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Weekly Drug News Round Up - January 30, 2013

Genzyme’s Kynamro Approved to Treat Inherited Cholesterol Disorder

Kynamro carries a Boxed Warning on the serious risk of liver toxicity due to elevated liver enzymes and fat accumulation Read More...

The U.S. Food and Drug Administration has approved Kynamro (mipomersen sodium) injection, an orphan drug used to treat patients with a rare and often fatal type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). HoFH, an inherited condition that affects about one out of every one million people in the U.S. Kynamro is used in conjunction with other lipid-lowering medications and diet to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and other lipids. In a trial of 51 patients, levels of LDL-C fell by 25 percent during the first 26 weeks. Juxtapid (lomitapide) was also approved for HoFH in December of 2012.

New Diabetes Compound Alogliptin Approved in Three Formulations

Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor that acts to stimulate the release of insulin Read More...

Takeda Pharmaceutical Co. received three drug approvals with their new type 2 diabetes drug alogliptin. Alogliptin was approved in the stand-alone form (Nesina), and in combination with metformin (Kazano), and pioglitazone (Oseni). Metformin, a biguanide, is an oral, first-line type 2 diabetes treatment that has been on the U.S. market since 1995. Pioglitazone (Actos), a thiazolidinedione, is also made by Takeda, but the Actos patent expired in 3Q 2012, opening the door for generic competition. Oseni’s label contains a boxed warning due to the potential of pioglitazone to cause or exacerbate congestive heart failure.

Oxytrol for Women: First OTC Patch for Overactive Bladder in Women

Oxytrol will remain prescription-only for men with overactive bladder Read More...

The U.S. Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) treatment for overactive bladder in women. Merck’s Oxytrol (oxybutynin) for Women is a transdermal skin patch applied once every four days and is used to modify symptoms such as frequent or urgent urination, incontinence (urine leakage), and increased nighttime urination. Oxytrol for Women contains an anticholinergic medication known as oxybutynin that helps to relax the bladder muscle to control symptoms. Oxybutynin tablets have already been available by prescription for overactive bladder. Prescription Botox (onabotulinumtoxinA) was also approved earlier this month for the treatment of overactive bladder.

FDA Panel Supports More Restrictive DEA Schedule for Hydrocodone

Over 22 million Americans have misused prescription painkillers since 2002 Read More...

The narcotic painkiller hydrocodone, commonly found in medications like Vicodin and Lortab (hydrocodone and acetaminophen) is a major culprit in the U.S. narcotic abuse epidemic. A panel of Food and Drug Administration advisors recommended this past week that hydrocodone combination treatments be reclassified from DEA Schedule III to Schedule II, meaning they would be more tightly controlled. Oxycodone is another common pain drug currently classified in Schedule II. However, opponents are concerned that reclassification of hydrocodone combination products to schedule II could limit access to those who need the opioid for legitimate pain reasons. Single entity hydrocodone is already classified in Schedule II, but hydrocodone only exists on the U.S. market in combination products.

Samsca Associated With Possible Liver Toxicity

Samsca is a selective vasopressin V2-receptor antagonist indicated for the treatment of hypervolemic and euvolemic hyponatremia Read More...

The U.S Food and Drug Administration is warning that the use of Samsca (tolvaptan) may result in significant liver toxicity. In a clinical trial evaluating tolvaptan effectiveness in Autosomal Dominant Polycystic Kidney Disease, three patients developed significant increases in serum alanine aminotransferase (ALT) enzymes and total bilirubin. Higher than normal doses were used in the study, but patients using tolvaptan in typical doses may still be at risk. Healthcare providers should perform liver function tests promptly in patients who report liver injury symptoms such as fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. If hepatic injury is suspected, Samsca should be promptly discontinued.