FDA review on Wednesday June 13: New Diet Drug and Suicidal Thoughts
From "Sham vs. Wham: The Health Insider" (Google for original text)
Here we go again . . . You'll recall how suicidal thoughts have been a problem on anti-depressant drugs in the last several years, especially when given to teens. Well, today a Food and Drug Administration advisory panel is considering whether regulators should approve US sales of an obesity drug that has had patients in clinical trials reporting suicidal thoughts or actions. This sounds to me to be a test of whether the Food and Drug Administration truly has the population in mind -- or, the drug company profits. As a diet drug, the FDA said a 20-milligram dose of the drug, Zimulti (rimonabant), produced clinically significant weight loss over one year. Along with a low-calorie diet, the drug "was shown to reduce body weight by approximately 5% relative to diet alone during trials of more than 6000 moderately overweight and obese subjects. Psychiatric problems represent the most common and worrisome rimonabant-induced adverse events, the reviewers stated. Depression was roughly twice as high for rimonabant patients compared with others who received a placebo. Let's see what happens. Will drug company profits come first, or the safety of the USA population? A new diet pill represents potential BILLIONS in sales. D. |
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