 This is FDA Patient Safety News. In this edition, a warning about counterfeit contraceptive patches sold over the Internet, false positive hepatitis tests for blood donors, a recall of some duergesic transdermal patches and potentially fatal errors when refilling implantable infusion pumps. These stories and more on this edition of FDA Patient Safety News. Welcome to the program. For the U.S. Food and Drug Administration, I'm Mark Barnett. And I'm Anita Reiner. Let's start with some medical products FDA recently approved. The FDA recently approved a new drug used to treat malignant pleural mesothelioma, a rare cancer usually associated with asbestos exposure. The drug is called olympta or Pemitrexidae sodium and it's distributed by Eli Lillian Company. Olympta is intended to be used along with cisplatin. Only about 2,000 new cases of mesothelioma are diagnosed each year in the U.S. Patients live on average 9 to 13 months after diagnosis. In a randomized clinical trial, patients receiving olympta along with cisplatin lived an average of 12 months after the trial began, compared with 9 months for those on cisplatin alone. Olympta must be supplemented with vitamin B12 and folic acid to decrease the incidence and severity of adverse effects. Those effects include low white blood count, nausea, vomiting, fatigue, rash and diarrhea. Now since the drug suppresses the bone marrow, patients are warned to report signs of infection, such as fever and chills. Here's an alert about counterfeit contraceptive patches that contain no active ingredient. They've been sold by an overseas internet site. The counterfeit patches were promoted by this website as OrthoEvra transdermal patches, which are FDA approved and made by Orthomacneal Pharmaceutical Incorporated. The authentic patch contains an estrogen-progestin combination for contraception. The patch is attached to the woman's skin and left in place for 7 days for 3 consecutive weeks, followed by 1 week without the patch. Obviously, a woman would be unprotected against pregnancy if she used one of the counterfeit patches. How could a person tell the difference between the real thing and the counterfeit? Well, in this case, it's not too difficult to tell the difference. The authentic product is a 1 3 quarter inch beige square made of a thin film. It comes in a sealed opaque white pouch with the product label attached to one side of the pouch. The lot number and expiration date appear on the attached label and also on the back of the pouch. The counterfeit product is a slightly smaller brown square made of woven material. It has 5 holes that look like red dots on the middle of the top side of the patch. The counterfeits were sent in simple plastic bags without any identifiers, lot numbers, or expiration dates. Now, people have been buying these things. Where are they getting them? Well, the counterfeit patches were bought from the website www.rxpharmacy.ws. At this point, we've also identified several other websites associated with the ones selling the counterfeit patches. These include usarxstore.com, europeanrxpharmacy.com, and generic.com. All of these websites sold drugs that they claimed were the same as FDA approved drugs, but in fact they're from unknown sources and of unknown safety and efficacy. So are these sites still in operation now? Well, no, they're not. With the cooperation of the internet service provider, service to those sites has been shut down. I'm assuming that's the end of the matter now. Not necessarily. We can't be certain that this was the only site that was selling the counterfeit patches. What's the message for patients here? Well, FDA is urging patients to be suspicious of any drugs that were purchased from any of these sites and that they can't assume that these drugs are safe or effective. Tell your patients that if they have products purchased from any of these websites, they shouldn't use them and should contact a health care provider immediately. It seems like there's a larger message here for patients too. Right. There's a lesson to be learned for patients who want to purchase drugs over the internet. Remind your patients that if they want to purchase drugs over the internet, they should have their prescriptions filled only at reputable online pharmacies. They should look for the sites that bear the seal Verified Internet Pharmacy Practice sites. That shows that the site is operating according to the standards of the National Boards of Pharmacy. Tell your patients to avoid foreign websites and sites that don't provide a U.S. address and phone number to contact if there's a problem. Janssen Pharmaceutical is recalling one lot of duragesic transnormal patches. The patches deliver the opioid fentanyl that's used to treat severe chronic pain. A small percentage of the patches in this lot may leak medication because of an improper seal along one edge of the patch. If the medication leaks from the patch directly onto the patient's skin, overdosing may occur. This can cause nausea, sedation, drowsiness, or potentially life-threatening complications. Caregivers can also be exposed so anyone who comes in contact with the leaked medication should rinse the exposed skin thoroughly with water and don't use soap. Patients could also be underdosed as a result of a leaking patch. In an opioid tolerant patient, this can lead to withdrawal symptoms such as sweating, sleeplessness, and abdominal discomfort. The affected lot contains duragesic 75 microgram per hour patches with the control number 0327192 and an expiration date of October 2005. You can find the control number on both the outer carton and on each foil pouch that contains a patch. At this time, we don't know of any other dosage strengths or lot numbers that are affected. If you have any product with control number 0327192, stop using, administering, or distributing it. Go to our website to find Janssen Pharmaceuticals instructions on product return and on helping patients who may have the affected product. Or you can call Janssen directly at 1-800-J-A-N-S-S-E-N. Bearing in our Ingleheim Pharmaceuticals Incorporated has notified healthcare professionals about new hepatotoxicity warnings for the drug Viramune or Navirapine. Viramune is a non-nucleoside reverse transcriptase inhibitor that's used in combination with other antiretroviral agents to treat HIV-1 infection. Severe life-threatening and in some cases fatal hepatotoxicity has been reported in patients treated with Viramune. These events are often associated with rash and they have included fulminant and colostatic hepatitis, hepatic necrosis, and hepatic failure. Women with CD4 counts greater than 250 cells per cubic millimeter, including pregnant women receiving chronic treatment for HIV infection, are at considerably higher risk of