LaViv and Pregnancy

The FDA has assigned a pregnancy Category C rating to LaViv (azficel-T) because no pregnancy studies have been performed on the drug. Because the risks are unclear -- and because this product is a cosmetic treatment that is not medically necessary -- your healthcare provider may recommend delaying treatment until after pregnancy.

Is LaViv Safe During Pregnancy?

LaViv™ (azficel-T) is a unique cellular therapy used to treat smile lines. It contains a person's own cells, multiplied in a laboratory, which are then injected back into the skin. It is not known if the product is safe for use during pregnancy.

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
LaViv received a pregnancy Category C rating because there is no experience with the drug in any pregnant animals or humans.
Because it takes three to six months after the initial skin sample (biopsy) for the laboratory to make your LaViv doses, it is altogether possible for a woman to become pregnant after the biopsy, before receiving any doses. In this situation, the unknown risks to the fetus should be weighed against having to discard the drug if it will expire before the baby is born. It is unclear who would be financially responsible in such a situation: the individual, the healthcare provider, or the laboratory.

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Last reviewed by: Kristi Monson, PharmD
Pregnancy and Pain