Download Illicit drugs in pregnancy - New York State Academy of

Managing common ambulatory
issues in the pregnant patient
Lee M. Stetzer, MD
Albany Regional Family Medicine Conference
October 15, 2011
Introduction
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“placental barrier”
Thalidomide: 30% of exposed infants with
developmental defects
1962: FDA requires that medications are shown
to be safe and effective
Do rate and extent of transfer of medications
result in significant concentration in the fetus?
Source: 1
FDA Risk Categories
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Rate medications as A, B, C, D, or X
Mandated for medications approved after
1980
Do not refer to breastfeeding risk
Danger of oversimplification
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Risk may be modified by when or how long
medications are used
Source: 1
FDA Risk Categories
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A: Controlled studies in women fail to
demonstrate a risk to the fetus in the first
trimester (and there is no evidence of risk
in later trimesters), and the possibility of
fetal harm seems remote.
FDA Risk Categories
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B: Either animal-reproduction studies have
not demonstrated a fetal risk but there are
no controlled studies in pregnant women
or animal reproduction studies have
shown an adverse effect (other than
decrease in fertility) that was not
confirmed in controlled studies in women
in the first trimester (and there is no
evidence of risk in later trimesters).
FDA Risk Categories
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C: Either studies in animals have revealed
adverse effects on the fetus (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
fetus.
FDA Risk Categories
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D: There is positive evidence of human
fetal 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).
FDA Risk Categories
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X: Studies in animals or human beings
have demonstrated fetal abnormalities or
there is evidence of fetal 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.
Cases:
Case 1:
23 year old G1P0 at 26 weeks EGA with
increasing nasal congestion that interferes with
sleep. She has similar symptoms every fall. No
fever, minimal facial pain or scratchy throat. She
has tried nasal saline and a cool mist vaporizer
in the bedroom without improvement. She has
put impermeable covers over her pillow and
mattress. She does not have any pets.
Case 1: allergic rhinitis
Case 1: allergic rhinitis
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First line
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Topical intranasal glucocorticoids
Other options
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Oral antihistamines
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With or without decongestants
Topical intranasal antihistamines
Topical intranasal cromolyn
Allergen immunotherapy
Source: 2
Case 1: allergic rhinitis
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Topical intranasal glucocorticoids
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Budesonide (Rhinocort Aqua): Category B
Fluticasone (Flonase, Veramyst): Category C
Mometasone (Nasonex): Category C
Beclomethasone (Beconase AQ): Category C
Source: 1, 3
Case 1: allergic rhinitis
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Oral antihistamines
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First generation
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Chlorpheniramine: Category B
Diphenhydramine: Category B
Second generation
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Loratidine: Category B
Cetirizine: Category B
Fexofenadine: Category C
Source: 1, 3
Case 1: allergic rhinitis
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Oral decongestants
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Pseudoephedrine: Category C
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Possible first trimester risk
Phenylephrine: Category C
Source: 1, 3
Case 1: allergic rhinitis
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Intranasal cromolyn
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Category B
Possible first-line agent for mild symptoms
Source: 1, 2
Case 1: allergic rhinitis
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Intranasal antihistamines
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Azelastine and olopatadine: Category C
No human data, probably low risk
Nasal vasoconstrictors
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Oxymetazoline: Category C
Source: 1, 2
Case 1: allergic rhinitis
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Allergen immunotherapy
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Reasonable to not initiate during pregnancy
Reasonable to continue maintenance therapy
during pregnancy
Source: 3
Pregnancy Rhinitis
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Hyperemia and edema of nasal mucosa
Pathophysiology unknown
Occurs in 20-30% of pregnant women
Therapy (if needed)
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Saline irrigation
Ipratropium nasal spray (Category B)
Intranasal steroids not effective
Source: 3
Case 1 ½
Same patient returns 2 weeks later. She felt
better for a few days, but then symptoms
returned with 10 days of increasing headache
and fever to 101° F. Also increased facial
pressure. Exam shows purulent intranasal
drainage.
Case 1 ½: Acute bacterial sinusitis
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Pain control
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acetaminophen (Category B)
Ibuprofen (Category B)
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Trimester specific risk exists
Naproxen (Category C)
Hydrocodone (Category C)
Codeine (Category C)
Source: 1, 4
Case 1 ½: Acute bacterial sinusitis
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If you choose to use antibiotics….
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Amoxicillin: Category B
Trimethoprim-sulfamethoxazole: Category C-C
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Avoid in first trimester and near term
Erythromycin: Category B
Azithromycin: Category B
Source: 1, 4
Case 2:
24 year old G2P1 at 28 weeks EGA comes in
with worsening heartburn, especially at night.
She does not have nausea, vomiting, diarrhea,
headache, edema, or RUQ pain. The same thing
happened during her last pregnancy 2 years
ago, and instantly resolved after she delivered.
Case 2: GERD
24 year old G2P1 at 28 weeks EGA comes in
with worsening heartburn, especially at night.
She does not have nausea, vomiting, diarrhea,
headache, edema, or RUQ pain. The same thing
happened during her last pregnancy 2 years
ago, and instantly resolved after she delivered.
