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News » 2.3.million adverse drug events reported to FDA over 33 years
 

2.3.million adverse drug events reported to FDA over 33 years

From 1969-2002, about 2.3 million (1.8 million from the US) cases of adverse drug events were reported to the FDA and reviewed. 53% of the cases occurred in females, 5% occurred in patients 14 years and under, 24% in 15 to 44 year olds, 16% in 45 to 59 year olds and 25% in those 60 years and over. The five most common adverse drug events reported were ineffective drug, nonspecific dermatitis, headache, nausea and nonspecific pruritus. The five most commonly reported adverse events were pyrexia, nonspecific dyspnea, vomiting, hypertension and worsening of condition. Safety problems have resulted in the removal of 75 drug products and from 1990 to 2002, 11 drugs needed additional precautions prior to prescription.

Source: summary of medical news story as reported by Adverse drug event surveillance and drug withdrawals in the US, 1969-2002. Archives of Internal Medicine. 2005;165:1363-1369.

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About: 2.3.million adverse drug events reported to FDA over 33 years

Date: 2005

Source: Adverse drug event surveillance and drug withdrawals in the US, 1969-2002. Archives of Internal Medicine. 2005;165:1363-1369.

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