drug safety News

Kenya and Nigeria Recall J&J Children’s Cough Syrup Over Suspected Toxicity

Kenya’s drug regulator is recalling a batch of Johnson & Johnson children’s cough syrup, it said on Thursday, a day after Nigeria recalled the same batch of medication under the Benylin Paediatric brand. Nigeria’s health regulator said laboratory tests on …

When Children Take Toxic Cough Syrup, and Live…

Devouring books from a young age, Sheena Almaera Maryam had been excited about her first day of kindergarten near Jakarta. But when she developed a fever in September 2022, the syrup she was prescribed turned out to be toxic. It …

Indonesian Court Papers Reveal Chain of Events That Led to Cough Syrup Deaths

Indonesian court documents have revealed for the first time the chain of events that led to toxic ingredients being used in cough syrup that was among the products blamed for the deaths of more than 200 children in the country …

Deadly Indonesian Cough Syrup Was Almost Pure Toxin, Prosecutors Say in Court Filing

An Indonesian drugmaker whose cough syrup is among products linked to the deaths of more than 200 children last year used ingredients with toxin concentrations of up to 99% in 70 batches of medicine, prosecutors said in a court filing. …

Cough Syrup Deaths Overseas Prompt US Crackdown on Toxic Testing

The U.S. FDA is cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups, a Reuters review of regulatory alerts found. The Food and Drug Administration has reprimanded …

U.S. Drug Regulator Vows Outside Review of Any COVID-19 Vaccines

The United States will need to have independent experts review COVID-19 vaccine candidates before approval, the country’s top drug regulator said on Friday, offering reassurance that his agency would not cut corners in the race to roll out a vaccine. …

FDA Vows Tougher Testing as More Manufacturers Outsource

U.S. regulators plan to revamp rules governing how medicines are manufactured, in an effort to ensure the safety of the nation’s drug supply as recalls of contaminated imports from developing countries widen. “We’ve seen a lot of instances of adulterated …

Tennessee Tightens Regulations on Compounding Pharmacies

The Tennessee Board of Pharmacy said it has adopted new regulations for compounding pharmacies licensed by the state following recent outbreaks of illnesses associated with tainted medicines created at these specialty pharmacies. The Pharmacy Board said in a news release …

Regulators Urged to Monitor Safety Throughout Drug’s Lifecycle

The U.S. Food and Drug Administration should review drugs on a regular basis for as long as they are on the market in order to catch any new safety issues, according to a report from an independent research body. The …