FDA Patient Safety News: Show #92, November 2009

Vaccines for 2009 H1N1 Influenza

FDA has approved four vaccines for immunization against the 2009 H1N1 influenza virus. Three of them are inactivated virus vaccines for injection, manufactured by CSL Limited, Sanofi Pasteur, Inc, and Novartis Vaccines and Diagnostics Limited. The fourth is a live, attenuated virus vaccine administered by nasal spray, manufactured by MedImmune LLC.

As with the seasonal influenza vaccine, the 2009 H1N1 vaccines are being produced in formulations that contain the preservative thimerosal as well as preservative-free formulations.

Here are some things to know about the 2009 H1N1 vaccines:

• First, these are monovalent vaccines without adjuvant, and they are different from the seasonal influenza vaccine. They protect only against the 2009 H1N1 influenza virus, a new strain that's never before circulated in humans. The seasonal influenza vaccine does not protect against the 2009 H1N1 virus. So it is important that people who should receive the seasonal influenza vaccine this year get it. And that means that some people should have both the seasonal vaccine and the 2009 H1N1 vaccine.

• Based on currently available information, children younger than 10 should receive two doses of the 2009 H1N1 vaccine approximately one month apart. People 10 years of age and older should receive one dose.

Potential side-effects from the 2009 H1N1 vaccine are expected to be similar to those from the seasonal vaccine. For the injectable vaccines, these include soreness at the injection site, mild fever, body aches and fatigue for several days after the injection. For the nasal spray vaccine, side-effects include runny nose or nasal congestion for all ages, sore throats in adults, and fever in children 2 to 6 years old. As with the seasonal vaccine, people who have a severe, life-threatening allergy to eggs should not receive the 2009 H1N1 vaccine.

Additional Information:

FDA Press Release. FDA Approves Vaccines for 2009 H1N1 Influenza Virus. September 15, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm


Vaccines for 2009 H1N1 Influenza

FDA has approved four vaccines for immunization against the 2009 H1N1 influenza virus. Three of them are inactivated virus vaccines for injection, manufactured by CSL Limited, Sanofi Pasteur, Inc, and Novartis Vaccines and Diagnostics Limited. The fourth is a live, attenuated virus vaccine administered by nasal spray, manufactured by MedImmune LLC.

As with the seasonal influenza vaccine, the 2009 H1N1 vaccines are being produced in formulations that contain the preservative thimerosal as well as preservative-free formulations.

Here are some things to know about the 2009 H1N1 vaccines:

• First, these are monovalent vaccines without adjuvant, and they are different from the seasonal influenza vaccine. They protect only against the 2009 H1N1 influenza virus, a new strain that's never before circulated in humans. The seasonal influenza vaccine does not protect against the 2009 H1N1 virus. So it is important that people who should receive the seasonal influenza vaccine this year get it. And that means that some people should have both the seasonal vaccine and the 2009 H1N1 vaccine.

• Based on currently available information, children younger than 10 should receive two doses of the 2009 H1N1 vaccine approximately one month apart. People 10 years of age and older should receive one dose.

Potential side-effects from the 2009 H1N1 vaccine are expected to be similar to those from the seasonal vaccine. For the injectable vaccines, these include soreness at the injection site, mild fever, body aches and fatigue for several days after the injection. For the nasal spray vaccine, side-effects include runny nose or nasal congestion for all ages, sore throats in adults, and fever in children 2 to 6 years old. As with the seasonal vaccine, people who have a severe, life-threatening allergy to eggs should not receive the 2009 H1N1 vaccine.

Additional Information:

FLU.Gov. Find a Flu Shot Near You.
http://www.flu.gov/individualfamily/vaccination/locator.html


Vaccines for 2009 H1N1 Influenza

FDA has approved four vaccines for immunization against the 2009 H1N1 influenza virus. Three of them are inactivated virus vaccines for injection, manufactured by CSL Limited, Sanofi Pasteur, Inc, and Novartis Vaccines and Diagnostics Limited. The fourth is a live, attenuated virus vaccine administered by nasal spray, manufactured by MedImmune LLC.

As with the seasonal influenza vaccine, the 2009 H1N1 vaccines are being produced in formulations that contain the preservative thimerosal as well as preservative-free formulations.

Here are some things to know about the 2009 H1N1 vaccines:

• First, these are monovalent vaccines without adjuvant, and they are different from the seasonal influenza vaccine. They protect only against the 2009 H1N1 influenza virus, a new strain that's never before circulated in humans. The seasonal influenza vaccine does not protect against the 2009 H1N1 virus. So it is important that people who should receive the seasonal influenza vaccine this year get it. And that means that some people should have both the seasonal vaccine and the 2009 H1N1 vaccine.

• Based on currently available information, children younger than 10 should receive two doses of the 2009 H1N1 vaccine approximately one month apart. People 10 years of age and older should receive one dose.

Potential side-effects from the 2009 H1N1 vaccine are expected to be similar to those from the seasonal vaccine. For the injectable vaccines, these include soreness at the injection site, mild fever, body aches and fatigue for several days after the injection. For the nasal spray vaccine, side-effects include runny nose or nasal congestion for all ages, sore throats in adults, and fever in children 2 to 6 years old. As with the seasonal vaccine, people who have a severe, life-threatening allergy to eggs should not receive the 2009 H1N1 vaccine.

