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Early pregnancy and risk of birth defects after taking antibiotics
We have just discovered that my wife is 4 weeks pregnant (fertilization took place between 15 to 20 days ago). My wife has been having unusual periods recently where a week before menstruation she has been seeing small traces of blood. So when a few days ago, she saw the small traces of blood again, we assumed she was not pregnant. My wife then took 3 doses of sparfloxacin (0.2g/dose) over a day and a half as this had been prescribed by a doctor to get her periods in order. After taking the three doses, my wife realized that her period was perhaps not coming and was maybe pregnant. We have since been to see three doctors about this and they have all told us that if my wife took this medicine within 14 days of the fertilization process then there should be no need for concern. However, if this was over 14 days (as it seems to be), then there is a very strong chance that there will be serious birth defects to our little baby (one doctor put the risk at 10-30%). All three doctors recommend that we should abort this baby and try again in 6 months. My wife and myself are utterly devastated and cannot believe that we have made such a stupid mistake. We have searched for lots of information and found that between 3 weeks and 8 weeks, the fetus is indeed very fragile to certain drugs. We have found one article that suggests that the US FDA apparently classifies Sparfloxacin as category X during the 1st trimester and then as category C during the 2nd and 3rd trimester. All other information that we have found just suggests that the effects are unknown. Is this information correct? What should we be considering?
My wife took ofloxacin in week 27 of her pregnancy for 3 days. Ultrasound in week 28 was fine. I later found out that this is a category c drug. I am paranoid regarding this event... Will everything be fine?
1 Comments
I'm sorry she took a cat C drug. Try not to worry though. Because it Can happen does not mean it will. Let us know how she is doing and how things turn out!
I understand how confusing it is. There's so little conclusive research on most medications used during pregnancy that it's frightening. I hope that somebody can give you the answer you guys need to make your decision...good luck.
We live in China and are trying to get in contact with some doctors in the UK. We have not been able to find that much information on this problem so far. Thanks for the info that you sent, The main concern is that some of the information that we found singled out sparfloxacin as a very dangerous antibiotic within the first trimester, with lesser effects in the second and third trimester. We are really confused at the moment and do not know what to think. Thanks for your help!
I'm sorry I meant to say seek a second opinion from a Maternal Fetal Medicine specialist. I am sorry but I don't know what they call them in the UK :(...but they specialize in the connection between maternal medication during pregnancy and it's effect on the growing fetus. they'll have the most expertise.
I am so sorry you guys are going through this right now...I found this information for you. It basically says that although there seems to be proof of major birth defects occurring from use during pregnancy, there's no way to predict what defects will occur or even if they will occur. the article seems to indicate that termination is not usually recommended in conjunction with usage during pregnancy, because although the risk for birth defects exists there is no conclusive research on it. All I can say is..follow your hearts. can you live with a child who may have serious birth defects? If you would still love your child the same, don't worry about it. If you feel like you're unable to care for a child who may have special needs, you may need to consider medical termination. The defects that seem to occur most often with this medicine (from research, mind you...I have no personal experience) are urogenital defects, abdominal wall defects, and limb-reduction defects. none of these sound like the end of the world, but again... you would be running a small risk of a baby with a serious defect and it needs to be a decision you and your wife take your time making and make sure you listen to your heart. maybe seek a second opinion.
anyway, here's the info I found for you I hope it helps.
Fetal Risk Summary
Sparfloxacin is an oral, synthetic, broad-spectrum antibacterial agent. As a fluoroquinolone, it is in the same class of agents as ciprofloxacin, enoxacin, levofloxacin, lomefloxacin, norfloxacin, and ofloxacin. Nalidixic acid is also a quinolone drug.
Reproduction studies, conducted in male and female rats, found no evidence of impaired fertility or reproductive performance at oral doses approximately 15 times the maximum human dose on a mg/m2 basis (MHD) (1). No teratogenic effects were observed in rats, rabbits, and monkeys at oral doses approximately 6, 4, and 3 times, respectively, the MHD, although maternal toxicity was evident at these dose levels. When the dose was increased to about 9 times the MHD or higher in pregnant rats, a dose-dependent increase in the number of fetuses with ventricular septal defects was observed. This effect did not occur in rabbits or monkeys.
In a prospective follow-up study conducted by the European Network of Teratology Information Services (ENTIS), data on 549 pregnancies exposed to fluoroquinolones (none to sparfloxacin) were described in a 1996 Reference (see also Ciprofloxacin) (2). Data on another 116 prospective and 25 retrospective pregnancy exposures to the antibacterials were also included. Of the 666 cases with known outcome, 32 (4.8%) of the embryos, fetuses, or newborns had congenital malformations. Based on previous epidemiologic data, the authors concluded that the 4.8% frequency of malformations did not exceed the background rate (2). Finally, 25 retrospective reports of infants with anomalies, who had been exposed in utero to fluoroquinolones, were analyzed, but no specific patterns of major congenital malformations were detected.
