Pharma Focus Asia
Eppendorf Bioprocess Solutions

Reducing Post-Marketing Drug Withdrawals

Promise of new biomarkers

Prasanthi Potluri, Editor Pharma Focus Asia

Adverse effects of drugs can sometimes outweigh their benefits. Exposure to a drug may injure sensitive organs, particularly liver, the most important organ in drug toxicity. To date, more than 900 drugs have been identified for causing liver injury. Withdrawal of safety-related drug marketing leading to drug failures is the main reason behind Drug-Induced Liver Injury (DILI).

According to a Prospective Pilot Cohort study that was conducted for a 24-week period in 2012, 12 (0.04%) patients out of a total of 28,145 were identified as having possible DILI, and 11 of these accepted to be included in the protocol. During the one-week proactive period, seven patients out of a total of 1407 inpatients (0.498%) were identified with possible DILI, and five were included in the protocol. Research says that identification of DILI is difficult, even among hospitalised patients.

Limitation of traditional biomarkers limits the pre-clinical testing and clinical development from eliminating all human hepatotoxins. DILI is considered the most common single adverse drug reaction leading to refusal of market approval subsequently leading to drug withdrawal from the market. This has become the challenge for agencies and authorities to assess the benefitrisk of stopping the drug.

However, new biomarkers hold a lot of promise of reducing drug attrition rates and saving lives from drug toxicity.

In the cover story of this issue of Pharma Focus Asia, Peter Gaskin, Principal, Aptuit Consulting, talks about the current scenario of post-marketing withdrawal of drugs due to drug-induced liver injury. The article also sheds light on how improved biomarkers are helping to reducing the number of drugs removed from the market due to safety concerns and of reducing drug attrition rates, particularly when used together in a multiplexed assay.

This issue also features articles on SAP ERP implementation strategy and how animation software could help find cures for cancer and HIV.

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Prasanthi Potluri
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