US Pharm. During the past 20 years, more medications have been made available without a prescription than ever before. This population includes many patients who have chronic health conditions, which can be worsened by the inappropriate use of OTC medications. Of particular concern is the safe use of nonprescription medications in pregnant women. A recent study showed that during pregnancy,
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In the FDA replaced the former pregnancy risk letter categories see below on prescription and biological drug labeling with new information to make them more meaningful to both patients and healthcare providers.
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In the FDA replaced the former pregnancy risk letter categories see below on prescription and biological drug labeling with new information to make them more meaningful to both patients and healthcare providers. The FDA received comments that the old five-letter system left patients and providers ill-informed and resulted in false assumptions about the actual meaning of the letters.
The new labeling system allows better patient-specific counseling and informed decision making for pregnant women seeking medication therapies.
Clinical interpretation is still required on a case-by-case basis. The Pregnancy and Lactation Labeling Final Rule PLLR went into effect on June 30, ; however, the timelines for implementing this new information on drug labels also known as the package insert is variable. Prescription drugs submitted for FDA approval after June 30, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, will be phased in gradually.
Medications approved prior to June 29, are not subject to the PLLR rule; however, the pregnancy letter category must be removed by June 29, For generic drugs, if the labeling of a reference listed drug is updated as a result of the final rule, the abbreviated new drug application ANDA labeling must also be revised.
The A, B, C, D and X risk categories, in use since , are now replaced with narrative sections and subsections to include:. The Pregnancy subsection will provide information about dosing and potential risks to the developing fetus and registry information that collects and maintains data on how pregnant women are affected when they use the drug or biological product.
Information in drug labeling about the existence of any pregnancy registries has been previously recommended but not required until now. Contact information for the registries will also be included, and pregnant women are encouraged to enroll to help provide data on the effects of drug use or biologics in pregnancy. If information for the subsections of Pregnancy Exposure Registry, Clinical Considerations, and Data is not available, these subsections will be excluded. The Risk Summary subheadings are always required, even if no data is available.
Information will include drugs that should not be used during breastfeeding, known human or animal data regarding active metabolites in milk, as well as clinical effects on the infant. Other information may include pharmacokinetic data like metabolism or excretion, a risk and benefit section, as well as timing of breastfeeding to minimize infant exposure. Clinically, many women require drug treatment during pregnancy due to chronic conditions such as epilepsy, diabetes, hypertension high blood pressure , or asthma.
To withhold drug treatment would be dangerous for both mother and baby. In addition, women are having babies at a later age, which can boost the number of women with chronic conditions. The FDA has received requests to improve the decades-old content and format of pregnancy prescription drug labeling since According to the Drug Information Division at the FDA, they obtained input from many affected groups and held public hearings, advisory committee meetings, and focus groups to assess the changes.
In , the FDA issued the proposed rule and then opened a docket for public comments. Clinicians and patients were often confused by the meaning of the pregnancy risk categories because, according to the FDA, it was overly simplistic, led to misinformation, and did not adequately address the available information. Examples of drugs approved since June 30th, showing various new pregnancy and lactation subsections in their labels:. In , the FDA established five letter risk categories - A, B, C, D or X - to indicate the potential of a drug to cause birth defects if used during pregnancy.
The categories were determined by assessing the reliability of documentation and the risk to benefit ratio. These categories did not take into account any risks from pharmaceutical agents or their metabolites in breast milk.
The former pregnancy categories, which still may be found in some package inserts, were as follows:. 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. Example drugs or substances: levothyroxine , folic acid , liothyronine.
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Example drugs: metformin , hydrochlorothiazide , cyclobenzaprine , amoxicillin. 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.
Example drugs: gabapentin , amlodipine , trazodone. 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.
Example drugs: atorvastatin , simvastatin , methotrexate , finasteride. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Subscribe to Drugs. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
We comply with the HONcode standard for trustworthy health information - verify here. Skip to Content. The A, B, C, D and X risk categories, in use since , are now replaced with narrative sections and subsections to include: Pregnancy includes Labor and Delivery : Pregnancy Exposure Registry Risk Summary Clinical Considerations Data Lactation includes Nursing Mothers Risk Summary Clinical Considerations Data Females and Males of Reproductive Potential Pregnancy Testing Contraception Infertility The Pregnancy subsection will provide information about dosing and potential risks to the developing fetus and registry information that collects and maintains data on how pregnant women are affected when they use the drug or biological product.
Examples of drugs approved since June 30th, showing various new pregnancy and lactation subsections in their labels: Addyi flibanserin - indicated for generalized hypoactive sexual desire disorder HSDD in premenopausal women. Descovy emtricitabine and tenofovir alafenamide fumarate - indicated for HIV-1 infection. Entresto sacubitril and valsartan - indicated for heart failure.
Harvoni ledipasvir and sofosbuvir - indicated for chronic viral hepatitis C infection HCV. Praluent alirocumab - indicated for heterozygous familial hypercholesterolemia, or patients with atherosclerotic heart disease who require additional lowering of LDL-cholesterol.
