Tag Archives: fda safety review

FDA Safety Warning For Multaq, A Heart Rhythm Drug

According to news sources , the drug Multaq is getting a new safety warning after a study found increased risks of heart attack, stroke and death associated with the drug with a subset of patients that took part in the study. The heart rhythm drug controls the heart’s chambers by allowing them to pump in sync for patients with atrial fibrillation. The new warning would allow the drug to remain on the market but would stress to doctors and patients that it be used only for treatment of the short-term variant of the condition Continue reading

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Ephedrine Dietary Supplements Seized By U.S Marshals

According to news sources , raw materials for dietary supplements containing ephedrine alkaloids have been seized by U.S Marshals directed by the Food and Drug Administration in an attempt to reign in on the banned material. The seizure of the raw materials imported by Infinity Marketing Group, Inc Continue reading

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Children Mechanical Cardiac Assist Device Approved By FDA

According to news sources , the Food and Drug Administration has recently approved a medical device to help children suffering from heart failure that will reportedly to stay alive while a heart transplant donor can be found. The device us called EXCOR Pediatric System and was developed by Berlin Heart for the purpose of fitting the different sizes of children, from newborns to teenagers. The average waiting time for a donor heart in the U.S is about 119 days due to the limited amount of pediatric sized donor hearts available usually available. Continue reading

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FDA Takes Closer Look At Arsenic Levels In Juice

According to news sources , the Food and Drug Administration is taking a closer look at the arsenic levels found in juices and juice concentrates to ensure compliance with existing safety standards. The FDA has been monitoring the levels of arsenic found in juices sold nationwide for more than 20 years and is currently taking additional steps to ensure the safety of the public’s health. Continue reading

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Clinical Trials Show Pradaxa Drug Safety Concerns

According to news sources , safety concerns regarding the drug Pradaxa have led The Food and Drug Administration to caution healthcare providers about the safety of the drug after a large scale clinical trial found “serious bleeding events” related to the drug. The FDA is currently in the process of attempting to identify if the drug causes more bleeding than what has commonly been expected. In a clinical trial including 18,000 patients found that those who took Pradaxa and warfarin experienced similar rates of major bleeding with both drugs, an FDA report said Continue reading

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