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cardiovascular risk 21 articles

Drug company Orexigen conducts tests on experimental diet pill Contrave

Interim analysis of Orexigen Therapeutics’ experimental weight loss drug Contrave showed successful results, setting the stage for possible marketing approval by United States drug regulators by June 2014. The Food and Drug Administration (FDA) rejected Orexigen’s bid for approval in February 2011, saying it needed more data from a large-scale study on the long-term effects the obesity medication has on the heart. Contrave is a combination of two already approved medications – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in in order to decrease food ... Read More

Eli Lilly closer to seeking approval for new type 2 diabetes drug

Late stage research on Eli Lilly and Co.’s potential new type 2 diabetes medication dulaglutide shows it was better than two other drugs at lowering blood sugar levels. The drug company says it hopes to apply for approval from United States drug regulators next year, but the timing depends on the completion of Food and Drug Administration (FDA) requirements for an assessment of the drug’s cardiovascular risk. Eli Lilly reported that two injections of dulaglutide lowered blood sugar levels better than twice-daily injections of exenatide and the oral treatments metformin and sitagliptin. More details of the study that provided this ... Read More

Diabetes drugs Actos, Avandia linked to bladder cancer, heart failure

Actos (pioglitazone) may control blood sugar levels in older diabetics better than metformin, but it still carries risks that patients should weigh before taking the drugs, said a medical expert for AARP.org. Actos is a medication used to treat type 2 diabetes. Actos is similar to Avandia (rosiglitazone), and both drugs are in a class of medications known as thiazolidinediones (TZDs). Whether used alone or with other antidiabetic agents, TZDs can cause or worsen heart failure. In 2010, the Food and Drug Administration (FDA) severely restricted the use of Avandia because of the cardiovascular risk, but the agency did not ... Read More

Takeda resubmits application for diabetes drug with cancer risk

Japanese drug maker Takeda Pharmaceutical is hoping to win Food and Drug Administration (FDA) approval for two diabetes drugs despite a highly publicized cancer risk with one of the drugs. Takeda announced that it is resubmitting its application for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in Takeda’s type 2 diabetes drug Actos. Takeda has been seeking FDA approval for alogliptin since 2009, when it was originally rejected because there was not enough information about potential cardiovascular risk. Takeda resubmitted its application only to have it rejected last May because the FDA wanted more information about ... Read More

Study: Actos, Avandia may increase risk of macular edema

The popular type 2 diabetes drugs Actos and Avandia may increase the risk of eye and vision problems, according to a study published this month in the Archives of Internal Medicine. The study, Association Between Thiazolidinedion Treatment and Risk of Macular Edema Among Patients with Type 2 Diabetes, followed more than 100,000 patients during a 10-year period. Researchers found that participants who used either Actos or Avandia had a two to three times greater risk of developing macular edema. Those who used the drug with insulin had an even greater risk. Macular edema occurs when fluid and protein deposits collect ... Read More

New diabetes drugs have to provide more proof they are safe

These days, drugs to treat diabetes have one of the highest safety standards to clear before they are granted approval by the Food and Drug Administration (FDA). Placebo-controlled studies are no longer enough to sway agency decision makers. Drug companies must prove their new diabetes treatments won’t cause more problems than the condition they are treating. Which is why excitement over promising data from phase II studies on LY2605541, a joint effort by Eli Lilly and Boehringer Ingelheim, is contained. The drug showed better or equal glycemic control for patients with type 1 or type 2 diabetes than other similar ... Read More

Aggressive approach needed to prevent diabetes in pre-diabetics

An earlier and more aggressive approach is needed in people at risk for developing type 2 diabetes in order to reduce the escalating number of people diagnosed with the disease each year, according to a study published in the Lancet. Type 2 diabetes is on the rise worldwide and unhealthy diets and sedentary lifestyles are to blame. People in the early stages of diabetes, known as pre-diabetes, who ignore important warning signs, such as elevated blood sugar, will most likely go on to develop the condition. Once someone develops type 2 diabetes, it is almost impossible to fully recover. However, ... Read More

Actos carries even greater risk for bladder cancer, heart attack, death

The type 2 diabetes drug Actos (pioglitazone) carries an even greater risk for bladder cancer and heart problems than previously noted during a Food and Drug Administration (FDA) review, according to a new study published in the British Medical Journal. Actos is in a class of type 2 diabetes medications known as thiazolidinediones, or TZDs. Another member in this class is Avandia (rosiglitazone). The safety of both drugs has come under scrutiny in recent years. In 2010, the FDA severely restricted the use of Avandia after the drug was linked to fatal heart attacks. Actos was considered a safer choice ... Read More

FDA panel recommends approval of controversial diet drug Qnexa

A new diet drug may soon be available for people battling the bulge, but it may come at a price. This week, a Food and Drug Administration (FDA) advisory panel reviewed clinical data on the weight loss drug Qnexa and voted to recommend its approval despite rejecting its application a year ago due to serious health concerns. The FDA is expected to make a final ruling about the drug later this year, but the agency typically follows the recommendations of its advisory panels. If approved, Qnexa will be the first prescription diet pill to hit the United States market since ... Read More

Ortho Evra birth control patch warning upgraded to a black box warning

A new black box warning has been added to the safety label of Johnson & Johnson’s birth control patch Ortho Evra (norelgestromin/ethinyl estradiol), alerting consumers that women aged 15-44 who use the patch may be at greater risk for life-threatening blood clots compared to women of the same age who take oral contraceptives. The boxed warning also informs users that cigarette smoking while using the patch puts them at greater risk for heart attacks. While the boxed warning regarding cigarette smoking and cardiovascular risk is consistent with the current labeling for other combination hormonal contraceptives, the boxed warning for blood ... Read More