FDA Counterfeit Drug Warnings
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Available online at http://www.doh.state.fl.us/disease_ctrl/aids/news/pc.html Issue 27,June 1, 2002 FDA Counterfeit Drug Warnings ADAP Award The Florida AIDS Drug Assistance Program Epogen (ADAP) has been recognized by the Title II In cooperation with the FDA, on May 8th Amgen Community AIDS National Network as the outstanding notified pharmacists and health care providers AIDS Drug Assistance Program of the year. Scott of counterfeit Epogen (epoetin alfa). The active ingredient Evertz, Director of the White House Office of National in ten-pack boxes of Epogen 40,000 U/mL vials (lot AIDS Policy, presented the award during the National number P002970) was found to be 20 times lower than ADAP Educational Forum in Washington, DC. The expected. Pharmacists and health care providers should National ADAP Educational Forum is an annual carefully examine all vials of EPOGEN before use. The meeting for representatives from the 54 state and “Dear Provider” letter and a detailed description of the territorial AIDS Drug Assistance Programs in the counterfeit product is available on the FDA website: United States to share strategies and best practices. http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm In response to the award, Florida Department of #epogen. Health Secretary John O. Agwunobi, M.D., MBA, Ziagen Mislabeled as Combivir stated, “It’s an incredible honor to have our Bureau of The Washington Post (5/11/02) reported that at least four HIV/AIDS recognized as an example for the nation”. sealed bottles of GlaxoSmithKline's antiretroviral medication Ziagen were improperly labeled and sold as Combivir. Mislabeled bottles were found in California, Early Access Program for Atazanavir Connecticut, Maryland and Florida by patients and pharmacists who noticed that the pills looked different. Bristol-Myers Squibb is now enrolling Although no patients have been harmed, the FDA is patients in an early access program monitoring adverse event reports for any possible increase (EAP) for the experimental protease in side effects among patients taking the drugs. inhibitor, atazanavir. While atazanavir has GlaxoSmithKline (GSK) spokesperson Mary Anne Rhyne not been approved for commercial use, the drug is in said an internal investigation concluded that the error did the late stage of clinical trials and approval is not occur within the company, leading the FDA's criminal anticipated. Phase II data supported the potency, investigations unit to believe the counterfeiting is part of a safety, tolerability, and sustained antiviral effect of "very sophisticated drug diversion and relabeling scheme" atazanavir in both treatment-naïve and treatment- that occurred somewhere in the distribution system. GSK experienced patients. The data also suggested that is urging patients and pharmacists to double check atazanavir could be the first once-daily protease medication. Any suspicious bottles should be returned to inhibitor and that, unlike current protease inhibitors, GSK for further investigation. Patients or pharmacists with atazanavir does not appear to produce elevated questions can call 1-888-825-5249 for more information. cholesterol and triglycerides. Eligible patients include those who are failing their current antiretroviral therapy Serostim (defined as an HIV RNA level > 5000 copies/ml and a On May 16, the FDA and Serono advised providers and CD4 cell count of < 300), and those who have severe pharmacists of a new lot of counterfeit Serostim® 6 mg HAART-associated hyperlipidemia despite lipid (somatropin). The counterfeit vials bear lot number S810- lowering therapy, defined as a triglyceride level > 750 1A1. Preliminary information appeared to indicate that the mg/dL or a cholesterol level meeting National counterfeit material might have been distributed via the Cholesterol Education Program (NCEP) guidelines for Internet. However, pharmacists should examine all use of a lipid lowering agent. The viral load and CD4 Serostim to ensure that the package does not bear lot count restrictions do not apply to this latter group of number S810-1A1. Any product labeled as Serostim® and patients. Restrictions regarding use of atazanavir with carrying this lot number should be considered to be some of the other antiretroviral medications will also counterfeit and returned for replacement. Additional be applied during the initial EAP. Medical providers information is available from Serono's product information who wish to participate in the atazanavir EAP should line at 1-888-275-7376. call 1-877-726-7327. In addition to the BMS application, DOH providers will need to submit a A complete summary of all FDA drug and safety proposal to the Departmental IRB. The Bureau of warnings is available on the MedWatch Internet site at HIV/AIDS has submitted a preliminary proposal to http://www.fda.gov/medwatch/SAFETY/2002/safety02.h facilitate the process for expedited reviews. DOH tm providers can call 850-245-4585 to obtain forms and information about the IRB process. New STD Treatment Guidelines Simultaneous administration of ddI 400 mg and MMWR, May 3, 2002 / 51(RR06);1-80 tenofovir 300 mg with a light meal resulted in a 60% increase in didanosine exposure. Administration of ddI Sexually transmitted diseases (STDs) infect an estimated 400 mg one hour before tenofovir 