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Ligand Pharmaceuticals and the FDA Changes Ontak Labeling

Date: 3/23/2006
Reason: Loss of visual acuity, usually with loss of color vision, has been reported following administration of Ontak.
Distribution: Nationwide.

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Ligand Pharmaceuticals and FDA notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Ontak, indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma. Loss of visual acuity, usually with loss of color vision, has been reported following administration of Ontak. While recovery was reported in some of the affected patients, most patients reported persistent visual impairment.

Other Drugs / Medicines Recalls and Alerts of Interest

Date: 11/12/2008
Reason: Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide.

Distribution: Nationwide
 
Date: 10/27/2008
Reason: Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death.

Distribution: Nationwide
 
Date: 11/6/2008

Reason: The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

Distribution: Nationwide

 
Date: 11/12/2008
Reason:  These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets.

Distribution: Nationwide
 

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