The FDA announced yesterday that it had completed its review of tumor necrosis factor (TNF) blockers and that it had concluded that there is an increased risk of cancer in children and adolescents who use TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but it does not specifically mention leukemia. TNF blockers are approved for the treatment of multiple immune system diseases including Crohn’s disease, rheumatoid arthritis, psoriatic arthirtis, plaque psoriasis, and juvenile idiopathic arthritis.

When a person suffers from chronic inflammatory diseases, such as the ones listed above, their body overproduces a protein called tumor necrosis factor-alpha (TNF-a). When this protein exists in large quantities in the body, it can cause inflammation and damage to bones, cartilage, and tissue. When patients suffering from chronic inflammatory diseases take TNF blockers, the drug targets the overproduced TNF-a and neutralizes it. Brand names of TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cinzia (cetolizumab pegol), and Simponi (golimumab).

The law firm of Schlichter, Bogard & Denton is currently investigating claims against the manufacturers of Remicade, Enbrel, and Humira. If you or a loved one has suffered adverse events from the above mentioned drugs, please contact an experienced pharmaceutical attorney at Schlichter, Bogard & Denton. We serve clients nationwide.

For more information, see the FDA Press Announcement at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm

See the MedWatch Safety Information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm

Labels: Crohn's disease, enbrel, humira, remicade, TNF Blockers, tnf-a

Abbott Laboratories is liable for $1.67 billion in a patent infringement suit against Johnson & Johnson. Abbott was found to have infringed on the patent for Remicade when developing its own best-selling drug, Humira. Remicade was developed by Centocor, a unit of Johnson and Johnson. The patent infringement suit was filed against Abbott in April 2007.

Humira and Remicade are anti-TNF drugs, which block tumor necrosis factor proteins in the blood. Excess TNF can cause inflammation, which leads to many of the symptoms suffered by those with autoimmune disorders like rheumatoid arthritis.

“We are particularly gratified that the jury recognized our valuable intellectual property, finding our patent both valid and infringed,” Kim Taylor, president of Centocor Ortho Biotech. Abbott had $4.5 billion in Humira sales in 2008.

Abbott will appeal the decision. The company contends that Humira was the first fully human anti-TNF antibody medicine. Remicade is partly made from mouse DNA. J&J acknowledged at trial that it did not start working on a fully-human antibody until 1997 – two years after Abbott discovered Humira and one year after Abbott filed its patent applications for Humira.

For more information please see: http://www.nytimes.com/2009/06/30/business/30drug.html?partner=rss&emc=rss

Labels: Abbott, humira, Johnson and Johnson, joint pain, remicade, rhematoid arthritis

The Food and Drug Administration (FDA) has reported that doctors are not consistently recognizing histoplasmosis and other invasive fungal infections in patients taking Tumor Necrosis Factor-alpha (TNF-α) blockers: Cimzia, Enbrel, Humira, Remicade and Simponi. TNF-α blockers are commonly used to treat moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis or chronic arthritis in the spine.

The failure to recognize fungal infections has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death.

Centocor Ortho Biotech and FDA recently reminded healthcare professionals of these risks associated with the TNF-α blocker Simponi. Centorcor Ortho Biotech of Horsham, PA manufactures Simponi.

Patients who develop an infection, including any persistent or reoccurring infections should have their Simponi or other TNF-α blocker discontinued. Empiric antifungal therapy should be considered until the source of the infection is identified. It may be appropriate to consult an infectious diseases specialist.

Patients and health care professionals are encouraged to report and to monitor signs of infection and be closely monitored during and after treatment with TNF-α blockers for invasive fungal infections. Symptoms include fever, malaise, weight loss, sweats, cough and dyspnea, pulmonary infiltrates on X-ray or serious systemic illness.

Patients who reside in or travel to regions where fungal infections are endemic like the Ohio and Mississippi River valleys and southwestern United States should be tested for invasive fungal infections if they develop a serious systemic illness.

All adverse events should be reported to Centocor Ortho Biotech or the FDA. It is important that all adverse events potentially associated with Simponi be reported so that the drug’s profile is updated appropriately as post-approval experience is gathered.

Centocor Ortho Biotech Inc. can be contact at 1-800-457-6399.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/medwatch/safety/2009/SIMPONI_DHCP%20letter_May09.pdf
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Simponi

Labels: ankylosing spondylitits, arthritis, Cimzia, enbrel, FDA, fungal infections, humira, posriatic arthritis, remicade, rheumatoid arthritis, Simponi, spine, tnf-a