5 Classified Category of Medicinal Drugs in Pregnancy

This article is all about Medicinal Drugs in pregnancy, their 5 category and some note on over the counter(OTC) drugs, In the past, the FDA had established prescription drugs in pregnancy risk categories as A, B, C, D or X, which helped to define if a drug could be thought of as safe to take during pregnancy.

FDA Pregnancy Risk Categories

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Comprises of safe drug in pregnancy

Example drugs or substances: levothyroxine, folic acid, liothyronine, multivitamins.

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. basically these drugs have adverse effect on animals but all studies in human are safe, hence this drug can be taken during pregnancy.

Example drugs: metformin, hydrochlorothiazide, cyclobenzaprine, amoxicillin, penicillin, nitrofurantoin, cephalosporin, metronidazole, didanosine.

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.That is, these drugs are found to be teratogenic in animals but inadequate studies to prove such in humans.

Example drugs: gabapentin, amlodipine, trazodone, mebendazole, albendazole, acyclovir, chloroquine, lamotrigine( anti epileptic drug, drug of choice in pregnancy for epilepsy)

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. It is a known human teratogen.

Example drugs: losartan, quinine, Antiepileptic (Phenytoin, Carbamazepine)

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. These are totally contraindicated drugs in pregnancy.

Example drugs: atorvastatin, simvastatin, methotrexate, finasteride, Alcohol, Vitamin A, Androgens, Lithium, Warfarin(in early pregnancy), Radioiodide, Tetracyclins, Cancer Chemotherapeutic drugs.

However, in 2015 the FDA decided to replace these risk categories on prescription drug labels with new information to make them more meaningful to both patients and healthcare providers, allowing better counseling and informed decision making.

Labeling for OTC medicines will not change; OTC drug products are not affected by the new FDA pregnancy labeling.
It’s important to learn about the safety of over-the-counter (OTC) medications before you become pregnant. the most common OTC medications used in the first trimester included:

• acetaminophen/ Paracetamol
• ibuprofen
• docusate
• pseudoephedrine
• aspirin
• naproxen

Medicinal Drugs in Pregnancy

In the US, 9 out of 10 women take medicine during pregnancy, but not all medicines are safe to take during pregnancy.
Fewer than 10% of medicines have enough information to determine the risk to the baby.
This raises concern as some medications used during organogenesis (the time period of a baby’s organ development in the first 12 weeks) can be associated with developmental abnormalities.
That’s why it is important to ask your health care provider about medication use if you are pregnant – even for over-the-counter medications, herbal products, and dietary supplements like vitamins.