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Actos 310 articles

Scientists on track for developing safer diabetes drugs

Scientists say they believe they are close to developing an effective type 2 diabetes medication that won’t cause serious side effects that may be linked to some of the top drugs currently marketed to treat the condition. Their findings are being published in an upcoming issue of the journal Nature. Actos and Avandia are two common drugs prescribed to treat type 2 diabetes; however, both are plagued with concerns. Avandia was recently severely restricted by the Food and Drug Administration (FDA) based on research that indicates the drug may put users at greater risk for potentially deadly cardiovascular events, including ... Read More

FDA, Europe approve new type 2 diabetes drug

The Food and Drug Administration (FDA) and European drug regulators have approved a new medication made by Eli Lilly and Co. and Boehringer Ingelheim to treat type 2 diabetes. The drug linagliptin, will be marketed in the United States as Tradjenta and in Europe as Trajenta. Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. Some of the more popular medications to treat the condition recently have been put under tighter controls by the FDA because of series health concerns. ... Read More

Actos sales shot up after Avandia was restricted

When the Food and Drug Administration (FDA) severely restricted the use of the type 2 diabetes drug Avandia earlier this year after reports that the drug put users at an increased risk for heart attacks, many patients turned to its primary competitor, Actos. Approved by the FDA in 1999, Actos sales shot up in the wake of the Avandia restrictions. In 2010 alone, the pills, also known as pioglitazone, generated $3.4 billion in sales for its manufacturer, Takeda Pharmaceuticals. But new reports that showed Actos may cause bladder cancer in patients could put a quick end to the Actos honeymoon. ... Read More

Actos maker rolling in profits despite lawsuits questioning drug’s safety

Japanese drug maker Takeda Pharmaceutical Co., reported an 8.3 percent rise in quarterly profits last month despite new lawsuits filed by consumers who claim the company’s top-selling diabetes drug Actos caused them serious injury. Takeda booked an April-June operating profit of 116.2 billion Yen, or $1.5 billion, thanks to an increased contribution from its prescription-drugs business. Earlier this month the Food and Drug Administration (FDA) approved new warnings on the label of the type 2 diabetes drug Actos after reviewing data that showed the drug’s active ingredient, pioglitazone, may increase the risk for bladder cancer. The new safety labels recommend ... Read More

Actos maker seeks approval of drug despite bladder cancer risk

Just as news that Takeda’s top-selling diabetes drug Actos has been slapped with stronger warnings because of reports that the drug increases the risk for bladder cancer, the drug company announced it is resubmitting two New Drug Applications (NDAs) to the Food and Drug Administration (FDA), one of which includes pioglitazone, the same active ingredient in Actos. Pioglitazone was approved by the FDA in 1999 for the treatment of type 2 diabetes. In June, the FDA issued a new warning about the drug based on a French epidemiological study and a five-year analysis of an ongoing study of Actos that ... Read More

Experimental diabetes drug may increase risk for bladder, breast cancers

The severe restrictions recently placed on Avandia because of cardiovascular risks, and new warnings that Actos may cause bladder cancer have created a vast need for safe and effective drugs to treat type 2 diabetes. Unfortunately, the outlook isn’t bright. Dapagliflozin, an experimental diabetes drug developed by Bristol-Myers Squibb and AstraZeneca, was found to raise the risk for both bladder cancer and breast cancer, based on data from a long-term clinical program. The findings were presented in June at the American Diabetes Association Meeting in San Diego. The study involved 5,478 patients on long-term dapagliflozin therapy, in which 9 breast ... Read More

European regulators demand stronger warnings on diabetes drug Actos

The top-selling diabetes drug Actos (pioglitazone) should carry stronger warnings on its safety label about the possible risk for developing bladder cancer, say European drug regulators. But the European Medicines Agency (EMA) fell short of banning the drug, arguing that the medicine remains a valid treatment option for some patients. The EMA said that before being prescribed Actos, patients should be screened more closely, and those who are prescribed the drug should have their treatment plans periodically reviewed. Recent studies have linked Actos to an increased risk for bladder cancer, particularly among those who take the drug long-term and those ... Read More

More evidence suggests Actos may cause bladder cancer

A new study is providing more evidence that the diabetes drug Actos (pioglitazone) may cause bladder cancer in patients. The drug has been under an ongoing safety review by the Food and Drug Administration (FDA) since last year when the agency received early results from a long-term study. That study, conducted by Actos maker Takeda Pharmaceuticals Co Ltd., showed a risk for bladder cancer in patients who used the drug long-term or in higher cumulative doses. The drug’s prescribing information already includes the possibility of developing bladder cancer. The new study involved data from 2004 to 2009 of more than ... Read More

Dangerous diabetes drug following same path as Darvon, Darvocet

Another drug appears to be going down a similar path as the painkiller propoxyphene, known by the brand names Darvocet and Darvon, in the annals of banned drugs. Last week, German and French drug regulators banned the type 2 diabetes drug piogliazone (Actos) after reviewing data from a French study that suggested the drug put users at greater risk for bladder cancer. However, the Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA) and Japanese drug authorities, opted to gather more data before deciding the fate of the drug. The FDA officially banned the popular prescription ... Read More

FDA reviews diabetes drug for possible bladder cancer risk

The Food and Drug Administration (FDA) alerting health care professionals that it is reviewing data to determine whether the type 2 diabetes drug Actos (pioglitazone) increases the risk of bladder cancer in patients who use the drug. The data is from an ongoing, 10-year epidemiological study in animals and humans that suggests this is a potential safety risk that needs further study. At this time, the FDA has made no conclusions about the safety of Actos, and the agency will update the public when it has additional information. Actos, also known by the generic pioglitazone, is a once-daily oral prescription ... Read More