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Dangerous Drug Side Effects Have Surged Since 1998

Sep 11, 2007 | Parker Waichman LLP, LLP A recently published study says that deaths and injuries due to drug side effects have tripled since 1998, raising serious concerns about Food & Drug Administration (FDA) oversight of drug safety.    These disturbing findings will no doubt increase calls for a complete overhaul of the US drug safety system.

The study, conducted by the Institute for Safe Medication Practices, found that around 87.1 percent of all side effects could be blamed on just 300 medications.  Narcotic pain relievers, like morphine, oxycodone, fentanyl and acetaminophen-hydrocodone were among the top 15 drugs linked to adverse event reports.   Four others were immune-system drugs, such as Infliximab and Interferon beta, and several others were anti-depressants including Risperidone and Clozapine.   The  popular over-the-counter pain reliever acetaminophen (best known as Tylenol) held the number five spot on the study’s list of dangerous drugs.

The study analyzed serious side effect reports received by the FDA between June 1998 and December 2005.   The study looked at “serious adverse events”- that is problems with drug side effects that caused death or serious injuries, including birth defects and disability.   In 1998 adverse event reports totaled just 34,966, but by 2005 a total of 89,842 injuries and deaths had been received by the FDA.   Most disturbingly, reports of deaths attributed to drug side effects jumped from just 5, 519 in 1998 to 15,107 in 2005.  The report’s authors found that about a quarter of the increase in adverse reports could be attributed to in the increased use of prescription drugs,  and another 15-percent could have been caused by the introduction of new biotechnology drugs since 1998.  But the other reasons behind the large spike in side effect reports are still not understood.  

When commenting on the study’s findings, the FDA tried to blame a new system that makes it easier to report drug side effects as the reason for the nearly three-fold increase.  But the report’s authors, while conceding that the new reporting system did account for some of the increase, said that it could not be blamed for such high numbers.  Rather, the researchers said that findings showing that a small minority of medications were responsible for a majority of adverse event reports suggested problems in the way high-risk drugs are monitored for safety.  Drugs like fentanyl and oxycodone – both highly addictive narcotic pain killers – probably deserve more scrutiny than other medications.   And the fact that a drug like insulin was high on the list of drugs responsible for side effect reports indicates that health care providers might be ill-equipped to manage some medications, as problems with insulin are usually the result of poor management.

But whatever the reasons behind an individual medication’s high number of adverse effect reports, the authors said that the findings as a whole reflect serious problems with the FDA’s drug safety system.   The authors concluded that such a significant increase in dangerous drug side effects only underscores the need for far-reaching changes in the way medications are approved and monitored for safety in the US.

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