REPORTS of at an alarming rate. Serious consequences, such as a reaction that threatened a patient鈥檚 life or caused a disability, were 2.6 times more frequent in 2005 than in 1998, while deaths increased by 2.7 times, from 5519 in 1998 to 15,107 in 2005, say researchers who examined data collected by the US Food and Drug Administration (FDA). By some estimates, UK figures are even worse (see 鈥淲hy we must listen to patients鈥�).
The results are worrying, but the range of possible explanations makes it hard to pinpoint a cause. Despite the hundreds of millions of dollars that are spent getting a drug to market, the system for monitoring drug safety after approval is far from watertight.
The FDA relies on reports from doctors and patients, but when several drugs are being taken at once it is often impossible to know which was to blame for any side effect. Also, since the system is voluntary, many reactions may be going unreported.
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This means that even though 90,000 reports were sent to the FDA in 2005, it is hard to know the true scale of the problem, says Thomas Moore of the Institute for Safe Medication Practices in Huntingdon Valley, Pennsylvania, one of the authors of the study (Archives of Internal Medicine, vol 167, p 1752).
Yet even if the absolute number remains unknown, the increase is troubling. The number of prescriptions went up between 1998 and 2005, but adverse reactions increased four times as fast. Drugs that were withdrawn for safety reasons caused a quarter of the early reactions, but contributed to less than 1 per cent of total reports in 2005.
Whatever the cause, the authors say, many different drugs seem to be involved, so monitoring needs to be beefed up. 鈥淭his growing toll of serious injury shows that the existing system is not adequately protecting patients,鈥� Moore says.
鈥淲hatever the cause, many drugs seem to be involved, so monitoring needs beefing up鈥�
