Tagged Articles

Crohn’s disease 9 articles

New Jersey high court reinstates $25 million Accutane verdict

A $25.16 million judgment in favor of an Alabama man who claimed he contracted Crohn’s disease after taking the acne drug Accutane was reinstated by the New Jersey Supreme Court, marking the latest action in the state’s decade-old mass tort litigation. The court ruled that the verdict in favor of Andrew McCarrell should stand despite his lawsuit being filed after the statute of limitations in Alabama. The court said that New Jersey’s more liberal statute of limitations should apply. “Over the years, our choice-of-law jurisprudence has striven to structure rules that will lead to predictable and uniform results that are fair, ... Read More

FDA panel questions whether bowel disease drug increases risk of deadly brain infection

A Food and Drug Administration (FDA) advisory panel is questioning the safety of Takeda Pharmaceutical’s inflammatory bowel disease drug candidate vedolizumab, claiming the drug could cause patients to develop a rare but deadly brain infection. The panel is set to rule on Dec. 9 whether to recommend the drug be approved for marketing in the United States. The medication fared well in clinical trials as a treatment for ulcerative colitis and Crohn’s disease, but experts say the drug carries the risk of progressive multifocal leukoencephalopathy (PML), a life threatening brain disease that affects immune deficient patients. No patients in clinical ... Read More

Labels on TNFa blockers get stronger warning

The black box warning for a class of immunosuppressant drugs known as Tumor Necrosis Factor-alpha (TNFa) blockers is being updated to include the risk of potentially deadly infections from two bacterial pathogens, Legionella and Listeria. TNFa blockers are biologic products that include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golmumab). TNFa blockers are drugs used to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis. Since TNFs blockers are immunosuprresants, patients who take these drugs are at increased risk of serious, including fatal, infections. These infections can involve ... Read More

MS, Crohn’s drug linked to serious brain infections

The Food and Drug Administration (FDA) is alerting doctors and patients that Tysabri (natalizumab), a drug used to treat multiple sclerosis (MS) and Crohn’s disease, has been linked to a rare but serious brain infection known as progressive multifocal leukoencephalopathy (PML). The alert includes updated prescribing information about the risk for PML, and revised labeling that includes a table summarizing the rates of PML with Tysabri according to the number of infusions, or how long the drug is taken or the duration of exposure, and information on a newly identified PML risk factor. The new prescribing information and labeling informs ... Read More

Chron’s, colitis drug linked to deadly cancer

A fast-growing and deadly type of cancer has been reported in patients – in particular, adolescents and young adults – who are taking a type of medication used to treat Crohn’s disease and ulcerative colitis. The Food and Drug Administration (FDA) alerted doctors that a rare cancer of white blood cells known as Hepatosplenic T-Cell Lymphoma or HSTCL has been linked to medicines called tumor necrosis factors (TNF) blockers, as well as with azathioprine and/or mercaptopurine. TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab). HSTCL is an aggressive cancer that is usually fatal. ... Read More

Accutane linked to bowel problem, serious skin condition

A new study on the side effects of Accutane published in the American Journal of Gastroenterology suggest that the acne drug may increase the risk of developing bowel problems. The findings come just weeks after a New Jersey jury awarded an Alabama man $25.16 million because they believed Roche’s Accutane caused the man to develop inflammatory bowel disease (IBD), a group of digestive disorders that includes ulcerative colitis and Crohn’s disease. Researchers looked at data from 87 health insurance providers and found more than 8,000 people had been diagnosed with IBD. The data also showed that people taking Accutane were ... Read More

MS, Crohn’s drug linked to numerous cases of serious brain infection

The Food and Drug Administration is updating health care professionals about a medication used to treat patients with relapsing forms of multiple sclerosis (MS) and moderately to severely active Crohn’s disease. New safety information indicates that the risk of developing a rare but life-threatening brain infection known as progressive multifocal leukoencephalopathy (PML) increases with the number of infusions received of Tysabri (natalizumab). The announcement updates a September 2009 warning about PML associated with use of the Tysabri. Since 2006, Tysabri has only been available through the Tysabri Outreach Unified Commitment to Health, also known as the TOUCH Prescribing Program. The ... Read More

Rheumatoid Arthritis drug linked to serious neurological disorder

The Food and Drug Administration (FDA) has received a third case of a serious and often fatal neurological disorder known as progressive multifocal leukoencephalopathy (PML) in a patient with rheumatoid arthritis (RA) treated with the drug Rituxan (rituximab). The report has led the agency to inform rheumatological health care professionals that patients with RA who have received Rituxan are at an increased risk of PML. Physicians should consider the risks in any patient treated with Rituxan who presents new onset neurological manifestations. The FDA advises consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. ... Read More

Serious neurological disorder linked to MS, Crohn’s drug

A medication used to treat multiple sclerosis (MS) and Crohn’s disease has been linked to a serious and usually fatal neurological disorder, according to an alert issued to neurological health care professionals and their patients by the Food and Drug Administration (FDA). Natalizumab, marketed as Tysbri, was approved by the FDA in 2004 to treat relapsing forms of MS. In 2008, the FDA approved the drug’s use for moderately to severely active Crohn’s disease. From July 2006, when Tysabri marketing resumed, to September 8, 2009, there were 13 reported cases of Tysabri-related progressive multifocal leukoencephalopathy (PML) confirmed worldwide in patients ... Read More