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Weekly Drug News Round Up - June 12, 2013

Belviq Launched in U.S. to Help Curb Weight Gain

Launch was delayed almost one year while the DEA assigned Belviq to schedule IV of the Controlled Substance Act Read More...

Arena Pharmaceutical’s Belviq (lorcaserin) is now available in U.S. pharmacies after a June 11th launch. Belviq helps people to feel more full after eating less by occupying the serotonin 2C receptor in the brain. Belviq, like all weight-loss drugs, should be used as a component of a long-term treatment plan that includes a healthy diet and regular exercise. The drug is used for long-term weight control in either obese (body-mass index, or BMI, of 30 or higher) or overweight (BMI of at least 27) patients with at least one weight-related condition, such as type 2 diabetes, high blood pressure, or high cholesterol.

Obama Administration Reverses Decision on Emergency Contraception

Research shows that oral emergency contraceptives have the potential to lower the rate of unintended pregnancies in the U.S. Read More...

The U.S. government is no longer trying to block a court order to allow over-the-counter (OTC) availability of the morning-after contraceptive pill to all women and girls. Plan B One Step prevents implantation of a fertilized egg in a woman's uterus through the use of levonorgestrel, a progestin used for decades in birth control pills. Other brands of emergency contraception include Next Choice and Ella (ulipristal). Ella is only available with a prescription. Studies have shown that women 15 years of age and older can understand how to safely use Plan B One Step.

Sanofi’s Fluzone Quadrivalent Vaccine FDA-Approved

The 2013 influenza season will be the first in which quadrivalent influenza vaccines will be available in the U.S Read More...

Sanofi Pasteur’s four-strain influenza vaccine, Fluzone Quadrivalent vaccine has been approved for use in children six months of age and older, adolescents, and adults. Fluzone Quadrivalent vaccine includes two A strains and two B strains to help protect against flu. Previously, all seasonal flu vaccines only contained one B strain. In recent years, up to 44 percent of influenza-associated deaths in children and adolescents 18 years of age and younger were due to influenza B. Fluzone Quadrivalent vaccine will be available to healthcare providers in the U.S. for the 2013-2014 influenza season in prefilled syringes and single-dose vials for intramuscular administration.

Revlimid: New Indication for Relapsed or Refractory Mantle Cell Lymphoma

Revlimid is the first oral therapy for relapsed or refractory Mantle Cell Lymphoma Read More...

Celgene Corporation’s Revlimid (lenalidomide) has received FDA-approval for a new indication for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (Velcade). In a Phase II trial in 134 patients with MCL, the overall response rate was 26 percent, a complete response rate was 7 percent, and the median duration of response was 16.6 months. Revlimid is an analogue of thalidomide, is contraindicated in pregnancy, and if used during pregnancy may cause birth defects or embryo-fetal death. Revlimid can also cause significant neutropenia and thrombocytopenia. It is only available through a restricted distribution program called Revlimid REMS.

Avandia: FDA Advisory Panel Votes to Lighten Safety Limits

Restrictions on Avandia availability were instituted in 2010 due to a concern for heart attack as a side effect of the drug Read More...

The majority of a Food and Drug Administration (FDA) Advisory Panel have voted to ease the restrictions on the type 2 diabetes drug Avandia (rosiglitazone) due to elevated heart risks. The majority of members voted to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program, while the remaining voted to continue the REMS (5) or withdraw (1) Avandia from the US market. Panelists noted an independent reexamination of the open-label RECORD study by Duke Clinical Research Institute (DCRI) increased their confidence that the RECORD trial was reliable and that the risks of death or heart attack with Avandia were less than previously thought.