managing common ambulatory issues in the pregnant patient lee m. stetzer, md albany regional family...

Managing common Managing common ambulatory issues in the ambulatory issues in the

pregnant patientpregnant patient

Lee M. Stetzer, MDLee M. Stetzer, MDAlbany Regional Family Medicine Albany Regional Family Medicine

ConferenceConference

October 15, 2011 October 15, 2011

IntroductionIntroduction

• ““placental barrier”placental barrier”• Thalidomide: 30% of exposed infants with Thalidomide: 30% of exposed infants with

developmental defectsdevelopmental defects• 1962: FDA requires that medications are 1962: FDA requires that medications are

shown to be safe and effectiveshown to be safe and effective• Do rate and extent of transfer of Do rate and extent of transfer of

medications result in significant medications result in significant concentration in the fetus?concentration in the fetus?

Source: 1

FDA Risk CategoriesFDA Risk Categories

• Rate medications as A, B, C, D, or XRate medications as A, B, C, D, or X• Mandated for medications approved Mandated for medications approved

after 1980after 1980• Do not refer to breastfeeding riskDo not refer to breastfeeding risk• Danger of oversimplificationDanger of oversimplification

• Risk may be modified by when or how Risk may be modified by when or how long medications are usedlong medications are used

Source: 1


• A: Controlled studies in women fail to A: Controlled studies in women fail to demonstrate a risk to the fetus in the demonstrate a risk to the fetus in the first trimester (and there is no first trimester (and there is no evidence of risk in later trimesters), evidence of risk in later trimesters), and the possibility of fetal harm and the possibility of fetal harm seems remote.seems remote.


• B: Either animal-reproduction studies B: Either animal-reproduction studies have not demonstrated a fetal risk but have not demonstrated a fetal risk but there are no controlled studies in there are no controlled studies in pregnant women or animal reproduction pregnant women or animal reproduction studies have shown an adverse effect studies have shown an adverse effect (other than decrease in fertility) that was (other than decrease in fertility) that was not confirmed in controlled studies in not confirmed in controlled studies in women in the first trimester (and there is women in the first trimester (and there is no evidence of risk in later trimesters). no evidence of risk in later trimesters).


• C: Either studies in animals have C: Either studies in animals have revealed adverse effects on the fetus revealed adverse effects on the fetus (teratogenic or embryocidal or other) (teratogenic or embryocidal or other) and there are no controlled studies in and there are no controlled studies in women or studies in women and women or studies in women and animals are not available. Drugs should animals are not available. Drugs should be given only if the potential benefit be given only if the potential benefit justifies the potential risk to the fetus.justifies the potential risk to the fetus.


• D: There is positive evidence of D: There is positive evidence of human fetal risk, but the benefits human fetal risk, but the benefits from use in pregnant women may be from use in pregnant women may be acceptable despite the risk (e.g., if acceptable despite the risk (e.g., if the drug is needed in a life-the drug is needed in a life-threatening situation or for a serious threatening situation or for a serious disease for which safer drugs cannot disease for which safer drugs cannot be used or are ineffective).be used or are ineffective).


• X: Studies in animals or human beings X: Studies in animals or human beings have demonstrated fetal abnormalities have demonstrated fetal abnormalities or there is evidence of fetal risk based or there is evidence of fetal risk based on human experience or both, and the on human experience or both, and the risk of the use of the drug in pregnant risk of the use of the drug in pregnant women clearly outweighs any possible women clearly outweighs any possible benefit. The drug is contraindicated in benefit. The drug is contraindicated in women who are or may become women who are or may become pregnant.pregnant.

