 This is FDA Patient Safety News. In this edition, a new type of coronary stent that may help prevent restenosis, an alert about counterfeit lipitor, a warning about serious burns from rotary surgical handpieces, and a possible link between syringes and amniocentesis problems. 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. In a recent news release, FDA announced the approval of a new drug-alluding stent for angioplasty. The device is called the Cypher Serolimus Alluding Coronary Stent, and it's manufactured by Cordus Corporation with a license from Wyeth Pharmaceuticals for the use of the drug. Mark, stenting is a pretty common way to keep occluded vessels open. What's so different about this stent? What's different about this stent is that it gradually releases a drug to help prevent restenosis. The drug is Serolimus. It's an immunosuppressant that acts to help prevent restenosis, possibly by inhibiting the proliferation of smooth muscle and endothelial cells. There are a lot of angioplasties done in this country. I'm assuming this device could have a pretty significant impact. Probably a significant impact in reducing the incidence of restenosis. About 800,000 angioplasty procedures are performed in the U.S. each year, and restenosis occurs in about 15 to 30 percent of them. In a U.S. study of about 1,000 patients, the restenosis rate among those who received the drug-alluding stent was about 9 percent compared to about 36 percent for those who received the conventional stent. The combined occurrence of repeat angioplasty, bypass surgery, myocardial infarctions, and death was about 9 percent for patients with a drug-alluding stent and about 21 percent for the other patients. Any limits on FDA's approval? Yes, the device was not studied under certain conditions. For example, the safety and effectiveness of this device weren't studied for blockages longer than 30 millimeters or for arteries narrower than 15 millimeters. Also not studied were patients who had their occlusions in bypass grafts, those who had previous intravascular radiation therapy, and those in whom the stent might be used during an infarction. Are the company's studies over? No, they're not over. As a matter of fact, there are more studies to come. FDA is requiring the manufacturer to conduct a 2,000-patient post-approval study to assess the long-term safety and effectiveness of the device and to look for rare adverse events that might result from using this product. In a recent talk paper, FDA announced that it had cleared for marketing a new type of diagnostic device to help monitor an asthma patient's response to anti-inflammatory treatment. The test, called the NIOX Nitric Oxide Test System, is manufactured by Erichron AB of Sweden. It works by measuring nitric oxide concentration in the patient's breath. The test is based on recent evidence that nitric oxide levels are increased in asthma patients and that these levels may rise or fall depending on the effectiveness of the anti-inflammatory treatment. In general, a reduction in nitric oxide levels may indicate whether or not an individual's asthma treatment is working. To use the device, a mouthpiece is placed in the patient's mouth connected by a breathing tube to an air supply and computer. The patient inhales air that's free of nitric oxide then slowly exhales into the mouthpiece. The nitric oxide concentration in the exhaled air is immediately displayed on the computer screen. FDA has recently approved three new products used to treat rare conditions. Fabrozyme, made by Genzyme Corporation, is used to treat fibrous disease and aldurazyme is used to treat several genetic disorders, including hurler syndrome. Both of these products are biotech drugs produced by recombinant DNA technology. The third product is Sumovert, made by Pharmacea Corporation. It's a growth hormone receptor antagonist and it's used to treat achromegaly. These approvals were granted under what's known as the Orphan Drug Act. This law provides for research grants and other incentives that encourage manufacturers to develop new drugs and biologics to treat rare conditions, those that affect fewer than 200,000 people in the U.S. One important incentive is that the company that makes the first product developed to treat a rare disease is allowed seven years of exclusive marketing for that product. Considering the small number of patients affected by these diseases, firms wouldn't be inclined to invest the time and money in product development and testing without these incentives. The Orphan Drug Act was signed into law in 1983 and since then it's been used to approve more than 200 products used to treat rare conditions including Crohn's disease, Hansen's disease, sickle selenemia, bleeding disorders like hemophilia A and B, rare cancers and leukemias, and the PCP pneumonia that affects HIV A's patients. FDA is alerting health care providers and patients about a recall of several lots of the cholesterol lowering drug Lipitor. The product in these lots is Counterfit Lipitor and it represents a potentially significant risk to consumers. The label on the counterfeit product says repackaged by Medpro Incorporated Lexington, Nebraska 68850. Health care providers and patients should check Lipitor packaging very carefully before using this product. Patients who have any product from these lots that are labeled as repackaged by Medpro Incorporated should be instructed not to take it and instead return the product to their pharmacies. FDA is continuing to investigate this counterfeigning incident so check our website frequently for updates. FDA has received several reports of serious medication errors, some of them fatal, with the drug Temadar manufactured by Shearing. This drug is a chemotherapeutic agent used to treat adult patients with refractory anoplastic astrocytoma. Temadar comes in four strengths, 5 milligrams, 20 milligrams, 100 milligrams and 250 milligrams. Each of those strengths is available in two package sizes, either five or 20 capsules per bottle. Unfortunately the milligram strength and the number of capsules per bottle appear alongside each other on the label and that's been the source of some of the errors. The number of capsules can be misread as the strength in milligrams and vice versa. One woman who was supposed to receive 20 milligram capsules actually received 250 milligram capsules because the 20 capsules on the label was misread as 20 milligrams. She died 10 days later. The FDA is working with the manufacturer to change the labeling so it's