FDA Patient Safety News: Show #50, April 2006

New Rotavirus Vaccine for Infants

FDA recently approved a vaccine for preventing rotavirus gastroenteritis in infants. The vaccine, called RotaTeq, is manufactured by Merck and Co.
RotaTeq is a liquid oral vaccine that's given in three doses when the child is between the ages of 6 and 32 weeks. RotaTeq is the only vaccine approved in the U.S. to help protect against rotaviral disease.

Rotavirus infection is a major cause of severe diarrhea in infants and young children in this country and around the world. 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.

In clinical studies, RotaTeq prevented 74 percent of all rotavirus gastroenteritis cases and nearly all of the severe cases. The vaccine also prevented about 96 percent of hospitalizations.

In 1998, FDA approved a different live vaccine against rotavirus that was later withdrawn from the market because of its association with an increased risk of intussusception, which can lead to fatal intestinal blockage. However, in a large-scale trial of about 70,000 children, no increased risk was seen when RotaTeq was compared to placebo. Given the experience with the previous vaccine, both the manufacturer and CDC will conduct additional studies of the vaccine's safety. FDA and CDC will carefully monitor reports of adverse events to be able to detect any increased risk of this problem.

The risk of serious adverse events during the studies was similar when RotaTeq 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.

Additional Information:

FDA Press Release - FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants. February 3, 2006.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108588.htm


Hepatotoxicity with Ketek

FDA has issued a Public Health Advisory about reports of serious hepatotoxicity associated with the use of Ketek (telithromycin). Telithromycin is a ketolide antibiotic that's used to treat respiratory infections, such as community-acquired pneumonia, acute bacterial sinusitis, and acute exacerbation of chronic bronchitis. Ketek is 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 Ketek. One patient recovered, one needed a transplant, and one died. All three patients had previously been healthy.

The actual frequency of adverse events is difficult to establish with case reports like these. 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. The product is not effective for viral infections, so a patient with a viral infection 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 taking telithromycin for signs or symptoms of liver problems, and discontinue the drug if these occur.

Additional Information:

FDA Drug Information - Telithromycin (marketed as Ketek). January 20, 2006.
http://www.fda.gov/cder/drug/infopage/telithromycin/default.htm


Boston Scientific Recalls Flextome Cutting Balloons

In December 2005, Boston Scientific recalled the company's Flextome 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 is 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 has broken off. The company says that they have received reports of eight patients who were affected by this problem. Three of them needed additional surgery.

The recall does not affect patients who have already received treatment with this device because the potential problem occurs during the procedure.
Boston Scientific says that these devices should not be used and should be returned to the company. To arrange for return of the recalled product, contact Boston Scientific at 1-800-811-3211.

Additional Information:

FDA MedWatch Safety Alert 2006 - Boston Scientific Flextome Cutting Balloon Systems. January 31, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151439.htm


Advisory on Benzocaine Sprays and Methemoglobinemia

FDA recently issued a Public Health Advisory to remind health care professionals that the overuse of benzocaine anesthetic sprays can cause methemoglobinemia, a potentially life-threatening condition that can result in cyanosis, confusion, hemodynamic instability and coma.

Benzocaine sprays, including those sold under the brand names Hurricaine, Topex and Cetacaine, are used to anesthetize the mucous membranes of the mouth and throat when preparing patients for minor surgery, endoscopic procedures and endotracheal intubation. Methemoglobinemia is a known side-effect when benzocaine 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. FDA recommends the following actions to help minimize the risk:

• Use only the minimum amount of benzocaine spray to produce the required anesthetic effect.

• Carefully observe patients treated with benzocaine 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 suspected of having high levels of methemoglobin. Supplemental oxygen alone is not effective. The only known treatment is intravenous administration of methylene blue.

• Do not rely on commonly available 2-wavelength pulse oximetry to detect hypoxia because it may be unreliable in cases of methemoglobinemia. Analyze blood samples with a co-oximeter instead.

• Infants less than 4 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 do not contain benzocaine or other forms of therapy.

Additional Information:

FDA MedWatch Safety Alert 2006 - Benzocaine Sprays. February 13, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150501.htm


Warning on Cutaneous Vasculitic Toxicities with Hydroxyurea

Bristol-Myers Squibb is notifying healthcare professionals about new safety information for the company's hydroxyurea capsules, sold under the brand names Hydrea and Droxia. Hydrea is used as an antineoplastic agent and Droxia is approved for treating certain patients with sickle cell anemia.

Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders who are being treated with hydroxyurea. These events occurred most often in patients who were 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 vasculitic ulcerations.

The company letter also emphasizes how important it is to handle the drug safely. In order to minimize dermal exposure, always wear impervious gloves when handling bottles containing Hydrea or Droxia capsules. That includes 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 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.

Additional Information:

FDA MedWatch Safety Alert 2006 - Hydrea (hydroxyurea capsules).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150609.htm


New Warnings in Labeling for Clozaril

Novartis has notified healthcare professionals about new warnings and drug information in the labeling for the antipsychotic drug Clozaril (clozapine).

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 WBC monitoring program.

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 (WBC) 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.

A new requirement to determine and report the absolute neutrophil count has been added. Previously, only the total white blood cell count was required.
There are new WBC requirements for initiating clozapine therapy: the total WBC count must be at least 3500 per mm3 and the absolute neutrophil count must be at least 2000 per mm3.

If a patient experiences a moderate decrease in either 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 that have received clozapine to treat behavioral symptoms, and it reminds physicians that this drug is not approved for use in dementia-related psychosis. There is also a new contraindication in patients who have paralytic ileus.

Additional Information:

FDA MedWatch Safety Alert - Clozaril (clozapine) tablets. January 13, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150511.htm


Warning about Hemolysis with WinRho SDF

Baxter Healthcare and Cangene are alerting healthcare professionals about new warnings for WinRho SDF, an IGIV product used to treat patients with immune thrombocytopenic purpura (ITP).

In rare cases, ITP patients being treated with WinRho 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 experienced symptoms of intravascular hemolysis within four hours of receiving the therapy.

Patients receiving WinRho 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.

Additional Information:

FDA MedWatch Safety Alert - WinRho SDF (Rho(D) Immune Globulin Intravenous [Human]). January 6, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152370.htm


Recall of “The First Years” Liquid-Filled Teethers

Consumers who have small children should be warned that in January 2006, a company called “The First Years” recalled six styles of liquid-filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain Pseudomonas aeruginosa or Pseudomonas putida.

Serious illness can occur if the teether is punctured and a 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 affected teethers were sold nationwide including major retailers, grocery, drug and specialty stores from July 2005 to January 2006. Consumers should stop using the recalled products immediately. The company is asking anyone who bought one of the recalled teethers 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.

Additional Information:

FDA MedWatch Safety Alert 2006 - The First Years Liquid-Filled Teethers. January 30, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151537.htm


Recall of “The First Years” Liquid-Filled Teethers

Consumers who have small children should be warned that in January 2006, a company called “The First Years” recalled six styles of liquid-filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain Pseudomonas aeruginosa or Pseudomonas putida.

Serious illness can occur if the teether is punctured and a 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 affected teethers were sold nationwide including major retailers, grocery, drug and specialty stores from July 2005 to January 2006. Consumers should stop using the recalled products immediately. The company is asking anyone who bought one of the recalled teethers 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.

Additional Information:

FDA Press Release - FDA Warns Consumers to Stop Using Recalled Liquid-Filled Children’s Teething Rings Manufactured by RC2 Brands (The First Years). February 9, 2006.
http://www.fda.gov/bbs/topics/news/2006/NEW01313.html



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