 This is FDA Patient Safety News. In this edition, a new stair-climbing wheelchair, warnings about asthma drugs containing salmeterol, more on drug name confusion, and a caution about drugs that may look like candy. 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. I'm Anita Reiner. Let's start with some medical products FDA recently approved. FDA has approved a new powered wheelchair that can climb stairs, go up and down curbs, and operate on gravel, grass, and sand. It can also raise itself up so that the seated user can have an eye-level conversation with a standing person or can reach high shelves. It's called the Independence EyeBot 3000 Mobility System, and it's manufactured by Independence Technology. It works using a computerized system of sensors, gyroscopes, and electric motors. Mark, I've seen other devices that have some of these features like elevating the user. But this device does three things. It climbs the curbs and stairs. It does elevate the user. It also operates on uneven surfaces. So can anyone who currently uses a wheelchair use this device? No, there are some important restrictions. Users must have the use of at least one hand to operate the controls on the chair. They can't weigh more than 250 pounds, and they can't have medical conditions that increase their risk of bone fractures. They also must be able to sit upright and bend their knees so they can use standard foot rests. And it's important that they have the judgment to avoid obstacles that could cause a fall. In fact, patients have to be trained in using the chair, and they have to pass a test to prove they can operate it safely. And health professionals have to undergo special training to prescribe the chair. FDA recently approved a new drug called Ximera for people with a deficiency of alpha-1 proteinase inhibitor who also have evidence of emphysema. Alpha-1 proteinase inhibitor, also called alpha-1 PI or alpha-1 antitrypsin, is a blood protein that protects tissues from being digested by enzymes released during the inflammation process. Ximera, made by a Venice bearing LLC, is highly purified human alpha-1 PI derived from human plasma. It's administered intravenously. So if you have this deficiency, what's the clinical result? Well, deficiency of alpha-1 PI shows up most frequently as lung disease, but it can also affect the liver. How common is this? Possibly more common than some people might think. It's generally thought to be very rare, but some evidence suggests that about one in 3,000 individuals in the U.S. may have this deficiency. Most affected people are not aware of their condition. Aren't there other products on the market to treat this deficiency? Well, there are, and they're made by different companies. But the availability of this new product offers more choice and provides further safeguards against any possible disruption in the supply of these treatments. GlaxoSmithKline has added a new boxed warning and other safety information to the labeling for several drugs containing Sol-Meterol, a long-acting bronchodilator that's used to treat asthma and chronic obstructive pulmonary disease. Those drugs include serovent inhalation aerosol, serovent discus, and advare discus. The new warning describes a small but significant increase in the risk of life-threatening asthma episodes or asthma-related deaths in patients who are taking Sol-Meterol. The new information comes from the so-called SMART study, a large placebo-controlled U.S. investigation of serovent. The study was designed to further investigate the safety of serovent, particularly whether it might cause rare but serious asthma-related adverse events. The trial compared the effects of adding Sol-Meterol versus a placebo to a patient's usual asthma therapy over 28 weeks. FDA and GlaxoSmithKline have analyzed the data, which includes about 13,000 patients each in the serovent group and the control group. There were 13 asthma-related deaths in the serovent group versus four in the control group. Subgroup analyses suggest that the risk may be greater in African-American patients than in Caucasians. FDA is emphasizing that the benefits of treating asthma and COPD with Sol-Meterol products continue to outweigh the potential risks when these drugs are used according to the instructions in the labeling. Patients should not discontinue treatment with serovent or adverse products without consulting with their physician because abruptly stopping these drugs can result in acutely deteriorating asthma control, which could be life-threatening. FDA points out that all asthma drugs, including Sol-Meterol, should be prescribed as part of a comprehensive plan that takes into account the severity of the patient's asthma and educates the patients about the disease and how it's treated. Here's an alert about the rabies vaccine, IMAVAX. The manufacturer, Aventus Pasteur, says that some of their old packages of IMAVAX are missing the vials of freeze-dried vaccine and they contain only a diluent syringe and two needles. Each box should include a vial of freeze-dried vaccine plus a diluent syringe and the two needles. If you stock this product in the older packages, which are gray boxes, Aventus Pasteur says you should open every box in your inventory to confirm that it contains the vaccine vial. And if you find a package where it's missing, contact the company. Pharmacia and Upjohn Company, a subsidiary of Pfizer Incorporated, has issued a letter to healthcare professionals alerting them to important new safety information about their growth hormone product, genotropin. One is used to treat children with growth failure due to Prader-Willi syndrome. Prader-Willi is a congenital disorder characterized by short stature, mental retardation, excessive eating, obesity, and sexual infantilism. Genotropin is used in Prader-Willi patients to increase stature and improve the ratio of lean to fat tissue. Mark, why the new safety information? What's the problem? Well, the company has found out about seven fatalities worldwide among children who were treated with genotropin because they had Prader-Willi. Well, aside from all having Prader-Willi syndrome, did these children have any characteristics in common that made them more susceptible? They did share one or more of certain risk characteristics. These risk factors were severe obesity, a history of respiratory impairment or sleep apnea, or an unidentified respiratory