Many antineoplastic drugs have been reported to be mutagenic, carcinogenic, and teratogenic in both animal and human studies. Antineoplastic drugs include multiple classes of drugs, including alkylating agents, antibiotics, hormones, antimetabolites, and antimitotic agents, each with different mechanisms of action, but most with documented reproductive toxic effects.
Antineoplastic agents may have adverse effects on both male and female fertility (117). In men, oligospermia and azoospermia have been noted in cancer patients treated with a variety of agents. These changes are often reversible with cessation of therapy. Freckman and colleagues (118) discovered a loss of ovarian primordial follicles along with amenorrhea in women treated with chlorambucil for breast cancer. The alkylating agents and vinca alkaloids were the types of agents associated with the greatest effect on fertility (117).
The teratogenicity of many antineoplastic agents has been documented in experimental animals. Alkylating agents and antimetabolites appear to be associated with the greatest incidence of congenital malformations in human studies (119). There also may be an association between exposure of men to antineoplastics and congenital malformations in their offspring (117).
Pharmacy personnel and nurses working with antineoplastics may be at risk from the adverse reproductive toxic effects of these agents. Historically, these agents have been prepared without hoods, and detectable levels of the drugs have been noted in workers under these conditions (120). Several studies demonstrated an increase in the mutagenic activity of urine of exposed workers (117), and cyclophosphamide can be detected in the urine of nurses handling this drug. Several studies documented that when vertical laminar-flow hoods were used in the handling and mixing of antineoplastic drugs, worker exposure was significantly decreased and that mutagenic agents were not detectable in the urine of hospital personnel (121). Horizontal laminar-flow hoods, which are used to prevent contamination of medications, are not effective in reducing worker exposure (122).
Selevan and colleagues (121) reported their findings on the association between fetal loss and exposure to antineoplastic agents in nurses in 17 Finnish hospitals. Each of the 124 nurses with fetal loss was compared with three controls who had live births. They found a statistically significant association between exposure to the agents and spontaneous abortions. The implicated agents were cyclophosphamide, doxorubicin, and vincristine. The women who experienced fetal loss were more than twice as likely to have had first-trimester exposures to antineoplastic drugs as those who had liveborn infants. No association was found between fetal loss and cumulative exposure to the drugs.
Hemminki and colleagues (123) found that nurses who gave birth to congenitally abnormal infants were five times as likely to have handled cytotoxic drugs more than once a week during early pregnancy as women who had healthy newborns. They found no association, however, between cytotoxic drug exposure and increased pregnancy wastage. Based on these findings, they suggested that pregnant workers exercise caution when handling antineoplastic drugs.
In 1986, OSHA published guidelines for the handling of antineoplastic agents in the workplace (124). The use of special handling procedures, including a glove-box or vertical laminar-flow hood, was recommended. In addition, OSHa recommends that all workers be given a physical examination that includes a complete blood count before beginning preparation of antineoplastic agents. OSHA also recommends that a record be kept of all drugs along with their doses prepared by individual workers. Male or female workers who are planning pregnancies and breastfeeding women should be offered alternative assignments after being informed of the potential risks of occupational exposure.
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