TABLE 4.1 Potential Toxic Effects of Antiretrovirals

Antiretroviral Drug

FDA Pregnancy Category

Placental Passage

Long-Term Animal Carcinogenicity Studies

Side Effects

Zidovudine (ZDV)

C

In humans

Positive (rodent, noninvasive vaginal epithelial tumor)

Anemia, gastrointestinal (GI) upset, headache, myopathy

Zalcitabine (ddC)

C

In rhesus monkeys

Positive (rodent thymic lymphomas)

Pancreatitis, stomatitis, peripheral neuropathy

Didanosine (ddI)

B

In humans

Negative

Pancreatitis, diarrhea, peripheral neuropathy

Stavudine (d4T)

C

In rhesus monkeys

Not completed

Pancreatitis, peripheral neuropathy

Lamivudine (3TC)

C

In humans

Negative

Minimal toxicity

Nevirapine

C

In humans

Not completed

Rash

Delavirdine

C

Unknown

Not completed

Rash

Indinavir

C

In rats

Not completed

Nephrolithiasis, hyperbilirubinemia, drug interactions

Ritonavir

B

In rats

Not completed

GI upset, paresthesias, drug interactions

Saquinavir (SAQ)

B

In rats/rabbits

Not completed

GI upset

Nelfinavir

B

Unknown

Not completed

Diarrhea

Efavirenz (EF)

 

 

Congenital anomalies in 13 infant monkeys whose mothers received EF during gestation

Central Nervous System (anencephaly, microphthalmia, cleft palate)

 

SOURCES: CDC 1998c, 1998d, 1998e; Dupont-Merck, 1998



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