comments Off NDA Status for Tramadol ER Updated by Biovail Bioval Corporation (NYSE:BVF) (TSX:BVF) from Toronto commented today to have received from the United States Food and Drug Administration (FDA) data concerning New Drug Application (NDA) for tramadol hydrochloride an extended release, once daily formulation. The FDA decided that response to the Tramadol ER Approvable Letter will be under review for six month, which means that the letter is a Class 2 response. The FDA has also stated that during the period of preliminary review additional clinical tests and trials will be necessary. Biovail is considering numerous options. According to the Company, the clinical data included in original (Read the article) December 21st 2006 Pos
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