FDA Patient Safety News: Show #98, May 2010

New Pneumococcal Vaccine for Children

FDA has approved a new pneumococcal vaccine that provides broader protection for infants and young children ages six weeks through five years. The new vaccine, called Prevnar 13, is effective against 13 serotypes of the bacterium Streptococcus pneumoniae. It will replace Prevnar, which was effective against seven serotypes.

Prevnar 13 is approved to prevent invasive pneumococcal disease, including bacterial meningitis and bacteremia, caused by the 13 serotypes in the vaccine. It is also approved to help prevent otitis media caused by the seven serotypes that are in the original Prevnar.

A multi-center study showed that Prevnar 13 induces antibodies comparable to those that are protective in Prevnar. Adverse reactions are also comparable. The most common include pain, redness and swelling at the injection site, irritability, decreased appetite and fever.

Prevnar 13, is available in single-dose, pre-filled syringes, and is commonly given in a four-dose schedule at 2, 4, 6 and 12 to 15 months of age.

Additional Information:

FDA Press Release. FDA Approves Pneumococcal Disease Vaccine with Broader Protection. February 24, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201758.htm


New Pneumococcal Vaccine for Children

FDA has approved a new pneumococcal vaccine that provides broader protection for infants and young children ages six weeks through five years. The new vaccine, called Prevnar 13, is effective against 13 serotypes of the bacterium Streptococcus pneumoniae. It will replace Prevnar, which was effective against seven serotypes.

Prevnar 13 is approved to prevent invasive pneumococcal disease, including bacterial meningitis and bacteremia, caused by the 13 serotypes in the vaccine. It is also approved to help prevent otitis media caused by the seven serotypes that are in the original Prevnar.

A multi-center study showed that Prevnar 13 induces antibodies comparable to those that are protective in Prevnar. Adverse reactions are also comparable. The most common include pain, redness and swelling at the injection site, irritability, decreased appetite and fever.

Prevnar 13, is available in single-dose, pre-filled syringes, and is commonly given in a four-dose schedule at 2, 4, 6 and 12 to 15 months of age.

Additional Information:

FDA Center for Biologics Evaluation and Research Approval. Prevnar 13. February 24, 2010.
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201667


Counterfeit Surgical Mesh

FDA is warning healthcare professionals and medical facilities about counterfeit versions of polypropylene surgical mesh. These products are labeled with the C.R. Bard/Davol brand name, but they were not manufactured by Bard.

FDA is investigating this situation. Samples of the counterfeit mesh are being tested by FDA's Winchester Engineering and Analytical Center (WEAC) to see whether it meets the authentic product's specifications, including strength, sterility and performance. FDA is also working to find out who may be responsible for the counterfeiting and how the distribution occurred.

In the meantime, here are FDA's recommendations for healthcare professionals and facilities:

• If you have surgical mesh labeled as C.R. Bard, check your stock against the sizes and lot numbers of the counterfeit products. If your mesh matches any of the counterfeit sizes and lots, do not use it.

• Examine polypropylene mesh products from all manufacturers for anything unusual that might indicate the product could be counterfeit.

• If you think your mesh may be counterfeit, contact the manufacturer listed on the label. Also contact the FDA's Office of Criminal Investigations at 1-800-551-3989.

• If you suspect that counterfeit mesh was implanted in a patient, monitor the patient as you would with any polypropylene mesh implant.

• Report any adverse events to FDA's MedWatch program.

Additional Information:

FDA MedWatch Safety Alert. Counterfeit Polypropylene Surgical Mesh: Initial Communication. March 12, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204224.htm


Counterfeit Surgical Mesh

FDA is warning healthcare professionals and medical facilities about counterfeit versions of polypropylene surgical mesh. These products are labeled with the C.R. Bard/Davol brand name, but they were not manufactured by Bard.

FDA is investigating this situation. Samples of the counterfeit mesh are being tested by FDA's Winchester Engineering and Analytical Center (WEAC) to see whether it meets the authentic product's specifications, including strength, sterility and performance. FDA is also working to find out who may be responsible for the counterfeiting and how the distribution occurred.

In the meantime, here are FDA's recommendations for healthcare professionals and facilities:

• If you have surgical mesh labeled as C.R. Bard, check your stock against the sizes and lot numbers of the counterfeit products. If your mesh matches any of the counterfeit sizes and lots, do not use it.

