The government warned that ibandronate injections for the treatment of osteoporosis could cause acute renal failure, a serious adverse reaction.
The Ministry of Food and Drug Safety issued the warning on Tuesday and said it would order pharmaceutical firms to add acute renal failure in precaution labels of ibandronate injections.
Local post-Marketing surveillance on ibandronate reported acute renal failure, the ministry said. After reviewing adverse reactions of the drug, the ministry concluded that it could not rule out a causal relationship between ibandronate injections and acute renal failure.
Under the government’s program to help patients get compensation for diseases caused by drugs’ side effects, a patient received payment for acute renal failure that occurred after the use of ibandronate. U.S. approval conditions for ibandronate already include the warning of acute renal failure.
Korea has approved 37 ibandronate injections, and major brands include Roche Korea’s Bonviva Inj. and Dongkook Pharmaceutical’s Bondron Prefilled Inj.
Drug companies can submit opinions about a change in precautions of ibandronate to the food and drug safety ministry by July 24.