Cases:Cases:

Case 1:Case 1:

23 year old G1P0 at 26 weeks EGA with 23 year old G1P0 at 26 weeks EGA with increasing nasal congestion that interferes increasing nasal congestion that interferes with sleep. She has similar symptoms with sleep. She has similar symptoms every fall. No fever, minimal facial pain or every fall. No fever, minimal facial pain or scratchy throat. She has tried nasal saline scratchy throat. She has tried nasal saline and a cool mist vaporizer in the bedroom and a cool mist vaporizer in the bedroom without improvement. She has put without improvement. She has put impermeable covers over her pillow and impermeable covers over her pillow and mattress. She does not have any pets.mattress. She does not have any pets.

Case 1: allergic rhinitisCase 1: allergic rhinitis


• First lineFirst line• Topical intranasal glucocorticoidsTopical intranasal glucocorticoids

• Other optionsOther options• Oral antihistaminesOral antihistamines

• With or without decongestantsWith or without decongestants• Topical intranasal antihistaminesTopical intranasal antihistamines• Topical intranasal cromolynTopical intranasal cromolyn• Allergen immunotherapyAllergen immunotherapy

Source: 2


• Topical intranasal glucocorticoidsTopical intranasal glucocorticoids• Budesonide (Rhinocort Aqua): Category Budesonide (Rhinocort Aqua): Category

BB• Fluticasone (Flonase, Veramyst): Fluticasone (Flonase, Veramyst):

Category CCategory C• Mometasone (Nasonex): Category CMometasone (Nasonex): Category C• Beclomethasone (Beconase AQ): Beclomethasone (Beconase AQ):

Category CCategory C

Source: 1, 3


• Oral antihistaminesOral antihistamines• First generationFirst generation

• Chlorpheniramine: Category BChlorpheniramine: Category B• Diphenhydramine: Category BDiphenhydramine: Category B

• Second generationSecond generation• Loratidine: Category BLoratidine: Category B• Cetirizine: Category BCetirizine: Category B• Fexofenadine: Category CFexofenadine: Category C

Source: 1, 3


• Oral decongestantsOral decongestants• Pseudoephedrine: Category CPseudoephedrine: Category C

• Possible first trimester riskPossible first trimester risk• Phenylephrine: Category CPhenylephrine: Category C

Source: 1, 3


• Intranasal cromolynIntranasal cromolyn• Category BCategory B• Possible first-line agent for mild Possible first-line agent for mild

symptomssymptoms

Source: 1, 2


• Intranasal antihistaminesIntranasal antihistamines• Azelastine and olopatadine: Category CAzelastine and olopatadine: Category C• No human data, probably low riskNo human data, probably low risk

• Nasal vasoconstrictorsNasal vasoconstrictors• Oxymetazoline: Category COxymetazoline: Category C

Source: 1, 2


• Allergen immunotherapyAllergen immunotherapy• Reasonable to not initiate during Reasonable to not initiate during

pregnancypregnancy• Reasonable to continue maintenance Reasonable to continue maintenance

therapy during pregnancytherapy during pregnancy

Source: 3

Pregnancy RhinitisPregnancy Rhinitis

• Hyperemia and edema of nasal Hyperemia and edema of nasal mucosamucosa

• Pathophysiology unknownPathophysiology unknown• Occurs in 20-30% of pregnant womenOccurs in 20-30% of pregnant women• Therapy (if needed)Therapy (if needed)

• Saline irrigationSaline irrigation• Ipratropium nasal spray (Category B)Ipratropium nasal spray (Category B)• Intranasal steroids not effectiveIntranasal steroids not effective

Source: 3

Case 1 ½Case 1 ½

Same patient returns 2 weeks later. She Same patient returns 2 weeks later. She felt better for a few days, but then felt better for a few days, but then symptoms returned with 10 days of symptoms returned with 10 days of increasing headache and fever to 101° increasing headache and fever to 101° F. Also increased facial pressure. Exam F. Also increased facial pressure. Exam shows purulent intranasal drainage.shows purulent intranasal drainage.

