Remicade
Remicade (infliximab) is a powerful drug used to treat autoimmune disorders such as rheumatoid arthritis, Crohn’s disease and ulcerative colitis.
Touted as a miracle drug, Remicade is very potent and side effects have been noted, including cancer, tuberculosis, invasive fungal infections, lymphoma, tumors, seizures, multiple sclerosis, heart failure, liver damage and death.
Although it was approved by the Food and Drug Administration in 1998, some medical experts claim that patients have not been adequately informed of these Remicade side effects.
Black-box warning
In August 2001, a “black-box” warning was added to the Remicade label stating that tuberculosis, invasive fungal infections and other opportunistic infections had been observed in patients getting Remicade infusions and that some of those infections had proven fatal.
Centocor sent out a “dear doctor” Remicade warning letter on October 5, 2001. It stated that tuberculosis and other serious opportunistic infections had been noted in both clinical research and post-marketing settings. As before, some of the infections have been fatal. According to Centocor, at least 84 cases of tuberculosis had been reported in patients getting Remicade infusions.
Just 13 days later, on October 18, 2001 a second such Remicade warning letter was sent to doctors, telling them not to initiate Remicade infusions with patients who had congestive heart failure (CHF), to stop giving Remicade infusions to patients with worsening CHF and to stop giving Remicade infusions even to patients whose CHF was stable.
Startling admission
In this letter, Centocor made the rather startling admission that “upon review of preliminary results of [the company’s] ongoing phase 2 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 Remicade infusions…. Seven of 101 patients treated with Remicade infusions died compared to no deaths among the 49 patients on placebo.”
In January 2002, the FDA, based upon adverse drug reaction reports, issued a Remicade warning about serious nervous system problems pertaining to demyelinization, multiple sclerosis and other conditions associated with Remicade infusions.
Remicade lawsuits being filed
Remicade lawsuits are being filed and won by plaintiffs. In April 2002, a Remicade class action lawsuit was filed in New Jersey, alleging that Centocor artificially boosted the price of the drug.
Studies have shown that taking Remicade infusions can be quite risky. Researchers have been finding more evidence of Remicade side effects, including cancerous tumors, infection and liver damage. In such cases, patients have hired Remicade lawyers to file suit against Centocor and Johnson & Johnson.
Learn the answer to frequently asked questions about the side effects of Remicade.
If you or a loved one have suffered as a result of using Remicade and are considering filing a Remicade lawsuit, please contact the attorneys at Hissey Kientz. They have abundant experience in helping people such as you. Call toll-free at (866) 275-4454 or fill out a free online case evaluation form to the right of this page.