• Examine polypropylene mesh products from all manufacturers for anything unusual that might indicate the product could be counterfeit.

• If you think your mesh may be counterfeit, contact the manufacturer listed on the label. Also contact the FDA's Office of Criminal Investigations at 1-800-551-3989.

• If you suspect that counterfeit mesh was implanted in a patient, monitor the patient as you would with any polypropylene mesh implant.

• Report any adverse events to FDA's MedWatch program.

Additional Information:

FDA Press Release. FDA Issues Warning on Counterfeit Surgical Mesh. March 11, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm204199.htm


Recall of Arrow IV Tubing Sets, Accessories

Arrow International is recalling the company's IV tubing sets and accessories, as well as certain other products, because they may not be sterile. The company discovered small holes in some of the products' sterile packaging. Using non-sterile products presents a potential for infection, which could lead to serious injury or death.

The recall covers approximately 2,000 types of products, including:

• Any Arrow product with a part number beginning with W followed by five numeric digits (such as, W12345)

• Any Arrow product with a part number beginning with MPI followed by five number digits (such as, MPI-12345) which is an IV tubing set or tubing set accessory

• Either of the following two part numbers: IV-850001-AAMC and IV-85020-UW

Anyone who has Arrow products covered by this recall should not use them and return them to the company. Contact Arrow at 866-396-2111.

Additional Information:

FDA MedWatch Safety Alert. Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall. March 16, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204532.htm


SureStep Test Strips Recalled

LifeScan is recalling certain lots of SureStep glucose test strips because they may provide falsely low results when glucose levels are above 400 mg/dL. If these results are used to adjust insulin doses, too little insulin could be administered. This could result in severe hyperglycemia, coma and death.

Patients who have SureStep OneTouch test strips from one of the recalled lots, should call LifeScan at 1-800-574-6139 to get replacements. It is important to continue monitoring your blood glucose while waiting for the new strips to arrive. To do this, use a meter that does not take the OneTouch strips if it is available. If not, patients can continue to use the recalled strips, but be sure to contact your healthcare professional if you get results above 400 mg/dL, because your actual blood glucose level might be significantly higher than that.

Certain lots of SureStep Pro test strips, which are used in hospitals and other medical facilities, have been recalled for the same reason. These strips are used in SureStep Pro, SureStep Flexx and OneTouch SureStep Hospital Blood Glucose Monitoring Systems. If your facility uses these systems, consider using an alternative glucose testing method until the company can provide replacement product.

If an alternative is not available, the company recommends adjusting the "critical high" threshold to no more than 400 mg/dL, and confirming any result above 400 mg/dL using another method.

Additional Information:

FDA MedWatch Safety Alert. OneTouch SureStep Test Strips (LifeScan): Recall. February 26, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202254.htm


SureStep Test Strips Recalled

LifeScan is recalling certain lots of SureStep glucose test strips because they may provide falsely low results when glucose levels are above 400 mg/dL. If these results are used to adjust insulin doses, too little insulin could be administered. This could result in severe hyperglycemia, coma and death.

Patients who have SureStep OneTouch test strips from one of the recalled lots, should call LifeScan at 1-800-574-6139 to get replacements. It is important to continue monitoring your blood glucose while waiting for the new strips to arrive. To do this, use a meter that does not take the OneTouch strips if it is available. If not, patients can continue to use the recalled strips, but be sure to contact your healthcare professional if you get results above 400 mg/dL, because your actual blood glucose level might be significantly higher than that.

Certain lots of SureStep Pro test strips, which are used in hospitals and other medical facilities, have been recalled for the same reason. These strips are used in SureStep Pro, SureStep Flexx and OneTouch SureStep Hospital Blood Glucose Monitoring Systems. If your facility uses these systems, consider using an alternative glucose testing method until the company can provide replacement product.

If an alternative is not available, the company recommends adjusting the "critical high" threshold to no more than 400 mg/dL, and confirming any result above 400 mg/dL using another method.

Additional Information:

LifeScan, Inc. February 24, 2010.
http://SureStep.com


Recall of UniCel DxC Clinical Analyzers

Beckman Coulter is alerting clinical laboratories about the importance of following twice-a-week maintenance procedures for the company's UniCel DxC clinical chemistry analyzers.

