THIS MEDICATION MAY CAUSE HARM TO YOUR BABY:
Altabax is expected to be safe during pregnancy and while breastfeeding a baby. There have been no human studies that have looked at the safety of Altabax during pregnancy. It is important to consider the risks versus benefits before administering this medication in pregnant women.
What is Altabax?
Altabax is a medication known as a topical antibiotic that is used on the skin in infants over 9 months old, children, adolescents, and adults. Altabax is currently only available as a brand name medication. It was approved by the FDA in 2007 as a new class of antibiotic. The active ingredient in Altabax is retapamulin. It is available as an external ointment and is applied twice daily for 5 days. It is only available with a prescription from your doctor.
What is Altabax used to treat?
Altabax is used to treat impetigo, a bacterial skin infection that occurs on the face, lips, legs, or arms. It is caused by Staphylococcal (staph) or Streptococcal (strep) bacteria that enter the skin through a cut or bite. Impetigo causes the development of red, itchy, and crusty sores on the face or limbs. Impetigo is contagious and can be passed on when others come into contact with the sores. Scratching, clothing, or towels can cause impetigo to spread to other areas of the body. Impetigo is most common in children 2-6 years of age. The most effective way to prevent impetigo is to wash the skin thoroughly after a cut, scratch, or bite. Impetigo is treated with antibiotics as well as measures to minimize its contagiousness such as washing hands after touching the infected area or applying an antibiotic even if using gloves, regularly washing clothes and towels, and separating infected persons from others while they are contagious.
How does Altabax work?
Altabax works by keeping bacteria from multiplying through interference with bacterial protein synthesis.
If I am using Altabax, can it harm my baby?
There is limited safety information available on Altabax use during pregnancy. It is recommended to use Altabax during pregnancy only if the benefits to the mother outweigh risks to the baby.
Evidence from animal studies with Altabax:
Adverse events have not been reported with use of Altabax in animal studies. Oral administration of retapamulin in pregnant rats caused maternal toxicity and decreased maternal weight gain, decreased weight in the babies, and decreased bone growth in the babies. No birth defects were reported in rats. Injectable retapamulin given at doses 8 times the maximum recommended human dose in pregnant rabbits caused maternal toxicity with decreased maternal weight gain and pregnacy loss, but no birth defects.
Evidence for the risks of Altabax in human babies:
There are no studies or case reports on the use of Altabax in human pregnancy.
Bottom line: Altabax is expected to pose a low risk of harm to the developing baby during pregnancy.
If I am using Altabax and become pregnant, what should I do?
If you are using Altabax and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.
If I am using Altabax, can I safely breastfeed my baby?
It is unknown if Altabax passes into human breast milk. The manufacturer of this medication recommends caution if using this medication by women who are nursing babies. Altabax is a topical ointment that is not expected to be widely absorbed into the body. This medication is not expected to cause any adverse events in nursing infants. It is recommended to weigh the risks versus benefits before administering this medication while breastfeeding.
Bottom line: Altabax is expected to be safe during breastfeeding.
If I am using Altabax, will it be more difficult to get pregnant?
There have been no studies in men or women that have looked at the effects of Altabax on fertility. Animal studies suggest that Altabax has no negative effects on male or female fertility.
If I am using Altabax, what should I know?
There are no available studies assessing the safety of Altabax during human pregnancy. However, because this medication is topically applied, it is expected to be safe to use in pregnancy and during breastfeeding.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of Altabax during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert reports about skin conditions and the medications used to treat them here. Additional information can also be found in the links below.
For more information about Altabax during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
Mayo Clinic : Impetigo
U.S. Food and Drug Administration: Altabax Prescribing Information