 This is FDA Patient Safety News. In this edition, a new rotavirus vaccine for infants, reports of liver problems with the antibiotic Chitek, a recall of flex-tone cutting balloons, and teething rings contaminated with pseudomonas. 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 a new vaccine against rotavirus infections. FDA recently approved a vaccine for preventing rotavirus gastroenteritis in infants. The vaccine, which is called ROTA-TEC, is manufactured by Merck & Company. ROTA-TEC is a liquid oral vaccine that's given in three doses when the child is between the ages of six and 32 weeks. It's the only vaccine approved in the U.S. to help protect against rotavirus disease. CDC estimates that rotavirus infection leads to about 55,000 infants and young children being hospitalized each year in the U.S. These infections rarely lead to death in this country, but in developing countries, rotavirus gastroenteritis is estimated to cause up to several hundred thousand deaths among infants and young children every year. How well does this vaccine work? Well, in clinical studies, ROTA-TEC prevented about 74% of all cases of rotavirus gastroenteritis and nearly all of the severe cases. It also prevented about 96% of hospitalizations. Now, there was a rotavirus vaccine on the market several years ago that was withdrawn because there was a risk of interseception, and that could lead to fatal intestinal blockage. What about that kind of risk with a new vaccine? Well, in a large-scale trial of about 70,000 children, no increased risk was seen when ROTA-TEC was compared to placebo. Still, given the experience with the previous vaccine, both the manufacturer and CDC will conduct additional studies of the vaccine's safety. And FDA and CDC will carefully monitor reports of adverse events so that we're better able to detect any increased risk of this problem. What about other risks with the vaccine? Well, the risk of serious adverse events during the studies was similar when ROTA-TEC was compared to placebo. Certain less serious side effects, such as diarrhea, vomiting, and ear infection, were reported more often in the vaccine group than the placebo group. You can find more information on our website. FDA has issued a public health advisory about reports of serious hepatotoxicity that's associated with the use of keytec or telithromycin. Telithromycin is a key to light antibiotics that's used to treat respiratory infections such as community-acquired pneumonia, acute bacterial sinusitis, and acute exacerbation of chronic bronchitis. It's indicated only for patients 18 years and older. The advisory describes a report published in the Annals of Internal Medicine about three patients who developed jaundice and abnormal liver function after being treated with keytec. One patient recovered, one needed a transplant, and one died. All three patients had previously been healthy. Although it's hard to establish the actual frequency of adverse events from case reports like these, the FDA is investigating this issue to determine if additional action is necessary. In the meantime, the advisory reminds practitioners and patients that telithromycin should only be used for infections caused by a susceptible microorganism. It's not effective for viral infections, so a patient with a viral infection who's treated with telithromycin would be exposed to the risk of side effects without any benefit. The advisory also says that patients should be instructed to contact their healthcare provider immediately if they notice any yellowing of their eyes or skin or if they have other problems like blurred vision. Healthcare providers should monitor patients who are taken to telithromycin for signs or symptoms of liver problems and discontinue the drug if these occur. In December, Boston Scientific recalled the company's flex-tome cutting-balloon monorail delivery system, which is an angioplasty balloon with microsurgical blades attached to its sides. These devices are being recalled because the catheter shaft that's used to place the balloon in the artery may fracture when the device is being withdrawn from the patient. If that happens, the procedure may be prolonged or the patient may require additional surgery to remove the piece that's broken off. The company says that it's received reports of eight patients who are affected by this problem. Three of them needed additional surgery. The recall doesn't affect patients who've already received treatment with this device because a potential problem occurs during the procedure. Boston Scientific says that these devices should not be used and they should be returned to the company. To arrange for return of the recalled product, contact Boston Scientific at 1-800-811-3211. In a previous program, we warned that the overuse of benzycane anesthetic sprays can cause methymoglobinemia, a potentially life-threatening condition that can result in cyanosis, confusion, hemodynamic instability, and coma. FDA recently issued a public health advisory to remind health care professionals about this problem and to highlight ways to reduce this risk. Benzycane sprays, including those sold under the brand name Hurricane, Topex, and Cetokane, are used to anesthetize the mucus membranes of the mouth and throat when preparing patients for minor surgery and discopic procedures and endotracheal intubation. Hemoglobinemia is a known side effect when benzycane sprays are used, but the risk can increase when practitioners use multiple sprays or sprays of longer duration than recommended. FDA is reviewing the safety data for these products to determine if additional action is needed. In the meantime, FDA recommends the following actions to help minimize the risk. First, use only the minimum amount of benzycane spray to produce the required anesthetic effect. Carefully observe patients treated with benzycane sprays for signs of methemoglobinemia. These include headache, lightheadedness, shortness of breath, anxiety, fatigue, pale gray or blue colored skin, and tachycardia. Blood that's chocolate brown in color is a late sign of life-threatening levels of methemoglobinemia. Promptly treat patients who are suspected of having high levels of methemoglobin. Analyzogen alone is not effective. The only known treatment is intravenous administration of methylene blue. Don't rely on commonly available two-wavelength pulse oximetry to detect