Presentation Dyspepsia Medications in Pregnancy

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DYSPEPSIA MEDICATIONS IN

PREGNANCY

HARYANTO RAHARDJO

Dept. of Internal Medicine, Panti Rapih Hospital Jogjakarta

Jogja Dyspepsia Forum 2009 – 5 Juni 2009 Inna Garuda Hotel



Dyspepsia is a common

disorder The annual prevalence of dyspepsia in Westerncountries is approximately 25%

Less than half of dyspepsia sufferers in Europeand the USA seek medical care for their complaints

2–5% of all primary care consultations are fordyspepsia

Drossman et al 1996

Talley et al 1998

Some 40% of referrals togastroenterologists are for functionalgastrointestinal problems



Possible causes of dyspeptic symptoms:

Functional (non-ulcer) dyspepsia

Chronic peptic ulceration

Gastroesophageal reflux disease

Gastric cancer

Miscellaneous: biliary tract disease; chronicpancreatitis; intestinal angina; diabetes mellitus(causes gastroparesis); drugs

Dyspepsia can be defined as “persistent or recurrent abdominal pain or abdominal discomfort centered in

the upper abdomen” Talley et al 1991

Talley 1996



Patients with risk factors requireimmediate investigation

those with alarm symptoms or signs, including:- unintentional weight loss - iron-deficiency anaemia- gastrointestinal bleeding - dysphagia and odynophagia- previous gastric surgery - persistent vomiting- epigastric mass - jaundice- previous peptic ulcer - use of a non-steroidal anti-disease inflammatory drug

those over the age of 45 years* at onset

Patients with dyspepsia who warrant immediateinvestigation are:

Agréus and Talley 1997

* The cut-off age may be below 45 years, depending on

regional differences in the incidence of gastric malignancy



Review patient’s history

Test for H. pylori • 13C-UBT or• Laboratory serology

Refer to gastroenterologist

Age 45 years or with alarmsymptoms (irrespective of age)

Age <45 years* withoutalarm symptoms

Dyspeptic patientFirst primary care visit

If H. pylori- positive,treat the infection

The European Helicobacter Pylori Study Group 1997

The Maastricht European Consensus Guidelineson the management of dyspeptic patients inprimary care

* The cut-off age may be below 45 years,depending on regional differences in theincidence of gastric malignancy



POPULASI

FD

ORGANIC DYSPEPSIA

DYSPESIA PREGNANT WOMEN

INTRODUCTION – DYSPEPSIA IN PREGNANCY



NVP

HYPEREMESIS

GERD

PUD

CLINICAL SPECTRUM DYSPEPSIAIN PREGNANCY



NVP (Nausea Vomiting in Pregnancy)

Occuring in 50 – 90% (1# Trimester)

Usually self limiting (2#-3# ???)

The pathophysiology is debatable Hormonal fluctuations, GI motility, Psychosocial

factors

Treatment : Mild : X Precipitating factors X, Change in diet Severe : Dictate the therapy

More Severe : Meclicine (B), Promethazine (C),Metoclopramide (B), Pyridoxine (Vit B6)



HYPEREMESIS GRAVIDARUM

Intractable nausea and vomiting – early pregnancy

Incidence : 3 – 10 cases/ 1000 pregnancy

Pathogenesis is poorly understood (Hormonal,Psychological factors may play a role)

Occurs early in 1# Trimester (Resolve by weeks18-20)

Risk factors : Obesity, Nulliparity, Multiplegestations, Trophoblastic disease

Treatment : Fluids, Elect, Vits, Minerals, Thiamin,Dietary – Antiemetics and Pyridoxine can be used



HEARTBURN IN PREGNANCY

ESTIMATED IN 30-50% of PREGNANCY

LES PRESSURE GRADUALLY FALLS – 33-50%

LES RELAXATION - INCREASE PROGESTERON

INCREASE ABDOMINAL PRESSURE

ABNORMAL GASTRIC EMPTYING/SMALL

BOWEL TRANSIT THE CHALLENGE – TERATOGENICITY OF

COMMON MEDICATION



THE PYRAMIDAL OF MEDICAL THERAPY FOR GERD



PPIs

H2RAs

Antacids,

metoclopropamide,sucralfate

LIFE STYLE MODIFICATIONS

HEART BURN - GERD



LIFE STYLE MODIFICATIONS

Elevated the head of the bed

Avoid bending or stooping positions

Eat small, frequent meals (High carbohydrate, lowfat)

Refrain from ingesting food (except liquids)within 3 hours of bed time



DUODENAL ULCERS DURINGPREGNANCY - PUD

PUD in Pregnancy should be considered separatelyfrom PUD in General Population 1. Pregnancy seems to alter the clinical presentation

and natural history ( )

2. Diagnostic Test – must be carefully for fetalsafety

3. Pregnancy influence the drug therapy

4. Ulcer surgery involves consideration (fetal andmaternal risk)



PUD – Cont’d

Risk factors for PUD in Pregnant women:

smoking, advance age, NSAID use, alcoholism,

genetic predisposition, gastritis, Hp infection,stress, sosioeconomic status.