The authors of the above study concluded that pregnancy exposure to quinolones was not an indication for termination, but that this class of antibacterials should still be considered contraindicated in pregnant women. Moreover, this study did not address the issue of cartilage damage from quinolone exposure, and the authors recognized the need for follow-up studies of this potential toxicity in children exposed in utero. Because of their own and previously published findings, they further recommended that the focus of future studies should be on malformations involving the abdominal wall and urogenital system, and on limb-reduction defects (2).
In summary, although no reports describing the use of sparfloxacin during human gestation have been located, the available evidence for other members of this class indicates that a causal relationship with birth defects cannot be excluded (see Ciprofloxacin, Norfloxacin, or Ofloxacin), although the lack of a pattern among the anomalies is reassuring. Because of these concerns and the available animal data, the use of sparfloxacin during pregnancy, especially during the 1st trimester, should be considered contraindicated. A 1993 review on the safety of fluoroquinolones concluded that these antibacterials should be avoided during pregnancy because of the difficulty in extrapolating animal mutagenicity results to humans and because interpretation of this toxicity is still controversial (3). The authors of this review were not convinced that fluoroquinolone-induced fetal cartilage damage and subsequent arthropathies were a major concern, even though this effect had been demonstrated in several animal species after administration to both pregnant and immature animals and in occasional human case reports involving children (3). Others have also concluded that fluoroquinolones should be considered contraindicated in pregnancy, because safer alternatives are usually available (2).
anyway, here's the info I found for you I hope it helps.
Fetal Risk Summary
Sparfloxacin is an oral, synthetic, broad-spectrum antibacterial agent. As a fluoroquinolone, it is in the same class of agents as ciprofloxacin, enoxacin, levofloxacin, lomefloxacin, norfloxacin, and ofloxacin. Nalidixic acid is also a quinolone drug.
Reproduction studies, conducted in male and female rats, found no evidence of impaired fertility or reproductive performance at oral doses approximately 15 times the maximum human dose on a mg/m2 basis (MHD) (1). No teratogenic effects were observed in rats, rabbits, and monkeys at oral doses approximately 6, 4, and 3 times, respectively, the MHD, although maternal toxicity was evident at these dose levels. When the dose was increased to about 9 times the MHD or higher in pregnant rats, a dose-dependent increase in the number of fetuses with ventricular septal defects was observed. This effect did not occur in rabbits or monkeys.
In a prospective follow-up study conducted by the European Network of Teratology Information Services (ENTIS), data on 549 pregnancies exposed to fluoroquinolones (none to sparfloxacin) were described in a 1996 Reference (see also Ciprofloxacin) (2). Data on another 116 prospective and 25 retrospective pregnancy exposures to the antibacterials were also included. Of the 666 cases with known outcome, 32 (4.8%) of the embryos, fetuses, or newborns had congenital malformations. Based on previous epidemiologic data, the authors concluded that the 4.8% frequency of malformations did not exceed the background rate (2). Finally, 25 retrospective reports of infants with anomalies, who had been exposed in utero to fluoroquinolones, were analyzed, but no specific patterns of major congenital malformations were detected.
The authors of the above study concluded that pregnancy exposure to quinolones was not an indication for termination, but that this class of antibacterials should still be considered contraindicated in pregnant women. Moreover, this study did not address the issue of cartilage damage from quinolone exposure, and the authors recognized the need for follow-up studies of this potential toxicity in children exposed in utero. Because of their own and previously published findings, they further recommended that the focus of future studies should be on malformations involving the abdominal wall and urogenital system, and on limb-reduction defects (2).
In summary, although no reports describing the use of sparfloxacin during human gestation have been located, the available evidence for other members of this class indicates that a causal relationship with birth defects cannot be excluded (see Ciprofloxacin, Norfloxacin, or Ofloxacin), although the lack of a pattern among the anomalies is reassuring. Because of these concerns and the available animal data, the use of sparfloxacin during pregnancy, especially during the 1st trimester, should be considered contraindicated. A 1993 review on the safety of fluoroquinolones concluded that these antibacterials should be avoided during pregnancy because of the difficulty in extrapolating animal mutagenicity results to humans and because interpretation of this toxicity is still controversial (3). The authors of this review were not convinced that fluoroquinolone-induced fetal cartilage damage and subsequent arthropathies were a major concern, even though this effect had been demonstrated in several animal species after administration to both pregnant and immature animals and in occasional human case reports involving children (3). Others have also concluded that fluoroquinolones should be considered contraindicated in pregnancy, because safer alternatives are usually available (2).
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