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Drug Problems: Dangerous Decision-Making at the FDA

On July 14, 2011, a retired social worker named Sidney Denham was taken to an emergency room in Savannah, Georgia. Weeks after undergoing prostate surgery, and days after resuming use of a relatively new blood thinner called Pradaxa, the 81-year-old widower was bleeding profusely from his urinary tract. He had lost so much blood that his pressure had plunged to about half the normal level and his body was in shock. In the intensive care unit, a medical team deployed treatment after treatment in a struggle to save him.

Sidney Denham and Family

Sidney Denham and grandchildren, 2006 (Photo courtesy of Mary Denham)

One of Denham’s daughters, Kay Denham, recalled the scene: “More blood than I think I've ever seen in my life … Millions of people in the room … They could not control the bleeding.”

A hospital record shows that Denham was given 12 units of red blood cells and another 12 of fresh-frozen plasma—almost two gallons. He was pumped with platelets and other blood products. He was put on dialysis to purge the Pradaxa from his system. Nothing worked.

Even as they replaced his blood, it was draining out of him.

“It was horrible,” said daughter Mary Denham, “that feeling of helplessness, for the people in the ER and for us. There was nothing they could do to stop the bleeding. My sister and I watched him bleed to death.”

Denham had been taking the anticoagulant Pradaxa to treat a condition called atrial fibrillation, in which irregular functioning of the heart can cause blood clots and strokes; the medicine is supposed to prevent the clots from forming. But, according to Denham’s “DEATH SUMMARY” from Memorial University Medical Center in Savannah, the FDA-approved drug contributed to his demise.

The patient, the document says, suffered an “uncontrollable hemorrhage from Pradaxa.”

The Food and Drug Administration is responsible for making sure medicines sold to the public are safe and effective. But how much comfort should medical consumers take from the words “FDA approved”?

A Project On Government Oversight investigation, based in part on thousands of pages of public records, many obtained through the Freedom of Information Act, calls into question the reliability of a crucial regulatory system.

To read the report, click here.

By: David S. Hilzenrath
Chief Investigative Reporter, POGO

David Hilzenrath David Hilzenrath is the Chief Investigative Reporter for the Project On Government Oversight.

Topics: Public Health and Science

Related Content: Food and Drug Administration, Drug Problems

Authors: David S. Hilzenrath

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