Johnson & Johnson (JNJ) warned that patients taking Remicade may face an increased risk of liver failure and pneumonia.
The company also said the Food and Drug Administration has approved Remicade for use in patients suffering from ankylosing spondylitis, a type of arthritis of the spine.
Remicade was previously approved to treat Crohn’s disease and rheumatoid arthritis in combination with another drug.
Centocor, the J&J unit that makes Remicade, said the drug has been linked to 38 cases of liver toxicity, including liver failure out of 576,000 patients who have used Remicade. However, the company said it has not been determined if Remicade actually caused liver damage.
The drug’s label will be changed to warn of a possible increased risk of liver damage and to warn of an increased risk of developing pneumonia. The label had already warned of an increased risk of developing upper respiratory infections. Remicade suppress people’s immune systems making them more vulnerable to infections.
Remicade was first approved by the FDA in 1998. It blocks production a protein in the body known as tumor necrosis factor, or TNF. Too much TNF is believed to play a role in Crohn’s disease, an inflammation of the digestive track and rheumatoid arthritis (RA), or inflamed joints.
J&J said it will send out letters Tuesday to doctors warning them of the new side effects for Remicade. In October, the warning label was updated to warn of an increased risk of developing lymphoma, a type of cancer. Remicade is administered through a two-hour infusion in a clinic about every eight weeks to treat Crohn’s and RA.
The company said the FDA based its approval for ankylosing spondylitis primarily on a clinical trial involving 279 patients treated over a 24-week period. About 60% of those receiving Remicade experienced a 20% or greater improvement in their symptoms, including a reduction in pain and increased spinal function.
Last week, J&J announced that the FDA has accepted an application for Remicade to be considered to treatment for ulcerative colitis, another digestive track condition. The FDA is reviewing the application over a six-month, fast-track period rather than the usual 10-month period.