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Weekly Drug News Round Up - November 21, 2012

Promacta Approved for Treatment of Thrombocytopenia in HCV

Roughly 3 to 4 million Americans are infected with chronic hepatitis C virus Read More...

Chronic hepatitis C viral infection (HCV) is the most common blood-borne infection in the U.S. The U.S. Food and Drug Administration (FDA) has approved Promacta (eltrombopag) for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. Promacta in combination with interferon-based therapy used in HCV can improve a patient's chance of achieving a sustained virologic response or viral cure. The approval of Promacta is based on results from the ENABLE 1 and 2 clinical trials in which over 1,500 patients also received either peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (Pegintron) plus ribavirin.

Zilver PTX Drug-Eluting Peripheral Stent FDA-Approved

Stent should not be used in women who are pregnant, breast-feeding or plan to become pregnant in the next five years Read More...

The first drug-eluting stent to treat blockages in a peripheral artery has been FDA-approved. Zilver PTX Drug-Eluting Peripheral Stent is indicated to treat peripheral arterial disease in the superficial femoral artery found in the thigh. The stent is inserted into the artery and expands like a scaffold to keep the artery open. The drug paclitaxel (Taxol) coats the stent and is taken up by the cells of the arterial wall to help prevent the renarrowing of the artery over time. In a clinical trial of 479 patients, 83 percent of narrowed arteries remained open after one year, compared to 33 percent in the control group.

Heart Risks Elevated with Herceptin Use in Older Women

Women with breast cancer should talk to their oncologists to weigh Herceptin benefits against risks Read More...

Herceptin (trastuzumab) treatment has previously been associated with a risk of heart failure and cardiomyopathy in women fighting breast cancer, even though it improves disease-free and overall survival. New research, published in the Journal of the American College of Cardiology, now shows that women aged 67 and older may be at an even greater risk. Studies in more than 45,000 older women with early-stage breast cancer showed that for every 100 patients, 32 of those on Herceptin and 42 of those on Herceptin and anthracycline developed cardiac problems by the three-year mark, compared to 19 of every 100 patients who did not get adjuvant therapy.

Ambien Increases Risk of Falling in Hospital

Decreasing hospital patient falls is a target for the U.S. Department of Health and Human Services Read More...

A commonly used drug for sleep greatly increases a hospital patients' risk of falling. Researchers from Mayo Clinic reviewed data on over 16,000 patients taking Ambien (zolpidem) and found the fall rate to be four times higher (3 percent) compared to those who did not use Ambien (0.7 percent). Researchers calculated that for every 55 patients who received Ambien, there was one extra fall that might has been averted if the drug has not been given. Based on the research, health administrators at Mayo Clinic have decided to phase out Ambien use and move toward sleep enhancement techniques not based on drugs.

Compounding Pharmacists Lobby Against Federal Oversight

Some members of Congress are calling for greater FDA regulation in response to the meningitis outbreak Read More...

The investigation continues into the New England Compounding Center (NECC) which is responsible for the mold-contaminated methylprednisolone corticosteroid injections that have resulted in at least 490 infections, including 34 deaths due to fungal meningitis. The head of the International Academy of Compounding Pharmacists testified on Thursday to the U.S. Senate that existing state regulations are adequate to monitor compounding pharmacies. In addition, according to the U.S. Food and Drug Administration (FDA), new federal laws and more government funding will be required for the FDA to monitor specialty compounding pharmacies which are not subject to federal oversight.

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