Getting ill such as cough, flu, and fever during pregnancy is a common matter, and almost every pregnant woman will face a decision about taking medicine during their pregnancy. Most of the time, people will recommend avoiding medications as it is hard to know if a medicine is safe for the foetus. Many medications are not studied on pregnant women as the researchers afraid they might be harmful to the unborn baby. However, on some occasion, medications may be a medical necessity to ease the illness symptoms. To decide whether or not to use the medicine, we should always consider the medicine’s benefits and risks to the mother and growing baby.
Fortunately, many medications have been prescribed over decades to pregnant patients and are considered safe to be taken during pregnancy. The majority of over-the-counter (OTC) medications are used for symptoms of allergy, respiratory and gastrointestinal conditions as well as general analgesia. Below is a summarized table of medications for minor ailments that are safe to be used during pregnancy.
|
Indications |
Medications |
|
Analgesia and antipyretic |
Acetaminophen / Paracetamol |
|
Cough |
Diphenhydramine, Dextromethorphan, Bromhexine |
|
Flu / Runny nose |
Chlorpheniramine, Loratadine, Cetirizine |
|
GERD / Heart burn |
Omeprazole, Gaviscon, Mixture Magnesium Trisilicate |
|
Nausea, vomit |
Meclozine (Veloxin), Dimenhydrinate |
|
Constipation |
Fruit Fibre, Lactulose |
|
Skin conditions: eczema / fungal infection |
Hydrocortisone 1% cream, Miconazole cream, Nystatin cream |
Source: Am Fam Physician. 2003 Jun 15;67(12):2517-2524. OTC Medications in Pregnancy.
In addition, the public should always check with healthcare professionals (doctor/pharmacist), product leaflets for the safe use of OTC medications. United States Food and Drug Administration (FDA) has implemented the Risk Category (Safety of Drugs in Pregnancy) for public and healthcare professionals to identify the benefits and risks of the medicines. The public can check on the category of the prescribed medications on MIMS Malaysia (www.mims.com/malaysia) and discuss with healthcare professionals when deciding about treatment.
|
Definitions of Risk Factors These definitions are those used by the United States Food and Drug Administration (FDA). These categories do not imply an increasing progression of risk from A to X. Drugs are categorised based on the risk of reproductive and developmental adverse effects and on risk versus benefit considerations. Drugs in categories D, X, and in some cases C, may pose similar risk, but may be categorised differently on the basis of different risk versus benefit considerations.
|
|
|
Category A:
|
Controlled studies in women fail to demonstrate a risk to the foetus in the 1st trimester (and there is no evidence of a risk in later trimesters), and the possibility of foetal harm remains remote.
|
|
Category B: |
Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
|
|
Category C: |
Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
|
|
Category D: |
There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
|
|
Category X: |
Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
|
|
Category Z: |
A group of drugs with pregnancy related alerts from expert committees or regulatory agencies, but not assigned with any US FDA Pregnancy Category, have been classified as Category Z.
There are studies, recommendations or alerts from respective expert committees and/or regulatory agencies for healthcare professionals regarding use of this drug during pregnancy. Read the accompanying text in the generic monographs for more information. |
Source: MIMS Malaysia.
I know you are about to ask: “Apart from OTC medicines, what about herbal remedies and vitamins? Are they safer compared to medicines?” No one can tell if the herbal product is 100% safe for pregnant women, so it is best not to use them. There are even some natural products that are contraindicated in women who are pregnant, such as St. John’s wort, Ephedra, Horseradish, Chasteberry, Black cohosh, etc. Some labels on herbal products claim that they will help with pregnancy, but most of the time there are inadequate studies to show their effectiveness. Therefore, it is advisable to discuss with healthcare professional before consuming any herbal product. Some vitamins are important throughout the pregnancy including folic acid and iron for the prevention of neural tube defect and anaemia. However, vitamins such as Vitamin A taken in high doses (as retinoids more than 25000 IU per day) are known to cause malformation to the baby. Alternatively, pregnant women can choose to use non-drug alternatives whenever possible to manage minor health concerns. For example, taking small frequent meals and avoid spicy food to prevent heartburn, use salt water (normal saline) nasal rinse to treat nasal congestion, taking enough rest as well as avoid foods that may trigger nausea, drinking hot honey lemon to relieve symptoms of cough and sore throat.
Last but not least, although the majority of the OTC medications deemed to be safe, there are still some products that could potentially harmful to the growing baby or causing problems during labour. The public is welcome to request information and recommendations from physicians and pharmacists to ensure the safe use of medications and OTC products during pregnancy.
By Ms Carol Leong, Vcare Pharmacist.
References:
- MIMS Malaysia
- Servey J, Chang J. Over-the-Counter Medications in Pregnancy. Am Fam Physician. 2014 Oct 15;90(8):548-55. Erratum in: Am Fam Physician. 2015 Sep 1;92 (5):332. PMID: 25369643.
- Centers for Disease Control and Prevention. Treating for two: safer medication use in pregnancy. www.cdc.gov/treatingfortwo. Accessed June 20, 2019.
