 This is FDA Patient Safety News. In this edition, new vaccines against pertussis for adolescents and adults, an update on the hazards of using veil and closed bed systems, the importance of avoiding pregnancy in HIV patients treated with Sustiva, and confusing dosage labeling on certain Tylenol products for children. 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 some medical products FDA recently approved. FDA recently approved two new vaccines that provide a booster immunization against whooping cough in combination with tetanus and diphtheria immunization. One of them is called boostrix, and the other is atticell. Boostrix is approved for adolescents aged 10 to 18, and it's made by GlaxoSmithKline. Atticell is approved for adolescents and adults up to 64 years of age. It will be distributed by a Venice Pasteur. But we've had booster vaccines for pertussis for a long time, so the question is, what's new about these? Well, the vaccines you're talking about have been for children. These two new vaccines are the first ones approved for use in adolescents and adults. But pertussis is basically a children's disease. You're absolutely right. But over the last 20 years or so, we've seen an increase in pertussis in adolescents and adults, and also an increase in infants less than one year who haven't received all their immunizations. Of course, pertussis can be especially serious or possibly even fatal in these very young infants. And so part of the rationale for immunizing adolescents and adults is to make it less likely that they'll transmit the disease to infants. In this case, we're immunizing older people to protect children. The FDA recently approved a drug called REQUIP to treat moderate to severe restless leg syndrome, or RLS. That's a neurologic disorder characterized by uncomfortable sensations in the legs that appear at rest, usually at night. And that induces a strong desire to move the legs, and that can result in chronic insomnia and sleep deprivation. REQUIP, or Ropinero, is manufactured by GlaxoSmithKline. The drug is a dopamine agonist, and it was first approved in 1997 to treat Parkinson's disease. REQUIP was found to be effective in treating RLS in three randomized, double-blind, placebo-controlled studies. The label for the drug will caution that REQUIP can have sedating effects and that syncope and symptomatic hypotension can occur, especially during initial treatment. Guidance Corporation is recalling certain models of the company's implantable defibrillators and cardiac resynchronization therapy devices. Several different problems have led to these actions. The first problem applies to three device models. The Prism 2DR Model 1861, manufactured Honor Before April 16, 2002. The Contact Renewal Model H135, manufactured Honor Before August 26, 2004. And the Contact Renewal 2 Model H155, also manufactured Honor Before August 26, 2004. These devices can develop an internal short circuit without warning, which can result in failure to deliver a shock during periods of arrhythmia. In a second action, Guidant has also notified physicians and patients about a possible component failure in a different set of defibrillators. The affected devices are the Contact Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF. A magnetic switch in these devices may become stuck in the closed position, and that may inhibit the device's ability to treat ventricular or atrial tachyarrhythmias, and it can accelerate battery depletion. In a third action, Guidant has notified physicians that certain implants with atrial therapy capability may experience a memory error that could limit available therapy. The affected devices are the Prism AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT. Go to our website for the latest recommendations on patient management for all of these actions and to learn about any further developments. There's an update on a story we did several months ago in which we warned about using veil and closed bed systems, models 500, 1000, and 2000. These beds were designed as an alternative to restraints for patients with cognitive impairment or unpredictable behavior, spasms, seizures, and other disorders. But using these beds poses a public health risk because patients can become entrapped and suffocate. FDA is aware of approximately 30 reports of entrapments, falls, and other incidents with these beds, including at least eight deaths. More than half of these incidents involve children 16 and under. Since our first story, Veil Products Incorporated has publicly stated that it's permanently ceasing the manufacture, sale, and distribution of these beds, and it will no longer be able to provide accessories, replacement parts, or retrofit kits. The company mailed revised instruction manuals and warning labels to its direct customers and distributors. FDA's advice to hospitals and nursing homes that have veil and closed bed systems remains the same. Stop using them and move patients to alternative beds. Consumers using these beds at home should consult with their physicians about their other options. If you have no choice but to continue using the veil and closed bed systems, it's very important to follow the safety precautions recommended by the company in order to minimize the risk of entrapment or falls. It's especially important to note that the company now contraindicates the beds for patients who weigh less than 46 pounds or who are less than 45 inches in height. These precautions are listed in the company's mailing. If you haven't received the mailing, you should contact Veil as soon as possible. You can also find a summary of the precautions on our website. Bristol Meyers Squibb and FDA are notifying healthcare professionals about the possibility of neural tube defects when Susteva or epheverins is given to women in the first trimester of pregnancy. This drug is used to treat HIV-1 infection. The company's letter notes that the pregnancy category for Susteva has been changed to Category D. That's positive evidence of fetal risk. This is based on four reports of neural tube defects in infants born to women who were exposed to the drug during the first trimester. The letter goes on to warn that pregnancy should be avoided in women receiving Susteva. It recommends that women of child-bearing age undergo pregnancy testing before receiving the drug and that if a woman becomes pregnant while she's on Susteva, she should be told about the potential risk to the fetus. The letter says that Susteva should be used in the first trimester only if the potential benefit outweighs