Metamizole is in the safety spotlight again after the Spanish regulator said it was investigating reports of deaths and serious side-effects in expatriate and holidaymaking Britons caused by the painkiller.
The European Medicines Agency says it is keeping an eye on developments in Spain after the country's medicines agency, the AEMPS, confirmed that it is gathering information on adverse reaction reports with the painkiller and antipyretic metamizole, in light of reports that at least 10 Britons have died after taking the product in Spain.
Local Spanish news sources have been reporting cases of serious side-effects of metamizole, including agranulocytosis, and deaths in people from...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.
Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
