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US study highlights increasing adverse effects in marketed drugs

An analysis in the latest edition of Archives of Internal Medicine exposes increases in dangerous side effects and deaths from approved drugs in the US

An analysis in the latest edition of Archives of Internal Medicine has exposed increases in dangerous side effects and deaths from approved drugs in the US.

The study, which was led by Thomas Moore and Michael Cohen of the Institute for Safe Medication Practices and Dr Curt Furberg of Wake Forest University School of Medicine, found that adverse events had almost tripled between 1998 and 2005.

The team analysed reports on serious side effects received by the FDA between January 1998 and December 2005. A total of 467,809 serious complications were found. Reported deaths almost tripled, increasing from 5,519 to 15,107.

A large and significant number of complications occurred in elderly patients, with women more likely to suffer than men (55.5 per cent versus 45.5 per cent). Children were involved in 7.4 per cent of the adverse event reports.

Drugs cited as the most dangerous to health were narcotic pain management drugs, such as Oxycontin (oxycodone). Other drugs frequently linked with serious but not fatal complications included insulin treatments, the arthritis drugs Vioxx (rofecoxib) and Remicade (infliximab), as well as the anti-depressant Paxil (paroxetine).

The study adds to increasing criticism of the FDA's lack of progress with regards to drug safety, including its handling of serious problems connected with Merck's Vioxx, which was removed from the market in 2004.

The study authors stated that the increasing incidents of serious injury showed that the existing system was not adequately protecting patients and underscored the importance of recent reports urging far-reaching legislative, policy and institutional changes.

The FDA defended its record by saying it was aware of the growing number of reported problems and took them seriously, but the reason for the increase was not completely known.

Dr Gerald Dal Pan of the FDA's surveillance and epidemiology office said in the statement: "While some of this has to do with the increasing number of prescriptions, there are clearly other factors responsible for this increase, such as the increase in public attention to drug safety, and use of the internet to make it easier for the public to submit."

30th September 2008

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