Can We Ensure the Safe Use of Known Human Teratogens?

Abstract

Minimising the public health burden of isotretinoin-induced teratogenicity has been a challenge for 24 years, the duration of availability of isotretinoin in the US for the treatment of severe, recalcitrant nodular acne. Although the teratogenicity of this drug is well known and risk-management programmes had been implemented, preventable fetal exposures continued to occur, largely as a result of the lack of sufficient controls within the programmes themselves. The manufacturers of isotretinoin implemented a new risk-management programme, iPLEDGE, in March 2006. iPLEDGE is a comprehensive distribution system that includes mandatory registration of patients, healthcare providers, pharmacies, and wholesalers. It allows real-time linkage of pregnancy-test results for verification prior to the dispensing of isotretinoin. Although the challenges of implementing a closed distribution system for a very widely used medication have been extensive, the potential public health benefits from preventing fetal exposure to isotretinoin are substantial.

A Case of Suspected Isotretinoin-Induced Malformation in a Baby of a Mother Who Became Pregnant One Month after Discontinuation of the Drug

“…Although the teratogenicity of this drug is well known and risk-management programs had been implemented, preventable fetal exposures have continued, largely as a result of the lack of sufficient controls within the programs themselves 4. The manufacturers of isotretinoin implemented a new risk-management program, iPLEDGE, in March 2006 5. iPLEDGE is a comprehensive distribution system that includes mandatory registration of patients, healthcare providers, pharmacists, and wholesalers.…”

Providing Contraception for Women Taking Potentially Teratogenic Medications: A Survey of Internal Medicine Physicians’ Knowledge, Attitudes and Barriers

“…Given the public health burdens of teratogen exposure resulting in birth defects and the subsequent infant mortality and childhood morbidity, there is significant benefit to employing such an initiative. 1,2,6,21,22 Assessment of physician behaviors is complicated and a single institution survey is unlikely to adequately quantify all the factors that affect prescribing practices. These results could inform the design of a larger study of prescribers across geographic regions and medical specialties to better define the barriers to providing contraception to women on potentially teratogenic medications.…”

Congenital microtia in a neonate due to maternal isotretinoin exposure 1 month before pregnancy: Case Report

“…The iPLEDGE a system, which includes mandatory registration of health‐care providers, patients, pharmacists, and wholesalers, was established in March 2006 by the manufacturers of isotretinoin for the purposes of a new risk‐management program. It recommends effective contraception with negative pregnancy test in fertile women, before starting the drug, for each month of therapy and 1 month after completing the treatment …”