Shock, horror!  I didn't see this one coming.  I'm so surprised...
Not.

<http://money.cnn.com/news/newsfeeds/articles/djf500/200803121753DOWJONESDJONLINE
001033_FORTUNE5.htm>:

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The Food and Drug Administration and a unit of Johnson & Johnson (JNJ)
warned Wednesday about liver damage and some deaths in patients
treated with the HIV drug Prezista.

In a letter posted Wednesday to the FDA's Web site, Johnson &
Johnson's Tibotec Therapeutics unit said it had received reports of
liver injury and some fatalities since the drug was approved in June
2006. The company also had reports of 15 cases of drug-induced
hepatitis among 3,063 patients in clinical trials.

A company spokeswoman did not have post-marketing figures available on
the number of liver injuries and deaths. Language about the reports of
liver injuries was added to Prezista's label.

The letter, however, noted that the liver-injury reports have
generally occurred in patients with advanced HIV disease who were also
on several other medications, as well as those who had chronic active
hepatitis B or C, which puts people at higher risk for liver injury.
The letter also said a causal relationship between the liver injuries
and Prezista treatment had not been established.

Prezista is prescribed in combination with Abbott Laboratories' (ABT)
Norvir, and in many cases other HIV drugs. Prezista is a protease
inhibitor aimed at blocking HIV replication.

The letter said doctors should test patients before starting treatment
with Prezista and continuing monitoring liver enzymes to look for
signs of possible liver injury. The letter also advised interrupting
or stopping treatment in patients if there's evidence of new or
worsening liver dysfunction.

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