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Weekly Drug News Round Up - December 12, 2012

Drug Safety Communication: Update on Chantix Heart Effects

Chantix is used to help adults quit smoking by blocking the effects of nicotine on the brain Read More...

In a combined analysis (meta-analysis), the use of the smoking cessation agent Chantix (varenicline) has been associated with a higher, but not statistically significant, occurrence of major cardiovascular (heart) side effects compared to placebo. Side effects included a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke. The cardiovascular side effects were reported as uncommon in both the Chantix and placebo groups, and researchers cannot say if the risk seen in the Chantix group was due to use of the drug or simply due to chance. FDA first notified the public about a possible increased risk of cardiovascular side effects with Chantix in a June 2011 Drug Safety Communication.

Heparin Container Labels Will List Total Strength More Clearly

Changes will eliminate the need for providers to calculate the total amount of heparin in containers greater than one milliliter Read More...

Heparin is a blood thinner used to prevent blood clot formation in conditions such as atrial fibrillation, myocardial infarction, and deep vein thrombosis. The FDA has issued a Drug Safety Communication detailing a change for container and carton labels of heparin. Manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP will be required to clearly state both the strength of the entire heparin container and how much is in one milliliter (mL). There will be a transition period before and after the implementation date on May 1, 2013, during which both the current and revised labels will be available.

Zytiga Gains Expanded Use for Late-Stage Prostate Cancer

Zytiga decreases the production of the male sex hormone testosterone Read More...

The U.S. Food and Drug Administration (FDA) has approved an expanded indication for Zytiga (abiraterone acetate) - for treatment of men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving docetaxel (chemotherapy). Patients who received Zytiga had a median overall survival of 35.3 months compared with 30.1 months for those receiving the placebo. Zytiga targets the cytochrome P450 17A1 protein and decreases the production of testosterone that stimulates cancer cell growth. In April 2011, Zytiga was originally approved in combination with prednisone to treat patients with late-stage castration-resistant prostate cancer who had already received docetaxel.

Avastin Not Shown Effective in Earlier Stages of Colon Cancer

Researchers from the U. of Florida show that Avastin adjuvant treatment in earlier stage colon cancer does not extend survival Read More...

The study, published in the Journal of Clinical Oncology, included 2,673 patients who had undergone surgery for stage 2 or 3 colon cancer -- meaning the tumor was either confined to the colon or had spread no farther than the lymph nodes. Patients received either six months of standard chemotherapy alone, or six months of standard chemotherapy plus one year of Avastin (bevacizumab). Researchers found the addition of costly Avastin made no difference in survival: about three-quarters of patients in each group were in remission after three years, and roughly 80 percent in each group were still alive after five years.

Weight May Impact Effectiveness of Blood Pressure Treatment

Controversy heats up over the use of diuretics for hypertension in obese, overweight or normal weight patients Read More...

A new study published in the The Lancet suggests that a patient's weight --whether lean or obese -- can alter the effectiveness of diuretics for high blood pressure. Researchers evaluated over 11,000 patients in a trial that compared treatment with a diuretic plus an ACE inhibitor Lotensin (benazepril), to a regimen of Lotensin plus the calcium channel blocker Norvasc (amlodipine). Among obese people, both drug regimens worked well with no significant differences. Normal-weight people in the diuretic group did the worst, and were 68 percent more likely to have a heart attack, stroke or die than obese patients taking a diuretic.