News and Document archive source
copyrighted material disclaimer at bottom of page

NewsMinecabal-elitecorporatepharmaceutical — Viewing Item

Arthritis drugs causing cancer in childen { April 29 2008 }

Original Source Link: (May no longer be active)

UPDATE 2-US probes cancer in children given arthritis drugs
Wed Jun 4, 2008 2:14pm EDT

(Adds details on cancer cases, company comments, byline)

By Lisa Richwine

WASHINGTON, June 4 (Reuters) - U.S. health officials are investigating whether drugs for rheumatoid arthritis and Crohn's disease are linked to cancers in children and young adults, the Food and Drug Administration said on Wednesday.

The prescription drugs, members of a family called TNF blockers, include Johnson & Johnson's (JNJ.N: Quote, Profile, Research) Remicade, Abbott Laboratories Inc's (ABT.N: Quote, Profile, Research) Humira, and Amgen Inc (AMGN.O: Quote, Profile, Research) and Wyeth's (WYE.N: Quote, Profile, Research) Enbrel.

The FDA said it was probing about 30 reports of cancer in children and young adults treated with TNF blockers plus other immune-suppressing medicines between 1998 and April 29, 2008. About half of the cancers were lymphomas.

A fourth TNF blocker, UCB's (UCB.BR: Quote, Profile, Research) Cimzia, won FDA approval on April 22, 2008.

The prescribing information for all four drugs already warns about a possible risk of cancer.

Still, "the reports of these events in children and young adults receiving TNF blockers are of concern and deserve further investigation," an FDA statement said.

The agency said it currently believed potential benefits outweighed the risks for certain young people with diseases the drugs are approved to treat.

The FDA said it asked the makers of Remicade, Enbrel and Humira for information on all cases of cancer reported in children and young adults treated with the drugs. UCB is planning a study of long-term risks of Cimzia, including cancer. That study is expected to start next year and take about 10 years to finish, the FDA said.

Amgen estimates that fewer than half of the 30 cases cited by the FDA were reported in Enbrel patients, company spokeswoman Sonia Fiorenza said. Enbrel was the first of the drugs approved, winning clearance in 1998.

Amgen and Wyeth support the FDA review and will provide any requested information, Fiorenza said.

For Remicade, the vast majority of patients who developed cancer were being treated for the bowel disorder Crohn's disease, and all but one also were given other immune-suppressing drugs that are suspected to carry a cancer risk, said Brian Kenney, a spokesman for J&J's Centocor unit.

Kenney said he could not provide the specific number of cancer cases reported for Remicade. Schering-Plough Corp sells Remicade outside the United States.

Abbott has not seen any cases of lymphoma or other cancers in children given Humira in clinical trials, company spokeswoman Raquel Powers said. The company is working with the FDA to evaluate all available data, she added.

UCB's Cimzia is not approved for children, company spokeswoman Antje Witte said.

The injectable drugs suppress the immune system by blocking the activity of TNF, a chemical that can cause inflammation.

Each is approved to treat one or more immune system diseases including rheumatoid arthritis, plaque psoriasis and Crohn's disease.

Cancers were reported in patients treated with the drugs for juvenile idiopathic arthritis, which the FDA said was a new name for juvenile rheumatoid arthritis, as well as Crohn's and other conditions.

The FDA said it would announce findings of its review and any recommendations within about six months.

Long-term studies are needed, however, to provide definitive answers as cancers take a long time to develop, the FDA said.

(Additional reporting by Philip Blenkinsop in Brussels, editing by John Wallace, Leslie Gevirtz)

Thomson Reuters 2008.

40 percent of americans take prescription drugs
ADD drugs give hallucinations of bugs and snakes { March 22 2006 }
American painkiller use skyrocketing
Anti depresents linked to suicide
Antibiotic causes liver damage
Antidepressant use by adults surges { December 3 2004 }
Antidepressants addictive to some people { August 6 2006 }
Antidepressants remove obsessive focus of love
Antidepressiants increases chance of suicide { December 13 2006 }
Arthritis drugs causing cancer in childen { April 29 2008 }
Bayer sent riskier drug asia latinamerica { May 22 2003 }
Birth defects from paxil in pregnant women { December 8 2005 }
Canada makes drug deals with 2 states against fda wishes { October 5 2004 }
Cholesterol drug causes kidney damage contradicting fda { May 24 2005 }
Cholesterol meds lower test results not improving health { January 15 2008 }
Clinical trials biased by profit funding
Company hid heartattack data for painkiller { December 8 2005 }
Congressman moves retired to drug lobby
Dc council legislation blocks pharmaceutical price gounging { September 21 2005 }
Doctor gives anti depressants to 4 yr old girl
Doctors get kickbacks to promote drugs
Doctors prescribe paxil whenever asked { April 27 2005 }
Drug aleve increases stroke heart attack risk { December 21 2004 }
Drug bill well financed victory
Drug company criminal charges { May 31 2003 }
Drug firms hide studies showing suicidal behavior { September 10 2004 }
Drug firms hype up diseases to boost sales
Drug leader at NIH takes pharmaceutical money { December 22 2004 }
Fda accused too cozy with pharmaceuticals { November 18 2004 }
Fda approval surprises many doctors
Fda prevented drug expert from speaking on anti depressants { April 16 2004 }
Fda wants suicide warning on anti depressants { March 23 2004 }
Fda whistle blower seeks legal help { November 24 2004 }
Fraud studies made by drug company { March 2008 }
Man arrested if not medicating child with drugs { June 7 2004 }
Mccain knocks steroids baseball
Minnesota school shooter using prozac and others { March 26 2005 }
More anti depressant drug warnings by fda
New diabetes pill poses deadly risk
New york state sues paxil company over coverup { June 3 2004 }
Newer antipsychotic drugs more costly less effective { September 20 2005 }
Parents reverse child hyper activity without drugs { December 22 2006 }
Paxil link found with birth defects
Pharmaceutical cholesterol drugs not lowering risk
Pharmaceutical companies court doctors for sells { April 11 2008 }
Pharmaceutical companies using tax exempt charities { June 28 2006 }
Pharmaceutical secrecy on antidepressant data { January 29 2004 }
Pharmaceuticals in tap water through sewage { March 10 2008 }
Pharmaceuticals pay fda more for speedy approvals { November 22 2006 }
Return of vioxx unusual not unprecendented
Rise of european behavior controlling drug
Ritalin could be dangerous to heart { February 10 2006 }
Senators told fda too cozy with drug industry { November 18 2004 }
Sharp rise in ritalin { July 19 2003 }
Sleeping pill causes sleep driving { March 15 2007 }
Sleeping pills once a day increase death rate { March 23 2006 }
Statin drug takers suffer heart attacks anyway
Study criticizes painkiller marketing { January 25 2005 }
Study drugs for students growing { June 11 2006 }
Study shows no good effect from anti depressants { February 25 2008 }
Suicide risk increase with antidepressants { February 18 2005 }
Supreme court allows pharmaceutical to bulldoze homes { June 23 2005 }
Teens increasing pharmaceutical drug abuse { April 21 2005 }
Teens use pharmaceutical drugs to get high { December 21 2006 }
Unapproved drug tested on children in nigeria { May 7 2006 }
Unfavorable drug studies never reported
Viox risk seen with short term use { May 17 2006 }
Women participating in lilly drug trial hangs self { February 9 2004 }

Files Listed: 68


CIA FOIA Archive

National Security
Support one-state solution for Israel and Palestine Tea Party bumper stickers JFK for Dummies, The Assassination made simple