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Weekly Drug News Round Up - August 21, 2013

FDA: Possible Nerve Damage with Fluoroquinolone Antibiotics

FDA warns about the peripheral neuropathy side effect with fluoroquinolone antibiotics that may be permanent Read More...

The U.S. Food and Drug Administration (FDA) is requiring updates for all fluoroquinolone antibiotics taken by mouth or injection to better describe the risk for peripheral neuropathy. Peripheral neuropathy is a type of nerve damage that causes weakness, numbness, and pain that may feel like burning or tingling, often in the hands and feet. The fluoroquinolone should be stopped if a patient develops these symptoms and they should be switched to a non-fluoroquinolone antibiotic, unless the benefit of continued treatment outweighs the risk. Approved fluoroquinolone drugs include levofloxacin, (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).

Fluoroquinolone Use In Diabetics May Alter Blood Sugar Levels

But experts also state that infection itself can lead to low or high blood sugar in diabetes Read More...

A new study in Clinical Infectious Diseases suggests that there may be a link between the use of fluoroquinolone antibiotics and blood sugar (glucose) swings in diabetic patients. In the study, 78,000 people in Taiwan who took certain fluoroquinolones, second-generation cephalosporins, or macrolide antibiotics were evaluated for hospital visits due to glucose fluctuations in the 30 days post-antibiotic administration. Patients using fluoroquinolones were more likely to have severe glucose changes compared to the other classes. The results identified moxifloxacin (Avelox) as the drug associated with the highest risk of hypoglycemia, followed by levofloxacin (Levaquin) and ciprofloxacin (Cipro).

Epaned: A Liquid Enalapril Approved for Children and Adults

Powder for oral solution now available for adults and children one month and older Read More...

Epaned (enalapril maleate Powder for Oral Solution) has been FDA-approved for hypertension (high blood pressure) in people one month and older who need a liquid formulation. Enalapril is called an ACE Inhibitor, in the same class of medicines as the widely prescribed lisinopril. In children, the effects of high blood pressure can begin during childhood. Mild to moderate high blood pressure is usually has no symptoms but may be linked with subtle changes in behavior or school performance. Childhood obesity rates in the US have tripled in the last 30 years, which may contribute to high blood pressure. Children should have their blood pressure checked at least once per year.

Trokendi XR Approved for Epilepsy

Supernus Pharmaceuticals expects to launch the product in the coming weeks Read More...

According to the Epilepsy Foundation, epilepsy affects nearly 3 million Americans at an estimated annual cost of $17.6 billion. The U.S. Food and Drug Administration has approved Trokendi XR, an extended-release formulation of topiramate given once daily. Trokendi XR is indicated for initial monotherapy in patients 10 years and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years and older with partial onset or primary generalized tonic-clonic seizures, and as adjunctive therapy in patients 6 years and older with seizures associated with Lennox-Gastaut syndrome. The product will be available in 25, 50, 100 and 200 milligram extended-release capsules.

Neurologists Not Well-Informed of Epilepsy Drug Safety Risks

Important safety warnings do not always get to the intended audience Read More...

A recent survey published in the journal Epilepsy found that one in five neurologists are unaware of newer epilepsy drug safety risks recently published by the U.S. Food and Drug Administration (FDA). These risks include increased danger of suicidal thoughts, a high risk for birth defects and mental impairment in children of mothers taking divalproex (Depakote), and the likelihood of serious hypersensitivity reactions in some Asian patients treated with carbamazepine (Tegretol). Researchers from the Johns Hopkins University School of Medicine state these results suggest the FDA needs to focus on new ways to inform physicians of important safety warnings.

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