FDA Alerts
FDA Compares Risks of Pradaxa and Warfarin
FDA research has taken a closer look at the risks of two medications commonly used to lower the risk for stroke and blood clots.
FDA Approves Rx to Lower Heart Attack and Stroke Risk
The FDA has approved a medication to lower various cardiovascular risks in certain high-risk patients.
FDA to Investigate Dangers of Testosterone Therapy
The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.
FDA Talks Safety of HeartStart Defibrillator
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.
Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death
ISSUE: The FDA is warning health care professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine).
FDA Approval Expands Access to Artificial Heart Valve for Inoperable Patients
The US Food and Drug Administration today approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart.
FDA Approves Label Changes to Blood Pressure Medicine Olmesartan Medoxomil
The US Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.
FDA Approves First Nimodipine Oral Solution, Nymalize
On May 10, the US Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage).
FDA Issues Proposal to Improve the Quality of Automated External Defibrillators
The US Food and Drug Administration today issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs).
Azithromycin (Zithromax or Zmax) and the Risk of Potentially Fatal Heart Rhythms
The US Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.