Latebreakers

CMS creates Part D help line for R.Ph.s

CMS has set up a dedicated telephone help line for pharmacists with Part D problems at 1-(866) 835-7595, available Monday through Friday from 8:00 A.M. to 8:00 P.M. Officials stressed that pharmacists should not give the phone number to patients or advocacy groups. Pharmacists who have questions about dual eligibles or WellPoint should phone 1-(800) 662-0210, and those trying to check whether a Medicare patient is enrolled in Part D should phone 1-(800) 388-2316.

R.Ph.s give CMS earful on Part D

WinRho SDF labeling revised

Postmarketing reports of severe and sometimes fatal intravascular hemolysis and potentially serious complications, including disseminated intravascular coagulation in patients with idiopathic thrombocytopenic purpura (ITP), have prompted the FDA and manufacturers Cangene and Baxter Healthcare to notify healthcare professionals of a revision in the labeling of WinRho SDF (Rho[D] Immune Globulin Intravenous [Human]). The changes alert ITP patients to immediately report to their physicians any symptoms of intravascular hemolysis, such as back pain, shaking chills, decreased urine output, sudden weight gain, discolored urine, fluid retention/edema, and/or shortness of breath. The potential for falsely elevated glucose readings when certain blood testing systems are being applied is also possible when using the product because it contains maltose, warns the FDA. Only glucose-specific testing systems should be used to test and monitor blood glucose levels in patients receiving the product.

Study shows increased mortality with clarithromycin

The FDA has issued an alert for healthcare professionals based on results of the CLARICOR study that showed increased mortality in patients treated with clarithromycin for 14 days. The placebo-controlled study, conducted in Denmark, was designed to evaluate whether treatment with clarithromycin could prevent another cardiac event in patients with stable coronary artery disease (CAD). Surprisingly, there were significantly more deaths in the clarithromycin group than with placebo, and the observed differences occurred about one year or more after the drug was given. Investigators say there is no clear explanation or biological mechanism to account for this phenomenon following a single two-week course of the drug. The authors recommend further study of the long-term effects of clarithromycin in CAD patients. The FDA is not recommending any specific changes to the use of the antibiotic at this time; however, it will be evaluating available sources of postmarketing data for patients receiving clarithromycin.

New treatment for hyponatremia approved

Astellas Pharma US has been granted approval for its arginine vasopressin antagonist Vaprisol (conivaptan HCl for injection), the first drug indicated specifically for the treatment of euvolemic hyponatremia in hospitalized patients. According to the company, the condition is thought to occur in up to 4% of hospitalized patients and is the result of increased total body water with little increase in sodium. Euvolemic hyponatremia can be associated with cancer, hypothyroidism, and the use of certain drugs. Severe cases can result in swelling of the brain, respiratory arrest, and death. The FDA has also issued an approvable letter for conivaptan for the treatment of hypervolemic hyponatremia.

Warning of worsening diabetic macular edema with rosiglitazone

The FDA has notified healthcare professionals of postmarketing reports of new-onset and worsening diabetic macular edema for patients receiving rosiglitazone. Products containing the drug include GlaxoSmithKline's Avandia and Avandamet. According to the company, patients also reported concurrent peripheral edema in most cases, and the macular edema resolved or improved following discontinuation of therapy in some cases. In one case, macular edema resolved following dose reduction. Glaxo will include the new precaution in all rosiglitazone product information for prescribers and patient information leaflets.