Analpram HC

Other Corticosteroid Combinations
Topical Anti-hemorrhoidals
Topical Anti-hemorrhoidals with Corticosteroids

Nonprescription preparations should not be used for self-medication for longer than 7 days; if condition worsens or symptoms persist, the drug should be discontinued and a physician consulted.
Wash hands before and after application.

Cream, ointment, gel: Apply sparingly in a thin film and rub gently into the cleansed affected area. Occlusive dressings may be necessary for severe conditions. 
Lotion: For cleansing, apply to cotton or cleansing tissue and gently wipe the affected area.

Aerosol foam: Shake the container vigorously for 5—10 seconds before each use. Prior to first use, while holding the container upright, prime the pump by pressing down several times (usually 1—2 pumps) on container cap until foam appears. Dispense foam onto a cleansing tissue or pad and gently rub into the cleansed affected area. Fingers or any other mechanical device should not be used to administer the aerosol foam. The container and cap should be disassembled and rinsed with warm water after each use.

Aerosol foam administration
NOTE: The aerosol foam can also be used for topical administration to the perianal area.
Wash hands before and after application.
Place cap on top of container and shake the container vigorously for 5—10 seconds before each use; cap should not be removed during use.
Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. Container must be held upright to obtain proper flow of medication.
Pull applicator plunger past the fill line on the applicator barrel.
Hold the container and applicator at eye level. Place the index and middle fingers on the container cap flanges and the thumb beneath container; support the applicator with the other hand. Prime the container by pressing down firmly on the flanges and then release. With initial priming, a burst of air may come out of the container. It usually requires 1—2 pumps for foam to appear.
To fill the applicator barrel, press down firmly on cap flanges, hold for 1—2 seconds, and release. Allow 5—10 seconds for foam to expand in the applicator barrel. Repeat until the foam reaches the fill line. It usually requires 3—4 pumps for foam to reach fill line. Remove applicator from container cap. If foam goes beyond fill line, it will continue to expand and flow backwards resulting in foam build-up under cap.
Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. Apply to anus only with the applicator provided with the foam. Do not insert any part of the applicator past the anus into the rectum. Fingers or any other mechanical device should not be used to administer the aerosol foam. Do not insert any part of the aerosol container directly into the anus.
The rectal foam can also be applied topically to the perianal area. For topical application prime the container as described above. Dispense foam onto a cleansing tissue or pad and gently rub into the cleansed affected area. Fingers or any other mechanical device should not be used to administer the aerosol foam.
The container and cap should be disassembled and rinsed with warm water after each use. The applicator parts should be pulled apart for thorough cleaning with warm water after each use.
Cream administration
NOTE: The cream can also be used for topical administration to the perianal area.
Wash hands before and after application.
Use provided cleansing wipe to gently clean the affected area.
Remove cap from tube and puncture foil. Attach the provided applicator and squeeze tube until the applicator is full.
Gently insert the tip of the filled applicator approximately 1/2 inch into the anus and squeeze the tube to dispense cream to the anus and the perianal area. Do not insert the applicator further into the anus or into the rectum. Cream can be applied topically to the perianal area with the fingertip.
Remove the applicator and tube and thoroughly clean the applicator.

anaphylactoid reactions / Rapid / Incidence not known
bronchospasm / Rapid / Incidence not known
skin atrophy / Delayed / Incidence not known

contact dermatitis / Delayed / Incidence not known
bleeding / Early / Incidence not known
edema / Delayed / Incidence not known
erythema / Early / Incidence not known
hyperesthesia / Delayed / Incidence not known
Cushing's syndrome / Delayed / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
glycosuria / Early / Incidence not known
hyperglycemia / Delayed / Incidence not known

urticaria / Rapid / Incidence not known
skin irritation / Early / Incidence not known
pruritus / Rapid / Incidence not known
infection / Delayed / Incidence not known
acneiform rash / Delayed / Incidence not known
miliaria / Delayed / Incidence not known
hypertrichosis / Delayed / Incidence not known
xerosis / Delayed / Incidence not known
purpura / Delayed / Incidence not known
skin hypopigmentation / Delayed / Incidence not known
striae / Delayed / Incidence not known

Analpram HC, EndaRoid, Enzone, Epifoam, HC Pram, Mezparox-HC, Novacort, PRAM-HCA, PramCort, Pramosone, ProCort, Proctocream-HC, ProctoFoam HC, Z-Pram, Zone A, ZyPram

Rx

Combination of a glucocorticoid and local anesthetic
Used for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
Available in topical cream, lotion, ointment, and aerosol foams

Apply a thin layer topically to the affected skin area(s) 3 to 4 times daily.

Apply a thin layer topically to the affected skin area(s) 3 to 4 times daily.

Apply topically to the affected skin area(s) 3 to 4 times daily.

Apply topically to the affected skin area(s) 3 to 4 times daily.

Apply to the affected area 3 or 4 times daily. The foam may also be placed on a perianal pad and applied externally as required to relieve pain and itching.

Apply to the affected area 3 or 4 times daily. The foam may also be placed on a perianal pad and applied externally as required to relieve pain and itching.

Apply a thin layer topically to the affected skin area(s) 3 to 4 times daily.

Apply a thin layer topically to the affected skin area(s) 3 to 4 times daily.

Apply topically to the affected skin area(s) 3 to 4 times daily.

Apply topically to the affected skin area(s) 3 to 4 times daily.

No dosage adjustment needed for topical or rectal products.

No dosage adjustment needed for topical or rectal products.

