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Weekly News Round Up - April 4, 2012

Altuzan (bevacizumab): Foreign Counterfeit Product Contains No Active Drug

Medical practices should not purchase illegal and unapproved foreign medications; patients at extreme risk Read More...

More counterfeit, ineffective and unapproved foreign drugs are making their way into U.S. medical practices. In February, fake Avastin (bevacizumab), a cancer treatment was found in the U.S. This week, another foreign brand of bevacizumab called Altuzan 400 mg/16mL was reported as counterfeit. Altuzan, while approved in Turkey, is not approved in the U.S. However, the Altuzan found in the U.S. is counterfeit and contains no active ingredient, putting cancer patients at extreme risk. Vials of Roche’s Altuzan with lot number B6021 should be considered counterfeit. If vials are found, call the U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations at 800-551-3989.

Neupro Returns to US Market for Parkinson’s Disease and Restless Legs Syndrome

New indications approved for Neupro; reformulated skin patch available July 2012 Read More...

Neupro (rotigotine), a dopamine agonist transdermal patch previously only approved for early stage Parkinson’s disease, was voluntarily recalled from the US market in 2008 due to a patch manufacturing issue. However, in July 2012, Neupro will return to the US market with indications for treatment of early stage and advanced Parkinson’s disease (PD), and Restless Legs Syndrome (RLS). Five placebo-controlled, clinical trials in PD, and two in RLS demonstrated statistically significant benefit for patients. Many side effects with Neupro are dose-related, and may include sudden onset of sleep, nausea, vomiting, application site reactions, excessive sweating, and loss of appetite.

Generic Avapro and Avalide Now Available from Teva Pharmaceuticals

Teva Pharmaceuticals announces generic launch of Avapro and Avalide tablets used in hypertension Read More...

In a continuing stream of generic launches, Teva Pharmaceuticals announced this week the availability of generic Avapro (irbesartan) and Avalide (irbesartan/hydrochlorothiazide). Irbesartan is an angiotensin II receptor antagonist used in patients with high blood pressure (hypertension) or diabetic nephropathy, a kidney disease often seen diabetes. Irbesartan is available in 75, 150 and 300 milligram (mg) strengths. Irbesartan combined with the diuretic hydrochlorothiazide is only indicated for treatment of hypertension, and can be obtained in 150mg/12.5 mg and 300mg/12.5 mg strengths. Over the previous two months, Teva has introduced dollar-saving generics for three major blockbusters, including quetiapine (Seroquel), olanzapine (Zyprexa Zydis) and escitalopram (Lexapro).

Levemir Insulin Now Has Pregnancy Category B

Levemir, a long-acting insulin analog, found to have similar overall safety profile to NPH insulin Read More...

The U.S. Food and Drug Administration (FDA) has approved Levemir (insulin detemir [rDNA origin] injection) for pregnancy Category B classification, which means it’s use in pregnant women with type 1 diabetes does not increase the risk of harm to the baby. Previously, Levemir had a Category C classification. The FDA changed was based on a randomized, controlled and comparative study in 310 women with type 1 diabetes. When the safety and effectiveness of Levemir was compared to NPH insulin (Humulin N), which has a pregnancy category of B, blood sugar control (A1C reduction), overall pregnancy outcomes and safety for the health of the newborn were found to be similar.

FDA and ISMP Collaborate on Medication Error Prevention

The FDA and Institute for Safe Medication Practices (ISMP) work to educate community and consumers in preventable drug errors Read More...

Research reveals that medication errors may cost the U.S. health care system well over $100 billion per year. The U.S. Food and Drug Administration (FDA) and the Institute for Safe Medication Practices (ISMP) are joining forces in an effort to educate and inform health care providers (HCP), communities and consumers about medication error prevention. Medications errors are preventable mistakes, and examples include: incomplete patient information, health care provider miscommunication, confusion between look-alike or sound-alike drug names, and similar drug packaging allowing for drug mix-ups. Last year ISMP and the FDA collaborated on dosing errors that were detected in the use of over-the-counter infant Tylenol (acetaminophen).