Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • May 1, 2011

    Uses:

    Treatment of medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease

    Vandetanib is a tyrosine kinase inhibitor that is thought to work by inhibiting the vascular endothelial growth factor pathway, epidermal growth factor receptor, and rearranged during transfection pathways. FDA approval of vandetanib for patients with advanced medullary thyroid cancer was based on results of the Phase III ZETA study. The trial showed that patients given vandetanib 300 mg daily (n = 231) had a significant improvement in progression-free survival compared with the 100 patients given placebo (22.6 vs. 16.4 mo). Because of its potential to cause torsades de pointes and sudden death, only prescribers and pharmacists certified with the vandetanib Risk Evaluation and Mitigation Strategy program can prescribe and dispense the drug, respectively.

  • May 1, 2011

    Uses:

    Treatment of patients with progressive neuroendocrine tumors located in the pancreas that are unresctable, locally advanced, or metastatic

    Approval was based on data from a randomized, double-blind, multicenter trial that compared use of everolimus 10 mg once daily plus best supportive care (n = 207) versus placebo plus best supportive care (n = 203) in patients with disease progression within the previous 12 months. Treatment with everolimus resulted in a statistically significant improvement in investigator-determined progression-free survival compared with placebo (median 11.0 vs. 4.6 mo).

  • May 1, 2011

    Data from one Phase II and three Phase III studies involving more than 3,300 infants showed that two doses of the vaccine given 3 months apart elicited a robust immune response against the serogroups in the vaccine. In addition, data from these studies showed that the measles-mumps-rubella-varicella vaccine and pneumococcal conjugate vaccine can be administered at the same as Menactra in children. The most common adverse events included injection-site reactions (i.e., swelling and tenderness) and irritability.

  • May 1, 2011

    Teva has voluntarily withdrawn its lansoprazole delayed-release orally disintegrating tablets (ODT) after FDA received reports that the tablets clogged and blocked oral syringes and feeding tubes, including gastric and jejunostomy tubes. The ODT tablets reportedly do not fully disintegrate fully when water is added or disintegrate and later form clumps that clog oral syringes and feeding tubes.

  • May 1, 2011

    Two lots of Topamax 100 mg tablets (0KG110 and 0LG222) have been voluntarily recalled by Ortho-McNeil Janssen after a small number of patients reported an uncharacteristic odor thought to be caused by trace amounts of TBA (2, 4, 6 tribromoanisole), a byproduct of a chemical preservative sometimes applied to wood where products are transported and stored. Although TBA is considered to be nontoxic, it can generate an offensive odor and some patients reported temporary gastrointestinal symptoms.

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