Post Tagged with: "FDA"

FDA Explores Invokana Increasing the Risk for Amputation?

FDA Explores Invokana Increasing the Risk for Amputation?

The FDA has issued a recent safety communication warning the public of the famous diabetes medicine canagliflozin. The safety issue was in relation to an ongoing  interim clinical trial that found an increase in leg and foot amputations that mostly affects the toes, in patients treated with the diabetes canagliflozin. The study also known as Canagliflozin Cardiovascular Assessment Study (CANVAS) revealed […]

Risperdal Gynecomastia Latest Lawsuit A Loss for J&J

Risperdal Gynecomastia Latest Lawsuit A Loss for J&J

The number of lawsuits filed against the long time corporate giant Johnson & Johnson continue to grow. Risperdal, an atypical anti-psychotic drug developed by Johnson & Johnson in an effort to combat the symptoms associated with the mental health disorders such as schizophrenia, bipolar disorder and in some cases autism in children is currently under scrutiny. The reported gynecomastia side effect […]

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FDA Advised to Scrap Approval Process for Medical Devices

FDA Advised to Scrap Approval Process for Medical Devices

In a report initially commissioned by the Food and Drug Administration, a 12 member panel of medical experts from the Institute of Medicine has recommended the U.S. government retire the 35-year-old system currently used to approve medical devices because it provides little or no assurance of safety for patients. The FDA was originally given responsibility for medical devices in 1976, […]

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FDA Proposes Regulating Mobile Health “Apps”

FDA Proposes Regulating Mobile Health “Apps”

It is estimated that there are currently more than 17,000 medical applications available for a Smart-phone, tablet computer or personal digital assistant. These apps can range from calorie counters to programs that let doctors view medical scans on their phones. The FDA is proposing to regulate some of those applications, specifically any app that helps to diagnose, treat or prevent […]

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Stop-smoking pill Chantix linked to heart problems

Stop-smoking pill Chantix linked to heart problems

 A new  international study, led by researchers at Johns Hopkins University has  found the drug Chantix increased the risk of hospitalizations for heart problems by  72 percent. The study, analyzed 14 Pfizer-sponsored drug trials with 8,216 patients and found about one new heart attack or similar disorder for every 400 patients taking Chantix. In all, of the 4,908 people taking  […]

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