Slipping through the drug safety net.

التفاصيل البيبلوغرافية
العنوان: Slipping through the drug safety net.
المؤلفون: Leipzig, Rosanne M.
المصدر: Focus on Healthy Aging; May2012, Vol. 15 Issue 5, p2-2, 2/3p
مصطلحات موضوعية: ANTICOAGULANTS, ACUTE coronary syndrome, MYOCARDIAL infarction risk factors, DRUG side effects, CLINICAL drug trials, DRUG approval, RANDOMIZED controlled trials, DISEASE risk factors
الشركة/الكيان: UNITED States. Food & Drug Administration
مستخلص: The article discusses a review associating the anticoagulant drug dabigatran with an increased risk of acute coronary syndrome and myocardial infarction (MI). It states that the finding comes even the drug had been approved by the U.S. Food and Drug Administration (FDA) only after extensive testing. It says that FDA approval means that in randomized controlled trials (RCTs), the drug's benefits outweighed its side effects.
قاعدة البيانات: Complementary Index