World Journal of
Pharmaceutical and Life Sciences

DRUG-RELATED TRAGEDIES: A COMPREHENSIVE REVIEW ON SAFETY FAILURES IN PHARMACEUTICALS

Aman Faiyaz*, Ashrubindu Bhunia, Dr. Beduin Mahanti

ABSTRACT

Here in, review into the past, present, and future constituencies of drug tragedies, where drug treatment for adverse effect brought remedies. Historically, drug tragedies have evolved the term pharmacovigilance, due to not only a proactive progression towards safety, but it has consisted of successive reactive measures found by public disaster. This paper systematically examines the "Cycle of Tragedy," commencing with the 1937 Elixir Sulfanilamide catastrophe, which fundamentally redefined the regulatory role, labeling overseer to a safety guardian. Also looked into the Thalidomide crisis of the late 1950s and early 1960s, which was a turning point that showed how important it was to test for teratogenicity and showed the importance of phase-I, phase-II, phase-III clinical trials within importance of Kefauver-Harris Amendment. While reviewing some of the major events, we found hidden tragedies associated with Diethylstilbestrol (DES), Rofecoxib (Vioxx), tragedy of opioids due to failure of regulatory system as there is more than one toxic molecule, tragedy of NSAID Diclofenac Sodium, ongoing problem of contamination of global cough syrup chains with diethylene glycol that results in children's death in developing countries and thus demonstrates an acute need for more robust manufacturing controls (recently Coldrif cough syrup tragedy in India). The fourth issue we consider concerns the present state of affairs in terms of the use of Artificial Intelligence/Machine Learning. We argue that while the regulatory strategy aims to be "predictive" as opposed to "reactive," historical precedents of the last century prove that constant vigilance is necessary. The review draws attention to the "price of progress" and suggests that ethical standards demand a halt to science outpacing humans.

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