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Weekly Drug News Round Up - November 27, 2013

Janssen’s Olysio Approved to Treat Hepatitis C Virus

Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells Read More...

The U.S. Food and Drug Administration has approved Olysio (simeprevir) for hepatitis C virus (HCV) genotype 1 infected adults with compensated liver disease, including cirrhosis. Olysio is a once-a-day, 150-milligram oral dose, given for 12 weeks, used in combination with peginterferon and ribavirin (PR). Peginterferon and ribavirin are dosed for 24 or 48 weeks based on prior treatment and history. Olysio plus PR effectiveness is reduced in patients with genotype 1a Q80K - testing is available for this genotype and alternate therapies may be needed.

Avandia REMS Program Modified for Heart Risks

Providers will receive manufacturer-sponsored Avandia training based on current label and knowledge of heart risks Read More...

The U.S. Food and Drug Administration (FDA) is updating rosiglitazone labeling to reflect new information concerning heart risks. FDA has determined that rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. The rosiglitazone REMS program requirements will be modified. Providers, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines. The reuptake of rosiglitazone into the U.S. market is questionable as Actos (pioglitazone) is available generically.

Nexavar: New Use for Late-Stage Differentiated Thyroid Cancer

Differentiated thyroid cancer is the most common type of thyroid cancer Read More...

The U.S. Food and Drug Administration (FDA) has expanded the approved uses of Bayer’s Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer. The National Cancer Institute estimates that 60,220 Americans will be diagnosed and 1,850 will die from this disease in 2013. The drug’s new use is intended for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive iodine treatment. In clinical trials, half of patients receiving Nexavar lived without cancer progression for at least 10.8 months compared to at least 5.8 months for participants receiving a placebo.

Avian Flu Vaccine Approved to Avert H5N1 Pandemic

Bird flu has caused serious illness and death in people outside of the U.S., mainly among those in close contact with infected poultry Read More...

Avian Flu occurs when people become infected with H5N1, and about 60 percent die, according to the World Health Organization. The U.S. Food and Drug Administration has approved Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, the first adjuvant vaccine for the prevention of Avian (bird) flu. Avian influenza is a bird infection caused by H5N1 and has pandemic potential because it continues to infect wild birds with outbreaks of influenza in poultry. Most humans have no immunity to H5N1. The H5N1 avian influenza vaccine will not be sold commercially but will be included within the National Stockpile for distribution by public health officials if needed.

Effectiveness of Emergency Contraceptive Questioned in Heavier Women

The FDA is reviewing studies to determine if label changes are needed in the U.S. Read More...

Norlevo, an emergency contraceptive sold in Europe, is identical in formula to the Plan B One-Step (levonorgestrel) emergency contraceptive pills sold in the U.S. A new warning on the European Norlevo label will caution that the pill starts to lose effectiveness in women heavier than 165 lbs. (75 kg), and is not effective in women who weigh more than 176 lbs. (80 kg). Similar warnings do not currently exist for the OTC Plan B One Step made by Teva Pharmaceuticals. Women in these weight ranges should consider discussing the effectiveness of levonorgestrel emergency contraception with their provider to determine if an alternate method may be more reliable.