 This is FDA Patient Safety News. In this edition, a new treatment for macular degeneration, a caution on treating women with navirapine, a recall of certain preloaded syringes used to flush IV lines and avoiding patient injuries when using helical tax and surgery. 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 Rainer. Let's start with a medical product FDA recently approved. FDA recently approved a new drug to slow vision loss in people with a neovascular or wet form of age-related macular degeneration. Although the wet form accounts for only 10% of all cases, it's often more visually debilitating than the dry form. The drug is called macagin or pegaptinibsodium injection and is distributed by ITEC Pharmaceuticals and Pfizer Incorporated. Macagin provides clinicians and patients with another alternative to the traditional laser treatment. It works by inhibiting the growth of abnormal retinal blood vessels that characterize the wet form of macular degeneration. It's injected into the affected eye once every six weeks. The safety and efficacy of macagin was studied in two clinical trials of patients with wet AMD. In both trials, patients who were treated with a drug lost vision at a slower rate than untreated patients. Serious adverse events related to the injection procedure included infections, retinal detachment, and traumatic cataracts. Patients who'd be monitored for signs of inflammation and infection for a week following injection. Other frequently reported adverse events were eye irritation, eye pain, increased intraocular pressure, subconjunctival hemorrhage, and blurred vision. FDA has issued a public health advisory about safety-related changes in the indications for viromuner navirapine, which is used in combination therapy to treat HIV. The labeling now recommends against starting navirapine therapy in women with CD4 cell counts greater than 250 cells per cubic millimeter unless benefits clearly outweigh the risks. These changes now appear in the indications and usage sections of the labeling, and a new medication guide for patients explains the risks associated with navirapine treatment. Why are women singled out for this recommendation? Well, both men and women on navirapine can develop symptomatic liver toxicity, but overall women have three times the risk that men do. Now why the cutoff point of 250 cells per cubic millimeter? Symptomatic liver toxicity can occur at any CD4 count, but it turns out that women with CD4 counts greater than 250 have 12 times the risk of women with lower CD4 counts. So when you combine those two factors, female gender and CD4 counts above 250, you end up with a group that's at particularly high risk. Now is there a similar cutoff point for men? There is, but it's higher. It's 400 cells per cubic millimeter. Well, we're talking about symptomatic liver toxicity. How does navirapine compare, then, with other similar drugs that are used to treat HIV? Symptomatic liver toxicity is more common with patients on navirapine, and it usually occurs within the first few weeks of dosing, and it can lead to liver failure even if lab results are being monitored. So why continue to use it? Well, first of all, triple antiretroviral therapy using drugs like navirapine is the standard of care in treating HIV patient, and it's important to have a number of drugs available to treat these patients in case they become drug resistant. The Public Health Advisory also points out several advantages to navirapine compared to other antiretrovirals. For example, unlike other antiretroviral drugs, symptomatic liver toxicity has never been reported when navirapine is given to a pregnant woman in a single dose to prevent perinatal HIV infection. Also, symptomatic liver toxicity hasn't been reported when navirapine is administered to children. You can see the Complete Public Health Advisory on our website. Medtronic Incorporated is recalling two of its defibrillator models. First, the company has issued an alert about certain LifePak 500 automatic external defibrillators because in some cases, these devices may not recognize that the electrodes are connected to the patient and thus they may not defibrillate those patients. The company is also recalling certain Medtronic implanted defibrillators because some of their batteries can develop internal short circuits. If this happens, the device can quickly become inoperative. For the latest information on these recalls, go to our website. FDA has issued nationwide alerts that warn against using certain preloaded syringes that contain heparin or saline flushes for IV catheters. The syringes are not approved by FDA and, in fact, the flushes may have caused pseudomonas infections in a number of patients. The syringes are manufactured by IV flush LLC and distributed by Pinnacle Medical Supply of Rallet, Texas. They were sold through distributors to hospitals, clinics, and home health care agencies. Health care facilities and consumers who have these preloaded syringes should not use them. Instead, immediately return them to IV flush LLC or to the original distributor. Consumers or health care facilities with questions can contact the company at 1-972-463-7389 or the FDA at 1-800-FDA-0178. If you suspect that your patients may have been infected from these products, you should also report these cases to your state or local health department, the FDA, and the CDC. A recent report from E.C.R.I. warns that serious patient injuries have occurred from helical tacks used with the autosuture tacker and autosuture protac that are manufactured by U.S. surgical. These corkscrew-like tacks are used to secure surgical mesh during endoscopic procedures, for example, in repairing hernias. The injuries occur when adjacent or underlying tissue is penetrated by the tacks. Now, these tacks are very widely used. How common is this problem? It's rare, but these events can be fatal. FDA received four reports of deaths between 1997 and 2003. In one report, a patient with a halal hernia died when the surgeon inadvertently tacked through the diaphragm and perforated the heart. The three other deaths involved perforation of the bowel during hernia repair. There were non-fatal cases, too, including perforations of the bowel and the bladder. So is one problem that the surgeon can't actually see how deeply the tack is going? That's right. ACRI points out that the tacks are four millimeters in length and that when they're given during an endoscopic