Safety of important dermatological drugs (retinoids, immune suppressants, anti androgens and thalidomide) in reproductively active males with respect to pregnancy outcome: A brief review of literature

Paternally transmitted damage to offspring is recognized as a complex issue. Each parent contributes 23 chromosomes to a child; hence, it is necessary to know the effects of both maternal and paternal pre-and peri-conceptional exposure to drugs on pregnancy outcome. While there are many studies on the effects of maternal drug exposure on pregnancy outcome, literature on paternal exposure is scarce. Of late however, paternal exposure has been receiving increasing attention. We present a brief review on the safety of commonly used drugs in dermatology, focused on retinoids, immune suppressants, anti androgens and thalidomide.

Problems to Be Addressed by Pharmacoepidemiology in Japan : A Personal View / 薬剤疫学

Objectives : To find the most important problems to be addressed by pharmacoepidemiology in Japan. My view presented in this article is personal conceived after having witnessed several drug-induced disasters (e.g., the SMON affair in 1970 and the Sorivudine case in 1993) and carried out a number of epidemiological studies while practicing as an internist.<BR>Methods : Preventive measures taken after having experienced major drug-induced disasters as well as the relationship between these measures and pharmacoepidemiology are compared between the foreign developed countries and Japan. The comparison is conducted based on my belief that pharmacoepidemiology must examine the major epidemic drug-related diseases, and find and verify the effective measures to prevent them.<BR>Results and Conclusion : It is found that in the USA and England, the drug-induced disasters have led the following effective countermeasures : revising the methods of approval of new drugs including the introduction of licensing for clinical trials of investigational products and improving postmarketingsurveillance according to the concept of “event monitoring”. Pharmacoepidemiology has been developed in association with those reforms. On the contrary, many measures posed after the drug disasters seen to have not worked well in Japan. Pharmacoepidemiology in Japan should have a more active role in (1) planning the measures to prevent drug disasters, (2) monitoring the methods and individual processes of approval of new drugs, (3) evaluating the investigational products particularly with respect to the safety (toxicity), and (4) carrying out orthodox pharmacoepidemiology researches including drug utilization studies, case-control studies, prescription-event monitoring, long term randomized controlled studies, pharmacoeconomic studies and so on.