Safety warnings

European Medicines Agency announces first public hearing to gather evidence for valproate safety review

Members of the public are being invited to speak about their experiences of an epilepsy drug as part of a safety review by the European Medicines Agency (EMA).…

Cholesterol-lowering statin therapy for healthy people is not as simple as ‘yes’ or ‘no’

Recent reports of large trials extolling the virtues of statins have led many to believe that low-risk patients should take them, but an examination of the evidence provides food for thought.…

Q&A: Invest in safety and make savings overall — interview with Don Berwick

The author of the 2013 report which looked at patient safety in the NHS after the Mid Staffordshire Hospital scandal speaks to Jenny Bryan to share his thoughts on whether progress has been made.…

FDA insists on warning labels for OTC chlorhexidine products

The US Food and Drug Administration (FDA) has told manufacturers of over-the-counter antiseptic products that contain chlorhexidine gluconate to add warning labels to their products about the possibility of a serious but rare allergic reaction.…

Dangers with inappropriate use of long-acting beta agonists

Caution is required when prescribing or dispensing long-acting beta agonists to manage airways diseases, such as asthma.…

Diabetics told to check faulty ‘hypo’ kits

The UK medicines safety regulator has asked patients with diabetes to check whether they have certain batches of GlucaGen HypoKits after a fault was identified with the kits’ needles.…

FDA strengthens fluoroquinolone warnings

Revised warnings about the risks of being left permanently disabled after taking fluoroquinolone antibiotics have been added to products in the United States following a safety review by the Food and Drug Administration.…

Antibiotics should be prescribed during idelalisib treatment, concludes review

All patients given the cancer drug idelalisib (marketed as Zydelig) should be prescribed antibiotics during treatment and for two to six months after treatment has ended to prevent pneumonia, according to a new Europe-wide proposal.…

The development and safety of proton pump inhibitors

Since the discovery of omeprazole in 1979, dispensing of proton pump inhibitors (PPIs) in England has increased more than 100-fold, and several products are now available without prescription. Although PPIs are effective and generally well tolerated, observational studies suggest an association with…

Brain scans recommended for at-risk patients taking natalizumab

New measures to reduce the risk of a rare brain infection in multiple sclerosis patients who are prescribed natalizumab (Tysabri) are being recommended by the European Medicines Agency.…