The FDA is working with the World Health Organization and foreign regulatory authorities to support an investigation into the source of contaminated cough syrups that have killed more than 300 children in Africa and Asia.
Tag Archive for: patient safety
Datascope, a unit of Getinge, had recalled 4,454 therapeutic devices in December following a death and four serious injuries from their use.
Last week the FDA and CDC flagged a potential link between the Pfizer/BioNTech coronavirus vaccine and stroke in older adults; today Israel’s coronavirus task force said it reviewed all its data and did not find an issue.
A safety monitoring system flagged that U.S. drugmaker Pfizer Inc (PFE.N) and German partner BioNTech’s updated COVID-19 shot could be linked to a type of brain stroke in older adults, according to preliminary data analyzed by U.S. health authorities.
FDA issued warning letters to Olympus’ units pertaining to a category of devices known as endoscopes, citing violations at its facilities.
An ECRI report identifies reasons medications have been under-utilized and urges action to help combat America’s obesity epidemic.
A letter published Wednesday in the NEJM links a stroke patient’s death to lecanemab. Eisai investigators respond.
Philips said the latest tests indicated that exposure to particulate matter emissions from degraded foam in DreamStation devices was “unlikely to result in an appreciable harm to health in patients”, provided the machines had not been treated with ozone-based cleansing products.
A parliamentary committee said that India-based drug maker Maiden Pharmaceuticals Ltd was responsible for the deaths of at least 70 children from acute kidney injury and called on the government to pursue legal action.
Full data presented Tuesday afternoon from the Phase III Clarity AD trial show Eisai and Biogen’s lecanemab has a favorable safety profile in patients with Alzheimer’s disease.