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Weekly Drug News Round Up - July 31, 2013

FDA Limits Use of Oral Antifungal Nizoral

The update does not affect topical formulations of ketoconazole, such as the cream, shampoo, foams or gels Read More...

The U.S. Food and Drug Administration (FDA) has issued liver, adrenal gland, and drug interaction warnings for orally administered ketoconazole tablets (Nizoral) and is recommending it not be used as a first-line treatment for any fungal infection or in patients with acute or chronic liver disease. Oral ketoconazole should only be used for the treatment of certain life-threatening fungal infections when the benefits outweigh the risks and alternative therapeutic options are not available or tolerated. FDA has removed the indications for treatment of skin, hair and nail fungal infections and Candida infections. Appropriate oral antifungal alternatives, depending upon indication, may include itraconazole (Sporanox), terbinafine (Lamisil), fluconazole (Diflucan) or griseofulvin.

Boxed Warning Added to Antimalarial Mefloquine Label

FDA strengthens warnings about neurologic and psychiatric side effects Read More...

The U.S. Food and Drug Administration (FDA) has updated the warnings for the antimalarial drug mefloquine. A boxed warning, the most serious kind of warning, has been added to the drug label and the Patient Medication Guide has been revised. Neurologic and psychiatric side effect warnings include the possibility of dizziness, loss of balance, ringing in the ears, feeling anxious, mistrustful, depressed, or having hallucinations. Mefloquine is used for the treatment and prevention of malaria. It was previously marketed under the brand name Lariam. Mefloquine is now available only as a generic in the U.S.

Fetzima: A New SNRI Approved for Depression in Adults

Forest Labs expects Fetzima to be available to retail stores in 4th quarter 2013 Read More...

Fetzima (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI) has been FDA-approved for treatment of Major Depressive Disorder (MDD) in adults. Levomilnacipran is the active enantiomer of milnacipran (Savella), approved only for fibromyalgia. In three, Phase III studies of adults with MDD, a statistically significant improvement in depression was seen for the three dosage strengths of 40, 80, and 120 mg once daily compared with placebo. Common side effects occurring in greater than 5 percent of patients included nausea, constipation, and sweating.

American Regent Receives Approval for Injectafer

Common adverse reactions with Injectafer include nausea, high blood pressure, flushing and dizziness Read More...

The U.S. Food and Drug Administration (FDA) has approved Injectafer (ferric carboxymaltose injection). Injectafer is an intravenous (IV) iron replacement product used to treat iron deficiency anemia (IDA) in adults who cannot tolerate or did not have a satisfactory response to oral iron products and for patients with non-dialysis dependent chronic kidney disease. Injectafer is the first non-dextran IV iron approved for the treatment of adult patients with IDA. Injectafer is given as a single dose of up to 750 mg of iron via an IV push or infusion followed by a second dose seven days later for a total treatment of up to 1500 mg of iron.

Fat-Soluble Statins May Lower Risk For Parkinson’s Disease

Parkinson’s disease is a progressive neurological condition resulting in movement disorders such as stiffness and tremors Read More...

In the U.S., one in four Americans aged 45 and older takes a statin drug that is used to lower cholesterol and reduce the risk of stroke and heart attack. In a recent observational study conducted in over 44,000 patients from 2001 to 2008, researchers found that those who stopped taking fat-soluble statins such as simvastatin (Zocor) or atorvastatin (Lipitor) were about 58 percent more likely to develop Parkinson's disease (PD) than those who continued the drugs. Participants taking water-soluble statins such as rosuvastatin (Crestor) and pravastatin (Pravachol) were twice as likely to develop PD than those on the fat-soluble statins. Experts state those at risk for Parkinson’s disease, such as those with a family history, might consider use of a fat-soluble statin.