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Weekly Drug News Round Up - December 11, 2013

Sovaldi: Breakthrough Therapy Approved for Hepatitis C Virus

Sovaldi cost is $84,000 or $168,000 per 12- or 24-week treatment course, respectively, dependent upon HCV genotype Read More...

The U.S. Food and Drug Administration has approved Gilead’s Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first oral drug of a new paradigm of treatment that has demonstrated safety and efficacy, in combination with ribavirin, to treat certain genotypes of HCV infection without the need for co-administration of self-injectable interferon alfa. The use of interferon is often associated with intolerable side effects such as flu-like symptoms, anemia, and nausea. However, for genotype 4, interferon plus ribavirin will still be needed with Sovaldi. In November, the FDA also approved Olysio (simeprevir), a once-daily protease inhibitor for HCV.

Xiaflex Receives New Indication for Peyronie’s Disease

Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) Read More...

The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with curvature of the penis, a condition known as Peyronie’s disease. If the curvature causes pain or interferes with sex, treatment may be needed. Peyronie’s disease is caused by scar tissue that develops under the skin of the penis. Xiaflex is believed to work by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity. Treatment cycles involve Xiaflex injections into the collagen-containing structure of the penis and a penile modeling procedure to aid in straightening of the penis.

Acid Reflux Therapy Linked to Vitamin B-12 Deficiency

Stomach acid is helpful in the absorption of vitamin B-12 Read More...

Preliminary research from a large Kaiser Permanente study suggests that certain acid reflux drugs, such as proton pump inhibitors (PPIs) like Prilosec, Nexium and Prevacid and histamine-2 receptor antagonists (H2 blockers) like Tagamet, Pepcid and Zantac may lead to a vitamin B-12 deficiency. The risk of developing a vitamin B-12 deficiency was 65 percent higher for the long-term PPI users and 25 percent higher for those taking H2 blockers, according to the study. Vitamin B-12 is found naturally in meat, fish, poultry, eggs, milk and other dairy products and helps to keep blood and nerve cells healthy.

Smoking Cessation Products Not Dangerous for Heart: Study

The use of drug treatment to aid with smoking cessation significantly outweighs the potential risk of these therapies Read More...

There’s good news for smokers who are trying to quit: aids such as nicotine gums and patches or smoking cessation drugs such as Chantix or bupropion (Zyban) won't harm the heart. A research group from Stanford analyzed 63 studies to assess the heart-related effects of these treatments. Researchers found that there was no increased risk of serious heart events with these treatments alone, although an increased heart rate may occur if nicotine replacement therapies are used while the patient is still smoking. As a precaution, patients should still consult with their doctor about smoking cessation therapies, especially if they have chronic conditions like heart or lung disease.

Should You Still Worry About Vitamin D Levels?

The Institute of Medicine recommends 600 international units of vitamin D for adults, and 800 international units for people over 70 Read More...

Vitamin D has been linked with diseases ranging from cancer to diabetes. A new set of research now finds that low vitamin D levels are probably the result of a particular disease, not the other way around. In a review published in The Lancet Diabetes & Endocrinology, 290 observational studies and 172 randomized clinical trials (RCT) of vitamin D use were assessed. Observational studies showed a benefit with use of vitamin D in such diverse diseases as heart disease or colon cancer. But when researchers looked at the more robust randomized trials that used vitamin D as a treatment, they failed to find any effect on disease occurrence or severity from raising vitamin D levels.