The former pregnancy categories, which still may be found in some package inserts, were as follows: 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.
Example drugs or substances: levothyroxine , folic acid , liothyronine 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. Example drugs: metformin , hydrochlorothiazide , cyclobenzaprine , amoxicillin 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.
Example drugs: gabapentin , amlodipine , trazodone 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.
See additional Similar Jobs. PlumX Metrics. See Additional Similar Jobs. Find your Sharp Rees-Stealy account number. CRH, produced in placental trophoblasts, fetal membranes, and decidual cells, , gradually increases in maternal blood as pregnancy progresses, and then rises exponentially in the month preceding labour. Share full text access. Order Journal Institutional subscription Personal subscription.
Perintology drug categories during pregnancy. Introduction
Pregnancy and OTC Cough, Cold, and Analgesic Preparations
US Pharm. During the past 20 years, more medications have been made available without a prescription than ever before. This population includes many patients who have chronic health conditions, which can be worsened by the inappropriate use of OTC medications. Of particular concern is the safe use of nonprescription medications in pregnant women. A recent study showed that during pregnancy, Analgesics and cough and cold preparations are two of the most common categories of OTC products purchased during pregnancy.
Due to ethical concerns, most safety data available have been provided by postmarketing surveillance reports and retrospective studies.
This classification system allows practitioners to make educated decisions about the use of medications during pregnancy. Each letter indicates the level of safety evidence available to support the use of a medication during pregnancy table 1. Benefits Versus Risks In the United States, about , babies are born each year with birth defects. Some of the most common defects are spina bifida, microtia, hypoplastic left heart, cleft palate, cleft lip, esophageal atresia, anencephaly, omphalocele, and limb reduction.
Since ailments treated with OTC and herbal products in pregnant women are not usually life-threatening, practitioners should also consider suggesting nonpharmacologic remedies, such as rest and fluids.
This article presents information on some common OTC analgesic and cough and cold preparations available. Each section discusses the product, pregnancy category, information regarding safety data in pregnancy, dosing, side effects, and contraindications. The comparison of risks and benefits must be considered for each individual patient.
Information relating to when patients should refer to a physician Tables 2 and 3 is included to assist with the decision-making process. Analgesics Acetaminophen: During pregnancy, acetaminophen is the most widely recommended analgesic medication. Acetaminophen is pregnancy category B during all three trimesters, making it the pain reliever of choice for pregnant patients.
The risk of gastroschisis in the infant was higher in mothers who had taken acetaminophen in conjunction with pseudoephedrine. Overall, acetaminophen is used extensively during pregnancy, and few adverse effects have been reported.
Pregnant patients should be instructed to use the smallest effective dose of the medication. If the medication is ineffective, or required use is more than 10 days, the patient should be referred to her physician.
Other pregnant women who should consult a physician before starting self-treatment are those with renal or hepatic dysfunction, a high-risk pregnancy, a complaint of headache in the third trimester a possible sign of increased blood pressure and eclampsia , any pain rated higher than 6 on a scale of 1 through 10, presence of fever or other signs of infection, or pain associated with any type of trauma. For example, a patient complaining of headache should try resting and lying down in a dark, quiet room.
All three are pregnancy category B in the first and second trimester, and category D in the third trimester. Similar to the OTC products, indomethacin is also a pregnancy category B in the first trimester and D in the third trimester. The data for indomethacin could be applied to the entire class of NSAIDs, as studies for other drugs in this class are lacking. The patient should be screened and referred to her physician when appropriate. Appropriate referrals include, but are not limited to, the criteria mentioned for acetaminophen, a history of gastrointestinal ulceration, blood pressure problems, and a history of NSAID-sensitive asthma.
Pregnant patients should not take NSAIDs for longer than 48 hours without contacting their physician. Salicylates Aspirin is a pregnancy category C in doses less than mg daily and a category D in standard doses in all three trimesters. A pregnant patient should never take aspirin without the approval and guidance of her physician. These oral decongestants are available as monotherapy and in combination products.
These combination products are often more convenient to the patient due to a decreased pill burden and cost. However, similar to nonpregnant patients, pregnant patients should use only the analgesic and cough and cold products that address their symptoms. This will help minimize potential risks from the use of unnecessary medications. Pseudoephedrine and phenylephrine are pregnancy category C in all three trimesters of pregnancy. However, they advise against the use of oral decongestants during the first trimester because of the potential increased risk of gastroschisis an abdominal wall defect.
One prospective study of women using decongestants in their first trimester showed no elevated risk for malformations. Oral decongestants may also result in vasoconstriction, which can induce maternal hypertension and lead to impaired blood flow to the fetus.
Since impaired blood flow can hinder fetal growth, the risks of taking oral decongestants in the first trimester may outweigh the benefits. In the second and third trimesters, pseudoephedrine can be recommended to pregnant patients in appropriate doses. To minimize exposure to the fetus, pregnant patients should take the immediate-release dosage form instead of the extended-release and take the minimum effective dose for the shortest duration possible. They also have sympathomimetic properties and may aggravate some medical conditions, such as diabetes mellitus and hyperthyroidism.
