Watch out for counterfeit Procrit, 2 lot numbers
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Ortho Biotech Products, L.P., with the knowledge of the Food & Drug Administration, notified pharmacists, health care providers, and wholesalers/distributors of counterfeit Procrit (epoetin alfa). Vials of Procrit labeled as 40,000 U/mL in four-pack boxes, lot number P002641, expiration date: 9/03, have been found to contain active ingredient that is approximately 20 times lower than would be expected for Procrit in 40,000 U/mL vials. Based on inventory and historic use patterns, it is thought that all existing inventory of authentic lot number P002641 may have been used.
Any product bearing this lot number should be considered suspect and be closely examined. A brief description of the differences between the actual product and the counterfeit, with comparative photographs, is provided in the Ortho Biotech letter.
In addition, lot number P002384, expiration: 03/2003 also has been determined to be counterfeit. Distinctions between this counterfeit lot and authentic Procrit still are being analyzed.
Distinctions may not be the same as those identified in the Dear Healthcare Professional letter dated June 6, 2002. Thus, any product bearing this lot number in particular should be considered suspect.
Procrit is used primarily for the treatment of anemia associated with chemotherapy, chronic renal failure (pre-dialysis), zidovudine treatment in HIV patients, and patients undergoing elective, noncardiac, nonvascular surgery.
For more information, check these web sites:
• www.fda.gov/medwatch/SAFETY/2002/procrit.htm.
• www.fda.gov/medwatch/SAFETY/2002/ProcrittamperDDL.PDF.
• www.fda.gov/medwatch/SAFETY/2002/procrit2.htm.
Product tampering labels Ziagen as Combivir
GlaxoSmithKline has received four reports of suspect bottles containing 60 tablets of Combivir (lamivudine plus zidovudine) that actually contained another medicine, Ziagen (abacavir sulfate) Tablets. The company has determined that counterfeit labels for Combivir Tablets were placed on two bottles of Ziagen and labels on another two bottles are suspect. Both medicines are used as part of combination regimens to treat HIV infection.
Pharmacists, physicians and patients should immediately examine the contents of each Combivir bottle to confirm they do not contain Ziagen tablets. The two kinds of 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.
The risk to patients is primarily because about 5% of individuals who receive abacavir sulfate in Ziagen or Trizivir (abacavir sulfate, lamivudine, and zidovudine) 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 Ziagen are advised to never take the medication again.
Patients taking Combivir would not have been advised about the hypersensitivity reaction and how to take Ziagen safely because Combivir does not contain abacavir sulfate. Patients who have had a hypersensitivity reaction to abacavir yet take Ziagen or Trizivir again experience more severe symptoms within hours that may include life-threatening hypotension (lowering of the blood pressure) 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.
Read the MedWatch 2002 Safety Information Summary including links to the GlaxoSmithKline press release at www.fda.gov/medwatch/SAFETY/2002/safety02.htm#comb.
Watch for counterfeit lot of Serostim
Serono Inc. has become aware of a counterfeit lot of Serostim [somatropin (rDNA origin) for injection]. The counterfeit material has been packaged to appear as drug product lot number S810-1A1. This is not a legitimate Serostim lot number. Preliminary information indicates that the counterfeit material may have been distributed via the Internet. However, pharmacists should examine Serostim prior to dispensing to ensure that the package does not bear lot number S810-1A1. Patients should check the product in their possession to ensure it does not bear the lot number S810-1A1.
Access the MedWatch 2002 safety information summary, including links to the current press release, Dear Doctor Letter, and past MedWatch alerts regarding serostim at www.fda.gov/medwatch/SAFETY/2002/safety02.htm#serost.
FDA warns about counterfeit Epogen
Amgen, in cooperation with the Food and Drug Administration, notified pharmacists and health care providers of counterfeit Epogen (epoetin alfa). Epogen is used to treat the anemia that some patients with HIV/AIDS experience while taking zidovudine, commonly called AZT.
Epogen 40,000 U/mL vials in 10-pack boxes, lot number P002970, expiration date: 7/03, has been found to contain active ingredient that is approximately 20 times lower than would be expected for Epogen in 40,000 U/mL vials. Pharmacists and health care providers should carefully examine all vials of Epogen before use. A brief description and pictures of the differences between the actual product and the counterfeit are provided.
For more information, read the MedWatch 2002 Safety Summary, including photos and a link to the Dear Healthcare Professional letter, at www.fda.gov/medwatch/SAFETY/2002/safety02.htm#epogen.
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