Tussionex and Pregnancy

The U.S. Food and Drug Administration has classified Tussionex (hydrocodone polistirex/chlorpheniramine polistirex) as a pregnancy Category C medication, which means it may not be safe for pregnant women to use this prescription medication. Some animal studies indicated that the drug might increase the risk of birth defects. However, this may not necessarily apply to humans, and the medicine may be prescribed if the benefits outweigh the risks.

Can Pregnant Women Take Tussionex?

Tussionex® Pennkinetic® (hydrocodone polistirex/chlorpheniramine polistirex) is a prescription medication used to relieve coughing and respiratory symptoms caused by allergies and the common cold. Based on animal studies and limited human studies, Tussionex may not be 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.
Tussionex has not been studied in pregnant women. However, hydrocodone, one of the active ingredients in it, has caused problems in animal studies. When given to pregnant hamsters, a single dose of hydrocodone increased the risk of birth defects, including cranial defects.
Limited human studies also indicate that hydrocodone use may increase the risk of birth defects, including heart defects. However, it is possible that in these human studies, the women's underlying disease or use of other medications contributed to the observed birth defects.
Hydrocodone is a narcotic and using this drug during the end of a pregnancy may cause narcotic withdrawal or breathing problems in the infant after delivery. Withdrawal symptoms may include:
  • Hyperactive reflexes
  • Fast breathing
  • Increased stools
  • Sneezing
  • Irritability and excessive crying
  • Shakiness (tremors)
  • Yawning
  • Vomiting
  • Fever.
Tussionex also contains chlorpheniramine, an antihistamine. The use of antihistamines during the last two weeks of pregnancy may increase the risk of retinopathy of prematurity (an eye problem in premature infants that can lead to blindness).
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
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