The company has received reports of erroneous sodium results from these analyzers, which may have led some patients to be hospitalized. In a January letter, Beckman Coulter said these errors may have been caused by excessive build-up of protein, bacteria and sample tube additives in the analyzers' ion-selective electrode flow cells.

In 2008, the company had provided laboratories with an optional twice-a-week maintenance procedure to help prevent build-up on the instrument. The company's letter says that because of the risks to health, it is now mandatory that laboratories perform this maintenance twice a week.

Additional Information:

FDA MedWatch Safety Alert. Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall. March 11, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204106.htm


Recall of UniCel DxC Clinical Analyzers

Beckman Coulter is alerting clinical laboratories about the importance of following twice-a-week maintenance procedures for the company's UniCel DxC clinical chemistry analyzers.

The company has received reports of erroneous sodium results from these analyzers, which may have led some patients to be hospitalized. In a January letter, Beckman Coulter said these errors may have been caused by excessive build-up of protein, bacteria and sample tube additives in the analyzers' ion-selective electrode flow cells.

In 2008, the company had provided laboratories with an optional twice-a-week maintenance procedure to help prevent build-up on the instrument. The company's letter says that because of the risks to health, it is now mandatory that laboratories perform this maintenance twice a week.

Additional Information:

Beckman Coulter. Urgent Field Safety Notice – UniCel DxC. January 4, 2010.
http://www.imb.ie/images/uploaded/documents/V8712_PCA-7879_NA-INTLFinal_LH_signed_01052010.pdf


Review of Invirase and Cardiac Arrhythmias

FDA is reviewing clinical trial data suggesting that using Invirase (saquinavir) in combination with Norvir (ritonavir) may increase the risk of cardiac arrhythmias. Invirase and Norvir are protease inhibitors used in combination to treat HIV infection.

The study was conducted by Roche, the manufacturer of Invirase, in response to FDA's request that all manufacturers of protease inhibitors evaluate the effect of these drugs on QT and PR intervals. The study showed that healthy volunteers given Invirase boosted with Norvir experienced a dose-dependent prolongation of the QT and PR intervals.

FDA is evaluating the data and will provide an update when the review is done. In the meantime, FDA recommends that healthcare professionals not treat certain patients with Invirase. These include those already taking Class 1A or Class III antiarrhythmic drugs, or other drugs that many prolong the QT or PR intervals. Also, Invirase should not be used in patients with a history of prolonged QT intervals, preexisting conduction system disease, ischemic heart disease, cardiomyopathy, or underlying structural heart disease.

Additional Information:

FDA MedWatch Safety Alert. Invirase (saquinavir): Ongoing safety review of clinical trial data. February 23, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201563.htm


Reducing the Risk of Overfill with HomeChoice Peritoneal Dialysis

Here's an alert about the risk of overfill in patients being treated with Baxter's HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. Overfill, or increased intraperitoneal volume, occurs when there's more fluid in the abdomen than was prescribed. This may result in serious injury or death from a number of conditions, including abdominal wall or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.

Over the last two years, Baxter has received reports of serious injuries and at least one death associated with overfill. Children may be more likely to experience this problem because of their smaller size. Critically ill patients and those with pulmonary and hemodynamic instability may also have a higher risk. Baxter alerted patients and clinicians to this problem in a January letter.

Although Baxter is not removing the HomeChoice systems from the market, clinicians should weigh the risks and benefits of continuing to treat their patients with these devices. Clinicians should also review their prescription settings for the HomeChoice systems.

Patients and caregivers should watch for potential signs and symptoms of overfill when using HomeChoice systems. This is especially important for children and for patients who are unable to communicate. If signs of overfill occur, patients or their caregivers should stop the device, start a manual drain, and contact the doctor immediately.

Here are some of the signs to watch for:

• Difficulty breathing or feeding
• Abdominal bloating, tension or pain
• Localized swelling around the groin, the genital areas, or the belly button, or around the catheter's tunnel tract or exit site.

In addition, patients and caregivers should ask their doctors about whether they should monitor vital signs, such as heart rate, blood pressure and oxygen saturation. They should also ask about whether to track pre- and post-treatment weight in order to compare the difference in weight to the recorded ultrafiltration volume on the device. For more information, call Baxter at 1-800-553-6898.