The patient should contact her physician if she has a high-risk pregnancy, a fever, or other signs of infection, if the congestion lasts longer than seven days, or if the medication does not relieve symptoms.
The amount of fetal exposure is minimal due to the small amount of medication absorbed systemically. Few studies are available for any of the nasal preparations. However, one prospective study of and 56 women exposed to intranasal oxymetazoline and phenylephrine, respectively, did not show an increased risk for malformations.
Contraindications include a high-risk pregnancy, fever or any other sign of infection, and congestion longer than seven days. These products should be used cautiously, if at all, in patients who cannot take oral decongestants. The presence of underlying conditions e. An appropriate dose of oxymetazoline is two to three sprays per nostril every 10 to 12 hours maximum two doses per day.
It is important that patients be instructed not to use the medication more often than recommended or longer than three days, due to the risk of rebound congestion. If the medication is not effective, the patient should refer to her physician. Expectorants and Antitussives Guaifenesin: Coughing is a protective reflex.
Guaifenesin works to break up the mucus in the patient's chest to make the cough more productive. If the patient is able to cough up more of the mucus, the cough will likely decrease in frequency as the mucus is cleared.
However, guaifenesin has not been proven effective against cough in patients with common cold symptoms. Guaifenesin is considered pregnancy category C.
Guaifenesin has not been studied as extensively as other OTC products. In one study of pregnant women, there was an association between guaifenesin exposure in the first trimester and an increased incidence of inguinal hernias. Fortunately, emphysema, chronic bronchitis, and heart failure are relatively rare in women who are of childbearing age.
Furthermore, ACE inhibitor use is also traditionally avoided in this patient subset. See table 3 for specific circumstances when patients should not be self-treated for a cough and should be referred to a physician. Dextromethorphan: Since coughing may be protective, it should generally not be suppressed except in certain situations. If the cough is not productive and interferes with sleep, or it is severe in nature, it can be suppressed.
Similar to guaifenesin, dextromethorphan has not been shown to be effective in patients with common cold symptoms. Dextromethorphan is equipotent to codeine as an antitussive and is a pregnancy category C medication. Dextromethorphan exposure in the first trimester has been studied, and no increased risk of malformations was detected.
In women with a first-trimester exposure to dextromethorphan, there were three major and seven minor malformations versus five major and eight minor malformations in the control group.
However, there is still theoretical concern that an antagonist at the N -methyl-d-aspartate receptor might affect fetal brain growth.
To date, this adverse effect has not been studied in humans. Concurrent use of dextromethorphan with central nervous system CNS depressants and monoamine oxidase MAO inhibitors within 14 days should be avoided. It has the same contraindications as guaifenesin therapy. Since the available OTC cough products do not relieve the underlying cause, ACCP advises against the use of cough suppressants and expectorants for cough due to postnasal drip.
For the postnasal drip cough, an antihistamine or decongestant is recommended. Given that guaifenesin and dextromethorphan have questionable efficacy for cough related to the common cold, they should be used sparingly at most in pregnant patients. Nonpharmacologic measures for cough may prove more effective with less risk to the patient.
Thus, loratadine does not treat either rhinorrhea or sneezing from a nonallergic source. Brompheniramine and triprolidine are pregnancy category C. The most common concerns about antihistamine use in pregnancy are cleft palate loratadine and diphenhydramine , polydactyly diphenhydramine , retrolental fibroplasias, and uterine contractions diphenhydramine.
An association was found between antihistamine use in the last two weeks of pregnancy and an increased risk of retrolental fibroplasia. This may cause uterine contractions. Due to lack of information and some theoretical risk, antihistamines should be avoided in the late stages of pregnancy. Several studies have examined antihistamine use in the first trimester and have not shown an increased risk of major malformations over those expected at baseline.
Two possible exceptions are brompheniramine and clemastine limb reduction defects. However, a cause-and-effect relationship has yet to be found. Triprolidine plus pseudoephedrine exposure in the first trimester has been studied in women. Whether this was caused by triprolidine or pseudoephedrine could not be determined due to concurrent use. Caution is also advised regarding antihistamine use if the patient has concurrent narrow-angle glaucoma, peptic ulcer disease, asthma, emphysema, or chronic bronchitis.
Patients should be warned that they may have motor impairment even if they do not feel drowsy. Other anticholinergic side effects are also possible. Menthol is a common ingredient of many throat lozenges, sprays, and topical ointments.
There are no human studies on the use of menthol during pregnancy; thus, its risk is undetermined. The concentration of menthol in these products is low, and the risk of malformations is therefore believed to be small. Retrospective studies with a camphor-based product Vicks VapoRub have not shown any developmental toxicity associated with exposures during pregnancy. However, the American Pharmacist's Association's Handbook on Non-Prescription Drugs recommends patients consult their physician before using these medications.
Echinacea: Echinacea is a common herbal medication used to stimulate the immune system. The evidence available to support the use of echinacea for decreasing the severity and duration of cold symptoms is controversial.