July 1, 2010: Risks of Drugs on the Market
A recent
article by Marilynn Marchione, released by the Associated Press, explores the
risks of drugs on the market and questions when a drug is too risky to be on
the market after drug safety questions arose again this week about the Diabetes
drug Avandia.
The author
cites examples to show that at times the FDA’s actions may seem inconsistent or
even confusing. She mentions two drugs tied to heart risk, one which was
removed from the market and another wasn’t. She also mentions a drug that was
pulled off, then put back on the market. She explains that the Food and Drug
Administration has vague guidelines for deciding what to do in these cases.
Dr. Joshua
Sharfstein, the FDA's principal deputy commissioner, explains "each drug
has its own complex story," so comparisons to previous decisions can't be
made, adding that the agency needs better criteria regarding drug safety.
The author
explains that the FDA can order a drug off the market, but this order can be
challenged in court and usually a company voluntarily withdraws the medicine at
the FDA's request. She explains that some of the factors considered in
assessing a drug’s safety are:
How
serious is the illness?
How
serious are the potentially adverse effects?
How
frequent are the risks?
She
continues by giving many examples of different decisions by the FDA but
ultimately discusses Avandia and its fate.
She
explains that there is a potentially safer alternative to Avandia, Actos, not
all studies have tied Avandia to heart risks and deaths, and more data need be collected.
The drug initially won approval in 1999 because it lowered blood sugar, which
is a less clear benefit than other results. She also mentions that some experts
are not happy that even though Avandia has been approved because according to
one expert “we still don’t know if it produces the benefits we really want.”
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