Veltin

THE SAFETY OF CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL 1.2%/0.025% (VELTIN) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:

Due to limited information on safety in pregnancy, topical clindamycin/tretinoin gel is not recommended in pregnant or nursing women except when the benefits to the mother outweigh the potential risks to the baby.

What is clindamycin/tretinoin gel?

Veltin is a gel containing a combination of clindamycin and tretinoin. It is a prescription medication used on the skin.  Clindamycin is an antibiotic that kills bacteria on the skin or in the body. Tretinoin is a type of vitamin A that reduces the amount of oil on your skin and helps skin heal faster.

What is clindamycin/tretinoin gel used to treat?

Clindamycin/tretinoin gel is used to treat acne in adults and children over 12 years of age.  Pregnant women experience acne as often as anyone else. You can read about common skin conditions during pregnancy here.

How does clindamycin/tretinoin gel work?

Clindamycin/tretinoin contains clindamycin, an antibiotic that interferes with bacterial protein formation, and tretinoin, a form of Vitamin A or a retinoid that increases the turnover of skin cells.

If I am using clindamycin/tretinoin gel, can it harm my baby?

Studies on the safety of topical clindamycin/tretinoin during pregnancy are limited. Animal studies have shown that the topical combination of clindamycin and tretinoin can cause negative side effects. Topical tretinoin doses several times greater than normal human doses were associated with an increased risk of birth defects in animals. Clindamycin does cross the human placenta. Injectable and oral tretinoin use during pregnancy are associated with a much greater risk for birth defects. Clindamycin/tretinoin gel should only be used in pregnant women when the benefits to the mother outweigh the risks to the developing baby.

If I am using clindamycin/tretinoin gel and become pregnant, what should I do?

Women who are trying to become pregnant or discover they are pregnant while taking clindamycin/tretinoin gel should speak with their doctor. This combination of medications should be avoided during pregnancy, but accidental exposure during early pregnancy is not expected to cause significant harm to the developing baby.

If I am using clindamycin/tretinoin gel, can I safely breastfeed my baby?

It is unknown if clindamycin/tretinoin gel is excreted into breast milk. Oral and injectable clindamycin do enter the breast milk. It is important to weigh the risks versus benefits before taking this medication while breastfeeding. Women should be cautious of where they apply clindamycin/tretinoin gel to avoid unnecessary infant exposure and wash their hands carefully after applying the gel and before handling their baby. The manufacturer of this medication recommends either discontinuing this medication or discontinuing breastfeeding while taking this medication.

If I am using clindamycin/tretinoin gel, will it be more difficult to get pregnant?

The effect of topical clindamycin/tretinoin on fertility has not been tested.

If I am using clindamycin/tretinoin gel, what should I know?

It is important to speak with your doctor to discuss the safety of topical clindamycin/tretinoin exposure during pregnancy or breastfeeding. Limited information is available on the safety of this medication while pregnant. Topical clindamycin and tretinoin are not expected to cause serious side effects, but this combination medication is not recommended during pregnancy or breastfeeding because of negative side effects associated with topical (animal studies), oral, and injectable tretinoin. Clindamycin/tretinoin gel should only be used in pregnant or nursing women when the benefits to the mother are expected to outweigh the potential negative effects on the baby.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of clindamycin/tretinoin gel during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about acne and reports about the medications used to treat it here.  Additional information can also be found in the links below. 

For more information about azelaic acid during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:

Almirall:  Veltin Prescribing Information 

American Academy of Dermatology: Acne

American Academy of Dermatology: Acne Treatment During Pregnancy

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.