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Remicade Side Effect Lawsuit
According to a safety alert issued by the FDA on September 6, 2011, Remicade and similar TNF inhibitor drugs put patients at an increased risk of infections from Legionella and Listeria bacteria. The federal regulator has updated boxed warnings on these drugs following receipt of more than 100 reports of pathogen infections, including 14 deaths, in the past decade caused by side effects of these immunosuppressive drugs. Most of the affected patients were within the 26-71 age group. Some of these patients suffered from serious viral, bacterial, and mycobacterial infections as early as within a month, while some others showed infection symptoms as late as 6 years after starting the TNF inhibitor drug therapy.
Of the 80 Legionella pneumonia cases reported, three patients died, four required mechanical ventilation, and five were put in intensive care units. There have also been 26 cases of serious meningitis, endophthalmitis, and sepsis infections, including seven deaths, caused by side effects of TNF inhibitor drugs. The FDA has asked healthcare experts to reconsider prescribing Remicade and similar drugs to patients above 65 years with immunosuppressant disorders or recurrent infections.
Remicade FDA Warnings
The FDA approved Remicade, brand name of infliximab, in 1988 for the treatment of Crohn's disease, psoriasis, and rheumatoid arthritis. The drug produced by Centocor, a subsidiary of pharma major Johnson & Johnson, is also certified as a medication for ankylosing spondylitis, psoriatic arthritis, and ulcerative colitis. However, the drug has been linked to decreased
ability to fight fungi or bacterial infections, tuberculosis, histoplasmosis, cancers, heart failure, liver problems, blood disorders, and nervous system disorders.
In April 2011, the FDA warned Remicade users about the risk of blood cancer associated with the drug. Of 43 reports, it received linking TNF blockers with Hepatosplenic T-Cell Lymphoma, a rare cancer that affects white blood cells, Remicade was used by patients in 20 cases. The risk of cancer in patients using Remicade, Humira, and similar immunosuppressive drugs was first reported in the May 2006 issue of the Journal of the American Medical Association. The research conducted by the Mayo Clinic highlighted that Humira and Remicade users were at the triple risk of developing cancers and double risk of serious infections. In June 2008, the FDA decided to probe the link between cancer and TNF drugs following reports of rare cancer in children and young adults who took the drug for juvenile arthritis and inflammatory bowel disorders. It added black box warnings to Remicade, Humira, Enbrel, and other TNF blockers in August 2009, informing consumers and doctors about the risk of adolescent and child cancers.
A report published in February 2009 by Berlin-based German Rheumatism Research Center claimed that patients using Remicade and similar drugs for rheumatoid arthritis treatment were at the increased risk of developing Shingles, a viral disease accompanied by painful skin rash and blisters. The study covered 5,040 patients, who took Remicade and similar TNF blockers.
In September 2008, the FDA sanctioned black box warnings on Remicade, Humira, and two other rheumatoid arthritis drugs, alerting about fatal bacterial and fungal infections, such as tuberculosis and histoplasmosis, in users. According to the FDA, these drugs suppress the immune system and render it ineffective in fighting against new or recurrent pathogen infections.
In August 2004, the FDA and the manufacturer of Remicade warned healthcare professionals about the potential risk of serious blood and nervous system disorders in patients using the drug for the treatment of rheumatoid arthritis and Crohn's disease.
Remicade Side Effects
Immunologic Side Effects/ Infections
Remicade blocks TNF protein, which, in turn, suppresses the immune system and hampers the body’s ability to viral, fungal, bacterial, and other pathogen infections. The drug side effects include fatal tuberculosis, skin abscess, lesions, and ulceration, and respiratory tract infections, such as bronchitis, sinusitis, sore throat, and pneumonia. It also causes coccidioidomycosis, cellulitis, histoplasmosis, ulcerative skin disorders, and other serious infections. In many cases, infections, including deaths, have occurred within the first few months of taking Remicade therapy.
Nervous System Disorders
The drug has been linked to serious central nervous system disorders, such as numbness, hypoesthesia, dysesthesia, impuissance, dizziness, tingling, and seizures. According to post-marketing reviews, Remicade neurologic side effects also include meningitis, muscle weakness, gait instability, headache, flu-like symptoms, confusion, acute neuropathy, brain infarction, radial nerve paralysis, and worsening lower extremity weakness. The FDA has received at least one report of death due to West Nile virus infection following Remicade therapy to treat heumatoid arthritis.
Gastrointestinal Side Effects
Remicade gastrointestinal side effects include nausea, abdominal pain and hernia, intestinal obstruction and perforation, gastrointestinal hemorrhage, and pancreatitis. The FDA has also received reports of gum infection, rectal abscess, stomatitis, and oral mycosis in patients taking the drug therapy.
Cardiovascular Side Effects
Remicade has been linked to worsening heart failure, hypotension, and angina in patients already facing heart problems. Cardiopulmonary reactions, chest pain, circulatory failure, arrhythmia, myocardial infarction, blood clots due to inflammation of a vein, and palpitations are other side effects of the drug. There have been reports of heart blocks and bradycardia in patients using Remicade therapy.
Oncologic Side Effects
The FDA has issued strongest possible warnings highlighting Remicade oncologic side effects. The drug puts children and young adults at the risk of fatal blood cancers. Research reports and FDA reviews have found links between Remicade and lymphoma, leukemia, skin, and solid organ cancers.
Dermatologic Side Effects
Skin rashes, itching, ulceration, and interstitial dermatitis are some of the dermatologic side effects of Remicade. There have also been reports of serious furunculosis, an acute skin problem characterized with painful boils, bullous skin lesions, and leprosy in rheumatoid arthritis patients using Remicade.
Other Remicade Side Effects
Hepatic side effects include autoimmune hepatitis, cholestatic liver disease recurrence of hepatitis B, and liver injury and failure.
Hematologic side effects include low white blood cell count, neutropenia, abnormal decrease in platelets, and pancytopenia or lower number of blood cells due to bone marrow tumor.
Musculoskeletal side effects include back pain, joint pain, tendon disorder, swelling of fingers, and tendon disorder problem.
Renal side effects include renal failure and kidney infarction.
The first-ever Remicade lawsuit was filed in April 2002 in a New Jersey court. The class action litigation claims that the manufacturer adopted fraudulent marketing practices and intentionally misstated the average wholesale price for the drug. The wide gap between the AWP and the actual selling price offers more profit to pharmacies and doctors, who, in turn, encourage consumers to buy the drug rather than its efficacy. It can add to the problems of Johnson & Johnson, which is facing cases of fraudulent marketing practices for its drug Omnicare.
Between January 2010 and April 2011, Johnson & Johnson paid more than $160 million to settle lawsuit related to wrong marketing, kickback allegations, quality problems and side effects of its drugs. The revelations in the past one decade regarding Remicade side effects have opened floodgates for litigations. Many plaintiffs have filed Remicade lawsuit seeking millions in compensation and punitive damages from Johnson & Johnson for serious injuries caused due to the drug therapy. Pfizer and Abbott face similar lawsuit for their TNF inhibitors Enbrel and Humira.
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