Lyrica or pregabalin is a drug usually prescripted to patients with diagnosed epilepsy. The medicine can be taken by pregnant women, however, a new study published by the Swiss Teratogen Information Service carried out by specialists from the division of Clinical Pharmacology at the Lausanne University Hospital may have discovered a link between the ingestion of Lyrica and birth defects.

There is a North American Antiepileptic Drug Pregnancy Registry where patients under Lyrica treatment can enroll to receive support and information about the safety of antiepileptic drugs during pregnancy. Image Credit:

The researchers, led by Dr. Thierry Buclin, found that 6 percent of infants born out of women using Lyrica presented major birth defects. The mothers took Lyrica during the first trimester of pregnancy.  However, the data is not enough to directly link Lyrica to birth defects, but instead, it must be seen just as a warning to epileptic patients who are planning to have a child.

Lyrica is a strong anticonvulsant that works with chemicals  to slow down the nerves in the brain where seizures origin, but also there is a trend to prescript pregabalin-derived medicine to control anxiety, bipolar disorders or psychosis and to treat fibromyalgia. The ingestion of Lyrica as a pain-killer is also getting really common.

About the study and its conclusions  

The study used data from women both taking Lyrica and women that were not under any type of pregabalin treatment and in that second group 2 percent of the newborns had major birth defects.  It demonstrated an increased risk in babies exposed to pregabalin.

This is not the first time, however, that Lyrica is linked with birth defects. In other experiments, mostly with animals, the drug showed an adverse effect in pregnant animals. Nevertheless, Dr. Buclin disregarded those results since animals and humans have different reactions to chemicals, and the pregnancy mechanisms are different.

Pfizer Inc., one of the world’s first biopharmaceutical companies in the world and the producer of Lyrica stated through its spokesmen that the study can not be used to draw definitive conclusions, and the author of the study agrees.  In that sense, the study aims to be just a first step in the field of pharmacology and human pregnancy interaction, and the authors claimed that this is not at all a certain proof of a definite risk.

The data of the study start out of 164 women who used Lyrica in the first trimester of the pregnancy, prescribed to control different affections and more than 600 women that did not ingest Lyrica. Among the women studied there were smokers and diabetes patients, and 22 out of the 164 were also in treatment with other drugs, so there are a lot of conditions that may have affected somehow the index of birth defects in the study’s conclusions. Abortion and other causes of pregnancy terminations were studied, but in no case, those situations were associated with the pregabalin effect.

About the birth defects

Heart defects and problems in the nervous system were the main issued linked to the ingestion of Lyrica. These defects may start in a very early stage of the pregnancy, so being aware of the pregnancy is essential in order to closely monitor the formation of the baby to detect any problem. In the study, the chromosomal aberration syndromes were excluded.

It is not known if pregabalin passes or affects somehow the breast milk of if it could harm in anyway a newborn baby, however, patients under pregabalin drugs may remain attentive to the development of the nursing baby and with strict medical supervision.

Lyrica has not been studied in children but patients must also take into account the regular side effects the drug may have on them and on the newborns, such as allergic reactions and swelling, troubles within the respiratory system, insomnia, rashes, hives, and blisters or dizziness.

Even though Pfizer states that it is not known if Lyrica can harm the unborn babies, the company recommend to patients in the Medical Guide approved by the U.S. Food and Drug Administration to warn the healthcare provider if they are pregnant or are planning to become pregnant, and let the physician decide whether the patient should take Lyrica while pregnant.

What to do?

The recommendation by most physicians is to avoid drug ingestion during pregnancy. The problem comes when a patient under Lyrica treatment may not have the option to drop the drug since its lack may aggravate the condition for which the treatment was prescribed from the beginning. The recommendation from physicians in the Harvard Medical School is to measure the circumstances of the medical status and to plan the pregnancy with medical supervision and to control very carefully the development of the baby.

Source: Neurology