Increase in Drug-Related Death/Injury Reports to US FDA
A new report has been published by the American Medical Association which describes how the amount of drug-related fatalities and serious injuries advised to the prime US regulatory body increased two-fold in the seven years from 1998 to 2005. It is anticipated that, consequently, renewed pressure will be placed on the US Food and Drugs Administration to restructure its system of overseeing the performance of drugs once they are market-available, and during the approval process. The "serious adverse effects" catalogued in the article including birth deformities and disabilities which can be attributed to drugs.
The principal suggestion made in the report, which features in the Archives of Internal Medicine, is that the US FDA is unable to properly manage medication - a claim additionally directed at the large healthcare network, and thus taking in hospitals, doctors and alternative caregivers alike. One drug in particular - Insulin - was cited amongst the prime drugs inducing disabilities in some patients. While not providing specific details, the author of the report highlighted how, when mismanaged, low levels of blood sugar in diabetes patients could lead to loss of balance, then, subsequent accidents and black-outs.
He, however, commented on the wider scale that "there is plenty of blame to go around". Thomas J. Moore - the principal author involved - added: "This is a direct set of data that shows that the system is failing and it is getting worse. We are in denial about drug safety."
Specifically, 34,996 adverse events were reported to the US FDA in 1998. Seven years later, the figure had skyrocketed to 89,842. Where these were fatal in nature, the data showed an increase of nearly 3 times - 5,519 to 15,107. The report elaborated on this: "The overall relative increase was four times faster than the growth in total U.S. outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion."
The majority of the medications in question, the report added, were still on the market, as opposed to Merck's high-profile Vioxx painkiller, which, three years ago, was withdrawn worldwide after it was linked to a higher risk of strokes and heart attacks. As per the report: "Contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time."
"Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system."
The drugs shown to be those most frequently associated with both cases of fatalities and "serious non-fatal outcomes" were Fentanyl and Oxycodone - both painkillers, and both within the opioid analgesics drug class. Resultantly, stated Mr Moore, "We are not managing some of the familiar drugs well."
In response to the article, the US FDA described the documented increase in side effects reports as not always a negative situation, highlighting how a lack of reports has, historically, proved problematic.
A spokeswoman from the body, Julie Zawisza, said: "More reporting to us gives us more information on which to evaluate a drug's safety once it is on the market."
She continued: "Now that we get more reporting, people are saying that there is something wrong. We know that underreporting is a problem, so one would think that when we get more reports it could suggest that the system is actually working better, but we don't know for sure."
According, however, to one critic, the article stood as "...another indication that the FDA's post-market review of drugs must be rigorous and timely". He added: "The FDA needs to commit itself to considering and acting on the additional data gathered from more adverse events being reported considering the deaths associated with these adverse drug events".
Source - Pharmaceutical International's US Reporter
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