 This is FDA Patient Safety News. In this edition, a new drug to treat adults with diabetes, a warning on using gabatryl in patients who don't have epilepsy, patient injuries from certain enclosed beds, and avoiding fenergan in children under two. 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 Anita Rainer. Let's start with a medical product FDA recently approved. FDA recently approved a new injectable drug to help control blood sugar in adult patients with type 1 and type 2 diabetes. It's called simlan, or premlan-tide acetate, and it's manufactured by amylin pharmaceuticals. Simlan is used in addition to insulin to help reduce post-prandial blood sugar levels in patients who can't achieve adequate control despite optimal insulin therapy. Tighter control of blood sugar may help to reduce the risk of long-term renal and cardiovascular and ocular events in these patients. Now patients with type 2 diabetes already have drugs other than insulin to help control their blood sugar. That's right. For patients with type 1, however, simlan will be the only therapy in addition to insulin that is available. But FDA and the manufacturer do have some safety concerns about this drug. They do, and they're mainly concerned with the way the drug is going to be used and prescribed. The first concern is that the drug may increase the risk of hypoglycemia. This risk is greatest in type 1 diabetics and in those with gastroparesis. The second concern is that patients might mix simlan with insulin in the same syringe, and that can alter the activity of the insulin. And the third concern is that the drug might be used inappropriately in patient populations where the risk-benefit profile hasn't been established. So it sounds like educating prescribers and patients is key to reducing the risk. It is, and that's why the FDA is going to require that a medication guide be distributed with each prescription of simlan to the patient, explaining how the drug is to be used and the possible risks involved. The labeling for physicians is going to specify that simlan is not to be used in patients with gastroparesis or those allergic to any of the drug's ingredients. HeartSign Technologies is recalling some of its Samaritan automatic external defibrillators. The affected devices may shut down before delivering a shock, which could delay treatment or even lead to death of a viable patient. We've received several user complaints that the device shut down during an attempted charge, but no injuries have been reported to date. This recall includes models SAM001, 002, and 003, with certain serial numbers within the range of 1270 to 2324. The HeartSign Samaritan PAD automatic external defibrillator is not affected by this recall. HeartSign Technologies notified its distributors and customers by letter on February 14, 2005, and the company is providing a software upgrade for the affected devices. If you have a device within this serial number range, but have not yet received an upgrade kit, you should contact the company as soon as possible to see if your product is affected and to get the kit. Go to our website for details on how to contact the company. FDA is requiring that a new bolded warning be added to the labeling for gabatril or tyagabine, an anti-epileptic drug that's approved as adjunctive therapy in treating partial seizures. The warning is being issued because of reports that gabatril has been associated with seizures in more than 30 patients who received it for conditions other than epilepsy. Now, you just said conditions other than epilepsy, but gabatril is only approved for treating epilepsy. Well, that's right, but in fact, gabatril has been used off-label for treating other conditions, mainly psychiatric conditions and also for chronic pain, and it's in those conditions where these seizures have occurred. Well, this seems like it could be a little confusing. Here we have a drug that's intended to control seizures in patients with epilepsy, but when it's used in other patients, it might actually be causing seizures. It is confusing, and in fact, the FDA advisory notes that some physicians have actually increased the dose of gabatril when they've observed seizures in their patients without epilepsy, taking the drug. They presumably did this because they weren't aware that it was the gabatril that might be causing the seizures, and they may have thought that since the drug is an anti-epileptic, it might actually control the seizures in these other patients. It sounds like this is a case where informing the practitioners is really key to the solution. It is a key, and in fact, the manufacturer has agreed to play an active role in doing that. In addition to changing the labeling, they've agreed to undertake an educational campaign for both physicians and patients, making people aware of the risks and discouraging off-label use. So what's the bottom line for practitioners here? The bottom line for practitioners is to understand that using gabatril for conditions other than epilepsy constitutes an off-label use, and what that means is that FDA has not approved the drug for these other uses. The advisory says that if a practitioner does decide to use a drug off-label, the risk of seizures should be explained to the patient. Here's a warning about certain enclosed beds that could be hazardous to patients. They're made by Veil Products, Incorporated, of Toledo, Ohio. On March 22nd, the FDA and the Justice Department initiated a seizure of all Veil Model 500, 1,000, and 2,000 enclosed bed systems because patients can become entrapped in the beds and suffocate. These canopy-like padded beds are used for at-risk patients with cognitive impairment, unpredictable behavior, spasms, seizures, and other disorders. They're advertised as an alternative to using a physical restraint or medication to reduce falls and prevent wandering. About 30 adverse events, including at least seven deaths, have occurred from entrapments, falls, and other incidents with these beds. More than half of these events involve children aged 16 and under. FDA recommends that hospitals, nursing homes, and consumers who have a Veil enclosed bed system stop using it immediately and move the patient to an alternate bed. If the only option for the patient is to continue using the Veil bed, FDA currently recommends that users follow these safety precautions that are recommended by Veil. First, use only the mattress recommended by the company. Always leave the side rails in the up position except when moving the patient from the bed. And if the bed has a high-low feature that raises and lowers the entire bed surface, never leave the feature in the high position when the patient