(Circulation. 1998;98:831-832.)
© 1998 American Heart Association, Inc.
Withdrawal of Posicor From Market
Ruth SoRelle, Circulation Newswriter
Early in June 1998, Roche Laboratories of Nutley, NJ,
abruptly and voluntarily withdrew its novel T-channel blocker, Posicor
(mibefradil), from the market. The drug, used to treat hypertension,
was just a few days short of celebrating its first year of release.
The withdrawal came after reports of dangerous and even fatal
interactions with at least 25 other drugs, including common
antibiotics, antihistamines, and cancer drugs. Posicor, which went onto
the general market in August 1997 after its final approval in June of
the same year, was being taken by almost 200 000 Americans and nearly
double that number worldwide for both hypertension and angina. Its
withdrawal was a logistical nightmare for many large
cardiology practices faced with the need to notify
patients that they would need to obtain a different prescription. In
light of other recent withdrawals of medications from the market, the
Posicor situation presented new questions about the perceived
haste of the US Food and Drug Administration (FDA) to approve new
medicines, a politically mandated speed-up that has drawn both praise
and criticism.
Posicor is a novel antihypertensive that blocks both the T-type and
L-type calcium channels, with greater selectivity for the T type. Also
called mibefradil, it did not induce reflex tachycardia but
slightly reduced the heart rate. In a talk paper released by the FDA,
the agency said that Posicor reduces the activity of certain liver
enzymes that are important in helping the body eliminate many other
drugs.
Posicor inhibits cytochrome P450 2D6 and 3A4 and . . . [Full Text of this Article]
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