The Drugs Most Reported for Risks

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Anticoagulants lead in the most number of reports for serious adverse events. In 2011 there was an increase of 9.4% in reported cases.


During 2011 an estimated 2 to 4 million people suffered a serious adverse drug event with the total number of reported cases increasing by 9.4% over the previous year, according to the latest report.

The report analyzes the full year of reports to the U.S. Food and Drug Administration, and in 2011 the FDA received a total of 179,855 reports. This is an increase of 15,386 over 2010’s total reports.


The majority of reported cases (88%) are submitted to the FDA by drug manufacturers while 12% were submitted directly to the FDA by health professionals and patients. And although direct reports are one of the most valuable drug safety risk indices, the FDA estimates that less than 1% of serious adverse events are actually reported.

The two drugs with the most direct reports sent to the FDA both inhibit the formation of blood clots.

“While a therapeutic goal of preventing strokes, pulmonary embolism, and other harm through unwanted blood clots is a worthy objective, these results demonstrate that treatment is accompanied by substantial risks,” according to the report.

Pradaxa accounted for 3,781 reports, including 542 patient deaths and had the most cases of hemorrhage (2,367), acute renal failure (291) and stroke (644). Coumadin accounted for 1,106 cases overall, including 72 deaths.

“The 2011 annual results emphasize that anticoagulant drugs used in a vulnerable older population are resulting in thousands of serious injuries and death, and these must rank among the highest risk of all outpatient drug therapies,” according to the report.

The five drugs that the FDA received the most direct reports on were Pradaxa, Coumadin, Levaquin, carboplatin and Zestril. These five account for 11.56% of all of the direct reports the FDA received.

The top five drugs most frequently cited in litigation in 2011 were (in order of most cases): metoclopramide, Yaz/Yasmin, Avandia, Chantix and Accutane.

“With an estimated 2 to 4 million serious injuries each year, drug therapy stands as one of the most significant perils to health resulting from human activity,” the report says. “Major health benefits can be achieved through safer medication use, which should be a much higher priority for medicine, government, and the public.”

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