WHO Drug Information Vol. 15, No. 3 & 4, 2001
(2001; 76 pages) View the PDF document
Table of Contents
View the documentWHO Drug Information
Open this folder and view contentsPersonal Perspectives
Open this folder and view contentsReports on Individual Drugs
Open this folder and view contentsQuality Assurance Issues
Open this folder and view contentsCurrent Topics
Open this folder and view contentsGeneral Information
Close this folderRegulatory and Safety Matters*
View the documentInfliximab and congestive heart failure
View the documentInfliximab: warning of opportunistic infections
View the documentBrimonidine ophthalmic drops: accidental ingestion
View the documentP-Glycoprotein and drug interaction
View the documentNonacog alfa: intensive surveillance
View the documentTenofovir disoproxil fumarate approved for HIV infection
View the documentCiprofloxacin hydrochloride for inhalation anthrax
View the documentDTPa and limb swelling
View the documentNitrofurantoin and peripheral neuropathy
View the documentContinued suspension for tolcapone
View the documentMMR vaccine and idiopathic thrombocytopenic purpura
View the documentNew communications and networking unit at EMEA
Open this folder and view contentsATC/DDD Classification
Open this folder and view contentsRegulatory Information
View the documentRecommended International Nonproprietary Names (rec. Inn): List 46
View the documentSelected WHO Publications of Related Interest

Infliximab and congestive heart failure

United States of America - The manufacturer of infliximab (Remicade®) has issued a warning concerning new safety information. Infliximab is a biological therapeutic product indicated for the treatment of rheumatoid arthritis and Crohn disease.

Following a recent clinical trial in 150 patients with moderate to severe congestive heart failure, higher incidences of mortality and hospitalization for worsening heart failure were seen in patients treated with infliximab, especially those treated with the higher dose of 10 mg/kg. Seven of 101 patients treated with infliximab died compared to no deaths among the 49 patients on placebo. In this trial, stable but symptomatic patients with moderate to severe congestive heart failure were treated with 3 infusions of infliximab - 5 mg/kg, 10 mg/kg or placebo, over 6 weeks.

For patients with rheumatoid arthritis or Crohn disease being considered for therapy with infliximab, do not initiate therapy in patients with congestive heart failure.

Patients with congestive heart failure currently receiving chronic infliximab treatment for rheumatoid arthritis or Crohn disease should be re-evaluated. Treatment should be discontinued in patients whose congestive heart failure is worsening; treatment discontinuation should be considered in patients with stable concomitant congestive heart failure.

Reference: Letter from Centoco, dated 18 October 2001. http://www.fda.gov/medwatch

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