Drug recalls and pharmacovigilance outset
Of all the drugs ever developed, thalidomide has undoubtedly had the greatest influence on pharmacovigilance outset and shaping the pharmaceutical industry as we know it today. Strong marketing pressure in an industry hungry for new medicines brought an inadequately tested drug to the market, targeted outsourcing quickly expanded the client base and finally market forces prevented timely withdrawal, even when evidence was emerging of disastrous side-effects. Consequently, this drug used in the late 1950s and early 1960s for the treatment of nausea in pregnant women, led to severe birth defects in thousands of children.
After that most famous disaster, the US Food and Drug Administration (FDA) revised their regulations through imposing stricter rules on medicine approvals and establishing a spontaneous reporting pharmacovigilance system to report the Adverse Drug Reaction (ADR) incidence in the healthcare sector.
Another drug that should be mentioned is certainly Rofecoxib (Vioxx, US). A non-steroidal anti-inflammatory drug (NSAID) used for the treatment of osteoarthritis, rheumatoid arthritis, acute pain, as well as the menstrual pain. Earlier, in the marketing stages, the company did not mention any cardiovascular disorders. But in the years after, reports started to emerge on the hazards of Vioxx. It took a 3-year clinical trial, leading to participants experience cardiovascular events such as heart attacks and strokes, for the drug to be withdrawn from the market.
In 2004, Food and Drug Administration’s Office of Drug Safety, stated: “The approval of rofecoxib (Vioxx, US) by the US FDA has led to the single greatest drug safety catastrophe in the history of this country or the history of the world”.
It has been estimated that 88,000 to 139,000 Americans have had heart attacks or strokes due to Vioxx. The drug was finally discontinued in 2004.
To summarize…
It is important to understand that pharmacovigilance has a significant role in early observation of the risk associated with the medicine, and that the knowledge and perception of healthcare professionals toward safety profile of medicines is crucial because no medicinal product is entirely or absolutely safe for all people, in all places, at all times.
References:
- Alomar M, Palaian S, Al-Tabakha MM. Pharmacovigilance in perspective: drug withdrawals, data mining and policy implications. F1000Res. 2019 Dec 16;8:2109. doi: 10.12688/f1000research.21402.1. PMID: 32161643; PMCID: PMC7050268.
- Ridings JE. The thalidomide disaster, lessons from the past. Methods Mol Biol. 2013;947:575-86. doi: 10.1007/978-1-62703-131-8_36. PMID: 23138926.
- James H Kim, Anthony R Scialli. Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicol Sci. 2011 Jul;122(1):1-6. doi: 10.1093/toxsci/kfr088. Epub 2011 Apr 19.
- Ankur Rohilla, et al.: Pharmacovigilance: Needs and Objectives. Journal of Advanced Pharmacy Education & Research, vol 2, issue 4, Oct-Dec 2012.
- Najafi S. Importance of Pharmacovigilance and the Role of Healthcare Professionals. J Pharmacovigil 2018, 6:1 DOI: 10.4172/2329-6887.1000252
