Tag Archives: black box warnings

1 in 3 FDA-approved Drugs May Lead to Death | AMA Journal

From myeclinik.com

A scathing post-market study on FDA-approved drugs conducted by some members of the American Medical Association has made it to the headlines. It concludes that almost “one-third of new drugs approved by U.S. regulators over a decade ended up years later with warnings about unexpected — sometimes life-threatening — side effects or complications.”

LATimes reports,

Researchers looked at potential problems that cropped up during the routine monitoring that’s done once a medicine has been approved by the Food and Drug Administration and is on the market. The results, published Tuesday, covered all 222 prescription drugs approved by the FDA from 2001 through 2010.

The 71 drugs that were flagged included top sellers for treating depression, arthritis, infections and blood clots. Safety issues included risks for serious skin reactions, liver damage, cancer and even death.

“The large percentage of problems was a surprise,” and they included side effects not seen during the review process, said senior author Dr. Joseph Ross, an associate professor of medicine and public health at Yale University.

While most safety concerns were not serious enough to prompt recalls, the findings raise questions about how thoroughly drugs are tested before approval, said drug safety expert Thomas Moore.

But Ross said the results suggest that the FDA “is kind of doing a great job” at scrutinizing drugs after approval.

New drugs are generally tested first in hundreds or even thousands of people for safety and effectiveness.

Surely, not one of those guinea pigs are their close relatives.

Among the drugs that were found to be life-threatening are Bextra, Raptiva, Zelnorm, and others:

… The study counted black-box warnings for dozens of drugs. These warnings involved serious problems including risk of death or life-threatening conditions linked with the drugs.

There were also alerts for less serious potential harms related to dozens of drugs. Among them: Humira, used for arthritis and some other illnesses; Abilify, used for depression and other mental illness; and Pradaxa, a blood thinner.

Three drugs were withdrawn because of the potential for death or other serious harm. They were Bextra, an anti-inflammatory medicine, because of incidence of heart problems; Raptiva, a psoriasis drug, which is linked to a rare nervous system illness; and Zelnorm, a bowel illness drug, which has been connected to heart problems. [1]

Source: 1 in 3 FDA-approved Drugs May Lead to Death | AMA Journal