Tagged Articles

Qsymia 13 articles

FDA approves new diet pill Contrave

A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence. Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 ... Read More

FDA delays decision on diet pill based on heart risk evaluation

The Food and Drug Administration (FDA) has delayed its decision by three months on the new diet pill contrave in order to reach an agreement with drug company Orexigen Therapeutics regarding post-marketing obligations related to the evaluation of cardiovascular risks associated with the drug. Orexigen and the FDA are currently in talks about the package insert and other post-marketing requirements. The FDA had rejected the drug in 2011, saying it needed more studies to put to rest concerns about heart risks. Orexigen came back nearly three years later with an analysis involving 8,900 patients showing patients taking contrave did not ... Read More

Type 2 diabetes drug Victoza tested as potential diet drug

The type 2 diabetes drug Victoza (liraglutide) can help overweight and obese people without diabetes lose weight, according to a new multinational clinical trial, but the drug comes with some risks. Victoza, an injectable drug in a class of diabetes medications known as glucagonlike peptide-1 (GLP-1) agonist, was approved by the Food and Drug Administration (FDA) in January 2010 to help lower blood sugar levels in people with type 2 diabetes. In an effort to expand the indication to non-diabetics who are overweight, the medication was pitted against a placebo and the currently marketed anti-obesity drug Qsymia, a combination of ... Read More

Johnson and Johnson, Janssen settle dozens of Topamax birth defects lawsuits

Johnson & Johnson and its subsidiary Janssen Pharmaceuticals have agreed to settle 76 lawsuits in Pennsylvania court over allegations that its anti-seizure and migraine drug Topamax caused birth defects in babies born to women who used the drug during pregnancy. News of the settlement comes a month after a Philadelphia County jury awarded $3 million in damages to the family of a 5-year-old who claimed the companies did not update the safety label of Topamax to reflect data that showed the drug increased the risk of cleft lip and cleft palate in newborn babies. Johnson & Johnson and Janssen also ... Read More

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

Diet pill Qsymia may reduce risk of type 2 diabetes in obese patients

Obese patients who took the new weight loss drug Qsymia were more than 70 percent less likely to develop type 2 diabetes compared to patients who were taking a placebo, according to a late-stage clinical trial. Type 2 diabetes is a chronic condition in which the body does not produce any or enough insulin, causing unstable blood sugar levels. Being overweight significantly increases the risk of developing the disease. Qsymia was approved last year and became the first weight loss pill to be approved for sale in the United States in 13 years. The drug is intended for people with a ... Read More

European drug advisors reject Qsiva (Qsymia) diet drug based on safety concerns

Advisors for the European Union’s health agency has again recommended against approving the new weight loss drug Qsiva, made by Vivus Inc. The Committee for Medicinal Products for Human Use raised concerns about the cardiovascular safety of the drug, saying it would need more data proving its safety before it would reconsider its rejection. Qsiva is a combination of two FDA-approved drugs – phentermine, an appetite suppressant, and topiramate, used to treat epilepsy and migraines. Phentermine was part of the fen-phen diet drug cocktail that was popular in the 1990s, but was pulled from the market after studies showed the ... Read More

European regulators skeptical about new prescription diet pills

European drug regulators are leery about approving the new weight loss drug Belviq because of safety concerns, including heart valve problems and psychiatric side effects in patients, and tumors observed during studies on lab rats. Belviq is currently under review by an advisory panel for the European Medicines Agency (EMA), which is expected to make a recommendation for the EMA by March whether to approve the drug. Arena Pharmaceuticals, the drug’s maker, has been working with the agency to answer questions and clear up any matters that stand in the way of approval. But its chances may be slim. The ... Read More

Drug company wants to speed review process for new diet drug Contrave

Orexigen Therapeutics Inc. is hoping the Food and Drug Administration (FDA) will grant its request to speed up the review process for its obesity drug Contrave. The agency rejected the weight loss drug in February 2011, saying it needed data from a large-scale study on the long-term cardiovascular effects associated with the medication before approval would be granted. Contrave is a combination of two medications already approved by the FDA – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in order to decrease food intake over ... Read More

New diet drug Qsymia may be rejected by European drug regulators

Qsymia, first diet drug to be approved in 13 years by the U.S. Food and Drug Administration (FDA), may not get clearance from the European Medicines Agency because of the potential for heart problems. A European Union advisory panel is expected to rule on the weight loss treatment sometime next month, but the drug’s maker Vivus Inc. says it has been getting some cold vibes from the group. If rejected, Vivus says it will file a new marketing application or appeal the decision. Vivus wants to market Qsymia in Europe under the name Qsiva. This summer, the FDA approved Qsymia ... Read More