Pzifer has announced that production of Tikosyn 0.5mg and Tikosyn 0.25mg resumed on Tuesday, January 22nd. According to the manufacturer:
- Tikosyn 0.5mg x 60 count will be available for re-order beginning Monday, January 28, 2008
- Tikosyn 0.250mg x 60 count will be available for re-order on Friday, February 1, 2008
However, until the shortage is resolved, they encourage physicians to refrain from placing new patients on Tikosyn and to contact current patients to discuss treatment options, as was noted in the message (see below) Heart Rhythm Society sent to its members on January 18.
For further details, please refer to the Pzifer Advisory letter.
For more information, you may also contact Isabelle Le Blanc at (202) 464-3465 or ileblanc@HRSonline.org.
The following letter was e-mailed to Heart Rhythm Society members on January 18, 2008 with the subject line, "Possible Tikosyn® (Dofetilide) Shortage in January 2008"
Dear Heart Rhythm Society Member:
In response to inquiries, we want to provide you with important information regarding inventory outages of 0.5mg and 0.25mg of the Pfizer drug Tikosyn® (Dofetilide).
According to Pfizer,
“The shortage is not the result of any efficacy or safety concern with Tikosyn. An unforeseen manufacturing issue coupled with distribution regulations for Tikosyn has resulted in the product outage. Until the outage is resolved, we encourage you to refrain from placing new patients on Tikosyn and to contact current patients to discuss treatment options.
“In efforts to bridge this shortage we are requesting you to please substitute the 0.125mg strength capsule for the 0.5mg dosages. The bioequivalence of four 0.125mg Tikosyn capsules with one 0.5mg capsule has been confirmed in a study designed to ascertain bioequivalence.”
Pfizer has stated that this shortage should be resolved by January 28, 2008.
For further details, please refer to the Pfizer advisory letter.
For more information you may also contact Isabelle LeBlanc at (202) 464-3465 or ileblanc@HRSonline.org.
