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March 4, 2005
1. What are these drugs and what are they used to
treat?
Avandamet is a combination product containing 2 drugs (rosiglitazone
maleate and metformin hydrochloride) for the treatment of type 2
diabetes mellitus.
Paxil CR is a controlled release medication for the treatment of
major depressive disorder and panic disorder.
2. What action did FDA take?
FDA and the Department of Justice have filed three actions in
federal court to seize remaining stocks of these products (Avandamet
and Paxil CR) in three locations. The seizures are meant to prevent
further distribution of the products.
3. Why did FDA take this action?
FDA took this action because several inspections of the GSK
manufacturing facility where these products are made since 2002
revealed significant violations of FDA's current Good Manufacturing
Practice (GMP) regulations at this facility. These violations have
not been adequately corrected by the firm and could result in
production of poor quality drug products that potentially could pose
risks to consumers.
FDA inspections of the facility that manufactures Avandamet and
Paxil CR revealed deficiencies in the process controls in place to
help assure manufacturing conditions and practices result in a high
quality product.
4. What were the manufacturing problems that
resulted in FDA's seizure action?
FDA inspections revealed that some lots of Avandamet tablets are
not always manufactured uniformly and that these tablets may not
have an accurate dose of rosiglitazone (one of the two active
ingredients in Avandamet). FDA also found that some lots of Paxil CR
tablets are not manufactured properly and can split apart, so that
patients may receive a portion of the tablets that lack any active
ingredient or a portion that contains the active ingredient and does
not have the intended controlled-release effect.
5. What impact will FDA's seizure of these drugs
have on their supply?
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The seizure of Avandamet and Paxil CR could result in a lack of
availability of both drugs until the company is able to correct the
manufacturing problems that necessitated the seizure.
FDA has determined that there are other products to treat the
diseases for which these two products are used.
Approved versions of the individual components of Avandamet
(i.e., rosiglitazone and metformin) are available in the same doses
as those found in the combination Avandamet tablets subject to
seizure, with the exception of the 1 mg dose of rosiglitazone.
Approved versions of the immediate release form of Paxil are also
available.
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6. When will these drugs be available again?
FDA will attempt to ensure that the manufacturer corrects the
manufacturing deficiencies as soon as possible so that production of
new product that meets our public health high quality standards can
occur.
7. What does the seizure of these drugs mean for
patients? What should patients do?
Patients taking either of these drugs should continue taking
their Avandamet and/or Paxil CR tablets and should talk to their
health care provider about alternative forms of rosiglitazone
(Avandia), metformin and/or Paxil or alternative products that could
be taken until the manufacturing problems with these drugs have been
corrected.
8. Does either of these products pose a risk to
consumers taking them?
FDA does not believe that the products subject to this seizure
pose a significant health hazard to consumers.
FDA is concerned that the extent of the manufacturing problems
noted at the Cidra GSK facility could adversely affect the quality
of these drug products, resulting in potential risk to consumers.
9. What doses of each drug are affected?
The following doses of Avandamet and Paxil CR tablets are subject
to the seizure:
- Avandamet 1 mg/500mg
- Avandamet 2 mg/500 mg
- Avandamet 2 mg/1,000 mg
- Avandamet 4 mg/500 mg
- Avandamet 4 mg/1,000 mg
- Paxil CR 12.5 mg, 25 mg and 37.5 mg tablets
10. Is the immediate release form of Paxil subject
to the seizure?
No, 10 mg, 20 mg, 30 mg, 40 mg of the immediate release form of
Paxil are approved and not subject to these seizures. Patients can
take these with confidence.
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