INDICES> ciprofloxacin and metronidazole in first trimester (3)

[helpline <helpline@best.net.pk>]

INDICES> ciprofloxacin and metronidazole in first trimester (3)
---------------------------------------------------------------

Dear Lakshmi,

I have not seen the query on indices. The response to your answer is that
both drugs are contraindicated in pregnancy and should only be used if
benefits outweigh risks. There can be safer alternatives to using
ciprofloxacin and metronidazole use is contraversial. Even the WHO
recommends its use only if the situation is life-threatening. It is best
avoided during the first trimester because of its carcinogenic potential.
In Pakistan, non-pharmacological therapies are instituted unless the
situation is lifethreatening. But these drugs are best avoided.
The reference that I have , I am passing it on to you.

CIPROFLOXACIN
1. U.S. Food and Drug Administration's Pregnancy Category C (Prod Info
Cipro(R), 1997).
2. Australian Drug Evaluation Committee's (ADEC) Category B3 (ADEC, 1996).
3. The outcomes in 103 women who took ciprofloxacin during pregnancy have
been reported. Normal healthy babies were delivered in 63 cases and 18 women
had therapeutic abortions. Spontaneous abortion occurred in 10 cases; 3 had
received other drug therapy during the pregnancy. Fetal death in utero was
reported in 4 cases; 2 of these women had also received either ampicillin or
metronidazole. Congenital abnormalities were reported in 8 neonates. The
reported abnormalities included Rubinstein-Taybi syndrome, hearing loss in
the right ear caused by deformity, hypoplastic left cerebral ventricle,
severe mental retardation, spasticity, and possible blindness. Other drugs,
in addition to ciprofloxacin, were administered in 3 of these cases (Bomford
et al, 1993).
4. Animal studies have not demonstrated that ciprofloxacin is teratogenic.
However, there are no well-controlled studies in pregnant women. In view of
these facts, ciprofloxacin should only be considered during pregnancy if the
potential benefit of the drug outweighs the potential risk to the fetus
(Prod Info Cipro(R), 1997).

METRONIDAZOLE
1. Metronidazole is CONTRAINDICATED during the first trimester (Prod Info
Flagyl(R), 1999).
2. Metronidazole crosses the placenta and enters fetal circulation rapidly
(Prod Info Noritate(R), 1999). Although there have been cases reported of
fetal malformations occurring in women who had been exposed to
metronidazole, there is no significant evidence indicating that prenatal use
of METRONIDAZOLE in early pregnancy increases the overall risk of birth
defects (Caro-Paton et al, 1997; Piper et al, 1993). In 1 cohort study
involving 124 women, use of metronidazole during pregnancy was not
associated with an elevated risk of congenital abnormalities, preterm
delivery, or low birth weight (Sorensen et al, 1999).
3. Results of a retrospective cohort study involving 328,846 children
younger than 5 years indicate that in utero exposure to metronidazole is NOT
associated with an increased risk of childhood cancers. However, although
not statistically significant, an increased risk of neuroblastomas was
observed among children exposed to metronidazole in utero (Thapa et al,
1998).

References:

   * Australian Drug Evaluation Committee: Medicines in Pregnancy - An
     Australian Categorisation of Risk of Drug Use in Pregnancy, 3rd ed.
     Australian Government Publishing Service, Canberra, Australia; 1996.
   * Bomford JAL, Ledger JC, O'Keeffe BJO et al: Ciprofloxacin use during
     pregnancy. Drugs 1993; 45(suppl 3):461-462.
   *  Caro-Paton T, Carvajal A, Martin de Diego I et al: Is metronidazole
     teratogenic? A meta-analysis. Br J Clin Pharmacol 1997; 44:179-182.
   * Piper JM, Mitchel EF & Ray WA: Prenatal use of metronidazole and birth
     defects: no association. Obstet Gynecol 1993; 82:348-352.
   * Sorensen HT, Larsen H, Jensen ES et al: Safety of metronidazole during
     pregnancy: a cohort study of risk of congenital abnormalities, preterm
     delivery and low birth weight in 124 women (letter). J Antimicrob
     Chemother 1999; 44(6):854-855.
   * Thapa PB, Whitlock JA, Worrell KGB et al: Prenatal exposure to
     metronidazole and risk of childhood cancer: a retrospective cohort
     study of children younger than 5 years. Cancer 1998; 83(7):1461-1468.

Regards

Ayesha Ahmed
Drug information Helpline
Pakistan

Email: helpline@best.net.pk   [please add email to signature! Thanks WB]
--
Send mail for the `INDICES' conference to `indices@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to:  `owner-indices@usa.healthnet.org'.