Case 1 ½: Case 1 ½: Acute bacterial Acute bacterial sinusitissinusitis• Pain controlPain control

• acetaminophen (Category B)acetaminophen (Category B)• Ibuprofen (Category B)Ibuprofen (Category B)

• Trimester specific risk existsTrimester specific risk exists• Naproxen (Category C)Naproxen (Category C)• Hydrocodone (Category C)Hydrocodone (Category C)• Codeine (Category C)Codeine (Category C)

Source: 1, 4

Case 1 ½: Case 1 ½: Acute bacterial Acute bacterial sinusitissinusitis• If you choose to use antibiotics….If you choose to use antibiotics….

• Amoxicillin: Category BAmoxicillin: Category B• Trimethoprim-sulfamethoxazole: Trimethoprim-sulfamethoxazole:

Category C-CCategory C-C• Avoid in first trimester and near termAvoid in first trimester and near term

• Erythromycin: Category BErythromycin: Category B• Azithromycin: Category BAzithromycin: Category B

Source: 1, 4

Case 2:Case 2:

24 year old G2P1 at 28 weeks EGA comes 24 year old G2P1 at 28 weeks EGA comes in with worsening heartburn, especially at in with worsening heartburn, especially at night. She does not have nausea, night. She does not have nausea, vomiting, diarrhea, headache, edema, or vomiting, diarrhea, headache, edema, or RUQ pain. The same thing happened RUQ pain. The same thing happened during her last pregnancy 2 years ago, and during her last pregnancy 2 years ago, and instantly resolved after she delivered.instantly resolved after she delivered.

Case 2: GERDCase 2: GERD

24 year old G2P1 at 28 weeks EGA comes 24 year old G2P1 at 28 weeks EGA comes in with worsening heartburn, especially at in with worsening heartburn, especially at night. She does not have nausea, night. She does not have nausea, vomiting, diarrhea, headache, edema, or vomiting, diarrhea, headache, edema, or RUQ pain. The same thing happened RUQ pain. The same thing happened during her last pregnancy 2 years ago, and during her last pregnancy 2 years ago, and instantly resolved after she delivered.instantly resolved after she delivered.

Case 2: GERDCase 2: GERD

• Lifestyle modificationsLifestyle modifications• Tums or Maalox (Category C)Tums or Maalox (Category C)• H2 blockers (all Category B)H2 blockers (all Category B)• PPIsPPIs

• Lansoprazole (Prevacid), esomeprazole Lansoprazole (Prevacid), esomeprazole (Nexium), pantoprazole (Protonix): Category B(Nexium), pantoprazole (Protonix): Category B

• Omeprazole (Prilosec):Category COmeprazole (Prilosec):Category C• Metoclopromide (reglan): Category BMetoclopromide (reglan): Category B

Source: 1

Case 3Case 3

A 30 year old G1P0 at 9 weeks EGA comes A 30 year old G1P0 at 9 weeks EGA comes in with “morning sickness”. She has been in with “morning sickness”. She has been having nausea for a few weeks. She vomits having nausea for a few weeks. She vomits once every few days. She has no fever, once every few days. She has no fever, abdominal pain, or diarrhea. She has had no abdominal pain, or diarrhea. She has had no weight loss. Labs are normal including weight loss. Labs are normal including electrolytes, renal and liver function, TSH, electrolytes, renal and liver function, TSH, and CBC. She would like to avoid and CBC. She would like to avoid medications and try “natural remedies” medications and try “natural remedies” first.first.

Case 3: NauseaCase 3: Nausea

• Overall, poor evidence for Overall, poor evidence for interventionsinterventions

• Lifestyle modificationsLifestyle modifications• Ginger… in any formGinger… in any form• Vitamin B6 (pyridoxine): Category AVitamin B6 (pyridoxine): Category A• Doxylamine: Category ADoxylamine: Category A

• DiclectinDiclectin

Sources: 1,5,6

Case 3: NauseaCase 3: Nausea

• Ondansetron (Zofran): Category BOndansetron (Zofran): Category B• Promethazine (Phenergan): Category Promethazine (Phenergan): Category

CC• MetoclopromideMetoclopromide• Meclizine: Category BMeclizine: Category B

Sources: 1,5,6

Case 4Case 4

A 19 year old G1P0 at 21 weeks EGA A 19 year old G1P0 at 21 weeks EGA presents with 2 days of dysuria. She presents with 2 days of dysuria. She also reports urinary frequency and also reports urinary frequency and urgency for the past 21 weeks. She urgency for the past 21 weeks. She has no fever or back pain.has no fever or back pain.

