Tagged Articles

Qsiva 3 articles

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

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