Blood Pressure Home > Tekamlo and Pregnancy

Based on the results of animal studies, the FDA considers Tekamlo (aliskiren/amlodipine) a pregnancy Category D medication. This means that the risk of problems the drug presents to the fetus is typically greater than any benefit the woman might gain from taking it. All other alternatives should be explored first since Tekamlo can cause serious birth defects and even fetal death.

Can Pregnant Women Take Tekamlo?

Tekamlo™ (aliskiren/amlodipine) is a prescription medication approved to treat high blood pressure (hypertension). Pregnant women should not take Tekamlo, due to possible problems seen with medications similar to the aliskiren component of it.
 

What Is Pregnancy Category D?

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 D is given to medications that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents.
 
Thus, a pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
 
Tekamlo was given a Category D classification based on problems seen with other related blood pressure medications. Because of these problems, Tekamlo has not been studied in any pregnant women, which would be unethical.
 

The Effects of Tekamlo on the Renin-Angiotensin System

Many blood pressure medications (including Tekamlo) work by acting on the renin-angiotensin systems. Such medications should be avoided during pregnancy in almost all situations, as they have been shown to cause serious problems.
 
Other medications that work on the renin-angiotensin system (such as angiotensin-converting enzyme inhibitors, also known as ACE inhibitors) have been shown to cause problems such as:
 
  • Low blood pressure of the fetus or newborn
  • Skull problems
  • Severe kidney problems
  • Fetal and newborn death.
     
These problems were seen when such medications were used in the second or third trimesters. Other problems (such as birth defects) have been reported when these medications were used in the first trimester.
 
Medications like Tekamlo that work on the renin-angiotensin system should never be used during pregnancy unless they are lifesaving to the mother and no other alternatives are available.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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