Drug Formulary Review Archives – April 1, 2005
April 1, 2005
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FDA panelists stop short of removing pain killers from market
A joint U.S. Food and Drug Administration (FDA) advisory panel has allowed three cyclooxygenase-2 (COX-2) inhibitors two narrowly to remain on the market. -
Meta-analysis: BP elevation with COX-2 inhibitors
A recently published meta-analysis associates cyclooxygenase-2 (COX-2) inhibitors with a point-estimate blood pressure (BP) elevation compared with placebo and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). -
More vigilance needed in prescribing for the elderly
Conventional wisdom has swung toward concerns about underuse of beneficial drug therapies for older Americans, says a physician who specializes in geriatric medicine and the use of drug therapy in the elderly. -
Aspirin helps prevent strokes, not heart attacks in middle-aged women
Results from a new major study show that middle-aged women who take aspirin lowered their risk of having a stroke, but their risk of myocardial infarction (MI) or death from cardiovascular causes was not affected. -
Biogen Idec voluntarily suspends natalizumab marketing
The FDA has announced that Biogen Idec is voluntarily suspending marketing of natalizumab (Tysabri) because of two serious adverse events reported with its use. -
FDA issues public health advisory on rosuvastatin (Crestor)
The FDA has announced that Astra-Zeneca Pharmaceuticals has revised the package insert for the cholesterol-lowering drug rosuvastatin (Crestor). The label changes include results from a Phase IV pharmacokinetic study in Asian Ameri-cans and highlight important information on the safe use of rosuvastatin to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. -
Americans count on drugs but question manufacturers’ motives
Although many Americans count on prescription drugs to improve their health and quality of life, many say drug makers place financial gain ahead of consumers well-being, a recent poll says. -
U.S. marshals seize lots of paroxetine, others
In a response to ongoing concerns about manufacturing quality, the FDA and the Department of Justice initiated seizures of paroxetine (Paxil) CR and rosiglitazone maleate and metformin HCl (Avandamet) tablets manufactured by GlaxoSmithKline (GSK) on March 4. -
New FDA Approvals
These drugs were recently approved by the U.S. Food and Drug Administration (FDA): Vaccinia immune globulin intravenous (VIGIV) by DynPort Vaccine Co. LLC. The FDA has approved vaccinia immune globulin intravenous (VIGIV), the first intravenous human plasma-derived product available to treat certain rare complications of smallpox vaccination. -
Drug Criteria & Outcomes: Solifenacin succinate (Vesicare) Formulary Evaluation
Because solifenacin is a substrate of CYP3A4, inducers or inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, and erythromycin) may alter solifenacin pharmacokinetics.