Case 2: GERD
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Lifestyle modifications
Tums or Maalox (Category C)
H2 blockers (all Category B)
PPIs
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Lansoprazole (Prevacid), esomeprazole (Nexium),
pantoprazole (Protonix): Category B
Omeprazole (Prilosec):Category C
Metoclopromide (reglan): Category B
Source: 1
Case 3
A 30 year old G1P0 at 9 weeks EGA comes in
with “morning sickness”. She has been having
nausea for a few weeks. She vomits once every
few days. She has no fever, abdominal pain, or
diarrhea. She has had no weight loss. Labs are
normal including electrolytes, renal and liver
function, TSH, and CBC. She would like to avoid
medications and try “natural remedies” first.
Case 3: Nausea
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Overall, poor evidence for interventions
Lifestyle modifications
Ginger… in any form
Vitamin B6 (pyridoxine): Category A
Doxylamine: Category A
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Diclectin
Sources: 1,5,6
Case 3: Nausea
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Ondansetron (Zofran): Category B
Promethazine (Phenergan): Category C
Metoclopromide
Meclizine: Category B
Sources: 1,5,6
Case 4
A 19 year old G1P0 at 21 weeks EGA
presents with 2 days of dysuria. She also
reports urinary frequency and urgency for
the past 21 weeks. She has no fever or
back pain.
Case 4: Cystitis
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Potential for obstetric complications
No evidence to support a first-line
antibiotic
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Cephalosporins all Category B
Nitrofurantoin: Category B
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Although recent report suggesting need for
increased study (9)
Fosfomycin: Category B
Sources: 1,7,8,9
Case 4: Cystitis
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Amoxicillin-Clavulanate: Category B-B
Trimethoprim-sulfamethoxazole
Ciprofloxacin: Category C
Sources: 1,7,8
Case 5
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A 24 year old G1P0 at 18 weeks EGA had a URI
onset about a week ago. Several days later she
presented to the ED with wheezing, dyspnea,
and nonproductive cough. No fever. She was
given albuterol nebulizer treatments (which
helped), and a prescription for an albuterol MDI,
which has been helping. She comes to your
office today, still using the inhaler 4 to 6 times a
day. She has had wheezing in the past with
exertion, but it was never this bad.
Case 5: Asthma
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Uncontrolled asthma associated with
increased risk for perinatal mortality,
preeclampia, preterm birth, and low
birthweight
Better control associated with decreased
risk
Course of asthma changes in 2/3 of
pregnant women
Source: 10
Case 5: Asthma
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Control, control, control
“It is safer for pregnant women with
asthma to be treated with asthma
medications than for them to have asthma
symptoms and exacerbations….
Inadequate control of asthma is a greater
risk to the fetus than asthma medications
are.” (10)
Source: 10
Case 5: Asthma
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Albuterol: Category C
Salmeterol, formoterol: Category C
Budesonide (Pulmicort): Category B
Mometasone (Asmanex), beclomethasone
(Q-Var), fluticasone (Flovent): Category C
Combination ICS/LABA: limited data
Prednisone: Category C
Source: 1,10
Case 5: Asthma
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Theophylline: Category C
Ipratropium: Category B
Montelukast: Category B
Source: 1,10
In conclusion
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There is always the potential for a
medication to cross the placenta
Must balance risks and benefits
Consent must be informed
Sources:
1) Briggs, Gerald G, et al. Drugs in Pregnancy and Lactation. 8th Ed. Lippincott Williams &
Wilkins. 2008.
2) deShazo, Richard and Kemp, Stephen. Pharmacotherapy of allergic rhinitis. Up to Date
ver 19.2. 2011.
3) Schatz, Michael. Recognition and management of allergic disease during pregnancy.
Up to Date ver 19.2. 2010
4) Hwang, Peter and Getz, Anne. Acute sinusitis and rhinosinusitis in adults. Up to Date
ver 19.2. 2011
5) Matthews A, Dowswell T, Haas DM, Doyle M, O'Mathúna DP. Interventions for nausea
and vomiting in early pregnancy. Cochrane Database of Systematic Reviews 2010,
Issue 9. Art. No.: CD007575. DOI: 10.1002/14651858.CD007575.pub2.
Sources continued:
6) Smith, Judith, et al. Treatment of nausea and vomiting of pregnancy (hyperemesis
gravidarum and morning sickness). Up to Date ver 19.2. 2011
7) Hooton, Thomas. Urinary tract infections and asymptomatic bacteriuria in pregnancy.
Up to Date ver 19.2. 2011
8) Vazquez JC, Abalos E. Treatments for symptomatic urinary tract infections during
pregnancy. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.:
CD002256. DOI: 10.1002/14651858.CD002256.pub2
9) Crider, Krista, et al. Antibacterial Medication Use During Pregnancy and Risk of Birth
Defects. Arch Pediatr Adolesc Med. 2009;163(11):978-985
10) NAEPP Working Group Report on Managing Asthma During Pregnancy:
Recommendations for Pharmacologic Treatment. U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES. National Institutes of Health. National Heart, Lung, and Blood
Institute. January 2005