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Update for
Pharmacists and wholesalers regarding supply disruption of Paxil CR
and Avandamet
March 18, 2005
This is to
alert you that Paxil CR (paroxetine hydrochloride) and Avandamet
(rosiglitazone maleate/metformin hydrochloride) Tablets are in
extremely short supply. Shortages have resulted form the March 4,
2005, seizure action (due to manufacturing issues) by the U.S. Food
and Drug Administration, currently disrupting the supply of these two products.
The FDA action
relates to all strengths of Paxil CR (12.5mg, 25 mg, and 37.5 mg) as
well as Avandamet (1mg/500 mg, 2 mg/500 mg, 2 mg/1000 mg, 4 mg/500 mg
and 4 mg/1000 mg).
GlaxoSmithKline
believes that the manufacturing issues do not present a health risk
to patients. GSK agrees with the FDA that patients who use these two
medicines should continue taking their tablets while supplies last.
Prescribers
have been advised to consider other treatment options for new
patients and for patients unable to fill current prescriptions for
these medications. If you are unable to fill prescriptions for these
two medications, please advise patients to contact their healthcare
professional about other treatment options.
Because Paxil
CR and the immediate-release formulation of Paxil are not
bioequivalent, we cannot make any definitive recommendations about
this treatment option.
In terms of
Avandamet, physicians may choose to transfer patients to comparable
dosages and dosing regimens of Avandia ( rosiglitazone maleate) and
metformin as separable tablets to ensure the equivalent daily dose is given.
Please be
assured that GSK is working with the FDA to resolve these issues as
quickly as possible, and we will continue to keep you informed of our
progress. We regret any inconvenience this action may cause.
Should you
have further questions, please contact the GSK Customer Response
Center at 1-888-825-5249 between the hours of 8 am and 8 pm EST,
Monday through Friday.
Sincerely,
John L. Fish
Vice President
Trade,
Pharmacy Sales and Operations.
Please see
accompanying complete Prescribing Information for Paxil and Paxil CR,
including BOXED WARNING.
Please see
accompanying complete Prescribing Information for Avandamet and
Avandia, including Avandamet BOXED WARNING for lactic acidosis and
contraindications for patients with renal disease and congestive
heart failure.
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