Adapalene; Benzoyl Peroxide: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
Benzalkonium Chloride; Benzocaine: (Moderate) Caution is advised if combining topical local anesthetics. The toxic effects of local anesthetics are additive. In addition, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed.
Benzocaine: (Moderate) Caution is advised if combining topical local anesthetics. The toxic effects of local anesthetics are additive. In addition, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed.
Benzocaine; Butamben; Tetracaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia. (Moderate) Caution is advised if combining topical local anesthetics. The toxic effects of local anesthetics are additive. In addition, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed.
Benzoyl Peroxide: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
Benzoyl Peroxide; Clindamycin: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
Benzoyl Peroxide; Erythromycin: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
Benzoyl Peroxide; Sulfur: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
Dibucaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
Ethyl Chloride: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
Lidocaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
Lidocaine; Epinephrine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
Lidocaine; Hydrocortisone: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
Lidocaine; Menthol: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
Lidocaine; Prilocaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
Lidocaine; Tetracaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
Tetracaine: (Moderate) Caution is advised if combining local anesthetics. The toxic effects of local anesthetics are additive. A major cause of adverse reactions appears to be excessive plasma concentrations, which may be due to accidental intravascular administration, slow metabolic degradation, or overdosage. In addition to additive toxic effects, rare and sometimes fatal cases of methemoglobinemia have been reported with the use of topical or oromucosal benzocaine-containing products. Clinicians should closely monitor patients for the development of methemoglobinemia when a combination local anesthetic is used during a procedure. If a patient becomes cyanotic or if elevated methemoglobin concentrations are suspected, immediately institute treatment to counteract methemoglobinemia (such as administration of methylene blue) as oxygen delivery is ineffective throughout the body until the condition is reversed. Patients who are receiving other drugs that can cause methemoglobin formation, such as prilocaine, are at greater risk for developing methemoglobinemia.
Tretinoin; Benzoyl Peroxide: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.

Analpram HC/EndaRoid/Enzone/HC Pram/Hydrocortisone Acetate, Pramoxine Hydrochloride/Hydrocortisone, Pramoxine/Mezparox-HC/PramCort/PRAM-HCA/Pramosone/ProCort/Proctocream-HC/Zone A/Z-Pram/ZyPram Topical Cream: 1-1%, 1.85-1.15%, 2.35-1%, 2.5-1%
Analpram HC/Pramosone Topical Lotion: 1-1%, 2.5-1%
Epifoam Topical Foam: 1-1%
Hydrocortisone Acetate, Pramoxine Hydrochloride/Hydrocortisone, Pramoxine/PRAM-HCA/Z-Pram/ZyPram Rectal Cream: 2.35-1%
Novacort Topical Gel: 2-1%
Pramosone Topical Ointment: 1-1%, 2.5-1%
ProctoFoam HC Topical Aer Foam: 1-1%

No maximum dosage information is available.

No maximum dosage information is available.

No maximum dosage information is available.

>= 2 years: No maximum dosage information is available.
< 2 years: Safety and efficacy have not been established.

•Hydrocortisone: Topical application of hydrocortisone produces anti-inflammatory, antipruritic, and vasoconstrictor actions to decrease local inflammation, itching, and swelling. The activity is thought to result at least in part from binding with a steroid receptor. Hydrocortisone reduces inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly other mechanisms as yet unknown.
 
Tachyphylaxis to the anti-inflammatory effects of hydrocortisone may occur with repeated application although the clinical importance of this effect is unknown. Following 3-times daily application to normal skin at the same site, diminished vasoconstrictor response may occur within 45 days. Withdrawal of the drug for 24 days restores response, although maximum vasoconstrictor response may be diminished; when application of the drug is reinstated, tachyphylaxis recurs.
 
•Pramoxine: Pramoxine hydrochloride is a local anesthetic that interferes with the transmission of impulses along sensory nerve fibers to relieve pain, itching, and irritation. Local anesthetics block both the initiation and conduction of nerve impulses from sensory nerves by decreasing the permeability of the neuronal membrane to sodium ions. This reversibly stabilizes the membrane and inhibits depolarization, resulting in the failure of a propagated action potential and subsequent conduction blockade.

Hydrocortisone and pramoxine combinations are given through topical or rectal administration.

Hydrocortisone: Percutaneous penetration of hydrocortisone varies among individual patients and can be increased by the use of occlusive dressings, by increasing the concentration of the hydrocortisone, and by using different formulation vehicles. Following topical application of hydrocortisone to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation; however, the absorption is markedly increased when the skin has lost its keratin layer and absorption can also be increased by the presence of inflammation and/or diseases of the epidermal barrier. Even after washing the area being treated, prolonged absorption of hydrocortisone occurs, possibly because it is retained in the stratum corneum. Topical preparations of hydrocortisone are metabolized in the skin.
Pramoxine: Pramoxine is applied topically to the skin and its anesthetic effects are typically apparent within 3—5 minutes. Although poorly absorbed through the intact epidermis, pramoxine is readily absorbed from mucous membranes. When skin permeability has been increased by abrasions or ulcers, the absorption and efficacy of pramoxine improves. No other pharmacokinetic information is available.

Hydrocortisone; pramoxine is classified FDA pregnancy risk category C; pregnant women should consult a qualified health care professional prior to the use of these drug products. There have been reports of complications associated with systemic corticosteroids (e.g. cleft palate, still birth, and premature abortion), however, systemic absorption of hydrocortisone; pramoxine should not be significant and adverse fetal and infant effects are not typically reported with topical corticosteroid use in the mother during pregnancy. Hydrocortisone; pramoxine should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women.

According to the manufacturer, caution should be exercised when topical corticosteroids are administered to a breast-feeding woman. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Additionally, the American Academy of Pediatrics (AAP) considers systemically administered prednisone to be usually compatible with lactation. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.