Teratogenicity, children

Toxicology LD50 (oral, rat) 2960 mg/kg, (skin, rabbit) 1500 mg/kg mod. toxic by ing. and skin contact harmful by inh., ing., skin contact irritating to eyes, skin, mucous membranes, upper respiratory tract readily hydrolyzed to release 2-methoxyethanol (a reproductive effector) may cause harm to unborn child teratogen TSCA listed Precaution Elamm. incompat. with strong oxidizing agents may dec. on exposure to moist air or water... 

All women of childbearing age and men who are able to father a child should use two forms of contraception during ribavirin therapy and 6 months after treatment because ribavirin has been documented to cause teratogenic and embryocidal effects. 

The Committee had required as a minimum, teratogenicity testing in two species, one of which should preferably be a non-rodent, for one generation only. They also recognised the limitations of teratogenicity tests in animals but emphasised that only in the most exceptional circumstances would they release any drug for clinical trial in women of child-bearing age rmtil the appropriate tests on animals had been carried out satisfactorily. 

Isotretinoin (1) works extremely well for severe acne, and is efficacious for 75% of all patients. However, like all oral retenoids, isotretinoin (1) has a spectrum of toxicity. Most prevalent of all is its profound teratogenic properties. The risk of a major congenital abnormality in the first tnmester in pregnant women is increased by 25-fold. Therefore, it is mandatory for women of child-bearing potential who are taking... 

Potential behavioral teratogenicity—the long-term effect of the medication on the functioning and behavior of the child many years later is an unknown factor for most medications used today, but no harm in this area is known for the antidepressants commonly prescribed. 

SAFETY PROFILE Poison by subcutaneous, intravenous, and intraperitoneal routes. Moderately toxic by ingestion. Human (child) pulmonary system effects by ingestion. Human systemic effects decreased body temperature, cardiac arrhythmias. An experimental teratogen. Other experimental reproductive effects. See also ATROPINE. When heated to decomposition it emits very toxic fumes of NOx and SOx. 

There is a substantial spontaneous background incidence of birth defect in the commimity (up to 2%) so that the detection of a low-grade teratogen that increases the incidence of one of the commoner abnormalities presents an intimidating task. Also, most teratogenic effects are probably multifactorial. In this emotionally charged area it is indeed hard for the public and especially for parents of an affected child to grasp that ... 

Women of child-bearing age should be careful when handling any substance of unknown properties. Certain substances are highly suspect teratogens and will cause abnormalities in an embryo or fetus. Among these are benzene, toluene, xylene, aniline, nitrobenzene, phenol, formaldehyde, dimethylformamide (DMF), dimethyl sulfoxide (DMSO), polychlori-... 

Because of possible teratogenicity, papaveretum is no longer recommended for women of child-bearing age (SEDA-17, 83). 

Ribavirin is teratogenic and embryotoxic in laboratory animals and should not be given to pregnant women. Concern has been expressed about the safety of people in the same room as patients being treated with ribavirin by aerosol, particularly women of child-bearing age. However, no ribavirin was detected in the urine, plasma, or erythrocytes of 19 nurses exposed to ribavirin administered via ventilator, oxygen tent, or oxygen hood over 3 days (22). 

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