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November 1, 2001

IMPORTANT DRUG WARNING

 

Dear Healthcare Professional:
Centocor, Inc. would like to inform you of important new safety information for REMICADE ® (infliximab). Upon review of preliminary results of its ongoing phase 2 trial in
150 patients with moderate to severe (NYHA class III-IV) congestive heart failure (CHF), higher incidences of mortality and hospitalization for worsening heart failure were seen in patients treated with REMICADE, especially those treated with the higher dose of 10 mg/kg. Seven of
101 patients treated with REMICADE died compared to no deaths among the 49 patients on placebo. In this trial, stable but symptomatic patients with NYHA Class III-IV CHF were treated with 3 infusions of REMICADE 5 mg/kg, REMICADE 10 mg/kg, or placebo over 6 weeks.
REMICADE is a biological therapeutic product indicated for the treatment of rheumatoid arthritis and Crohn?s disease.
Centocor, in consultation with FDA, is alerting physicians to these potential adverse effects of REMICADE in patients with CHF. At present, there are insufficient data to determine optimal patient management. However, based on these preliminary findings, and pending additional data, physicians should consider the following precautionary measures. For patients with rheumatoid arthritis or Crohn?s disease being considered for therapy with REMICADE:
? Do not initiate therapy in patients with congestive heart failure.
Patients with CHF currently receiving chronic REMICADE treatment for rheumatoid arthritis or Crohn?s disease should be reevaluated.
? Treatment should be discontinued in patients whose CHF is worsening.
? Treatment discontinuation should be considered in patients with stable concomitant CHF, especially in those who have not had a significant clinical response to REMICADE therapy.
If a decision is made to continue treatment, cardiac status should be closely monitored.



Xeloda (capecitabine)

Audience: Oncologists, Pharmacists, and other healthcare professionals FDA and Roche have added a BLACK BOX WARNING and strengthened the PRECAUTIONS section in the label for Xeloda, indicated for the treatment of colorectal and breast cancer. A clinically important XELODA-Warfarin drug interaction was demonstrated in a clinical pharmacology trial. Postmarketing reports have shown clinically significant increases in prothrombin time and INR in patients who were stabilized on anticoagulants at the time XELODA was introduced. Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. The Patient Package Insert was also revised to reflect this new safety information. New information is highlighted in the labels below.

[Nov 01, 2001 Label - (Revised sections only) - 25 Kb PDF file]
[Nov 01, 2001 Label - (Full Revised Label) - 1.77 MB PDF file]
[Nov 01, 2001 Label - (Revised Patient Package Insert) - 35 Kb PDF file]


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Remicade (infliximab) - Clinical Alert: Congestive Heart Failure

Audience: Rheumatologists, Gastroenterologists and other healthcare professionals Centocor, in consultation with FDA, is alerting physicians to potential serious adverse effects of REMICADE in patients with CHF. Preliminary results of an ongoing phase 2 trial in patients with moderate to severe CHF demonstrated higher incidences of mortality and hospitalization for worsening heart failure in patients treated with REMICADE, especially those treated with the higher dose of 10 mg/kg. Based on these preliminary findings, and pending additional data, precautionary measures were recommended in a "Dear Healthcare Professional" letter.

Source: FDA

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.