Complain about a product or service

FDA Probes Arthritis Drug Link To Cancer

Drugs are used to treat arthritis in children, young adults

June 4, 2008

Drug Safety • FDA Cracks Down on Web Sites Selling Unapproved Drugs • FDA Unveils Safe Medication Use Program • Bayer Hit With Suit Over Prostate Claims • Feds Seize Alleged Seizure-Inducing Drugs • Matrixx Failed to Give FDA 800 Zicam Complaints • Matrixx Initiatives Pulls Zicam Products • FDA Issues Warning About Zicam Cold Remedy • FDA Issues Warning About Clarcon Skin Products • FDA Requires Additional Warning For OTC Pain Relievers • NY Mandates Multi-Lingual Rx Labels, Counsel • Two Firms Stopped From Making Unapproved Drugs • Supreme Court Upholds Consumers' Right to Sue Drug Companies In State Court • Psoriasis Drug Linked To Three Deaths • Bayer Agrees to Correct Misleading Information about Yaz • FDA Urged to Ditch Darvon • FDA Warns of Skin Numbing Product Dangers • Bayer Pays $97 Million to Settle Kickback Charges • FDA Seizes More Contaminated Heparin • FDA Warns Bayer on "Illegal" Drugs • Feds Seize More Than $24 Million in Unapproved New Drugs • Consumers Increasingly Exposed to Counterfeit Drugs • FDA Wants Black Box Warning on Antibiotics • Public Citizen Sues FDA for Failure to Act on Darvon • FDA Probes Arthritis Drug Link To Cancer • FDA Wants New Labeling Rules To Protect Pregnant, Nursing Women • Anti-Smoking Drug Chantix Linked to Seizures, Heart Problems, Diabetes • Bayer Pulls Trasylol From Market • MIT Researchers Confirm Contamination in Heparin • Be Careful Using Over-the-Counter Creams, Ointments • Another Heparin Producer Announces a Recall • FDA Moves Closer To Setting Up Shop In China • Study Raises Concerns About Anemia Drugs • Congress Hears Warnings about FDA • China Connection in Heparin Problems? • Heparin Linked to Severe Allergic Reactions • Antibiotic Leads to Tendon Ruptures • Second Safety Warning on Fentanyl Skin Patch • Merck Recalls Children's Vaccines • Study: Avandia May Do More Harm than Good • Texas Sues Drug Manufacturer Blamed for West Coast Deaths • Bayer Withdraws Antibleeding Drug Trasylol --- • More drug safety news ...

The U.S. Food and Drug Administration has announced an investigation into a class of drugs used to treat arthritis, over concerns they might be linked to the development of cancer.

The agency said it has received 30 reports in the last ten years that the drugs, called tumor necrosis factor blockers, caused cancer in children and young adults.

While arthritis is usually thought to be an affliction of middle and old age, this class of drug is used to treat forms of the disease that affect younger people. The blockers are prescribed to treat Crohn's disease and idiopathic arthritis, among other conditions.

One of the drugs in question, Enbrel, is a joint venture between Amgen and Wyeth. The two drug-makers have issued a statement in support of the FDA review, but expressing confidence in the safety of Enbrel.

"Amgen provided the FDA with information from both companies' adverse events databases and is continuing to work with the Agency to evaluate the overall risk benefit of Enbrel in pediatric patients," the statement said.

The two drug companies note that the FDA has been aware of the possible association between the use of TNF blockers and the development of cancers, since the prescribing information for all four TNF blockers warns about the possible risk of cancer. Despite that, they point to an FDA Early Communication on the issue that said the FDA believed that "the potential benefits of the use of TNF blockers outweigh the potential risks in certain children and young adults having one of the diseases for which the TNF blockers are approved to treat."

Until the evaluation is completed, the FDA said healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients. Amgen and Wyeth said they agreed with that position.

Enbrel was first approved for juvenile idiopathic arthritis (JIA), formerly called juvenile rheumatoid arthritis, in 1999, and is the only approved use for Enbrel in the pediatric population.

The drug is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older. ENBREL has been studied in JIA for up to nine years in controlled and open-label portions of a clinical study, the two companies said.

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.

Share		Follow us on Twitter.