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GlaxoSmithKline has issued a letter to healthcare providers and
community educators regarding apparent third-party tampering that
caused misbranding of Ziagen® (abacavir) tablets as Combivir®
(lamivudine and zidovudine) tablets and employed counterfeit labels for
Combivir tablets. According to the March 29 notice, these incidents
appear to be isolated and limited in scope to one pharmacy in
California. To date, there have been no reports of similar
incidents in other cities or in other states.
No injuries
or adverse reactions have been reported. Company tests have shown no
problems with the medicine itself: both Ziagen and Combivir are
authentic drug products. GlaxoSmithKline is working with the U.S. Food
and Drug Administration to investigate.
Involved in the
misbranding cases were two 60-count bottles of Combivir tablets.
Combivir tablets (in a legitimate bottle) contain 150 mg of lamivudine
and 300 mg of zidovudine; however, the misbranded bottles of Combivir
contained 300 mg tablets of Ziagen. The counterfeit labels
identified Lot No. 6ZP9760 with expiration dates of April 2010 and
April 2009.
The risk to patients is primarily due
to the fact that approximately 8% of individuals who receive abacavir
have developed a potentially life-threatening hypersensitivity
reaction. Symptoms generally resolve after discontinuing the
medication; however, patients who have had a hypersensitivity reaction
to abacavir-containing products are advised to never take the
medication again, due to the risk of rapid and potentially fatal
symptoms.
In addition, the replacement of Combivir, which
contains two antiviral drugs, with Ziagen, a single antiviral, may
decrease the effectiveness of a patient's treatment regimen.
GlaxoSmithKline
is encouraging patients who have bottles of Combivir tablets to examine
the contents of each bottle to confirm that they indeed contain
Combivir tablets. The Combivir and Ziagen tablets are easily
distinguishable.
Combivir is a white capsule-shaped tablet engraved with "GX FC3" on one side; the other side of the tablet is plain:
Ziagen is a yellow capsule-shaped tablet engraved with "GX 623" on one face; the other side is plain:
If
any patient discovers a bottle of Combivir that contains anything but
Combivir tablets, please notify the GSK Response Center at
1-888-825-5249 (toll free) between 8:00 a.m. and 8:00 p.m. ET, Monday
through Friday.
For additional helpful information on how to avoid unsafe medicines and vendors, see a helpful website sponsored by The Partnership for Safe Medicines