hepatotoxicity. The greatest risk of severe and potentially fatal hepatic events occurs in the first six weeks of Viramune treatment. However, the risk continues after this time and so patients should be monitored closely for the first 18 weeks of treatment with the drug. In some cases, hepatic injury progresses even though Viramune treatment has been discontinued. Although this new information describes patients that increased risk, any patient on Viramune can experience hepatic events and should be monitored carefully. It's also important to counsel all patients on this drug that if signs or symptoms of hepatitis, severe skin reactions, or hypersensitivity reactions occur, they should discontinue Viramune treatment and seek medical evaluation immediately. Viramune should not be restarted in those patients. You can report adverse reactions to Viramune and find complete monitoring recommendations on our website. True or false, MedWatch is a special timepiece used to keep track of when patients take their medications. False, MedWatch is a system that health professionals or consumers can use to report adverse events with medical products to the FDA. Here's a report you might want to share with colleagues in your blood banking facility. Ortho-clinical Diagnostics Incorporated has sent a letter to blood banks and other health care professionals alerting them to reports of false positive test results with the company's screening test and confirmatory test for hepatitis B antibody. These tests are used by blood banks to screen blood donors. Over the last several months, blood donors may have been notified by their local or hospital blood bank that they had a positive hepatitis test because of these false positives. Has the company been able to pinpoint the cause of these problems? Not yet. They're doing an investigation, but they don't have the answer yet. In the meantime, is there anything that blood banks can do to reduce the chance of getting one of these false positives? Well, the company is recommending that blood facilities take certain steps to try to reduce the possibility of getting a false positive, and there are several things to do. First of all, they say prepare only enough test substrate for use within two hours or less. Secondly, where feasible, use the semi-automated wash method for initial and repeat testing, and if you're using the ortho-summit processor, run the weekly maintenance software function on a daily basis. Now, you said there were also false positive results with ortho's confirmatory test, which could make it more difficult to catch the error. What about dealing with that problem? Well, the company says they're going to be making changes to the instructions for use with the confirmatory test. The quality control procedures are going to have new information on how to calculate results on test samples and summarize how to determine if a specimen is truly positive. Go to our website for more information, or you can contact Ortho Clinical Diagnostics and customer technical services at 1-800-421-3311. And for questions about donor re-entry, you can contact the FDA at 301-827-2000. In a recent article, the Institute for Safe Medication Practices warned about fatal accidents that have occurred with implantable infusion pumps used to deliver drugs intrathecally. This type of drug delivery system is used to administer opiates for intractable chronic pain and baclofen to treat spasticity associated with MS, cerebral palsy, and spinal cord injuries. The pump is implanted under this skin, and it's attached to a catheter that resides in the intrathecal space. The drug is administered very slowly through the catheter from a reservoir in the pump. The reservoir is periodically refilled by injecting a supply of the drug through a port that's located under the skin. The problem arises because some models of this device have two ports. The first port refills the reservoir, and the second one, which is used for myelography or removing CSF, leads directly into the catheter. These accidents occurred when the drug refill, instead of going into the reservoir port, was accidentally injected into the catheter access port. As a result, the drug intended for the reservoir went directly into the intrathecal space, and the patient received a massive overdose. To help users locate the reservoir port when they're refilling the pump, the manufacturer provides a template. There's a different template that's used to find a catheter access port. ISMP points out that if this template is mistakenly used to try to locate the reservoir, the medication could be injected directly into the catheter and then into the intrathecal space. If you use implanted infusion pumps or if any of your patients have them, please go to our website and read ISMP's article. It has a number of recommendations to prevent this kind of accident. By the way, one of the simplest recommendations is to implant pumps that only have one port when this is appropriate for the patient. The FDA has launched a nationwide campaign to educate consumers about using analgesics and antipyretics safely. FDA's chief concerns are the potential hepatotoxicity associated with acetaminophen and the GI bleeding and renal toxicity that's associated with NSAIDs. Although these risks are rare, they're largely preventable, and so FDA's campaign is designed to increase the public's awareness of the potential risks and how they can minimize them. For example, consumers who take several OTC cold and pain remedies that contain acetaminophen may unknowingly exceed the recommended dose. To add to the problem, prescription drugs containing acetaminophen may not be labeled with that information, and this can lead to the patient taking an even higher dose. Also, people may not be aware that having more than three alcoholic drinks a day can increase the risks associated with both acetaminophen and NSAIDs. And children can receive improper dosages if they're given the adult dose or the wrong formulation of the drug, or if the pediatric dose based on weight is calculated incorrectly. Check our website for more information on the campaign and on what to tell your patients about how to use these drugs safely. You can also get educational brochures to give your patients and reprints of an article for consumers on using caution with pain relievers. That's all for this edition of FDA Patient Safety News. Remember, you can get more information on all the stories you've seen here today by visiting our website. We also urge you to use the website to report problems you've encountered with medical products. That's how we learn about problems so we can alert others. We'll be back next month with another edition, so watch for us. Until then, for the U.S. Food and Drug Administration, I'm Anita Rayner. Thank you.