Case 4: CystitisCase 4: Cystitis

• Potential for obstetric complicationsPotential for obstetric complications• No evidence to support a first-line No evidence to support a first-line

antibioticantibiotic• Cephalosporins all Category BCephalosporins all Category B• Nitrofurantoin: Category BNitrofurantoin: Category B

• Although recent report suggesting need for Although recent report suggesting need for increased study (9)increased study (9)

• Fosfomycin: Category BFosfomycin: Category B

Sources: 1,7,8,9

Case 4: CystitisCase 4: Cystitis• Amoxicillin-Clavulanate: Category B-BAmoxicillin-Clavulanate: Category B-B• Trimethoprim-sulfamethoxazoleTrimethoprim-sulfamethoxazole• Ciprofloxacin: Category CCiprofloxacin: Category C

Sources: 1,7,8

Case 5Case 5• A 24 year old G1P0 at 18 weeks EGA had a URI A 24 year old G1P0 at 18 weeks EGA had a URI

onset about a week ago. Several days later she onset about a week ago. Several days later she presented to the ED with wheezing, dyspnea, presented to the ED with wheezing, dyspnea, and nonproductive cough. No fever. She was and nonproductive cough. No fever. She was given albuterol nebulizer treatments (which given albuterol nebulizer treatments (which helped), and a prescription for an albuterol MDI, helped), and a prescription for an albuterol MDI, which has been helping. She comes to your which has been helping. She comes to your office today, still using the inhaler 4 to 6 times a office today, still using the inhaler 4 to 6 times a day. She has had wheezing in the past with day. She has had wheezing in the past with exertion, but it was never this bad.exertion, but it was never this bad.

Case 5: AsthmaCase 5: Asthma

• Uncontrolled asthma associated with Uncontrolled asthma associated with increased risk for perinatal mortality, increased risk for perinatal mortality, preeclampia, preterm birth, and low preeclampia, preterm birth, and low birthweightbirthweight

• Better control associated with Better control associated with decreased riskdecreased risk

• Course of asthma changes in 2/3 of Course of asthma changes in 2/3 of pregnant womenpregnant women

Source: 10


• Control, control, controlControl, control, control• ““It is safer for pregnant women with It is safer for pregnant women with

asthma to be treated with asthma asthma to be treated with asthma medications than for them to have medications than for them to have asthma symptoms and asthma symptoms and exacerbations…. Inadequate control exacerbations…. Inadequate control of asthma is a greater risk to the fetus of asthma is a greater risk to the fetus than asthma medications are.” (10)than asthma medications are.” (10)

Source: 10


• Albuterol: Category CAlbuterol: Category C• Salmeterol, formoterol: Category CSalmeterol, formoterol: Category C• Budesonide (Pulmicort): Category BBudesonide (Pulmicort): Category B• Mometasone (Asmanex), Mometasone (Asmanex),

beclomethasone (Q-Var), fluticasone beclomethasone (Q-Var), fluticasone (Flovent): Category C(Flovent): Category C

• Combination ICS/LABA: limited dataCombination ICS/LABA: limited data• Prednisone: Category CPrednisone: Category C

Source: 1,10


• Theophylline: Category CTheophylline: Category C• Ipratropium: Category BIpratropium: Category B• Montelukast: Category BMontelukast: Category B

Source: 1,10

In conclusionIn conclusion

• There is always the potential for a There is always the potential for a medication to cross the placentamedication to cross the placenta

• Must balance risks and benefitsMust balance risks and benefits• Consent must be informedConsent must be informed

Sources:Sources:1) Briggs, Gerald G, et al. 1) Briggs, Gerald G, et al. Drugs in Pregnancy and Lactation. Drugs in Pregnancy and Lactation. 88thth Ed. Lippincott Ed. Lippincott

Williams & Wilkins. 2008.Williams & Wilkins. 2008.

