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titlelines Tikosyn® December 2009 Shortage

Pfizer has informed health care professionals of a shortage of 60 count bottles of TIKOSYN® 250 mcg and 500 mcg expected in early December 2009. Pfizer notes this product shortage is a result of a manufacturing issue and not the result of any efficacy or safety issues with TIKOSYN®.

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The following letter (download PDF, 16K) was received by the Heart Rhythm Society. Additional resources regarding the TIKOSYN® (dofetilide) 60 count bottles (250 mcg and 500 mcg) shortage:


Richard Page, MD, FHRS
President
Heart Rhythm Society
1400 K Street NW, Suite 500
Washington, DC 20005

Dear Dr. Page:

We would like to take this opportunity to inform your organization of a shortage of TIKOSYN® (dofetilide) 60 count bottles (250 mcg and 500 mcg) that is expected to begin in early December.

This product shortage is a result of a manufacturing issue and not the result of any efficacy or safety issues with TIKOSYN. Pfizer is working as quickly as possible to resolve the situation. In addition, we have advised the TIKOSYN prescribing community of this shortage by fax, mail, Pfizer.com / PfizerPro.com, Tikosyn.com, and the FDA’s web site.

We recognize that your association represents a significant membership of over 4,500 heart specialists. We would like to partner with your organization to distribute vital information about the imminent TIKOSYN shortage. As it is likely that many of your members will be reaching out to your organization as a source of information about this shortage, we are providing you with TIKOSYN information related to the shortage. Enclosed is a copy of the TIKOSYN shortage letter (PDF, 314K) that we hope you will distribute through your communication channels.

Our goal is to ensure that TIKOSYN patient therapy is not interrupted and that prescribers are made aware of the availability of alternate TIKOSYN supplies.

We will continue to provide advisories about the shortage through the websites listed above as information becomes available.

We are working diligently to have both dosage forms available through our normal wholesale and retail channels as soon as possible.

Sincerely,

Angela Hwang
Vice President, US Established Brands

Jonathan Shilstone Ph.D.
Senior Medical Director

Pfizer Inc
235 East 42nd St.
New York, NY 10017

Please see the enclosed full prescribing information (PDF, 428K) for TIKOSYN®.

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