CFDA prompts attention to adefovir dipivoxil and risk of osteomalacia

Release date: 2014-12-15

The State Food and Drug Administration has recently released the 64th "Notice of Adverse Drug Reactions", prompting attention to the risk of hypophosphatemia and osteomalacia caused by adefovir.

Adefovir dipivoxil is marketed in China in 2005. It is available in tablets and capsules. It is clinically used to treat evidence of replication of hepatitis B virus activity, accompanied by a sustained increase in serum Amino Acid transferase (ALT or AST). Or liver histologically active lesions in liver function compensated adult chronic hepatitis B patients. Analysis of the National Adverse Drug Reaction Monitoring Database suggests that adefovir dipivoxil can cause hypophosphatemia and osteomalacia after prolonged use. Osteomalacia is mainly non-mineralized bone-like tissue hyperplasia, bone softening, and a series of clinical symptoms and signs such as bone pain, bone deformity and fracture.

A total of 21 cases of adverse reactions to osteomalacia caused by adefovir dipivoxil were reported in the National Adverse Drug Reaction Monitoring Database. In addition to bone softening, adverse reactions also manifested as renal tubular acidosis, renal tubular disease, Fanconi syndrome, fractures, etc., and were associated with decreased blood phosphorus. Adefovir dipivoxil causes a long period of osteomalacia, and the course of disease progresses slowly. It occurs more than 3 years after administration. There may be a decrease in blood phosphorus in the early stage. Measures such as withdrawal or related symptomatic treatment can achieve good prognosis.

According to the analysis of the national database of adverse drug reaction monitoring, the State Food and Drug Administration recommends:

1. Clinicians should fully understand the adverse reactions of adefovir dipivoxil and identify them promptly. For patients with hypophosphatemia and osteomalacia who are treated with adefovir dipivoxil, measures such as withdrawal or related symptomatic treatment should be taken promptly. When adefovir dipivoxil is used in patients, renal function and serum phosphorus should be routinely monitored.

2. Relevant production enterprises should revise and improve the relevant contents of the drug manual, strengthen the monitoring of adverse drug reaction monitoring and clinical drug safety, and ensure that product safety information is timely communicated to patients and doctors to reduce and prevent serious adverse drug reactions.

Source: CFDA

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