2) deShazo, Richard and Kemp, Stephen. 2) deShazo, Richard and Kemp, Stephen. Pharmacotherapy of allergic rhinitisPharmacotherapy of allergic rhinitis. . Up to Date ver 19.2. 2011.Up to Date ver 19.2. 2011.

3) Schatz, Michael. 3) Schatz, Michael. Recognition and management of allergic disease during Recognition and management of allergic disease during pregnancypregnancy. Up to Date ver 19.2. 2010. Up to Date ver 19.2. 2010

4) Hwang, Peter and Getz, Anne. 4) Hwang, Peter and Getz, Anne. Acute sinusitis and rhinosinusitis in adultsAcute sinusitis and rhinosinusitis in adults. Up . Up to Date ver 19.2. 2011to Date ver 19.2. 2011

5) Matthews A, Dowswell T, Haas DM, Doyle M, O'Mathúna DP. Interventions 5) Matthews A, Dowswell T, Haas DM, Doyle M, O'Mathúna DP. Interventions for nausea and vomiting in early pregnancy. Cochrane Database of for nausea and vomiting in early pregnancy. Cochrane Database of Systematic Reviews 2010, Issue 9. Art. No.: CD007575. DOI: Systematic Reviews 2010, Issue 9. Art. No.: CD007575. DOI: 10.1002/14651858.CD007575.pub2.10.1002/14651858.CD007575.pub2.

Sources continued:Sources continued:6) Smith, Judith, 6) Smith, Judith, et aet al. l. Treatment of nausea and vomiting of pregnancy Treatment of nausea and vomiting of pregnancy

(hyperemesis gravidarum and morning sickness)(hyperemesis gravidarum and morning sickness). Up to Date ver 19.2. . Up to Date ver 19.2. 20112011

7) Hooton, Thomas7) Hooton, Thomas. Urinary tract infections and asymptomatic bacteriuria in . Urinary tract infections and asymptomatic bacteriuria in pregnancypregnancy. Up to Date ver 19.2. 2011. Up to Date ver 19.2. 2011

8) Vazquez JC, Abalos E. Treatments for symptomatic urinary tract infections 8) Vazquez JC, Abalos E. Treatments for symptomatic urinary tract infections during pregnancy. Cochrane Database of Systematic Reviews 2011, Issue during pregnancy. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD002256. DOI: 10.1002/14651858.CD002256.pub21. Art. No.: CD002256. DOI: 10.1002/14651858.CD002256.pub2

9) Crider, Krista, 9) Crider, Krista, et alet al. Antibacterial Medication Use During Pregnancy and Risk . Antibacterial Medication Use During Pregnancy and Risk of Birth Defects. of Birth Defects. Arch Pediatr Adolesc Med.Arch Pediatr Adolesc Med. 2009;163(11):978-985 2009;163(11):978-985

10) 10) NAEPP Working Group Report on Managing Asthma During Pregnancy: NAEPP Working Group Report on Managing Asthma During Pregnancy: Recommendations for Pharmacologic TreatmentRecommendations for Pharmacologic Treatment. U.S. DEPARTMENT OF . U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. National Institutes of Health. National HEALTH AND HUMAN SERVICES. National Institutes of Health. National Heart, Lung, and Blood Institute. January 2005Heart, Lung, and Blood Institute. January 2005

managing common ambulatory issues in the pregnant patient lee m. stetzer, md albany regional family...

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evidence of risk

potential risk

controlled studies

fda risk categories

fda risk categories

fda risk categories

animalreproduction studies

animal reproduction