infection. Male patients with one or more of these risk factors may be at greater risk than females. The package now states that growth hormone is contraindicated in Prader-Willi patients who are severely obese or who have severe respiratory impairment. The warnings go on to say that patients should be evaluated for upper airway obstruction before beginning treatment with growth hormone and that the treatment should be interrupted if patients show signs of upper airway obstruction. For additional information, you can contact Pfizer Medical Information at 800-323-4204. Here's a warning about the drug Risperdol, or Risperidone, manufactured by Janssen Pharmaceutical and used to treat schizophrenia. The warnings section of the label for this drug now describes cerebrovascular adverse events in elderly patients being treated for dementia-related psychosis in clinical trials. These events, some of them fatal, included stroke and TIA. The warning goes on to say that Risperdol has not been approved for the treatment of patients with dementia-related psychosis. In a recent letter to practitioners, Janssen Pharmaceutical is offering additional information on these and other clinical trials that are conducted in elderly patients. Call the company at 1-800-Janssen. Every now and then, we alert you to mix-ups that can occur when drug names look or sound alike. This time, we're talking about the similarity between the trade name of one drug and the generic name of another. Puranthal is the trade name of a potent anti-metabolite used in oncology, whose generic name is myrcaptopurine. Propylouricyl is an antithyroid agent available only in generic form. The Institute for Safe Medication Practices points out that although these drug names appear to be quite distinct, there are several common characteristics that may cause confusion. Both names start with P and end with L, both common 50-milligram tablets, and the ure sound in purine and uracil can increase the risk of error. And propylouricyl is often abbreviated PTU, which can be mistaken for purinthal. ISMP describes several examples of mix-ups between purinthal and propylouricyl. In one case, a child with acute lymphoblastic leukemia mistakenly received propylouricyl instead of purinthal for six months, even after his parents asked why the tablet looked different. No direct harm occurred, but the patient missed six months of chemotherapy, which then led to modifications in the therapy. Perhaps more serious is the reverse kind of error when purinthal is administered instead of propylouricyl. The dose of propylouricyl is often several hundred milligrams a day, which could be up to six times the maximum dose for purinthal. So mistakes where purinthal is given at these high doses could lead to significant harm, including bone marrow suppression, hepatotoxicity, immunosuppression, and teratogenicity. ISMP suggests some ways to help reduce the risk of this kind of mix-up. Separate these two drugs on pharmacy shelves. List both the brand name and the generic name on prescriptions for purinthal. Avoid using abbreviations. Counsel patients before dispensing these two drugs and fully investigate situations where they report that their drugs look different than usual. In a recent medication safety alert, the Institute for Safe Medication Practices cautions that brightly colored pills could be mistaken for candy by young children. They cite the case of a two-year-old brought to the emergency room after ingesting well-buttern SR. They note that this product is brightly colored in all three of its strengths and that viewed upside down, the drug name and strength that are printed on the tablets might look like a happy face to a child. ISMP reiterates the general need to educate parents to use safety caps, to keep medications out of children's reach, and to teach their children about poisons. But they note that this may be especially important with medications that can look to a child like candy. Speaking of children, the FDA and the Counsel on Family Health have issued a new brochure that helps parents use over-the-counter medications safely for their kids. It's called Gotta Sick Kid and it goes through 10 tips for giving the right medicine in the right amount. It also provides a chart that shows the recommended immunization schedule for children. You can get copies of the brochure from the Counsel on Family Health by calling 202-331-7373. And while we're talking about brochures, the FDA has a new one for patients and caregivers who are using medical devices in the home. It's a checklist that helps people use these products safely and effectively. It also provides general tips on maintaining medical devices so they continue to work as they're supposed to, as well as instructions for reporting adverse events. To find out how to get copies, go to our website. If you have patients or family members who wear hearing aids, you may know that they often have trouble using cell phones. Some cell phones cause radio-frequency interference with hearing aids, and user hears high-pitched whistling sounds through the hearing aid or static or thumping sounds. But all cell phones aren't alike in this respect. Some of the phones have lower radio-frequency emissions or different technology that can reduce the unwanted effects on the hearing aids. So you should advise hearing aid wearers that are shopping for cell phones to try several brands and models before they decide. Some hearing aids may be so susceptible to interference that they simply won't work with any of the cell phones that are available while other ones are designed to be resistant to interference. So the same trial-and-error approach is also important when shopping for hearing aids. Fortunately, hearing aids are improving, and before long, it's going to be much easier for hearing aid wearers to find a compatible phone. Also, FDA has begun working with the hearing aid industry on ways to help clinicians and consumers choose hearing aids in cell phones that are likely to work together. The phones will be improving, too. The Federal Communications Commission recently announced that they'll require cell phone manufacturers to make at least some models usable by hearing aid wearers within the next two years. 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 for 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 Mark Barnett. And I'm Anita Rayner. See you next time.