U.S. panel wants more data on arthritis drug risk
Tuesday March 4, 6:45 pm ET
By Lisa Richwine
SILVER SPRING, Md., March 4 (Reuters) - Members of a U.S. advisory panel on Tuesday said more data was needed to assess whether a class of rheumatoid arthritis drugs may be linked to rare reports of lymphoma.
The drugs -- Abbott Laboratories' (NYSE:ABT - News) Humira, Johnson & Johnson's (NYSE:JNJ - News) Remicade and Amgen's (NasdaqNM:AMGN - News) Enbrel - are injectable, bioengineered products known as TNF blockers.
The FDA asked the panel for advice on whether evidence suggests the drugs may be linked to cases of lymphoma, a blood cancer, and how the issue should be studied and described in the drug labels. The panel did not take any votes.
"There are not enough numbers to say there's causality, but there's enough to say there may be a signal," Dr. Steven Abramson said in summarizing the panel's opinion. Abramson is the panel's acting chairman and the head of rheumatology and medicine at New York's Hospital for Joint Diseases.
The panel felt "we need more information and people need to be aware" of the issue, Abramson said in an interview.
"Whatever goes into the label should not be used to say one drug is better than another," Abramson added.
The drugs' makers said lymphoma cases in treated patients were rare and the rate was comparable to what is expected for rheumatoid arthritis patients. Studies show patients with the disease face a higher risk of lymphoma than the general population.
BENEFITS EXCEED RISKS
All three firms said they were further studying the issue but stressed that the benefits for relieving rheumatoid arthritis exceed any risks. The drugs work by inhibiting a protein linked to the inflammation that causes painful, swollen joints in rheumatoid arthritis.
The products' labels already carry varying language referring to lymphomas or malignancies in treated patients, but FDA officials said they are considering whether to add new information or revise warnings.
Enbrel and Remicade hit the U.S. market in 1998. The FDA approved Humira at the end of December 2002.
Clinical trials revealed six lymphoma cases in patients treated with one of the drugs, compared with zero cases in patients given placebos, the FDA said.
The agency also received post-marketing reports of lymphoma that appeared following treatment with one of the drugs, officials said, but noted the reports generally do not provide enough information to tell if the drugs may be related.
Panel member Wendy McBrair, director of the Southern New Jersey Regional Arthritis Center, said it was "important not to scare patients. People with rheumatoid arthritis are grateful for these medicines, and I don't think anything we've heard today is going to keep them from these."
Ira Loss, an analyst for Washington Analysis, said he expected the FDA to require similar warning sections about lymphoma on all three drugs, while another section on adverse reactions would list specific data for each particular product. |
