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New Drugs May Not Be Safe

In an April 30, 2002, Associated Press report, came a story based on a May 1, 2002 article in the Journal of the American Medical Association (JAMA) that claims that many newly released drugs are still dangerous when released because not enough is known about them before they are released into the market. The AP story begins with a dangerous warning, "One in five new drugs has serious side effects that do not show up until well after the medicine has received government approval."

The study published in JAMA was conducted at the Department of Medicine, Cambridge Hospital and Harvard Medical School, and also starts off with an ominous statement, "Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs." The JAMA article goes on to say, "Adverse drug reactions (ADRs) are believed to be a leading cause of death in the United States. Prior to approval, drugs are studied in selected populations for limited periods, possibly contributing to an increased risk of ADRs after approval. Pharmaceutical companies frequently market new drugs heavily to both patients and clinicians before the full range of ADRs is ascertained."

This study suggests that in many cases newer drugs are not fully understood, or their reactions fully known before the general public is given them. Robert J. Temple, MD; and Martin H. Himmel, MD, also commented in the same JAMA issue by warning that even those who check common sources for drug reactions may not be getting the full story. They stated, "Use of the Physicians' Desk Reference to determine the timing of the labeling change is convenient, but does not give an accurate measure." Additionally, they commented, "Premarketing trials in a few thousand (usually relatively uncomplicated) patients do not detect all of a drug's adverse effects, especially relatively rare ones."

The results of the study as published in JAMA showed that out of a total of 548 new drugs that were approved in 1975-1999; 56 (10.2%) acquired a new 'black box' warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%.

Black box warnings are special warnings that are prominently displayed in the Physicians' Desk Reference to alert practitioners to serious risks. According to the Federal Register; special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box, known as the 'black box'.

The conclusion of the researchers was, "Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years."