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100,000 People Die Annually Over FDA-approved Medications

Nov 8, 2013

Drugs approved by the U.S. Food and Drug Administration (FDA) are the culprit in some 100,000 deaths every year over so-called “adverse drug reactions” (ADRs).

In addition, about 2 million people in the United States suffer from non-fatal adverse reactions due to drugs deemed safe by the agency, according to

An ADR is a negative reaction brought on from taking a drug in accordance with drug manufacturer or physician guidelines, wrote. ADRs do not include deaths associated with drug abuse or overdose.

According to the agency, ADRs are the fourth-leading cause of death in the U.S., “ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile deaths.”

According to The Lancet, “any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. The risk of such effects ranges from near zero … to high.” The World Health Organization (WHO) uses a definition that has been in place for three decades, describing an adverse reaction as “a response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function.”

In the past, adverse drug reactions were mostly seen in patients 60 years of age and older; however, adverse drug reaction reports are now occurring more and more in people younger than 50, according to Public Citizen, which notes that adverse drug reactions lead to 1.5 million hospitalizations in the U.S. each year. This translates into some 4,000 people suffering an adverse drug reaction serious enough to warrant hospitalization—every day in the United States.

What’s more, a review of those hospitalized patients revealed that the attending physicians at admission did not recognize 57 percent of the cases of adverse drug reactions.

According to Public Citizen, a number of studies found that such admissions could have been prevented. Public Citizen also reported that nearly 19 percent of medications prescribed prior to these admissions had been contraindicated. Other research revealed that 88 percent of hospital admissions for ADRs in seniors are preventable and that the elderly are four times likelier to require hospitalization for an ADR than the non-elderly.

But the elderly are not the only group at risk for dangerous reactions following treatment with agency-approved medications. About 2.09 percent of all hospitalizations for children under the age of 19—pediatric patients—were due to ADRs; 39 percent of these were life threatening, according to Pubic Citizen.

In addition to hospital admissions due to adverse drug reactions, another three-quarter of a million people suffer from an adverse drug reaction after hospitalization each year; these reactions are serious and include symptoms such as cardiac arrhythmia, kidney failure, bleeding, and dangerously low blood pressure. In fact, these patients experienced a nearly two-fold risk of death when compared to other, comparable hospitalized patients who did not suffer an ADR, according to Public Citizen.

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