clearer. But in the meantime, Anita, if I'm a health professional what can I do to prevent this problem from occurring? Well there are a couple of things to do. First, the FDA recommends that you circle or highlight the milligram strength on the label to distinguish it from the number of tablets. As an alternative, you can dispense the temadar in unit dose form rather than from a multiple dose bottle. Wasn't the dosing schedule also a problem with this drug? Yes, in fact it was and in certain cases the drug was used too long. The dosing schedule for temadar calls for five consecutive days of treatment in each 28 day dosing cycle followed by 23 days off the drug. In some of the reported cases it was used far longer than that. One patient died after taking the drug for 22 consecutive days and another died after taking the drug five times a week for three consecutive weeks. It's not clear whether these errors were due to miscommunication by the pharmacist or non-compliance by the patient. What's the FDA recommending to prevent this kind of a problem? Well actually we're recommending two things. First, don't dispense more than a five-day supply of the drug at one time and second, be sure to clarify all orders or prescriptions that are vague or unclear about the dosage or dosing instructions. FDA has received several dozen reports of patient burns when rotary surgical handpiece is overheated. Some of the burns have been serious enough to later require plastic surgery. Medical personnel have also been burned by these devices. Surgical handpieces are used in a variety of orthopedic and general surgical procedures to cut shape or drill tissue. Almost all of them have bearings that allow the cutting tools to spin at high speeds. In normal use the bearing lubricant is slowly removed by repeated cleaning and sterilization. If the lubricant isn't replenished regularly the bearings will degrade and eventually disintegrate and the handpiece can overheat. Here's how to help keep the handpiece in safe working order. First inspect and test these devices regularly to look for evidence of overheating and be sure to do this before each use. Check to see when the handpieces were last serviced and lubricated and follow the manufacturer's instructions for servicing and lubrication. Most manufacturers of these devices recommend that the units be returned to them for servicing every year but no matter who does the regular servicing the bearings should still be properly lubricated. FDA has recently received reports in which cell growth was inhibited in amniocentesis cell cultures. This seems to have happened when the amniotic fluid wasn't transferred quickly from the collection syringe to the transport tube. Initial testing suggests that this inhibition of cell growth may be caused by the syringe stopper, the black rubber like grommet, on the end of the plunger rod. If I'm doing amniocentesis work how can I prevent this problem from happening? Well there are at least two things to do. The manufacturers of the affected syringes have sent letters to labs and clinicians suggesting two precautions to help avoid this kind of inhibition of cell growth. First they said minimize the time the amniotic fluid stays in the syringe. The fluid should be transferred to the transport tube as soon as possible and not stored in the syringe. And second keep the amniotic fluid from coming into contact with the stopper by keeping the syringe tipped down until the fluid is transferred. Now do these recommendations apply just to amniocentesis? Well not necessarily. Although the recent reports have only concerned amniocentesis syringe manufacturers note that these recommendations should be followed any time a syringe is used to collect amniotic fluid or other primary cell samples. They also emphasize that these syringes can still be safely used for routine clinical applications like blood collection and intravenous or hypodermic injections. We'll continue to work with syringe manufacturers on this issue and we'll update you with any new information. The Institute for Safe Medication Practices has reported on several cases where a mix up between two products led to unnecessary treatment. The products are the vaccine tetanus de theriotoxoid and tuberculin PPD both manufactured by the same company, Aventus Pasteur. In these situations, a series of patients who are supposed to get PPD skin tests inadvertently received intradermal injections of the TD vaccine instead. The reactions from the TD injections were read as positive PPDs and the patients were started on isoniazid. The errors were discovered after staff noticed a cluster of positive PPD skin tests. The patients were retested and the INH therapy was stopped after the retests were negative. ISMP points out that the similar packaging of these two products may have contributed to the errors. They both come in stylized colorful cartons, although the carton colors do differ. Both products are available in cartons of the same size and both have a circle on the front panel with the number five in it. Both products are stored in the refrigerator and may be located side by side. So if your facility uses these Aventus products, be particularly alert to this possible mix up. ISMP also suggests removing TD and other vaccines from floor stock if feasible and have the pharmacy dispense the vaccine instead. Before we go, we wanted to draw your attention to several recently updated FDA websites. First, there's FDA SARS page. Here you can find out what FDA is doing to help develop SARS treatments, vaccines and diagnostic tools. You'll also find FDA's guidance for blood establishments on safeguarding the blood supply, including recommendations on deferring potential blood donors who have had SARS or may have been exposed to SARS. On a different site, there's revised guidance for blood establishments on assessing donors for West Nile infection. In particular, there's a new recommendation that donors be asked a specific question about whether they've experienced a fever with headache within the week prior to donation. And finally, some people have been asking whether they can use flu vaccine left over from last year for this coming season's immunizations since the composition of this year's vaccine is going to be the same as last year's. FDA does not recommend this because last year's vaccine will be past its expiration date and the potency of the vaccine may have declined. Well, 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 Rainer. And I'm Mark Barnett. See you next time.