procedure, essentially it's done blindly. Once the leading edge of the tack penetrates the tissue, it's no longer visible and if the tissue is less than four millimeters thick, the tack could penetrate into underlying tissue such as the pericardium, the heart, or the intestines. But if something like that were to happen, the surgeon would take action at that point to correct the problem. Well, not necessarily. ACRI points out that sometimes the damage doesn't become manifest until the post-surgical period when the patient starts to move around normally. And they also point out that if the tack isn't affixed firmly during this post-surgical period, during movement, the tack can become dislodged and it can fall into the surgical cavity. So if these tacks are four millimeters long, one of the ways to avoid this kind of problem would be to not use these tacks in areas where the tissue is thinner than that. That's one of ACRI's recommendations and they also recommend not to use them in areas where you can't visualize hemostasis. ACRI also says to be sure that the surgical staff are aware of the potential risks and complications of using these tacks and be sure they have appropriate training in handling the tacks. And they say always be aware of the underlying tissue and take extreme care when tacking near the heart, the major arteries, or the intestines. ISMP is warning about the danger of having unlabeled containers in the OR. They report on a recent case where chlorhexidine antiseptic solution was injected into a patient's artery instead of a contrast medium prior to cerebral angiography. The patient died several weeks later after undergoing a leg amputation, a stroke, and multiple organ failure. This happened because the two solutions, both clear, were present on the sterile field in identical unlabeled basins. ISMP also cites an earlier case where a cup containing gluteraldehyde, a preservative, was near a similar cup containing some of the patient's spinal fluid, which had been removed earlier to reduce cerebral pressure. Both cups were unlabeled. The gluteraldehyde was mistakenly drawn into a syringe, it was injected intrathequally, and the patient died. Now here are some of ISMP's recommendations to prevent these kinds of tragedies. Require labels on all medications and medication containers on and off the sterile field and also in perioperative units even if there's only one medication or solution involved. Make labeling easy by purchasing sterile markers and labels that can be opened onto the sterile field during procedures. If drug or solution names are similar, highlight the differences on the label. If possible, use skin antiseptic products in prepackaged swabs or sponges in order to distinguish them from medications. When preparing a label, require the scrub person and circulating nurse to verify the information by reading aloud the product name, strength and dosage from the labels. When passing a medication to the clinician who's performing the procedure, read the label aloud. Finally, discard any unlabeled medication or solution found in the area and report the event as a hazardous condition. The Institute for Safe Medication Practices has cautioned about possible mix-ups between different dosage forms of the mucolytic agent acetylcysteine. For many years, acetylcysteine products such as mucomyst were only approved for bronchopulmonary use and they were intended to be administered by nebulization. But ISMP points out that acetylcysteine was frequently administered orally off-label for other purposes, particularly to treat acetaminophen overdoses. In 2004, FDA approved an IV formulation of acetylcysteine called acetadote to treat patients with acetaminophen overdoses. Now with nebulization, oral and IV roots all being used, ISMP says there's bound to be some confusion, especially since the oral product comes in a vial with a rubber stopper, making it look like an injectable product. In one recent case, an error was averted when the nurse called a pharmacist to question whether the oral drug that she received from the pharmacy was compatible with the patient's IV fluids. In another case, a patient being prepped for radiology was given the oral medication intravenously. To confuse matters further, another source of error is that the drug may be ordered in milligrams, but some non-injectable product labels list the strength in percent only. So ISMP makes several suggestions. First, depending on the route of administration, consider dispensing acetylcysteine in different packaging or with visible auxiliary labels. For oral administration, the pharmacy could remove the drug from the original vial and place the proper dose in an oral solution bottle with a label showing the drug, the strength, and the route of administration. Similar labels should be placed on vials dispensed for IV administration or nebulization. Include a caution on drug administration records so that it's clear which product to use. Alert staff that there's a new FDA-approved formulation for IV use with acetaminophen overdoses. And finally, remind them that if the route of administration is unclear, double-check with the prescriber. A recent ISMP alert warns about the danger of confusing various extended release forms of the same drug. They also point out that the problem is likely to increase as drug manufacturers expand their product lines to include more forms of the same drug. ISMP cites the example of Welbutron, which is now available as Welbutron, Welbutron XL, and Welbutron SR. Or Metadate, which is available as Metadate ER and Metadate CD. Or Ritalin LA and Ritalin SR. Or Depacote and Depacote ER. ISMP cautions that these various extended release formulations are not substitutable. Here are some of the steps ISMP recommends to prevent mix-ups. First, ensure that staff who prescribe, dispense, and administer these products know about the different extended release formulations and their dosing schedules. Design your computer mnemonics so that the various dosage forms don't appear on the screen simultaneously, or place alerts on the screen to distinguish between them. Consider warnings on pharmacy shelves to prevent errors in selecting the drugs. And alert patients about the importance of these suffixes in the names of their drugs so they can help to identify an error before taking the drug. 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, Barnett and I'm Anita Rayner. See you next time.