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JAMA STUDY REPORT
JAMA Reports, 20% of New Drugs Will Be
Labeled “hazardous” or Withdrawn from Market.
A
study released in the May 1, 2002 issue of the Journal of the
American Medical Association discovered that the dangers of newly
FDA-approved drugs are much higher than primarily realized prior to going to
market.
According to the report: “Premarketing drug trials are often underpowered
to detect ADRs (adverse drug reactions), and have limited follow-up. In some
cases, drugs are approved despite identification of serious ADR’s in
premarketing trials.” The study involved the review of 548 new “chemical
entities” that were approved by the FDA between 1975 and 1999. A surprising
8.2 percent (45 drugs) of these received one or more “black box warnings” in
the Physicians’ Desk Reference (PDR), with 2.9% (16 drugs) being withdrawn
from the consumer market altogether for safety reasons.
Using
Kaplan-Myers analyses these are the findings: “…the estimated probability of (a new
drug) requiring a new black box warning or being withdrawn from the market
over 25 years was 20 percent.” This fact is important for
consumers to understand when accepting prescriptions for lately approved
drugs. It was noted: “Nearly 20 million patients in the United States
took at least one of the five drugs withdrawn from the market between
September 1997 and September 1998. Three of these five drugs were new,
having been on the market for less than two years.”
“Only
half of newly discovered serious ADRs are detected and documented in the
Physicians’ Desk Reference within seven years after drug approval,” the
researchers found; only half of the withdrawals of unsafe drugs take place
in the first two years.” The authors specify that their definition of a
serious ADR was “conservative", since it was limited to Physicians’
Desk Reference black box warnings. We did not consider other labeling
changes such as bolded warnings without boxes, ‘Dear Health Care
Professional’ letters, or case reports in the medical literature.”
P atients
should also be warned against taking any prescription for a drug released
within the last seven years, mainly those released in the last two years.
The report concludes with this warning:
“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.”
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