New
Statin and Aspirin Combo gets FDA Panel Support
It
will be a combination package in 3 strengths of pravastatin and 2
strengths of aspirin.
Advisors
to the US Food and Drug Administration (FDA) on Thursday reversed an
earlier panel decision and endorsed the co-packaging of Bristol-Myers
Squibb Company's Pravachol (pravastatin) with low-dose aspirin for the
prevention of various cardiovascular events, including acute heart
attacks.
The
FDA's Cardiovascular and Renal Drugs Advisory Committee voted in
support of permitting the New York City-based drugmaker to co-package
and market three different doses of Pravachol with either 81mg or
325mg of aspirin.
The
vote reversed an earlier recommendation by the same FDA advisory
committee back in January, due in part to concerns that the
co-packaged product would limit treatment flexibility and mask
patients' contaminate use of aspirin.
Bristol-Myers
Squibb earned the committee's backing for a revised application that
was amended to include additional packages with either 20mg or 40mg of
Pravachol.
"There
is an issue and there is some risk here that someone will get aspirin
that shouldn't," added committee member Dr. Steven Nissen, vice
chairman of the Department of Cardiology at the Cleveland Clinic
Foundation in Ohio.
Others
also argued that the expected improvement in patient compliance is at
best speculation, although the benefits of co-packaging may appear
self-evident.
The
FDA often follows its committees' recommendations, but the agency is
not bound by their advice.
Did
you know?
A
group of overweight Americans have sued several US fast food giants
accusing them of knowingly serving meals that cause obesity and
disease. The lawsuit -
filed in New York State Supreme Court in the Bronx - says that
McDonald's, Burger King, Wendy's and Kentucky Fried Chicken misled
customers by enticing them with greasy, salty and sugary food.
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