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May 10, 2002

Doctors, maybe you can help spread the word:

GlaxoSmithKline on Friday said two bottles of an HIV (news - web sites) drug that causes a life-threatening allergic reaction in some patients had been tampered with and falsely labeled as a different, more expensive HIV drug.

The British drug maker said it received reports of the possible criminal tampering after four bottles of two HIV drugs aroused suspicions by patients, pharmacists and doctors in California, Connecticut, Maryland and Florida.

Glaxo said fake labels of Combivir, an HIV drug which retails for 515 a month, had been placed on two bottles actually containing Ziagen, which sells for 320 per month and causes a dangerous allergic reactions in 5 percent of people taking it.

Combivir, which contains two HIV treatments, and Ziagen are both in the same class of HIV medicines called reverse transcriptase inhibitors.

Fake labels of Combivir were also found on two bottles that actually contained Combivir. Glaxo said original labels have lot numbers that allow authorities to trace where a bottle of medicine is made and which wholesalers and retailers take possession of it before it is sold to a patient.

Removing a label and replacing it with a counterfeit label, even for the correct drug, erases all such historical information and could allow criminal profiteers to disguise their identities, a company spokesperson said.

"The incidents appear to be isolated and limited in scope," the company said. It said no injuries or adverse reactions have been reported and that company tests have shown no problems with the medicine itself.

Glaxo is concerned, however, that some other mislabeled bottles could still be in circulation and patients could unwittingly take Ziagen without knowing its severe allergic risks.

Glaxo said it was not issuing a recall on the drugs, but was asking patients and health professionals to be on alert.

"Pharmacists, physicians and patients should immediately examine the contents of each Combivir bottle to confirm they do not contain Ziagen tablets," Glaxo said, adding the pills are easy to tell apart.

Combivir is a white capsule-shaped tablet engraved with "GX FC3" on one side and having a plain opposite side. The Combivir label shows a color photo of the tablet.

Ziagen is a yellow capsule-shaped tablet engraved with "GX 623" on one face, while the other side is plain.

Response from Dr. Henry

Thank you for the notice. KH

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