Drugs' risk of cancer under US scrutiny
NEW YORK - US regulators are investigating a possible association between rheumatoid arthritis drugs made by Johnson & Johnson and Amgen Inc. and childhood cancer.
The Food and Drug Administration found 30 cases of lymphomas, or immune-cell cancer, in patients age 18 or younger who took anti-inflammatory drugs from a group that includes J&J's Remicade and Amgen's Enbrel, according to an "early communication" posted yesterday on the agency's website.
The FDA began investigating cancer cases linked to the class of medicines, known as TNF blockers, which also includes Abbott Laboratories' Humira, 10 years ago. The prescribing information for all of the medicines already warns of cancer risks. The top three therapies in the class generated $13.5 billion combined last year.
"While the review is ongoing, FDA advises prescribers to weigh the possible association with lymphoma and other cancers against the benefits of treatment when prescribing TNF blockers to children and young adults," the agency said.
J&J fell 21 cents to close at $66.55, while Abbott rose 27 cents to $56. Amgen rose 35 cents to $44.50.
The family of drugs is approved to treat childhood rheumatoid arthritis and Crohn's disease, an intestinal disorder. Both diseases are caused by an abnormal immune response that attacks and damages healthy tissue.
Enbrel, the world's fifth best-selling drug, generated $5.3 billion last year for Amgen, based in Thousand Oaks, Calif., and its partner, Wyeth, of Madison, N.J.
"Amgen and Wyeth support the FDA review of the safety information and are committed to providing the FDA with any additional information needed," Amgen spokeswoman Sonia Fiorenza said.
J&J, of New Brunswick, N.J., had Remicade sales of $5.2 billion. Abbott, of Abbott Park, Ill., had Humira revenue of $3.1 billion.
J&J has provided additional data to the FDA and will be working "very closely" with the agency to answer their questions, said Michael Parks, a company spokesman.