300 mg (both in the 15 million people each year in the United States. The fasting state) resulted in a 44% increase in didanosine Centers for Disease Control and Prevention (CDC) has exposure. Patients taking tenofovir and standard issued new national guidelines to help health care doses of Videx concomitantly should be monitored providers protect their patients from STDs. The 2002 closely for didanosine-associated adverse events. Guidelines for the Treatment of Sexually Transmitted Fatal and non-fatal pancreatitis, lactic acidosis, and Diseases include new recommendations for effective severe hepatomegaly have occurred with didanosine treatment regimens, screening procedures, and prevention and it is not known if the elevated ddI levels resulting strategies. The guidelines are available online at from coadministration with tenofivir would increase the http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5106a1.ht risk of serious complications. A complete copy of the m. Changes from previous guidelines included: BMS letter to HIV providers is available online at Rescreening for Chlamydia – It is now recommended http://www.atdn.org/warn1.html. Additional information that women with chlamydial infections be rescreened three is also available from the BMS Virology Department at to four months after treatment is completed. This is the first 1-800-426-7644. time CDC has recommended rescreening in the management of chlamydia. Potential Shortage of Western Alternative Gonorrhea Treatments - Ciprofloxacin- Blot Test Kits resistant strains have become so common on the west coast that the use of fluoroquinolone antibiotics to treat In the United States, the HIV testing process begins gonorrhea is inadvisable in California. This is the first time with an initial screening enzyme immunoassay (EIA). If CDC has issued this guidance in the continental United reactive, the EIA is repeated in duplicate on the same States. The antibiotics cefixime and ceftriaxone are now specimen. If repeatedly reactive, the specimen is then recommended as first-line drugs to treat gonorrhea in tested with a more specific confirmatory or Hawaii and California. supplemental test to validate the EIA results and to Annual HIV Test and STD Screening for MSM Clients- prevent notification based on false-positive results that Health care providers are now urged to assess the sexual might occur with the screening tests. In April, Calypte risk for all male patients, including the gender of partners. Biomedical Corporation announced it’s intent to stop For sexually active men who have sex with men, the production of the Cambridge Biotech HIV-1 Western guidelines recommend annual screening for STDs – HIV, Blot (WB) kit. The Cambridge kit is one of only two chlamydia (anal, urethral), syphilis and gonorrhea (anal, HIV-1 WB kits licensed by the FDA for confirmatory pharyngeal, urethral) – and vaccination against hepatitis A HIV testing. The other WB test is the Genetic Systems and B. More frequent STD screening may be indicated for Western blot kit made by BioRad Laboratories. A third those who indicate having multiple anonymous partners or WB kit made by OraSure Technologies is approved for having sex in conjunction with illicit drug use. supplemental testing of reactive oral fluid samples but New Serological Tests to Diagnose Genital Herpes - not for screening and supplemental testing of blood New testing procedures may help providers diagnose and and plasma. Supplemental tests include the WB test or manage genital herpes type one (HSV-1) or type two the more expensive indirect immunofluorescence (HSV-2). Since antiviral therapy may benefit individuals assay (IFA). Some laboratories are experiencing with herpes symptoms, providers who are aware of their delays in obtaining WB supplemental test kits, and the patient’s viral serotype can tailor counseling and treatment potential exists for future delays in supplemental plans to best fit their needs. testing. CDC is collaborating with FDA and other Treatment for Partners- CDC stated that it is "critical" for private and public health partners to develop providers to make every effort to see that patients' partners alternative strategies for HIV diagnostic testing if the get tested and treated for STDs. shortage of supplemental test kits continues. As an established customer of BioRad, the Florida state lab DDI and Tenofovir Warning has not experienced any difficulty obtaining an adequate supply of WB kits. There has been a price A recent study by BMS and Gilead Sciences, investigated increase of $4.00 per test, which will increase the the pharmacokinetics of co-administration of ddI annual cost of testing by $20,000 dollars. Laboratories (didanosine, VIDEX EC) with tenofovir. The results experiencing difficulty obtaining kits for confirmatory showed when compared to the administration of DDI alone testing can contact the CDC at 404-639-4581. Persons in a fasted state, the administration of ddI 400 mg two being tested for HIV may need to be counseled that hours before tenofovir 300 mg with a light meal, resulted in they might experience delays in receiving their HIV an 46% increase in serum didanosine levels. test results. Send questions, comments, and/or submissions for future issues via email, phone, or fax to: Gayle McLaughlin@doh.state.fl.us, 850-245-4444, suncom 205-4444, ext. 2534, fax 850-414-6719.