Abbott's manufacturing malady is hard to swallow
In late July, Abbott Labs alerted the
AIDS community to a production snafu discovered during routine
quality-assurance tests: "Undesired" crystals in the capsules of its
protease inhibitor, Norvir (ritonavir). Because the crystals affect
absorption, Abbott halted production indefinitely.
"The crystals aren't contamination," Abbott spokesperson Melissa
Brotz said. "We don't know how they got there, or what it's going to
take to make them go away." Luckily for Abbott -- and the 65,000
Norvir-popping PWAs around the world -- the defective drugs were
caught prior to distribution. With production suspended, however,
the company said pharmacy shelves would be soon wiped clean of
Since the glitch is likely mechanical and won't require altering
the Norvir brew, FDA re-approval may not be necessary. Shelves
should be restocked a few weeks after the problem is pinpointed;
however, when that will happen is another mystery. (Some say
it could take up to a year; at press time, Abbott hadn't released
any official timetables).
Until it dissolves its cryptic crystals, Norvir-users must make
do with a liquid version identical to the capsules in both price and
HIV-fighting composition. Abbott and several treatment gurus say
switching to liquid should neither affect antiretroviral regimens
nor foster additional side effects.
Nevertheless, there are important differences -- and potential
problems -- between the two formulations. Unlike capsules, which
require refrigeration, the liquid should not be kept in the
fridge. And its high-alcohol content -- 43 percent -- may be of
concern to recovering alcoholics and people with liver disease or
hepatitis. But what many label as the biggest burden is liquid
Norvir's taste. "It's like awful liquor that makes your mouth and
gut tingle and sting the whole way down," said treatment advocate
Dave Gilden after sampling the elixir. "I kept burping it up." For
those who can't stomach it, nonadherence could become the big issue.
For more info and updates, log on to the IAPAC Norvir Advisory at
http://www.iapac.org/. For tips on how to make the
med palatable, see The Bitter End.