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China Pharmacovigilance

By Berry Pan, GBI Analyst


National Adverse Drug Reaction (ADR) Monitoring Center recently released a notice (# 37 Adverse Drug Reaction Bulletin) informing the public of adverse events caused by bisphosphonate drugs indicated for the treatment of osteoporosis, as well as hypercalcemia and bone metastases from malignant diseases. The center highlighted reports of ADRs including musculoskeletal injury, esophageal injury, renal dysfunction, and mandibular injury.


The Center is becoming increasingly active; last month, safety warnings for anti-obesity drug orlistat, were issued. Per the notification, patients taking orlistat as a weight-loss medication should have a body mass index (NYSE:BMI) of 24, and physicians and pharmacists were required to maintain heightened vigilance for ADRs. Last year, the SFDA required manufacturers of orlistat to revise drug inserts after severe cases of liver injury were reported after intake of the drug, and subsequently released the ‘guiding instructions for the revision of orlistat insert’ which required the drug's manufacturers in China to revise its insert and clear indication of possible ADRs such as hepatic injury.


Other instances of SFDA actions in response to pharmacovigilance include the last year’s market withdrawal of Abbot’s sibutramine, and use restrictions placed on rosiglitazone from GSK. In many cases, Chinese drug authorities have taken their cues from events in overseas markets. Going forward, however, China has begun to codify additional policy surrounding domestic pharmacovigilance which may improve the agency’s ability to detect local ADRs and issues in an increasingly responsive manner.