 This is FDA Patient Safety News. In this edition, a new drug to treat advanced prostate cancer, the first drug to treat botulism in infants, a recall of certain comfort gel nasal masks, a caution on administering IV push medications too quickly, and fatal errors with intrathecal contrast media. Many 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. FDA recently approved a new drug to treat advanced prostate cancer for patients who have no alternative therapy. The drug called plenaxis is a gonadotropin-releasing hormone antagonist that lowers testosterone levels. Plenaxis, or aborellic for injectable suspension, is made by Pracist Pharmaceuticals Incorporated. Plenaxis is approved to treat the symptoms of advanced prostate cancer in men who can't take other hormone therapies and refuse surgical castration. A clinical trial of 81 such patients showed that these men could avoid surgical castration by undergoing at least 12 weeks of treatment. Some of these patients also showed other benefits, including decreased pain and relief from urinary problems. There's a decrease in effectiveness of the drug over time, so serum total testosterone concentration should be measured in patients about every eight weeks. Now there was a problem with allergies with this drug, wasn't there? Right, there was. Three patients in the clinical trial experienced systemic allergic reactions within minutes of receiving the drug. I'm assuming that that kind of reaction happens after the patient's gotten a few doses of the drug. Well actually no, it turns out that these kinds of reactions can occur even with the first dose, but as you might expect, the cumulative risk of getting this type of reaction increases the longer the patient is receiving the drug. So I guess patients have to be watched carefully after the injection to be sure of it. Right, that's really important. Patients have to be observed for at least 30 minutes after receiving each injection. That's so if allergic reactions occur, they can be managed appropriately. In fact, it's required that Plenaxis be administered in a doctor's office or medical facility. But there's more to it than that. Pracist Pharmaceuticals will administer a risk management plan for Plenaxis, which has several components. First, marketing of the drug will be restricted. Plenaxis will only be available from physicians with certain qualifications who enroll in the company's risk management program. The drug should only be used in patients with advanced symptomatic prostate cancer who do not have other treatment options. Pracist is establishing educational programs for physicians, patients, and hospital pharmacists about the risks and benefits of Plenaxis. And finally, patients will be asked to read and sign a patient leaflet before receiving the drug. FDA recently approved the first drug to treat botulism in infants under one year of age. The new product is botulism, immune, globulin, intravenous human, and it's going to be sold under the name baby big. It can be used for both type A and type B botulism. In clinical studies, when baby big was given within the first three days of hospitalization, it significantly reduced the length of hospital stay in infected infants. It also reduced the average length of stay in the ICU and the average length of time on a ventilator. Keep in mind, though, that baby big has only been studied in infants under one year of age, so it's not known if the drug would be safe and effective for other age groups. It's important to remember that IGIV products of this kind may be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. IGIVs that contain sucrose as a stabilizer, such as baby big, have accounted for a disproportionate number of these events. Now, these events are rare and no cases of renal failure were seen during the trials. Still, patients predisposed to acute renal failure should receive baby big at the minimum concentration available and at the minimum rate of infusion that's feasible. These patients include those with any degree of preexisting renal insufficiency, diabetes, volume depletion, sepsis, or paraproteinemia, and also those on drugs that are known to be nephrotoxic. A Venice Pharmaceuticals has sent a letter to healthcare professionals alerting them to new warnings and precautions in the labeling for oreva or lafunamide, a drug used to treat active rheumatoid arthritis. The new labeling information is based on reports of rare but serious hepatic injuries, some of them fatal, as well as reports of severe infections, including sepsis. Most of the liver injuries were in patients who had preexisting liver disease or were exposed to other hepatotoxins. And most of the serious infections occurred in patients who had comorbid illnesses or who were receiving immunosuppressants. The new labeling provides further guidance about liver function tests and adjusting the dose or discontinuing the drug based on those tests. The labeling also provides a schedule of periodic blood tests that these patients should receive in order to monitor for possible bone marrow suppression. If you prescribe oreva or care for patients on this drug, you should read the letter from Aventus, which describes in detail the periodic lab tests that should be performed on these patients. Respironix Incorporated is recalling some of the company's comfort gel nasal masks. The masks are used with CPAP devices to treat patients with obstructive sleep apnea or respiratory failure. The recalled masks were distributed from September the 5th through September the 15th, 2003. Now, the affected devices are being recalled because a small number of those masks don't have a built-in port that allows exhaled air to exhaust properly. Well, Mark, what happens if these masks don't have this port? Well, without the port, it's possible that the patient would rebreathe CO2 and, of course, that could lead to an oxygen deficiency. In some cases, it's possible that the patient could suffocate. Also, the user instructions with these recalled masks can be confusing, because they tell the patient that the mask does have an exhalation port and doesn't need a separate one. And, of course, with some of these masks, that's not the case. Well, haven't most of these recalled devices already been retrieved by this point? They have. Most of the devices have already been returned to the company, and no patient injuries have been reported. But there could be some patients out there who are still using these masks. If you have a patient who might be using one, you should contact Resperonix, and that phone number is 1-800-345-6443. For more information, you can go to our website. Alon Pharmaceuticals, the manufacturer