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FDA Issues Stronger NSAIDs Warning

The FDA revised its warning and labeling recommendations for antiinflammatory drugs because of a greater understanding of the increased risks they pose for stroke and myocardial infarction...

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FDA Investigates MRI Safety after Studies Find GBCA Deposits in Brain

The FDA is investigating the safety of MRIs using gadolinium-based contrast agents, which recent studies have shown may leave deposits of those chemicals in patients’ brain tissue after multiple scans...

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High-Risk Medical Devices Backed by Few Studies

(Reuters Health)—Many high-risk therapeutic devices get U.S. Food and Drug Administration (FDA) approval with only one study proving their safety and efficacy before going to market. Studies of how the...

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GSK Shuts U.S. Plant Due to Bacteria

(Reuters)—Drugmaker GlaxoSmithKline temporarily closed a North Carolina factory on Tuesday after testing at a cooling tower found bacteria that causes deadly Legionnaire’s disease. The Legionella...

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Nuclear Medicine Exposures Up Health Risks for Radiology Techs

NEW YORK (Reuters Health)—Technologists working in nuclear medicine have a heightened risk for some cancers and myocardial infarction, according to a nationwide U.S. survey led by National Cancer...

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FDA Warns Makers of Superbug-Prone Scopes over Testing Violations

(Reuters)—Manufacturers of duodenoscopes linked to recent superbug outbreaks at U.S. hospitals skirted a host of testing, manufacturing and reporting requirements, the U.S. Food and Drug Administration...

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Regulatory Backlog in Emerging Nations Adding Years to Drug Approvals

BASEL (Reuters)—A regulatory backlog in developing countries including China has created wait times for drugs awaiting approval of up to seven years, Roche Holding AG Chief Executive Severin Schwan...

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U.S. Bans Another Indian Drug Plant over Production Quality

MUMBAI (Reuters)—The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country...

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FDA Issues Warning for Joint Pain from Diabetes Drugs

Severe and disabling joint pain has been connected to the use of dipeptidyl peptidase-4 inhibitors and combination therapies for diabetes, prompting a new FDA warning...

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FDA Issues Stronger Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Warning

The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due...

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Adverse Events More Common with Off-Label Drug Use

NEW YORK (Reuters Health)—Adverse drug events (ADEs) are more common when drugs are used off label, especially when the off-label use lacks strong scientific evidence, researchers from Canada report....

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RA Drugs Tested & FDA Orders Drug-Interaction Studies for Kayexalate

In multiple trials, baricitinib has proved promising for treating RA. Also, the FDA is requiring drug-interaction studies for sodium polystyrene sulfonate...

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WHO Warns of Widespread Misunderstanding of Superbug Threat

LONDON (Reuters)—People across the world are confused about the major threat to public health posed by drug-resistant superbugs and do not know how to stop that risk growing, the World Health...

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Drug Shortages in U.S. Emergency Departments on the Rise

(Reuters Health)—U.S. emergency rooms are increasingly running short on medications, including many that are needed for life-threatening conditions, a recent study documents. Since 2008, the number of...

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French ‘Cannabis’ Drug Trial Leaves 1 Brain Dead, 5 Injured

PARIS (Reuters)—One person has been left brain dead and five others are in a serious condition after taking part in a clinical trial in western France of an experimental medicine from an unnamed drug...

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FDA Approves New Drugs for Pain

FDA Updates Belbuca, buccal-administered buprenorphine, has received U.S. Food and Drug Administration (FDA) approval for treating severe chronic pain.1 The dosage form is a dissolving film that is...

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French ‘Cannabis’ Drug Trial Volunteer Dies

RENNES, France (Reuters)—A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated. The Rennes hospital said in a statement that five...

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CVS to Make Overdose Drug Naloxone Prescription-Free in Ohio

(Reuters)—CVS Health Corp said it would make naloxone, available without a prescription at all its pharmacies across Ohio, a state with one of the highest rates of overdose-related deaths. Naloxone is...

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No Cause Found Yet for Botched French Drug Trial

PARIS (Reuters)—An initial report into a drug trial in northwestern France that left one person dead and five others hospitalized last month did not identify the exact cause, French Health Minister...

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FDA Restricts Use of Systemic Fluoroquinolones Due to Side Effects & Will...

The FDA has issued new safety guidelines for systemic fluoroquinolones, restricting their use to patients with no alternative treatment options...

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