Is using dipyrone in pregnancy safe?
The answer is yes and no . It all depends on the time of pregnancy and the woman’s health conditions. In general, for safety, the use of dipyrone is not indicated for pregnant women, since it is known that the substance crosses the placental barrier.
Especially in the first and third trimester of pregnancy, the drug should be avoided .
During the second trimester (months 4, 5 and 6), dipyrone can be taken. But remember, with medical advice . Only the doctor can tell whether or not in your specific case it is dangerous to use a medication during pregnancy.
Read more: What is self-medication, causes and what are the consequences?
For pharmacist Dr. Francielle Tatiana Mathias, “dipyrone is not the first medication option for pregnant women. There are studies that demonstrate the possibility of blood changes, mainly in the defense cells. Within the categories of risk of use during pregnancy, the drug demonstrates evidence of risk to the fetus and therefore the use should be evaluated by the doctor, to see if the benefits outweigh the possible risk. ”
Pregnancy risk categories
The Food and Drug Administration (FDA) , the agency that regulates food and medicines in the United States (similarly to ANVISA here in Brazil), classifies the drugs in 5 categories according to the risk of use in pregnancy. The risk categories are A, B, C, D and X. The dipyrone is in D category .
The excerpt below, related to each of the categories, was taken from the “Technical Regulation that establishes warning phrases for active ingredients and excipients in package inserts and medication labeling”, published by ANVISA. Understand the differences:
- Category A : in controlled studies in pregnant women, the drug showed no risk to the fetus in the first trimester of pregnancy. There is no evidence of risk in the subsequent quarters, the possibility of fetal damage being remote;
- Category B : animal studies have shown no fetal risk, but there are also no controlled studies in pregnant women; or else, animal studies revealed risks, but they have not been confirmed in controlled studies in pregnant women;
- Category C : studies have not been carried out on animals or pregnant women; or else, animal studies have shown risk, but there are no studies available in pregnant women;
- Category D : the drug has demonstrated positive evidence of human fetal risk, however, the potential benefits for women may eventually justify the risk, as, for example, in cases of serious or life-threatening illnesses, for which there are no other safer drugs;
- Category X : in studies in animals and pregnant women, the drug caused fetal abnormalities, with clear evidence of risk to the fetus that is greater than any possible benefit for the patient.
Therefore, before using any medication during pregnancy, read the package leaflet and talk to your doctor.
Does Dipyrone in pregnancy harm the baby?
Use during the first trimester can be dangerous because there is a risk of causing fetal malformations, while in the last trimester, dipyrone can cause the arterial duct to close early.
The arterial duct is a small blood channel in fetuses that diverts venous blood from the lungs, which are not yet used by the unborn baby. When this duct closes prematurely, the baby suffocates since without the lungs or the arterial duct, he is not able to breathe.
Read more: Pregnancy week by week: symptoms, stages and baby formation
Which pregnant medicine can you take?
Pregnant women may prefer pain medications that do not include dipyrone. During pregnancy, complaints of headache and toothache are common , two situations in which medications can be a great relief.
In such cases, paracetamol may be an alternative, as it is a drug that is classified as risk level B, being one of the least harmful to the fetus. But be careful, always consult your doctor before taking a medication . The risk of using medications varies from pregnant to pregnant and several factors can increase this risk.
For example, paracetamol is not indicated for people with liver problems. Other factors like blood pressure also influence the risks. Be sure to talk to your doctor.
Commercialization of dipyrone in other countries
Some locations, such as the United States and countries in the United Kingdom, prohibit the sale of dipyrone. The veto is due to the possible risks associated with the drug, especially in relation to agranulocytosis – a condition that causes a drop in the levels of granulocytes (white blood cells) in the blood and that can be fatal.
However, studies that correlate these effects with substance use are controversial. So much so that, as in Brazil, the drug is sold in some European countries. In an evaluation panel developed to clarify the risks of dipyrone, released in 2001, ANVISA (regulatory agency of the Ministry of Health) reached some conclusions:
- The risks attributed to the use of dipyrone in our population are low, and the available scientific data indicating the occurrence of these
risks is not sufficient to indicate a change in regulatory status (sale without prescription);
- The risks of dipyrone are similar to, or less than, that of other analgesics / antipyretics available on the market;
- The change in the current regulation of dipyrone would incur negative aspects for the population, increasing the risks of using other drugs indicated for the same therapeutic purpose.
These results played an important role in the decision to maintain the regulation of the drug in Brazil.
If you are pregnant, even in the second trimester of pregnancy, talk to your obstetrician before using dipyrone. Also remember to notify your doctor of pregnancy or if there is a possibility that you may be pregnant.
If you are in the first or third trimester, stay away from the medication and prefer other options that a specialist can indicate.