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Pharmacokinetics of orally administered tramadol in domestic rabbits (Oryctolagus cuniculus).

Am J Vet Res. 2008 Aug;69(8):979-82

Authors: Souza MJ, Greenacre CB, Cox SK

Objective-To determine the pharmacokinetics of an orally administered dose of tramadol in domestic rabbits (Oryctolagus cuniculus). Animals-6 healthy adult sexually intact female New Zealand White rabbits. Procedures-Physical examinations and plasma biochemical analyses were performed to ensure rabbits were healthy prior to the experiment. Rabbits were anesthetized with isoflurane, and IV catheters were placed in a medial saphenous or jugular vein for collection of blood samples. One blood sample was collected before treatment with tramadol. Rabbits were allowed to recover from anesthesia a minimum of 1 hour before treatment. Then, tramadol (11 mg/kg, PO) was administered once, and blood samples were collected at various time points up to 360 minutes after administration. Blood samples were analyzed with high-performance liquid chromatography to determine plasma concentrations of tramadol and its major metabolite (O-desmethyltramadol). Results-No adverse effects were detected after oral administration of tramadol to rabbits. Mean +/- SD half-life of tramadol after administration was 145.4 +/- 81.0 minutes; mean +/- SD maximum plasma concentration was 135.3 +/- 89.1 ng/mL. Conclusions and Clinical Relevance-Although the dose of tramadol required to provide analgesia in rabbits is unknown, the dose administered in the study reported here did not reach a plasma concentration of tramadol or O-desmethyltramadol that would provide sufficient analgesia in humans for clinically acceptable periods. Many factors may influence absorption of orally administered tramadol in rabbits.

PMID: 18672959 [PubMed - in process]

(Source: American Journal of Veterinary Research)

Iatrogenic neuropsychiatric syndromes.

Aust Fam Physician. 2008 Aug;37(8):627-9

Authors: Choong K, Ghiculescu RA

BACKGROUND: Although tramadol induced neuropsychiatric toxicity, dependence and withdrawal have been extensively reported in chronic pain sufferers, such cases continue to surface in clinical practice. OBJECTIVE: We describe two cases of atypical withdrawal after abrupt discontinuation of tramadol and a case of serotonin syndrome. The outcome was favourable in all three cases. DISCUSSION: Patients and prescribers are reminded of the risk of severe morbidity including seizures associated with tramadol withdrawal. Serotonin syndrome can be precipitated with tramadol use especially in combination with other serotonergic drugs.

PMID: 18704211 [PubMed - in process]

(Source: Australian Family Physician)

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UCB announced that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults. The company will seek clarification from the FDA of its position and of the additional information required to obtain final marketing approval.

Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced that it has received written guidance from the U.S. Food and Drug Administration (FDA) that one post-operative pain trial (Sinatra Study) and one fever trial (Study 302) are sufficient to meet the pivotal clinical trial requirements for submission of a New Drug Application (NDA) for Acetavance, the company's intravenous formulation of acetaminophen for the treatment of acute pain and fever in adults and children.

Roche announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) by a near unanimous (10-1) vote recommended approval of Actemra (tocilizumab), a novel interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, for reducing the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).

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