By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 1 In the name of God The Safety of Dermatological Drugs During Pregnancy & Lactation Dr.Mohammad Baghaei (Pharm .D), Dr. Hamidreza Zolfaghari(MD), Dr. Hamidreza Mohseni (MD), Dr.Aliasghar Aliyari (MD), Dr. Ali Abedi (Pharm .D), Dr. Alireza Khosravi (MD)
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By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 1
In the name of God
The Safety of Dermatological Drugs
During Pregnancy & Lactation
Dr.Mohammad Baghaei (Pharm .D), Dr. Hamidreza Zolfaghari(MD),
Dr. Hamidreza Mohseni (MD), Dr.Aliasghar Aliyari (MD),
Dr. Ali Abedi (Pharm .D), Dr. Alireza Khosravi (MD)
By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 2
INCLUDES:
Introduction
Dermatological drugs during Pregnancy
FDA category
Dermatological drugs during Lactation
References
By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 3
Introduction
Treatment of many dermatologic conditions is elective. Some drugs which used by the
dermatologist for the patient who is pregnant or lactating may have potentially harmful
effects on the mother and fetus or nursing infant. Likewise, not every pregnancy (in the
absence of drug therapy) results in the delivery of a perfectly healthy baby, and physicians
are anxious to have litigation about prescribe a medication that might possibly have
contributed to the problem. For this reason, a general reluctance exists among physicians
to prescribe medications during pregnancy and lactation. There are, however, drugs for
which use during pregnancy and lactation have no apparent contraindication. It may be
have both interest and comfort to the clinician and patient to become familiar with this
select list of drugs.
This book identifies contraindications of various drugs with the possible extent information which
currently available.
By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 4
Pregnancy:
During the first trimester drugs may produce congenital malformations (teratogenesis),
and the period of greatest risk is from the third to the eleventh week of pregnancy. During
the 2nd and 3rd trimesters drugs may affect the growth and functional development of the
fetus or have toxic effects on fetal tissues. Drugs given shortly before term or during
labour may have adverse effects on labour or on the neonate after delivery.
The natural occurrence of fetal abnormalities in 1-2% of human pregnancies makes
interpretation of case reports difficult. Data from animal teratogenicity studies are
extremely valuable; however, they are not always applicable to humans. Drugs that are
teratogenic in animals may be safe in humans and versa. One factor which makes the
gathering of appropriate information on the effect of drugs in pregnancy very difficult is
that the manufacturers of many of the drugs carry a blanket warning on use in pregnancy
in their product information literature.
If treatment is clearly indicated and the patient is willing to accept potential risks but the
safety of the treatment in pregnancy has not been established, then the first approach
should be topical therapy when possible.
By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 5
The term "Pregnancy Risk Factor" followed by letter A, B, C, D or X signifies a pregnancy
category. The FDA established these five categories to indicate the potential of a systemically
absorbed drug for causing birth defects. The categories are determined by the reliability of
documentation and the risk to benefit (risk: benefit) ratio.
Pregnancy category X is particularly distinguished in that if any data exists that may
implicate a drug as a teratogen (potentially causing birth defects) and the risk to benefit ratio
is clearly negative, the drug is contraindicated (prohibited from use) during pregnancy.
Sometimes a drug taken by a woman during pregnancy may enter a fetus, causing damage or
birth defects. The risk of damage to the fetus is the greatest in the first few weeks of
pregnancy, when major organs are developing. However, researchers do not know if taking
medicines during pregnancy may also have negative effects on the baby later on.
Introduced in 1979, the pregnancy category of a pharmaceutical agent is an assessment of the
risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during
pregnancy. It does not include any risks given by pharmaceutical agents or their metabolites
that are present in breast milk.
By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 6
The FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to
be defined as pregnancy category A. As a result of this, many drugs that would be considered
pregnancy category A in other countries are allocated to category C by the FDA.
FDA CATEGORIES
Category A: Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the
first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears
unlikely.
Category 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 a decrease in fertility) that was not confirmed in controlled studies in women in the
first trimester and there is no evidence of a risk in later trimesters.
Category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or
embryocidal effects or other) and there are no controlled studies in women, OR studies in women and
By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 7
animals are not available. Drugs should be given only if the potential benefits justify the potential risk
to the fetus.
Category 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).
Category 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.
By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 8