[procaare] Adverse Effects of AIDS Medications - New Warnings

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Adverse Effects of AIDS Medications - New Warnings
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1. Serious Adverse Events Attributed to Nevirapine Regimens for Postexposure Prophylaxis
After HIV Exposures--Worldwide, 1997-2000"
2. FDA/Bristol Myers Squibb Issues Caution for HIV Combination Therapy with Zerit and
Videx in Pregnant Women
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1. Serious Adverse Events Attributed to Nevirapine Regimens for Postexposure Prophylaxis
After HIV Exposures--Worldwide, 1997-2000"
Morbidity and Mortality Weekly Report (www.cdc.gov/mmwr)
(01/05/01) Vol. 49, No. 51, P. 1153

In September, 2000, the Centers for Disease Control and Prevention [USA] received two
reports of life-threatening hepatotoxicity (liver damage) among health care workers taking
nevirapine for post-exposure prophylaxis (PEP) after occupational exposure to HIV.
Nevirapine has not been recommended for PEP use and has previously been associated with
instances of serious skin
conditions, liver damage, and death when used for treating HIV-infected individuals.  The
recent reports prompted a review
of the Food and Drug Administration's registry of serious adverse events, which identified
20 other reports of serious side effects
among people who had taken nevirapine for PEP.  These 22 cases, in healthy, uninfected
individuals who took the drug for a
relatively short period of time (two weeks, on average, before onset of symptoms) are
cause for serious concern.  Anyone
considering PEP should consult with their physician to carefully weigh the risks of HIV
infection related to their exposure, the
potential benefits of post-exposure therapy, and the possible side effects of any PEP
regimen.

Recommended regimens are outlined in "Public Health Service Guidelines for the Management
of Health-Care Worker Exposures to HIV and Recommendations for Postexposure Prophylaxis"
(MMWR, Vol. 47, RR-7, May 15,1998; available online at www.cdc.gov/hiv/treatment.htm).  In
most circumstances, the risks associated with nevirapine as part of an occupational PEP
regimen might outweigh the anticipated benefits.

Source: [AEGiS] CDC HIV/STD/TB Prevention News Update 01/05/01

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2. FDA/BRISTOL MYERS SQUIBB ISSUES CAUTION FOR HIV COMBINATION THERAPY WITH ZERIT AND
VIDEX IN PREGNANT WOMEN

FDA [USA] and Bristol Myers Squibb are warning health care professionals that pregnant
women may be at increased risk of fatal lactic acidosis when prescribed the combination of
the HIV drugs stavudine (Zerit) and didanosi (Videx or Videx EC) with other antiretroviral
agents.

Lactic acidosis occurs when cells of the body are unable to convert food into usable
energy. As a result, excess acid accumulates in the body and vital organs such as the
liver or pancreas may be damaged. Severe lactic acidosis is an infrequent, but
well-described complication of the class of HIV drugs known as nucleoside analogues.
Pancreatitis is also a well-described complication of Videx and Zerit.

This new warning follows three reported cases of fatal lactic acidosis, with or without
pancreatitis, that occurred in pregnant women taking Zerit and Videx in combination with
other drugs used to treat HIV. Two of the cases were reported from ongoing clinical trials
of an investigational HIV drug, and one was identified through worldwide post marketing
surveillance. In addition FDA has received several nonfatal reports of lactic acidosis,
with and without pancreatitis, occurring in pregnant women receiving only Videx and Zerit.
Although data have suggested that women may be at increased risk for the development of
lactic acidosis and liver toxicity, it is unclear whether pregnancy potentiates these
known side effects.

On January 5, 2001, Bristol Myers Squibb issued a letter to alert health care
professionals to the potential increased risk of lactic acidosis and liver damage in
pregnant women treated with the combination of Zerit and Videx. Bristol Myers Squibb
recommends that the combination of the two drugs should be prescribed for pregnant women
only when the potential benefit clearly outweighs the potential risk. One situation where
the benefit may outweigh the risk is the use of didanosine plus stavudine in women who
have
exhausted other treatment options. The letter points out that decisions about using the
drugs for pregnant women should be made by health care professionals experienced in
treating HIV infection.

Because of these reports, the FDA will strengthen the existing black box warnings to
include this new prescribing information. Women who are prescribed the combination drug
therapy should be closely monitored for clinical or laboratory signs of lactic acidosis
and liver damage. This syndrome may develop abruptly, and in the absence of abnormal
laboratory values in the weeks preceding its development. Therefore, it is imperative that
healthcare providers maintain a high index of suspicion when monitoring these patients.
Healthcare providers are encouraged to report any adverse events related to stavudine and
didanosine to Bristol Myers Squibb Company (800-426-7644).

Reports may be submitted to FDA by telephone (800-FDA-1088 fax (800-FDA-0178), online at
www.fda.gov/medwatch/ or by mail to:MedWatch (HF-2), Food and Drug Administration,  5600
Fishers Lane, Rockville, MD 20857

January 5, 2001
T01-02
Print Media: 301-827-6242
Broadcast Media: 301-827-3434
Consumer Inquiries: 888-INFO-FDA

Source:  [AEGiS] FDA/BRISTOL MYERS SQUIBB ISSUES CAUTION FOR HIV


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