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...
View ArticleFDA 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...
View ArticleHigh-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...
View ArticleGSK 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...
View ArticleNuclear 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...
View ArticleFDA 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...
View ArticleRegulatory 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...
View ArticleU.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...
View ArticleFDA 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...
View ArticleFDA 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...
View ArticleAdverse 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....
View ArticleRA 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...
View ArticleWHO 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...
View ArticleDrug 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...
View ArticleFrench ‘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...
View ArticleFDA 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...
View ArticleFrench ‘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...
View ArticleCVS 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...
View ArticleNo 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...
View ArticleFDA 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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