Additional Information:

FDA MedWatch Safety Alert. Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall. March 3, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202885.htm


Risk Management Program for Procrit, Epogen and Aranesp

FDA is requiring that Erythropoiesis-Stimulating Agents (ESAs) be prescribed and used under a special risk management program. This program is designed to inform healthcare providers and their patients about the risks of these drugs and to ensure that they're administered appropriately when they're used to treat cancer patients for anemia.

ESAs, sold as Procrit (epoetin alfa), Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), and stimulate the bone marrow to produce red blood cells. They're approved to treat anemia resulting from chemotherapy, chronic kidney failure and some HIV treatments, and also to reduce the number of blood transfusions during and after certain major surgeries.

Studies have shown that ESAs can increase the risk of tumor growth and shorten survival in cancer patients. Also, any patient treated with these drugs may have a higher risk of heart attack, heart failure, stroke or blood clots.

The risk management program requires health care professionals to provide patients receiving an ESA with a Medication Guide that contains information on how to safely use the drug. In addition, Amgen, the manufacturer of the three products, will oversee a training and certification program called APPRISE for health care professionals who administer chemotherapy to patients with cancer. Providers who treat these patients with ESAs must register and maintain active enrollment in the APPRISE program and complete a special training module on how to use ESAs in patients with cancer. They must also discuss the risks, benefits, and FDA-approved uses of ESAs with patients and document their discussion with a written acknowledgement from the patient. The APPRISE program does not apply to patients treated with an ESA for conditions other than cancer.

Additional Information:

FDA MedWatch Safety Alert. Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication. February 16, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200391.htm


Risk Management Program for Procrit, Epogen and Aranesp

FDA is requiring that Erythropoiesis-Stimulating Agents (ESAs) be prescribed and used under a special risk management program. This program is designed to inform healthcare providers and their patients about the risks of these drugs and to ensure that they're administered appropriately when they're used to treat cancer patients for anemia.

ESAs, sold as Procrit (epoetin alfa), Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), and stimulate the bone marrow to produce red blood cells. They're approved to treat anemia resulting from chemotherapy, chronic kidney failure and some HIV treatments, and also to reduce the number of blood transfusions during and after certain major surgeries.

Studies have shown that ESAs can increase the risk of tumor growth and shorten survival in cancer patients. Also, any patient treated with these drugs may have a higher risk of heart attack, heart failure, stroke or blood clots.

The risk management program requires health care professionals to provide patients receiving an ESA with a Medication Guide that contains information on how to safely use the drug. In addition, Amgen, the manufacturer of the three products, will oversee a training and certification program called APPRISE for health care professionals who administer chemotherapy to patients with cancer. Providers who treat these patients with ESAs must register and maintain active enrollment in the APPRISE program and complete a special training module on how to use ESAs in patients with cancer. They must also discuss the risks, benefits, and FDA-approved uses of ESAs with patients and document their discussion with a written acknowledgement from the patient. The APPRISE program does not apply to patients treated with an ESA for conditions other than cancer.

Additional Information:

ESA APPRISE Oncology Program
https://www.esa-apprise.com/ESAAppriseUI/ESAAppriseUI/default.jsp


Avoiding Maalox Mix-ups

All liquid Maalox products are not the same. Maalox Total Relief, Maalox Advanced Regular Strength, and Maalox Advanced Maximum Strength may look similar but they are not interchangeable. In fact, using the wrong one could be harmful.

FDA has received several reports where people mistakenly took Maalox Total Relief instead of Maalox Advanced in regular or maximum strength. The Maalox Advanced products contain antacid ingredients to relieve conditions such as acid indigestion, heartburn and sour stomach. Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication.

Maalox Total Relief contains bismuth subsalicylate, which is chemically related to aspirin, so it can have similar side effects. That means people who should avoid aspirin products should not take Maalox Total Relief, including those with a history of ulcers or bleeding disorders, as well as children and teens recovering from a viral infection.

The maker of Maalox brand products has agreed to change the name of Maalox Total Relief to one that does not include the word "Maalox". The company is also changing the drug's packaging to avoid further confusion.

Until that happens, people should check the "Drug Facts" box on Maalox labels to be sure they are picking the right product for their condition.

Additional Information:

FDA MedWatch Safety Alert. Maalox Total Relief and Maalox Liquid Products: Medication Use Errors. February 17, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200672.htm



FDA Patient Safety News is available at www.fda.gov/psn