hypoxia because it may be unreliable in cases of methemoglobinemia. Analyze blood samples with a cooxymeter instead. Keep in mind that infants less than four months of age and patients with certain hemoglobin and enzyme abnormalities are at increased risk for developing toxic levels of methemoglobin. Patients who have breathing problems such as asthma, bronchitis, or emphysema, patients with heart disease, and patients who smoke are at greater risk for complications related to methemoglobinemia. All of these patients would likely benefit from either the use of topical anesthetics that don't contain benzycane or other forms of therapy. Bristol-Wyer's Squibb is notifying healthcare professionals about new safety information for the company's hydroxyurea capsules, which are sold under the brand names Hydria-Androxia. Hydria is used as an anti-neoplastic agent, and Droxia is approved for treating certain patients with sickle cell anemia. Cutaneous vascular toxicities, including vascular ulcerations and gangrene, have occurred in patients with myeloproliferative disorders who are being treated with hydroxyurea. These events occurred most often in patients who are currently receiving interferon or had a history of interferon therapy. Because of the risk of severe outcomes, hydroxyurea should be discontinued in patients with myeloproliferative disease who develop cutaneous vascular ulcerations. In order to minimize dermal exposure, always wear impervious gloves when handling bottles containing Hydria-Androxia capsules. That includes when unpacking and inspecting the bottles, transporting the drug within the facility and preparing and administering the doses. Patients and caregivers should wear disposable gloves when handling hydroxyurea or the bottles that contain the capsules. They should wash their hands before and after contact with the bottle and capsules. If the powder in the capsule is spilled, it should be wiped up immediately with a damp disposable towel and discarded in a closed container, such as a plastic bag. Novartis has notified healthcare professionals about new warnings and drug information in the labeling for the anti-psychotic drug Closaril or Clozapine. Because patients taking Clozapine are at increased risk of potentially life-threatening agranulocytosis, the labeling has required white blood cell monitoring for these patients. The new labeling provides for a number of changes regarding the white blood cell monitoring program. First, the frequency of monitoring may be reduced to once every four weeks after the first year of Clozapine treatment in patients who have maintained satisfactory white blood cell counts. Monitoring instructions for the first year of therapy remain the same, weekly for the first six months and every two weeks for the second six months. Second, a new requirement to determine and report the absolute neutrophil count has been added. Previously, only the total white blood cell count was required. Third, there are new white blood cell requirements for initiating Clozapine therapy. The total white blood cell count must be at least 3500 per cubic millimeter and the absolute neutrophil count must be at least 2000 per cubic millimeter. And fourth, if a patient experiences a moderate decrease in either the total white blood cell count or absolute neutrophil count, evaluate the risks and benefits of continuing Clozapine treatment. If Clozapine is continued, white blood cell counts must be monitored weekly for the next 12 months. The new labeling also warns of increased mortality in elderly patients with dementia who've received Clozapine to treat behavioral symptoms and it reminds physicians that this drug is not approved for use in dementia-related psychosis. There's also a new contraindication in patients who have paralytic ileus. Baxter Healthcare and Canjean are alerting healthcare professionals about new warnings for WinRow SDF, an IGIV product used to treat patients with immune throbocytopenic perpura. In rare cases, ITP patients being treated with WinRow SDF have experienced severe intravascular hemolysis, including potentially serious complications such as clinically compromising anemia, acute renal insufficiency, and disseminated intravascular coagulation. In some cases, these complications have been fatal. Most of these patients experience symptoms of intravascular hemolysis within four hours of receiving the therapy. Patients receiving WinRow SDF should contact their physicians immediately if they experience symptoms of hemolysis, such as back pain, shaking chills, fever, or discolored urine. The company also has a new patient information sheet that describes these symptoms. True or false? When FDA approves a new medical product for marketing, this assures that it's completely safe. False. FDA does require clinical testing in many cases, but this testing can't always reveal rare adverse effects, the kind that will occur only after the product is in widespread use over a period of time. That's why FDA relies on reports from health professionals to identify new problems and take action. If you have patients with small children, you should warn them not to use certain teasers made by a company called the First Years. The problem is that these teasers contain a liquid that may be contaminated with pseudomonas. Although no illnesses have been reported so far, these bacteria can cause serious illness in children if the teaser is punctured and the child ingests or inhales the liquid, or if the liquid is absorbed through a cut in the mouth. The risk of illness is especially high in infants whose immune systems are compromised by malnutrition, blood disorders, or cancer therapy. The First Years company recalls several different styles of liquid-filled teasers in late January. These styles all have the same general construction. They were sold nationwide between July 2005 and January 2006 at major retailers and grocery, drug, and specialty stores. Anyone who has one of these teasers should stop using it immediately. The company is asking consumers who bought one of the recalled teasers to put it in a plastic bag and return it to them. Consumers can contact the firm's service center at 1-866-725-4407 for additional information. 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. Until then, for the U.S. Food and Drug Administration, I'm Mark Barnett. And I'm Anita Rayner. See you next time.