DOCTORS WARNED OF HIV DRUG RISKS IN PREGNANCY
Reuters 1 February 2001
London -- Doctors throughout Europe are being warned
of a potentially fatal side effect if pregnant women infected with
HIV take Bristol-Myers Squibb's AIDS drugs Zerit (stavudine) and
In a public statement, the European Medicines Evaluation Agency
(EMEA) said seven cases of lactic acidosis--three of them fatal--had
been reported worldwide in pregnant women taking the two drugs in
Lactic acidosis occurs when the body's cells are unable to convert
food into usable energy. The condition causes excess acid to
accumulate in the body, potentially damaging vital organs such as the
liver and pancreas.
Echoing last month's warning by the US Food and Drug Administration
(news - web sites), the EMEA pointed out that lactic acidosis is a
known side effect of the class of HIV drugs called nucleoside reverse
transcriptase inhibitors (NRTIs). The use of this class of drugs is
not recommended during pregnancy unless the potential benefit clearly
outweighs the potential risks.
Two of the deaths occurred in women taking part in a multinational
clinical study--one in a patient taking the triple combination
therapy didanosine/stavudine/nelfinavir, the other in a patient on
didanosine/stavudine and an experimental protease inhibitor.
The statement said there was insufficient information to decide
whether pregnancy is an additional risk factor for lactic acidosis.
"It is also uncertain whether any increased risk of lactic acidosis
is specific to stavudine and didanosine or whether it might be
increased with all combinations of nucleoside analogues.''
It added that the EMEA's scientific committee and national agencies
had requested more information from all companies marketing NRTIs so
that they could evaluate the whole issue.
A company spokeswoman in Brussels told Reuters Health that the three
dead women were from the UK, South Africa and Argentina.
The company is distributing the EMEA's public statement to doctors in
She said deciding how to treat HIV-infected women who became pregnant
was a "big issue'' for doctors, particularly if the women were
already resistant to some antiretroviral therapies.