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Weekly Drug News Round Up - December 5, 2012

Budeprion XL 300 Milligram Pulled From the Market

The 150-mg tablets of Budeprion XL are not affected by this decision Read More…

As reported in the New England Journal of Medicine this week, a lack of bioequivalence with the extended release (XL) form of bupropion -- Budeprion XL -- at the 300 milligram (mg) dose suggests that this generic form of Wellbutrin may not be safe and effective. At this time the lack of bioequivalence applies to only the Impax/Teva product because of its unique formulation, but the FDA is requesting that the other four manufacturers submit bioequivalence data by March 2013. Patients who are concerned about their version of bupropion should check with their physician and not stop taking their medicine.

Cometriq Approved for Rare Form of Thyroid Cancer

Cometriq is an orphan drug - designated for treatment of a rare diseases occurring in less than 200,000 people in the U.S. Read More...

Cometriq (cabozantinib) is a kinase inhibitor approved for the treatment of patients with progressive medullary thyroid cancer that has spread to other parts of the body. Cometriq received priority review at the U.S. Food and Drug Administration (FDA) and is a designated as an orphan drug. In a clinical study of 330 patients, the group that received Cometriq lived roughly 11 months without tumor growth compared to four months in the placebo group. Reductions in tumor size lasting an average of 15 months were also seen in the Cometriq group; however, treatment with Cometriq did not extend patients’ lives. Caprelsa (vandetanib) was also approved in April of 2011 for treatment of this rare disease.

Popular Diabetes Drug May Offer Hope to Women with Ovarian Cancer

Additional studies are required to determine if metformin should be used regularly in nondiabetic patients with ovarian cancer Read More...

A common and inexpensive oral diabetes treatment - metformin (Glucophage) - may have a survival effect in the treatment of ovarian cancer. In a retrospective study published in Cancer, Mayo Clinic researchers reported that 67 percent of women using metformin at their cancer diagnosis had not died within five years, while only 47 percent of those not on the drug had survived that long. Overall, patients taking metformin were 3.7 times more likely to survive throughout the study. Scientists are not sure why metformin has an effect in cancer, but speculate lowering blood sugar levels and boosting insulin sensitivity, two factors linked with cancer growth, may be at play.

High Dose of Intravenous Ondansetron (Zofran) Withdrawn From Market

FDA continues to recommend weight-based dosing and oral ondansetron for prevention of chemotherapy-induced nausea and vomiting Read More...

Zofran (ondansetron) is approved to prevent chemotherapy-induced and postoperative nausea and vomiting. FDA is notifying healthcare professionals that the 32 milligram (mg), single intravenous (IV) dose of ondansetron hydrochloride, used to prevent chemotherapy-induced nausea and vomiting, will no longer be marketed because of the potential for serious cardiac risks, including a potentially fatal heart rhythm known as torsades de pointes. FDA does not anticipate that removal of the 32 mg IV dose currently sold as a pre-mixed solution will contribute to a drug shortage of IV ondansetron, as the 32 mg dose makes up a small percentage of use.

CDC Warns That Flu Season Is Early and Could Be Severe

Each year, roughly 200,000 Americans will be hospitalized with the flu, and as many as 40,000 will die from its complications Read More...

The U.S. Centers for Disease Control and Prevention (CDC) is reporting the 2012-2013 flu season is underway with peak flu hitting in February. The predominant circulating flu strain, influenza A H3N2, may be particularly virulent, according to the CDC. Experts suggest that now is the time to get the flu vaccine if you have not received one yet for this season. Five states hit hard already with flu cases include: Alabama, Louisiana, Mississippi, Tennessee and Texas. Georgia and Missouri are also seeing moderately high levels of flu. The current 2012-2013 vaccine covers the circulating flu strains well, and there is no shortage this year.