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Talacen and Pregnancy

In animal studies, one of the active ingredients in Talacen (acetaminophen and pentazocine) appeared to cause a variety of birth defects. In addition, abusing this drug during pregnancy may lead to problems such as withdrawal symptoms in the newborn, premature birth, and low birth weight. However, a healthcare provider may still prescribe this medication during pregnancy if the benefits outweigh the risks.

Can Pregnant Women Take Talacen?

Talacen® (acetaminophen and pentazocine) is a prescription pain medication used to treat mild-to-moderate pain. It may not be safe for use during pregnancy, although the full risks are currently unknown.
 

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. Talacen is classified as a pregnancy Category C medicine.
 
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. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Talacen is a combination medication. It contains pentazocine, a narcotic pain medication, and acetaminophen (Tylenol®), a non-narcotic pain medication. Talacen itself has not been studied in pregnant women or pregnant animals. However, there is some information about the use of the individual components of this medication during pregnancy.
 
Pentazocine, one of the active components of the drug, was shown to cause a variety of birth defects when given to pregnant hamsters as an injection under the skin (a subcutaneous, or SC, injection). However, it did not appear to cause problems when given to pregnant rabbits or rats.
 
Talacen is an opioid medication associated with the potential for abuse. Abusing it during pregnancy may cause a variety of problems in the newborn, including premature birth, low birth weight, reduced infant head size, and withdrawal symptoms. This is based on reports of women who abused pentazocine while pregnant.
 
Talacen may also cause dependence in an unborn baby if used regularly during pregnancy. There have been reports of withdrawal symptoms occurring in newborns whose mothers took pentazocine chronically during pregnancy. Symptoms of withdrawal in the newborns included:
 
  • Trembling
  • Changes in behavior, such as irritability, jitteriness, and hyperactivity
  • High-pitched crying
  • Sweating
  • Diarrhea
  • Vomiting.
 
Many studies have suggested that taking acetaminophen (the other active component of Talacen) when pregnant does not increase the risk for miscarriages, birth defects, or any other problems. In fact, when used alone, acetaminophen is considered a pregnancy Category B medication, which means it would probably be safe for use during pregnancy. However, taking acetaminophen every day or for most days in late pregnancy may increase the risk of wheezing in the newborn. In some cases, the wheezing may persist into childhood.
 
In addition, taking too much acetaminophen may cause problems, including liver failure and death of the fetus. Many products contain acetaminophen, including prescription and nonprescription pain medicines, as well as many nonprescription cough and cold products. It is important to keep track of the total amount of acetaminophen you take. Do not take more than your healthcare provider recommends.
 
It should be noted that a pregnancy Category C medicine, including Talacen, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. Therefore, a healthcare provider may recommend this product if safer medications are not an option for treating mild-to-moderate pain in a pregnant woman. If your healthcare provider recommends taking this drug during pregnancy, your baby may need to be monitored more closely after birth.
 
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