(AP) - In a June 4 story about arthritis drugs, The Associated Press
reported erroneously that the drug Remicade is made by Schering-Plough Corp. The
drug is made by Johnson & Johnson subsidiary Centocor Pharmaceuticals, and is
marketed in Europe by Schering-Plough.
A corrected version of the story appears below.
WASHINGTON (AP) -- Federal regulators are investigating whether a group of
best-selling arthritis drugs made by Abbott Laboratories and other companies
heighten the risk of cancer in youngsters.
The Food and Drug Administration said Wednesday it has received 30 reports
of children and young adults developing cancer while taking the drugs over the
last 10 years. Roughly half the cases were lymphomas, a type of immune-system
cancer. Others reported were leukemia, melanoma and cancers of various organs.
The drugs under review include Abbott Labs' Humira, Johnson & Johnson's
Remicade, and Enbrel, which is marketed by Amgen Inc. and Wyeth. They are
prescribed to children with arthritis to block a chemical that causes
inflammation. The drugs also are used to treat children with the intestinal
disorder Crohn's disease.
In a statement Wednesday, Amgen and Wyeth said Amgen provided the FDA with
data from both companies' adverse events database related to Enbrel, and is
continuing to work with the agency to evaluate the overall risk benefit of the
drug in pediatric patients.
The products, known as tumor necrosis factor blockers, are key revenue
drivers for the companies. Abbott's Humira was the company's best-selling
product last year with over $3 billion in sales.
The safety of Humira was reviewed in February when the FDA first cleared it
for use in juvenile arthritis, Abbott said in a statement. The company has not
recorded any instances of lymphoma in children.
The FDA said the drugs' labeling already warns of a potential association
with cancer, but the agency's investigation will focus on risks to younger
patients.
The statement posted to the FDA's Web site said it will take long-term
studies to definitively assess the drugs' safety risks since cancers take years
to develop.
Belgian drug maker UBC is conducting a long-term study of risks, including
cancer, with its drug Cimizia, which is part of the medication class. But the
FDA said that study won't be complete until 2019.
The agency has asked drug makers to provide all information about children
who developed cancer while taking the medications. Regulators will report the
findings of their review by November.
Doctors should consider the risks of cancer when considering prescribing the
drugs for youngsters, the FDA said.
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