of Roxxanol morphine sulfate products, has sent a letter to health care professionals warning about accidental overdoses of morphine sulfate oral solutions. They know that Roxxanol concentrated oral solution contains 20 milligrams of morphine sulfate per milliliter. Serious overdoses have occurred when the medication was prescribed in milligrams, but then administered in milliliters. In one case, for example, five milligrams of morphine was ordered, but five milliliters of the Roxxanol solution was administered to the patient. And so the patient received 100 milligrams, and that's a 20 fold overdose. To prevent such errors, Alon Pharmaceuticals recommends that prescriptions for morphine sulfate oral solution show the concentration of the oral solution to be used, the intended dose of morphine in milligrams, and the volume of that dose in milliliters. For example, if the prescriber wants the patient to have a dose of 15 milligrams of morphine, here's the way the prescription should be written. Roxxanol 20 milligrams per milliliter, SIG 15 milligrams, 0.75 milliliters, or CC, every four hours PRN, dispense 30 milliliters. In a previous program, we told you that FDA had cleared a new rapid laboratory test for invasive aspergillus infection. The test called Platellia aspergillus EIA detects aspergillus galactomanin antigen in serum, which can be a good indicator of invasive infection. Results from this test are available in about three hours compared to about four weeks for the standard culture method of testing for aspergillus. Now the firm has notified us about reports of a possible interaction between this test and the drug Zocan. This interaction may cause false positive test results. Zocan is an injectable antibacterial combination of peppericillin and tasobactym that's distributed by Wyeth Pharmaceuticals. Certain patients treated with Zocan had positive aspergillus test results, but they did not have invasive aspergillus infection. So patients being treated with Zocan who have positive aspergillus results with the Patellia test should also be tested by another method. And laboratories that report a positive test result should inform clinicians about the potential interaction between Zocan and the Patellia aspergillus test so that the patient's drug therapy can be taken into account. BioRed has notified their customers and they're changing the product labeling. They want to alert users that positive test results in patients treated with Zocan should be interpreted cautiously and confirmed by other diagnostic methods. The Institute for Safe Medication Practices recently warned about potentially harmful errors that can occur when IV medications are administered too quickly. ISMP sites several examples of these kinds of errors and sometimes they've been minor like the rapid administration of IV ampicillin. But other cases have been more serious. For example, severe hypotension and red neck syndrome, which is a flushing of the upper body, can occur when IV vancomycin is given too rapidly. Serious adverse effects can also occur with too rapid administration of potassium chloride. The same holds true for verset or medazolam, which should be given slowly while the drug's effects on the patient are monitored. ISMP also reports on a case that led to a patient's death. An ED physician prescribed a labetolol 20 milligram IV push for a patient experiencing a hypertensive crisis. The nurse got the drug quickly, but the patient was already being transported to radiology. So on the way, the nurse administered the drug in a matter of seconds. The patient immediately arrested and could not be resuscitated. Here are some of ISMP's recommendations to reduce patient harm from rapid injections of IV medications. First, for medications that have a high risk of adverse events if they're given too fast, provide practitioners with ready access to information about the maximum rate of administration in milligrams per minute. Provide this information as an alert on pharmacy-applied product labels and as a special notation on computer-generated medication administration records. Also, post a list of these drugs in their administration guidelines in medication use areas or on a hospital intranet or in a small pocket guide. Second, consider using less concentrated solutions when you're giving a drug that could be dangerous if administered too quickly. For example, you could use the 1 milligram per milliliter strength, the verse said, rather than the 5 milligram per milliliter strength so staff can titrate the dose slowly during administration. Or you could dilute medications and administer them as a piggyback or with an infusion pump. And you could use a syringe pump to infuse small-volume IV medications. Finally, with drugs that should be administered for one minute or longer, avoid using terms such as IV push or IVP or bolus. Use more specific terms like IV over five minutes. Here's a story you may want to pass on to colleagues in the radiology department. The Institute for Safe Medication Practices recently reported on a patient who received an intrathecal injection of the wrong contrast medium prior to undergoing myelography and died as a result. ISMP points out that only certain products can safely be used intrathecally. In fact, FDA requires the manufacturers of contrast media that are not intended for this use to mark the packages not for intrathecal use or not for myelography. But these warnings can still be overlooked. And so ISMP has several suggestions to minimize the possibility of error. For example, the pharmacy might consider placing auxiliary warning labels on media that should not be used for myelography. Various types of contrast media could be stored separately based on their use. ISMP mentions one facility where media for myelograms are stored in a locked box in an exam room that's used exclusively for intrathecal procedures. No other contrast medium is stored there. Another hospital packages special myelogram kits that include the proper contrast medium. Of course, pharmacists should visit these areas periodically to be sure that the right media are in the right places. And when a contrast medium is to be administered intrathecally, clinical staff should perform an independent double check to be sure the product they're using is the right one for that purpose. It's also important for the clinical staff to be able to promptly recognize an error and begin treatment, because this may prevent a fatal outcome. You can see the entire ISMP article on our website. 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 US Food and Drug Administration, I'm Anita Rainer. And I'm Mark Barnett. See you next time.