New Boxed Warnings From FDA: On Remicade®, and Simponi®

This might be why Merck's stock price declined on the NYSE, this afternoon, despite being started at "Buy", in a new UBS analysts' research report of this morning (link in drug's brand name is to FDA's updated notice text):

. . . .Remicade^® (infliximab) for IV injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009

BOXED WARNING
Malignancy

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Remicade.

WARNINGS
Malignancies

Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use in rheumatoid arthritis and other indications. Even in the absence of TNF blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.

MEDICATION GUIDE

Updated information pertains to the risk of malignancies in pediatric patients, leukemia in adults, and psoriasis-like lesions associated with use of products within the class of TNF-blockers. . . .

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. . . .Simponi^® (golimumab)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009

BOXED WARNING
Malignancy

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Simponi is a member

WARNINGS and PRECAUTIONS
Malignancies

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which Simponi is a member.

Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression, and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months (range 1 to 84 months) after the first dose of TNF blocker therapy. Most of the patients were receiving concomitant immunosuppressants. These cases were reported post-marketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports.

MEDICATION GUIDE
Cancer

There have been cases of unusual cancers in children and teenage patients taking TNF-blocking agents.

For children and adults taking TNF-blocker medicines, including Simponi, the chances of getting lymphoma or other cancers may increase.

People with inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, especially those with very active disease, may be more likely to get lymphoma. . . .

Vytorin also got a less-alarming new FDA warning on the package insert and label -- I'll post that in a moment.