Important Notice about Combivir and ZiagenDate: April 10, 2007
Source: Food and Drug Administration (FDA)
GlaxoSmithKline recently issued a 'Dear Pharmacy Professional' letter to raise awareness of an isolated,
but potentially serious, apparent tampering incident involving Ziagen and Combivir tablets for treatment
of HIV. The complete text of the letter follows.
Dear Pharmacy Professional,
We would like to call to your attention an apparent third-party tampering that caused misbranding of
Ziagen® (abacavir sulfate) Tablets as Combivir® (lamivudine and zidovudine) Tablets and employed
counterfeit labels for Combivir Tablets. Both Combivir and Ziagen are medicines used as part of
combination regimens to treat HIV infection.
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 product. 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 milligrams of lamivudine and 300 milligrams of zidovudine; however, the
misbranded bottles of Combivir contained 300 milligram tablets of Ziagen. The counterfeit labels
identified Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009.
If you have bottles of Combivir Tablets in your pharmacy, you should immediately examine the
contents of each bottle of Combivir to confirm that it does indeed contain tablets of Combivir. You
may choose to counsel patients who have recently received Combivir. 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. Please see the enclosed photos of Combivir and Ziagen.
If you discover 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
The risk to patients is primarily due to the fact that approximately 8% of individuals who receive abacavir
sulfate in Ziagen Tablets, Trizivir (abacavir sulfate, lamivudine and zidovudine) Tablets or Epzicom
(abacavir sulfate and lamivudine) Tablets 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. Patients taking Combivir would not have been advised about the hypersensitivity reaction and how
to take abacavir-containing products safely because Combivir does not contain abacavir sulfate
(abacavir). Patients, who have had a hypersensitivity reaction to abacavir and take Ziagen, Trizivir or
Epzicom again, experience more severe symptoms within hours that may include life-threatening
hypotension and death.
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.
At GlaxoSmithKline, patient safety is our first priority. We appreciate your help as we try to resolve this
matter as quickly as possible. GSK is taking all possible steps to protect the quality and integrity of our
products. If you or your patients have any additional questions, please contact the GSK Response Center
at 1-888-825-5249 between 8:00 a.m. and 8:00 p.m. ET, Monday through Friday. Full product
information is available on the GlaxoSmithKline website, www.gsk.com.
For additional helpful information on how to avoid unsafe medicines and vendors, see the following
website sponsored by The Partnership for Safe Medicines: