 This is FDA Patient Safety News. In this edition, the first drug to treat moderate to severe Alzheimer's disease, a recall of certain pro-thrombon time test strips, what can happen when IV bags are removed from their over wraps, and an update from CDC on alcohol-based hand rubs and fire safety. 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. FDA has approved the first drug in a new class of antibiotics called cyclic lipopeptide antibacterial agents, and they're intended to treat serious skin infections. The new drug's name is Cubicin or Daptomycin for Injection. So, Mark, we're not talking here about something to treat everyday cuts and scratches. Not at all. We're talking about the kinds of serious skin infections, for example, that hospitalized patients would undergo. Cubicin is indicated for treating complicated infections of the skin and skin structure, caused by susceptible strains of certain staph, strep, and enterococcal bacturia, things like major abscesses, post-surgical wound infections, and infected ulcers. Clinical studies have shown that Cubicin's effectiveness in treating these infections is equivalent to standard treatments, such as vancomycin, oxacillin, or naphthalin. Well, what about side effects? Well, they tended to be mild to moderate. Side effects include GI disorders, injection site reactions, fever, headache, insomnia, dizziness, rash. Weren't there also reports of muscle injury? There were, although they were rare. And for the most part, the patients who experienced this didn't show symptoms. What they did show was an elevated blood level of CPK. Well, what are the practical implications of these elevated blood CPK levels? Well, you'll find that in the drug's labeling. The labeling recommends that patients receiving Cubicin be monitored for muscle pain or weakness, and that their CPK levels be checked weekly. FDA recently approved the first drug for treating moderate to severe Alzheimer's disease. Previous Alzheimer's drugs have been indicated for patients with mild to moderate disease. The new drug is memantine, and it will be marketed under the trade name NEMENDA by Forest Labs. The way memantine works is different from other drugs currently available for treating Alzheimer's. It's thought to work by blocking the action of the chemical glutamate in the brain. Two double-blind studies of memantine, each about six months in duration, were conducted in the U.S. on a total of about 650 patients. In one study, all patients were concurrently taking Dinepizil. Both studies showed that patients on memantine experienced less mental deterioration than patients treated with placebo. A third study conducted in nursing homes in Latvia was a 12-week double-blind study in 166 patients with severe Alzheimer's, and it also showed a statistically significant advantage of memantine over placebo. All of the studies had a low incidence of minor side effects. It's important to note that although memantine helps to treat the symptoms of Alzheimer's disease in some patients, there's no evidence that the drug modifies the underlying pathology. Go to our website for more information. Roche Diagnostics has issued a recall of coagulec PT test strips. These strips are used both in clinical settings and by patients at home to monitor anticoagulation therapy. The problem is a packaging defect that could cause false readings. A small percentage of the foil pouches that hold the strips were not cut properly. When this happens, the easy open notch on the side of the pouch cuts through the seal of the pouch, exposing the strips to moisture and air. When that occurs, even for just a few minutes, falsely higher or low readings can occur. Roche Diagnostics says that all lots of both the professional use and the patient's self-testing strips that have a lot number lower than 669 may have this problem. But the company says that test strips in these lots can still be used if these steps are followed. First, inspect each foil pouch to make sure that the easy open notch is in the correct position and that the pouch is sealed properly. If the notch cuts into the part of the pouch with the test strip in it, don't use any test strips from that box. Second, even if the pouch looks like it's sealed properly, the company says you should run two tests and compare results in case there's a defect that couldn't be seen. For more information, you can call Roche Diagnostics at 1-800-428-4674 or you can go to our website. FDA has issued a public health advisory that warns about serious adverse events when a blue dye, FDNC blue number one, is used in enteral feeding solutions as a way to visually detect pulmonary aspiration. Blue number one is allowed by FDA for certain uses in foods, drugs and cosmetics, but FDA hasn't evaluated its safety when it's used in enteral feedings. Why did FDA issue the advisory? Because we've received 20 reports of toxicity associated with the use of blue number one in enteral feedings. What were the clinical signs in these patients? Well, first of all, all the patients had systemic absorption of the dye manifested by blue discoloration of the skin or body fluids. Some of the cases were also associated with serious complications such as refractory hypotension and metabolic acidosis. Twelve of these patients died. So did these patients get more of the dye than normal? No, the concentration and the total amount of the dye was not abnormally high in these cases, but the patients did share a distinguishing characteristic. A large proportion of them were likely to have increased gut permeability, including those with sepsis, burns, trauma or inflammatory bowel disease. And so the advisory cautions that patients with these conditions may be at increased risk of absorbing blue number one from tinted enteral feedings. But the blue number one hasn't definitely been established as the cause of these adverse events, isn't that right? No, it hasn't been, but the advisory points out that the safety and the utility of this practice have not been evaluated by FDA. Well, what about just substituting another blue dye? FDA isn't making any recommendations for alternatives to blue number one in enteral feedings. The advisory points out that other blue dyes haven't been evaluated in this setting and they could be equally or more toxic. So replacing blue number one with another blue dye wouldn't solve the problem. Roxanne Laboratories is stopping the sale and distribution of the drug Orlam. Orlam is a synthetic opioid agonist solution that's used as second line therapy to manage opioid dependence. The company has received increasing reports of severe cardiac related adverse events since the drug was first introduced in 1995. In 2001, these adverse events led to extensive labeling changes in the U.S. and removal from the market in Europe. Since these changes, the use of Orlam has decreased dramatically. In a recent letter to healthcare professionals, Roxanne Laboratories now says that the risks of using the drug no longer outweigh its benefits, given that less toxic treatments are available. The company estimates that the current inventory of Orlam will be gone by February 2004, so no new patients should be started on Orlam therapy. The company says that current Orlam patients should be transferred to alternative treatments, such as methadone and the recently approved buprenorphine as soon as possible before Orlam becomes unavailable. For more information, go to our website. Here's a reminder about the importance of keeping premixed IV bags covered in their plastic overwraps. The Institute for Safe Medication Practices describes how the protective overwrap serves an important purpose to control the amount of water vapor that escapes from an IV solution. When you see water droplets forming inside a protective overwrap, that's the water vapor moving from the 100% humidity within the bag to the lower humidity in the overwrap. Once IV bags are removed from their overwraps and exposed to room air, the rate of evaporation increases and over time the drug's concentration will increase because the amount of drug in the bag stays the same while the amount of fluid decreases. You can actually lose a large proportion of the liquid in a bag this way. You sure can. ISMP cites a case where half of the liquid in the bag was lost. In this case, a patient was supposed to receive 40 mA equivalents of potassium chloride in 100 mLs over an hour, but the bag was empty in half an hour. That's because the overwrap had been removed from the bag and over time, half of the water had evaporated, leaving 40 mA equivalents of potassium in just 50 mLs of solution. But don't manufacturers have recommendations about how long you can leave the bag out of the wrap before you have to use it? Well, they do have recommendations, but they can vary quite a bit. Companies say that some bags should be discarded after several days if they don't have an overwrap. Others say discard them after a few months. The time span depends on the material used for the IV bag, the volume of solution, and the drug in the solution. So how do you get around to all this variation? Well, ISMP says the simple way to deal with it is to leave the bag in the overwrap until you're ready to use it. But that doesn't always happen. Sometimes they are removed and there is a delay before it's used on the patient. Then what happens? Well, ISMP encourages nurses to talk to their pharmacist about the best way to handle these bags once they've been removed from their overwraps. One solution may be to send them to the pharmacy so they can be sent to a unit where a patient is currently receiving the solution and they can be used right away. ISMP also cautions against writing an expiration date directly on the bag because volatile chemicals from the ink may leach into the solution. CDC has issued an update on alcohol-based hand rubs and fire safety. These hand rubs are an important tool in improving hand hygiene practices and reducing nosocomial infections and they're becoming more and more widely used in hospitals. But alcohol is flammable and so there's some concern that if stored or used improperly, these hand rubs could ignite. To keep that from happening, CDC recommends three things. First, when using these products, be sure to rub your hands until the alcohol has evaporated and your hands are dry. Second, keep your dispenser of alcohol-based hand rub away from high temperatures or flames. And third, store your excess supplies of this product in cabinets or areas approved for flammable materials. In an earlier show, we summarized an article from the Institute for Safe Medication Practices that warned about potentially fatal hemolysis if sterile water for injection were given intravenously. ISMP cited a case in which a physician gave a patient an IV infusion of sterile water for injection because he mistakenly believed that it would correct a patient's hypernatremia. But Mark, where did that sterile water for injection come from? It's supposed to be used just in the pharmacy to prepare various IV solutions. That's an interesting question. In this particular case, the physician prevailed upon the pharmacist to supply him with a bag of the water. But you know the ISMP points out now that those bags of sterile water can get into patient care areas or patient rooms in other ways. Sometimes they turn up in dispensing cabinets. In one case, a supplier mistakenly socked the cabinets with sterile distilled water instead of 5% dextro solution. In another case, the hospital's purchasing department placed leader bags of sterile water in the cabinets because poor bottles of the water weren't available at the time. ISMP recommends ensuring that sterile water cannot be stocked or ordered in patient care areas without special permission and precautions. They also point out that sometimes bags of sterile water are included in emergency boxes to treat malignant hyperthermia where they're used to dilute IV dantrium and they may later end up being mistakenly hung as an IV solution during emergency treatment. ISMP suggests using 50 milliliter vials of sterile water for this purpose instead of the 1 liter bags. Well Mark, isn't sterile water also used to humidify patient ventilators? Some ventilators do require sterile water and of course then those bags end up in the patient's room. But aren't these bags labeled differently? Well they are labeled sterile water for inhalation, but they can still look like IV bags. So what does ISMP suggest doing in these kinds of situations? Well they have several suggestions. First of all you can use humidification devices that don't require using bags of sterile water. If you have to use bags of inhalation water, warn staff members not to leave unopened bags in the patient's room and not to hang them from IV poles. You can also consider using 2 liter bags for the inhalation water and of course that helps to distinguish them from the IV bags. 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 Reiner. And I'm Mark Barnett. See you next time.