The report incidence rate is 0.005% (probablyunderistimated)

Treatment :H2RA, Tx. Hp (after pregnancy and breastfeeding), Lansoprazole



Theory References

1.Gestational increase in plasma histaminases levels cause a reduce

histamine level and gastric hypochlorhydria during pregnancy

2.Hypochlorhydria caused by gestational hyperestrogenemia

3.Increase gastric mucus layer caused by hyperprogesteronemia

4.Immunologic tolerance during pregnancy permit Hp. Colonizationwithout immunologic attack and mucosal injury

5.Elevated epidermal growth factor plasma level stimulated

gastroduodenal mucosal growth

6.Maternal avoidance of ulcerogenic factors (Smoking, alcohol,NSAID

7.Reduce psychological stress, greater bed rest, and more nutritious

diet during pregnancy

[24,32,33]

[5]

[45]

[233]

[48]

[49,50]

[9]

Hypothesis why Peptic Ulcer Disease remits

During Pregnancy*

* All this theories unproven

MS Capell/ Gastroenterol Clin N Am 2003



AL

GORIT M

DIAGNOSIS



FDA classification Definition

Category A Well controlled studies in human show no fetal risk

Category B Animal studies show no risk, but human studies

inadequate or animal studies show some risk not

supported by human studies

Category C Animal studies show risk but human studies are

inadequate or lacking or no studies in humans or animals

Category D Definite fetal abnormalities in human studies but

potential benefits may outweigh the risks

Category X Contraindicated in pregnancy, fetal abnormalities inanimals or humans. Risk outweigh benefits

FDA Classification of drug for pregnancy

J.E. Richter, 2005. Blackwell Publishing Ltd



Drug FDA class Comment

Antacids

Al, Ca, Mg

Mg. trisilicates

Sodium Bicarbonate

Mucosal protectant

Sucralfate

H2RA

Cimetidine

Ranitidine

Famotidine

Nizatidine

Promotility agents

Cisapride

Metoclopramide

Proton Pump Inhibitor

Omeprazole

LansoprazoleRabeprazole

Pantoprazole

Esomeprazole

None

None

None

B

B

B

B

B

C

B

C

BB

B

B

Most are safe for use during pregnancy and for aspiration prophylaxis during labor

because minimal absorption

Avoid long-term, high dose therapy in pregnancy

Not safe for use in pregnancy as causes fluid overload and metabolic alkalosis

No teratogenicity in animals, acceptable foe human of minimal absorption

A prospective controlled study suggests acceptable for use in humans

Same above. Ranitidine is the only H2RA whose efficacy during pregnancy has been

established

Same as Cimetidine

Not recommended during pregnancy In animals , spontaneous abortion

Embryotoxic and fetotoxic in animals, recently removed by FDA for fatal cardiac

arrhythmias

No teratogenicity effects in animals or humans reported

Embryotoxic and fetoxic in animals Cases reports in human suggest

No fetal teratogenicity or harm. Limited human pregnancy dateSame above

Same above

Same above

FDA Classification of drugs used for GERD in Pregnancy

J. E. Richter, 2005. Blackwell Publishing Ltd



Drug Safety Comments

Antacids

Sucralfate

H2RA

Cimetidine

Ranitidine

Famotidine

Nizatidine

Proton Pump Inhibitor

Yes

Yes

Yes

Yes

Yes

No

No

Not concentrated in breast milk

Minimal, if any, excretion in breast milk

American Academy of Pediatrics classified as compatible with

breast feeding

Excreted in breast milk, similar to cimetidine

Lowest concentrations in breast milk of all H2RA

Growth depression in pups of lactating rats

Little known of excretion in breast milk

Growth depression in pups of lactating rats receiving omeprazole

and rabeprazole

SAFETY OF GERD MEDICATIONS

DURING LACTATIONS

JE Richter 2005,



Drug FDA Category Recommendations for

pregnancy

Recommendations for

breast-feeding

Aluminium-basedantacids

Bisacodyl

BismuthSubsalicylate

Calcium-base

antacids Cimetidine

Esomeprazole

Famotidine

Kaopectate

Lactulose

Lansoprazole

None

C

C

None

B

C

B

C

B

B

Most low risk; minimalabsorption

Low risk in short timeused

Not safe: teratogenicity

Most low risk; minimalabsorption

Controlled data: low risk

Limited data: low risk

Paucity of safety data

Unsafe because now

contains bismuth No human studies

Limited data: low risk

Low risk

Safety unknown

No human data: potentialtoxicity

Probably compatible

Compatible

No human data: potential

toxicityLimited human data:

probably compatible

No human data: probably

compatible

No human data: probablycompatible

No human data: potentialtoxicity

Gastrointestinal Medications during Pregnancy and Lactation

Adapted from Mahadevan and Kane



How to treat dyspepsia in pregnant women

The focus of therapy has to be guided by thedictum “ FIRST, DO NO HARM “, but this must

sometimes be achieved by overcoming the instinctto delay or withhold treatment that couldpotentially produce an adverse outcome for themother or fetus

Thukral and Wolf. Gastroenterology & Hepatology May 2006

CONCLUSION



THANK YOU

Presentation Dyspepsia Medications in Pregnancy

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