is unattended because the patient can become entrapped. The company may take additional steps to address these safety issues. Check our website for additional information and for updates as they become available. FDA recently provided health care practitioners and patients with updated information about the risks and benefits of Crestor or Rasuvastatin calcium, a cholesterol-lowering drug made by AstraZeneca Pharmaceuticals. Crestor, like all other statins, has been associated with rhabdomyolysis. The incidence of this effect is low and the risk of serious muscle damage doesn't appear to be greater for Crestor than for other statins. But as with all statins, the risk of myopathy increases with higher drug levels. So Crestor's labeling has been changed to re-emphasize the risk of myopathy, particularly at the highest approved dose of 40 milligrams. The labeling also stresses the need to consider using lower starting doses in some patients. This may be particularly important when treating Asian Americans since a large pharmacokinetic study found that this group of patients had drug levels about twice as high as a Caucasian control group and that could increase their risk for myopathy. The revised labeling now recommends that the 5 milligram dose of Crestor be considered as the starting dose for Asian Americans and also for others with predisposing factors for myopathy, including patients on cyclosporine and those with severe renal insufficiency. FDA recently issued a public health advisory describing reports of sudden unexplained death in children taking Adderall and Adderall XR, which are used to treat ADHD. Sudden death has been reported in children with underlying cardiac abnormalities who are taking recommended doses of amphetamines, including Adderall and Adderall XR. A very small number of cases of sudden death have been reported in children without cardiac abnormalities who are taking Adderall. At this time, it doesn't appear that the number of sudden deaths in children taking Adderall is greater than the number that would be expected in this population without treatment, but it's possible that patients with underlying heart defects might be especially at risk and so the advisory re-emphasizes the warning in the product labeling that these patients should ordinarily not be treated with Adderall products. The advisory advised healthcare professionals and patients about a potential cancer risk from two topical immunosuppressant products that are used to treat atopic dermatitis or eczema. The drugs are eladil or pymicrolimus and protopic or tachrolimus. The advisory cautioned that these products should only be used as directed and only after other eczema treatments have failed. FDA is also adding a boxed warning for these two products and developing a medication guide for patients. The concern about possible cancer risk is based on information from animal studies, on case reports and a small number of patients and on the drugs mechanism of action. Long term human studies may be needed to determine whether eladil or protopic pose a cancer risk in humans and the extent of the risk if any. In the meantime FDA has several recommendations to help to minimize the risk. First, use eladil and protopic only as second line agents for treatment of eczema in patients who have failed or can't tolerate other prescription treatments. Use eladil and protopic only for short periods of time, not continuously. The long term safety of these drugs is not known. Use the minimum amount of eladil or protopic needed to control the patient's signs and symptoms. In animals, increasing the dose resulted in higher rates of cancer. Don't use these drugs in children and adults with a weakened or compromised immune system. And finally, avoid using these drugs in children younger than two years of age. Eladil and protopic are not approved for this use and the effect of these drugs on the developing immune system in infants and children is not known. The FDA and Wyeth have notified healthcare professionals that Fenergan tablets and suppositories are contraindicated in children under the age of two because the drug could cause fatal respiratory depression. The labeling also warns practitioners to be cautious when using Fenergan in older children. It notes that respiratory depression can also occur in this age group even when the dose has been calculated according to the child's weight. The risk is increased when Fenergan is used concomitantly with other drugs that may cause respiratory depression. The labeling goes on to remind practitioners that anti-imidics such as Fenergan are not recommended for treating uncomplicated vomiting in children. Another reason to avoid using Fenergan in children is that it can cause extra-perimital symptoms that can be mistaken for the CNS signs of diseases such as encephalopathy or RISE syndrome. FDA recently finalized a new rule that's designed to increase the safety of human cells, tissues and cellular and tissue-based products that are used for transplantation. The rule requires that manufacturers of these products recover, process, store, label, package and distribute them in a way that prevents the spread of communicable diseases. You said manufacturer, but that's hard to reconcile with the idea of donated human tissue. Well, the FDA uses the word manufacturer as a sort of umbrella term that encompasses the wide variety of different actions an establishment might take to prepare for use. And many different types of establishments may be involved in the various steps from recovery, donor screening and testing to storage and distribution. If an establishment is involved in any of the steps covered by the new regulation, FDA calls it a manufacturer. So what products are actually covered by the new rule? Well, the new regulations apply to a broad range of products. They include bone, ligaments, skin, corneas and poetic stem cells. They also apply to human heart valve and human dura mater allografts. There weren't human cells and tissues regulated before this? There were some regulations that were in place to help assure the safety of these products, but the new rules apply to a broader range of products and they're more comprehensive. What's the bottom line in all this for the healthcare practitioner? The new requirements will help assure that the tissue and cellular products they use are the safest available. If you use these products, you can help us monitor their safety by reporting any serious or life-threatening adverse reactions in your patients. You can find out how to report on our website. 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 Mark Barnett. And I'm Anita Rayner. See you next time.