FDA approves three type 2 diabetes pills from Takeda

U.S. health regulators approved Takeda Pharmaceutical Co's alogliptin to treat type 2 diabetes as a standalone drug and in two other formulations in combination pills with older diabetes medicines.

The U.S. Food and Drug Administration announced the three approvals simultaneously on Friday.

Alogliptin by itself will be sold under the brand name Nesina, the agency said. The drug in combination with metformin - one of the most common initial treatments for the disease - will be sold as Kazano, and alogliptin along with pioglitazone - the chemical name for Takeda's Actos - will be sold as Oseni, the FDA said.

Type 2 diabetes is a growing health crisis that can lead to numerous serious complications, such as heart disease, circulatory problems and amputations, kidney damage, and blindness. It affects about 24 million Americans and accounts for more than 90 percent of diabetes cases diagnosed in the United States, the FDA said.

Alogliptin, which lowers blood sugar levels by stimulating the release of insulin after a meal, was shown to be safe and effective in 14 clinical trials involving about 8,500 patients with type 2 diabetes.

Due to caution about the heart safety of diabetes drugs after GlaxoSmithKline's Avandia was shown to cause heart problems, the FDA is requiring five postmarketing studies for Nesina, including a cardiovascular outcomes trial to assure that the drug does not increase of the risk of heart attacks or strokes. Another study to be conducted once the drug is being used by the public will monitor for liver abnormalities and serious cases of pancreatitis.

Kazano's label will include a boxed warning for lactic acidosis, a build-up of lactic acid in the bloodstream associated with metformin use, the agency said.

The Oseni label will have a boxed warning for heart failure associated with pioglitazone use. Pioglitazone belongs to the same class of diabetes drugs as Avandia, known as thiazolidinedione, or TZDs.

(Reporting by Bill Berkrot; Editing by Bernard Orr)

FDA cracks down on thousands of websites for selling bad drugs

 The U.S. Food and Drug Administration on Thursday said it has cracked down on thousands of online pharmacies for selling potentially unsafe, unapproved or fake pharmaceuticals, including the erectile dysfunction drug Viagra and antiviral Tamiflu.

The FDA, working with international regulatory and law enforcement agencies from about 100 countries, said it took action against more than 4,100 Internet pharmacies, bring civil and criminal charges, removing offending websites and seizing drugs worldwide.

The move was part of the fifth annual International Internet Week of Action, a global effort to fight the online sale and distribution of potentially counterfeit and illegal medicine.

Action taken between September 25 and October 2 resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of $10.5 million worth of drugs.

The goal of this annual effort, which involved law enforcement, customs and regulatory authorities from 100 countries, was to identify producers and distributors of illegal pharmaceutical products and medical devices and remove these products from the supply chain.

The FDA targeted websites selling unapproved and potentially dangerous medicines. In addition to Tamiflu and Viagra, the agency targeted Domperidone, which was removed from the U.S. market in 1998 because it may cause serious adverse side effects, and Isotretinoin, previously marketed as Accutane in the United States, used to treat severe acne and carries risks, such as birth defects.