Pediatric study deaths called into question
The All India Institute of Medical Sciences (AIIMS) has reported 49 infants have died in clinical trials over the past two and a half years, but denies these were caused by investigational drugs, according to FDAnews.
The All India Institute of Medical Sciences (AIIMS) has reported 49 infants have died in clinical trials over the past two and a half years, but denies these were caused by investigational drugs, according to FDAnews.
The institute's Department of Pediatrics reportedly enrolled a total of 4,142 subjects since 2006, of whom 2,728 were younger than 12 months. The institute claims the deaths occurred due to pre-existing disease causes, although an Indian nongovernmental organization is calling for an investigation to gain further information about the trials.
The full FDAnews report can be found here.
Major congenital malformations not linked to first trimester tetracycline use
November 22nd 2024A large population-based study found that first-trimester tetracycline exposure does not elevate the risk of major congenital malformations, though specific risks for nervous system and eye anomalies warrant further research.
