From the FDA MedWatch on November 24, 2008:

FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found in the links provided below.

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

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Active ingredient(s): Eltrombopag

Dosage form: 25mg and 50mg oral tablets

Manufacturer: GSK

Usage: thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to coritcosteroids, immunoglobulins, or splenecteomy.

Approval Date: November 20, 2008

For more information visit http://www.fda.gov/cder/foi/label/2008/022291lbl.pdf

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

Active ingredient(s): Rufinamide

Dosage form: 100mg, 200mg, 400mg tablets

Manufacturer: Eisai

Usage: adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

Approval Date: November 14, 2008

For more information visit http://www.fda.gov/cder/foi/label/2008/021911lbl.pdf

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

From the FDA MedWatch on November 12, 2008:

FDA issued an update to the Agency’s review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

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Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

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