CATEGORY

1
CATEGORY

• A
• CONTROLLED STUDIES SHOW NO RISK.
• Adequate, well-controlled studies in pregnant
  women have failed to demonstrate a risk to the
  fetus in any trimester of pregnancy

2
CATEGORY

•  B
• NO EVIDENCE OF RISK IN HUMANS.
• Adequate, well-controlled studies in pregnant
  women have not shown increased risk of fetal
  abnormalities despite adverse findings in
  animals, or, in the absence of adequate human
  studies, animal studies show no fetal risk. The
  chance of fetal harm is remote, but remains a
  possibility.

3
CATEGORY

• C
• RISK CANNOT BE RULED OUT.
• Adequate,well-controlled human studies are
  lacking, and animal studies have shown a risk to
  the fetus or are lacking as well. There is a
  chance of fetal harm if the drug is administered
  during pregnancy but the potential benefits may
  outweigh the potential risks.

4
CATEGORY

• D
• POSITIVE EVIDENCE OF RISK.
• Studies in humans, or investigational or
  post-marketing data, have demonstrated fetal
  risk. Nevertheless, potential benefits from the
  use of the drug may outweigh the potential risk.
  For example, the drug may be acceptable if needed
  in a life-threatening situation or serious
  disease for which safer drugs cannot be used or
  are ineffective.

5
CATEGORY

• X
• CONTRAINDICATED IN PREGNANCY.
• Studies in animals or humans, or investigational
  or post-marketing reports, have demonstrated
  positive evidence of fetal abnormalities or risks
  which clearly outweighs any possible benefit to
  the patient.

6
Acyclovir (Zovirax )

• Antiviral CATEGORY B Crosses placenta
• Inhibitor of viral DNA polymerase Block viral
  syntesis
• (maternalcord ratio of 1.3 after IV/PO
  exposure). In a prospective epidemiological
  registry 1st trimester exposure to acyclovir in
  749 pregnancies resulted in no increase in major
  or minor fetal anomalies. However, the
  manufacturer cautions, the small size of the
  registry is insufficient to evaluate the risk for
  less common defects or to permit reliable or
  definitive conclusions regarding the safety of
  acyclovir in pregnant women and their developing
  fetuses. BREAST FEEDINGCompatible. Concentrated
  in human milk. Compatible NEONATAL SIDE EFFECTS
  None reported.
• Sid effectsLocal burning,Nephrotoxicity,Neurotox
  icity,Mutagenic
• Decrease spermatogenesis and cause
  testicular atrophy in animals

7
Amantadine (Symmetrel)

• Antiviral CATEGORY C In a surveillance study
  of Michigan Medicaid patients 1st trimester
  exposure in 64 infants resulted in 5 birth
  defects The sample size is too small to draw firm
  conclusions. BREAST FEEDING The manufacturer
  reports amantadine is excreted in human milk, and
  recommends the drug not be used in nursing
  mothers
• NEONATAL SIDE EFFECTSPotential release of
  levodopa, urinary retention, vomiting, and rash
  after breast feeding.
• Side effects Dose dependent GI and CNS
  complications (nervousness,ligtheadedness,difficul
  ty in concentration,insomnia,losspf
  apetitenausea.)

8
Gancyclovire

• Category C
• Inhibits viral replication
• Side effectsMyelosuppression,Neutropenia(2nd
  week)
• CNS side effects,Anemia,Rash ,Fever
• Mutagenic,Carcinogenic,immunosuppressive
  irreversible repoductive toxicity
• Tratogrnicity,emberitoxicity,testicular atrophy

9
Safety of HAART in pregnancy

• Similar adverse events occur as with HAART in
  non-pregnant patients
• little hard data suggesting major problems with
  pregnancy outcomes - difficult to separate out
  effects of HIV and drug therapy
• only drug which is absolutely contraindicated is
  efavirenz - teratogenic in cyanomolgus monkeys
• Didanosine and stavudine together seem to pose
  and especial risk of lactic acidosis in pregnancy
  
• very very rare reports of AZT and lamivudine
  associated with mitochondrial toxicity in
  non-infected exposed infants

10
Lamivudine

• CategoryC
• Placental passageyes
• CarcingenicityNo
• Animal teratogrnicityNo
• Nucleoside and nucleotide analoge reverse
  transcriptase inhibitor

11
Zidovoidine

• Category C
• Placental passageYes
• Long term anima carcinogenicityPositive
• Animal TeratogenicityYes
• Nucleoside and nucleotide analoge reverse
  transcriptase inhibitor