Safety drugs in pregnancy & lactation

Childbirth and Children in Ancient Egypt A squatting woman giving birth, assisted by two goddesses (Hathor and Taweret), from the Temple of Hathor at Dendera A woman, supporting a child with her left hand, reaches for a fig, from the 25th Dynasty relief in the tomb of Montemhet on the West Bank at Luxor

Safety of dermatologic agents in pregnancy

Safety of dermatologic agents in pregnancy

Even in ophthalmology !!!

Even in ophthalmology !!!

Thalidomide Those subjected to thalidomide while in the womb experienced limb deficiencies in a way that the long limbs either were not developed or presented themselves as stumps. Other effects included deformed eyes and hearts, deformed alimentary and urinary tracts, blindness and deafness. The negative effects of thalidomide led to the development of more structured drug regulations and control over drug use and development Today, thalidomide is being mainly as a treatment of certain cancers (multiple myeloma) and of a complication of leprosy. Medical uses Thalidomide is used for a number of conditions including: erythema nodosum leprosum, multiple myeloma and a number of other cancers, for some symptoms of HIV/AIDS, Crohn's disease, sarcoidosis, graft-versus-host disease, rheumatoid arthritis Baby born to a mother who had taken thalidomide while pregnant

Tylenol Use During Pregnancy Expectant mothers often take Tylenol, with the active ingredient acetaminophen, to deal with back pain, headaches or mild fevers during pregnancy. But frequent use may be linked to poorer language skills and behavior problems among their children.

considerations in pregnant patients with liver disease

"And the villain still pursues her", a satirical Victorian era postcard

Two 25ml samples of human breast milk Two 25ml samples of human breast milk. The sample on the left is foremilk, the watery milk coming from a full breast. To the right is hindmilk, the creamy milk coming from a nearly empty breast.

Breastfeeding Risk Categories L1. Safest Drug which has been taken by a large number of breastfeeding mothers without any observed increase in adverse effects in the infant. Controlled studies in breastfeeding women fail to demonstrate a risk to the infant and the possibility of harm to the breastfeeding infant is remote, or the product is not orally bioavailable in an infant. L2. Safer Drug which has been studied in a limited number of breastfeeding women without an increase in adverse effects in the infant; and/or, the evidence of a demonstrated risk which is likely to follow use of this medication in a breastfeeding woman is remote. L3. Moderately Safe There are no controlled studies in breastfeeding women; however, the risk of untoward effects to a breastfed infant is possible; or, controlled studies show only minimal non-threatening adverse effects. Drugs should be given only if the potential benefit justifies the potential risk to the infant. L4. Possibly Hazardous There is positive evidence of risk to a breastfed infant or to breastmilk production, but the benefits of use in breastfeeding mothers may be acceptable despite the risk to the infant (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). L5. Contraindicated Studies in breastfeeding mothers have demonstrated that there is significant and documented risk to the infant based on human experience, or it is a medication that has a high risk of causing significant damage to an infant. The risk of using the drug in breastfeeding women clearly outweighs any possible benefit from breastfeeding. The drug is contraindicated in women who are breastfeeding an infant.

Timing of exposure All-or-none period The first two weeks after conception, that is, from the time of conception to the time of the first missed period is often called the ‘all-or-none’ period. It is generally believed that exposures during this time do not cause malformations, as the conceptus is a mass of dividing stem cells with minimal contact with the maternal circulation and which have not yet differentiated into organs.   Embryonic period The embryonic period or period of organogenesis (4-11 weeks’ amenorrhoea) is the most critical period of development, during which time exposures can cause structural birth defects such as neural tube defects, cardiac defects and orofacial clefting. Most teratogens exert their teratogenic effects during a relatively small window of time. For example, thalidomide caused limb defects after exposure between 20 and 35 days post conception (5-7 weeks’ amenorrhoea). Fetal period During the fetal period exposures do not cause malformations but may cause disruption of normally formed organs by a number of mechanisms. In many instances these effects are due to the drug’s recognised pharmacological actions. For example, NSAIDs, ACEIs and angiotensin-II-receptor antagonists can impair fetal renal function and thereby decrease fetal urine production and amniotic fluid volume. This causes fetal joint contractures and pulmonary hypoplasia as a result of the oligohydramnios.

Safety of dermatologic agents in lactation

Safety of dermatologic agents in lactation

Safety of dermatologic agents in lactation

Safety of dermatologic agents in lactation

Safety of dermatologic agents in lactation

Safety of dermatologic agents in lactation Many mothers are required to use drugs during breastfeeding. Though most medications do pass into breast milk, it is almost always in an amount less than one percent of the adult dose. Although very few medications are contraindicated for use during lactation, it is wise to be cautious.  The volume of milk ingested by infants is commonly estimated as 0.15 L/kg/day. An arbitrary cut-off of 10% of weight adjusted infant dose has been selected as a guide to the safe use of drugs during lactation. Drugs with more than 10% of weight-adjusted infant dose in the breast milk should be avoided . For drugs with greater inherent toxicity, such as cytotoxic agents, ergotamine, gold salts, immunosuppressives and isotretinoin, the cut-off of 10% is too high and breastfeeding is contraindicated. As a general rule, maternal use of topical preparations carries less risk to a breastfed infant than systemically administered drugs due to lower maternal concentrations. Apart from the dose received via breast milk, the following factors need to be considered while determining the safety of the drugs during lactation: 1. Transfer of drugs into breast milk is influenced by protein binding, lipid solubility and ionization. Nearly all drugs transfer into breast milk to some extent. Drug transfer from maternal plasma to milk is, with rare exceptions, by passive diffusion across biological membranes. The milk composition varies within and between feeds and this may also affect the transfer of drugs into breast milk. For example, hind milk contains considerably more fat than foremilk and may concentrate fat-soluble drugs. 2. Infants have lower drug clearance than adults. Drug clearance in an infant is a particularly important consideration and premature infants have a severely limited ability to clear drugs. 3. Minimal drug exposure reduces the risk to the breastfed infant. In general, if the infant dose as a percentage of the maternal dose (corrected for weight) is close to 1%, the drug can be considered safe regardless of the infant age. For drugs where the weight-adjusted dose is closer to 10%, the infant clearance should also be taken into account.

Drug interactions of some commonly used drugs in dermatology

Drug interactions of some commonly used drugs in dermatology

No “easy button” for creating a family