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Weekly News Round Up - December 7, 2011

FDA Drug Safety Communication: Review of Pradaxa Serious Bleeding Events

Patients with atrial fibrillation should not stop Pradaxa without talking to their healthcare provider due to stroke risk Read More...

The Food and Drug Administration is evaluating post-marketing reports of serious bleeding events with the anticoagulant dabigatran etexilate mesylate (Pradaxa). Pradaxa is approved for clot and stroke prevention in non-valvular atrial fibrillation. Bleeding is a well-known complication of all anticoagulant therapies. However, the FDA is reviewing new reports to determine if the incidence of bleeding is higher than expected. At this time, FDA believes that Pradaxa provides an important health benefit and health care providers should follow approved package labeling. Patients should not stop taking Pradaxa without talking to their healthcare provider. The FDA will communicate additional Pradaxa safety information as it becomes available.

FDA Warning: Over-the-Counter HCG is Illegal

Unapproved human chorionic gonadotropin (HCG) sold illegally as OTC weight loss product; claims are unsupported Read More...

Weight loss can weigh heavily on your mind this time of year, with upcoming New Year’s resolutions. But dieting should be gradual, sensible and safe. The Food and Drug Administration (FDA) has issued seven letters to companies illegally selling over-the-counter (OTC) homeopathic human chorionic gonadotropin (HCG) as weight loss products. These products are marketed as oral drops, sprays, and pellets. Users are often directed to follow a potentially dangerous, 500-calorie per day diet in addition to the HCG. FDA advises consumers who have purchased homeopathic HCG for weight loss to stop using it, throw it out, and stop following the calorie-restrictive diet. Prescription HCG is FDA-approved for female infertility and other conditions, but weight-loss claims for OTC HCG are unsupported.

National Influenza Vaccination Week: It’s Not Too Late

Health experts urge Americans to get flu vaccine before supply shortens; flu shot recommended for everyone six months and over Read More...

The statistics are grim: each year up to 20 percent of the population may get the flu, and over 200,000 may be hospitalized. While current influenza activity has been light in the U.S., the flu typically peaks in January and February. And it takes about two weeks after vaccination for full immunity to kick in, so now is a good time to get the vaccine. The flu vaccine is especially important for health care workers, young children, pregnant women, seniors and those with chronic illnesses, such as asthma, diabetes, and heart or lung disease. Authorities suggest acting now, while vaccine supplies are still ample and flu activity is low.

Cancer Makes Strides with Targeted Drugs, Lung CT Scans in 2011

Targeted drug therapy and lung cancer screening top advances in cancer therapy, diagnosis Read More...

It’s always good to reflect on significant news at the year’s end, especially when significant advances in cancer care top the headline. Leading oncologists, looking at major impacts in cancer care in 2011, have selected several finalists. Targeted drug therapies, such as the newly approved melanoma agents vemurafenib (Zelboraf) and ipilimumab (Yervoy), and the non-small-cell lung cancer drug crizotinib (Xalkori) top the list. In addition, convincing evidence now exists that exemestane (Aromasin) is an option to reduce the threat of breast cancer in high-risk postmenopausal women. A top breakthrough for lung cancer screening, computed tomography (CT) has been shown to outperform regular chest X-rays and significantly reduce the risk of death.

Opioid Prescribing Climbs for Chronic Stomach Pain

Opioid use for chronic stomach pain may increase risk for worsening symptoms due to drug side effects Read More...

Although the number of outpatient visits for chronic stomach pain decreased by 2.6 million in 2006-2008 compared to 1997-1999, prescriptions for opioids increased by 6.3 percent, according to a new study published in Clinical Gastroenterology and Hepatology. Experts state evidence is limited in support of opioid use for non-cancer chronic stomach pain. Opioid side effects, such as nausea, vomiting and constipation may worsen the stomach pain condition. According to the American College of Gastroenterology, stomach pain due to an identifiable cause should be treated. For chronic stomach pain not due to an identifiable cause, low doses of pain-modifying drugs such as amitriptyline or trazodone may be effective options.