the risk to the fetus, such as in women with HIV who don't have any other therapeutic options. FDA is notifying healthcare professionals and consumers about a nationwide recall of all drugs manufactured by Able Laboratories of Cranberry, New Jersey. Able Laboratories makes mostly generic prescription drugs, including drugs containing acetaminophen. Drugs are being recalled because of serious concerns that they weren't produced according to quality assurance standards. The company has stopped all current production. Patients who have been taking drugs produced by Able Laboratories should continue taking their medications until they've spoken to their doctor or pharmacist to get a replacement drug. You can find a complete list of the recalled drugs and their imprint codes on our website. In a recent letter, Sius Incorporated notified health professionals about newly published reports on the safety of the drug Natricor or Nasirotide, which is used to treat acutely-decompensated congestive heart failure. The reports raised the question of whether Natricor may have adverse effects on survival and on kidney function when compared with standard medications such as nitroglycerin or diuretics. Sius has changed the important safety information labeling for Natricor to describe the mortality data more fully. The company also convened an expert panel to review and analyze the safety data. The panel made several recommendations on the use of the drug, when information to provide to health care professionals, and obtaining further safety data. You know that lots of patients are now buying medicines and medical products online. That can be a convenient way to shop, but unless people are very careful buying medicines online can be a hazardous proposition. The FDA has a new brochure that can help guide people safely through that process. It's called Buying Prescription Medicine Online a Consumer Safety Guide, and you can get free copies to give your patients by going to our website. You know, Mark, in the past, we've talked about the possible dangers of buying products like this over the internet, but is there actually any evidence that this is a problem? Certainly there are cases in which people have bought things over the internet that have been substandard in potency, that have been fake, that have been counterfeit, that have been unapproved by the FDA, and sometimes just plain dangerous. Let me give you two examples. You probably remember that back in 2001, soon after the anthrax contamination incident that happened in a Washington Postal Center, there was a great demand for the drug Cipro, because people feared an anthrax attack. So many of them tried to purchase the drug and to stockpile it. So to satisfy that demand, Cipro, or products that were claiming to be Cipro, were suddenly offered on foreign websites. And we had no way of knowing whether what was being sold was manufactured properly, or even whether it was actually Cipro. For a later example, earlier this year, we warned consumers not to use a wide variety of home diagnostic kits which had not been reviewed or approved by the FDA. These kits were sold on the internet by a company called Globus Media, and they included home tests for pregnancy, syphilis, and HIV. And again, there was no way to know whether these kits actually worked, and the manufacturer wasn't even identified in the packaging. So here he had a situation where people could be testing themselves for HIV and getting erroneous results, and that could be tragic in many ways. Well, you mentioned this new brochure. What does it advise people to do? Well, without giving away the whole story, the main thing it says is to buy from a reputable website. Well, maybe that's easier said than done. Well, there are things that people can do to determine whether the site is reputable. For example, they should be sure the site is licensed by a state board of pharmacy. Some sites display a so-called VIPSEAL, which shows that they meet state and federal rules. And consumers should be sure that the site has a registered pharmacist to answer questions. You can find out how to get copies of the brochure in either English or Spanish by going to our website. McNeil's Specialty Pharmaceuticals is alerting consumers and health care professionals about certain children's Tylenol products because the packaging is potentially confusing. This could lead to children getting the wrong dose, including a possible overdose. The effective products include all lots and all flavors of children's Tylenol meltaways 80 milligram, packaging bottles and blisters, children's Tylenol soft chews 80 milligram, packaging blisters, and junior Tylenol meltaways 160 milligram, packaging blisters. Now, there are two ways that the confusion can arise. The first concerns the way the individual tablets are packaged and labeled. Each tablet of children's Tylenol meltaways and soft chews contains 80 milligrams of acetaminophen. Some of the blister cavities contain one of these 80 milligram tablets and some contain two. This allows parents to adjust their child's dose by selecting the correct number of individual tablets using the dosing chart on the carton. The confusion arises because the back of the two tablet blister cavity is labeled 80 milligrams, and that's intended to mean that each of the two tablets in the blister contains 80 milligrams, and consumers may interpret this to mean that the two tablets in the blister taken together contain 80 milligrams, and that could lead to accidentally doubling the child's dose. To resolve the confusion, the company is removing these Tylenol products from store shelves, and they're correcting the way they're labeled. The second possible source of confusion is the way the carton is labeled. The carton for some children's Tylenol meltaways and the junior Tylenol meltaways identifies the product's strength as medicine per dose rather than medicine per tablet. The company has proposed to change the labeling on the cartons to clear up the possible confusion. In the meantime, given the possibility of acetaminophen overdose, it's important to remind parents that the labeled strength of acetaminophen in these products is per tablet. They should be sure to follow the dose directions in the drug facts labeling to determine the correct number of individual tablets to be given per dose based on the child's age and weight. 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're going to be back next month with another edition, so watch for us. I'm Mark Barnett. And I'm Anita Rayner. See you next time.