Additional Information:

FDA Center for Biologics Evaluation and Research. Influenza A (H1N1) 2009 Monovalent. September 15, 2009.
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm


Pedi-Cap End-Tidal CO2 Detectors Recalled

Covidien is recalling certain lots of its End-Tidal CO2 Detectors, the Pedi-Cap and Pedi-Cap 6, because a modification made by the manufacturer may occlude the patient's airway. This could make it difficult to manually ventilate a patient, and lead to ineffective ventilation. Also, the indicator paper might not change color, so the operator can't detect changes in CO2 levels.

The recall affects about 80 lots of these devices. In August, the company sent letters to its customers, advising them to review their inventory and return all devices from the affected lots.

Additional Information:

FDA MedWatch Safety Alert. Covidien Pedi-Cap End-Tidal CO2 Detector. September 10, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181878.htm


Pedi-Cap End-Tidal CO2 Detectors Recalled

Covidien is recalling certain lots of its End-Tidal CO2 Detectors, the Pedi-Cap and Pedi-Cap 6, because a modification made by the manufacturer may occlude the patient's airway. This could make it difficult to manually ventilate a patient, and lead to ineffective ventilation. Also, the indicator paper might not change color, so the operator can't detect changes in CO2 levels.

The recall affects about 80 lots of these devices. In August, the company sent letters to its customers, advising them to review their inventory and return all devices from the affected lots.

Additional Information:

Covidien Nellcor Product Notices. Covidien Initiates a Nationwide Voluntary Medical Device Recall of the Pedi-Cap End-Tidal CO2 Detector (Pedi-Cap and Pedi-Cap 6). August 14, 2009.
http://www.nellcor.com/legal/prodnotices.aspx


Life-Threatening Skin Reactions with Intelence

Tibotec Therapeutics is notifying healthcare professionals of severe and potentially life-threatening skin reactions from Intelence (etravirine), an antiretroviral drug used in HIV combination therapy. Intelence has been associated with cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions have also been reported, sometimes leading to organ dysfunction, including liver failure.

New labeling for Intelence warns that the drug must be discontinued immediately if severe skin or hypersensitivity reactions develop. Signs include severe rash, malaise, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis and eosinophilia. The labeling cautions practitioners that a delay in stopping treatment after the onset of a severe rash may result in a life-threatening reaction.

Additional Information:

FDA MedWatch Safety Alert. Intelence (etravirine). August 27, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180579.htm


Liberte Coronary Stent Now Called VeriFLEX

Boston Scientific has changed the name of the company's Liberté Bare-Metal coronary stent to VeriFLEX. The company took this action after reports that Liberté Bare-Metal stents were inadvertently implanted instead of TAXUS Liberté Drug-Eluting stents, and vice versa.

To avoid these mix-ups, Boston Scientific has notified its customers that the Liberté Bare-Metal stent is being renamed the VeriFLEX. The TAXUS Liberté Drug-Eluting stents will keep the same name. The company is re-labeling the outer boxes of all Liberté Bare-Metal stents currently in facilities' inventories.

However, the pouch label, patient guide and directions for use card for these products are not being re-labeled at this time and will still bear the Liberté name. Boston Scientific is offering to provide hospitals and cath labs with additional information and training. The company can be contacted at 1-877-TAXUS-411.

Additional Information:

Boston Scientific Field Correction Notice. Important Notice about the use of Liberté Bare-Metal coronary stents and TAXUS Liberté Paclitaxel Eluting coronary stents. September 18, 2009.
http://www.bostonscientific.com/templatedata/imports/collateral/Coronary/liberte-field-action-091109.pdf


Inaccurate Readings with Philips Avalon Fetal Monitors

Philips Healthcare has alerted healthcare professionals about the possibility of inaccurate fetal heart rate readings from the company's Avalon fetal monitors, which use ultrasound to measure fetal heart rate. Inaccurate readings could result in unneeded interventions, failure to take a needed intervention, or failure to identify fetal distress. The affected Avalon models are the FM20, FM30, FM40 and FM50 with the ultrasound transducer.

Inaccuracies occur mainly during the second stage of labor, and include halving or doubling of the fetal heart rate, and switching between the fetal and maternal heart rates.

The company recommends several steps to help reduce risk. For example, continue to confirm that the fetus is the source of the heartbeat while the monitor is in use, especially if abrupt changes occur. If in doubt, consider monitoring the maternal heart rate or using a fetal scalp electrode.

Additional Information:

FDA MedWatch Safety Alert. Philips Avalon Fetal Monitors. September 4, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181505.htm


Pure Red Cell Aplasia with CellCept and Myfortic

Healthcare professionals have been notified by the manufacturers of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) that these drugs, in combination with other immunosuppressive agents, have been associated with cases of pure red cell aplasia. Both drugs are used to prevent organ rejection in transplant patients.

CellCept is made by Roche and Myfortic is made by Novartis. The labeling for these drugs has been changed to reflect the new information.

Pure red cell aplasia is a type of anemia characterized by selective reduction of red blood cell precursors. Patients may present with fatigue, lethargy and pallor. In some cases, reducing the dose or stopping the drug reversed the aplasia, but reducing immunosuppression in transplant patients could place the graft at risk.

Additional Information:

FDA MedWatch Safety Alert. CellCept (mycophenolate mofetil). August 14, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177397.htm


Pure Red Cell Aplasia with CellCept and Myfortic

Healthcare professionals have been notified by the manufacturers of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) that these drugs, in combination with other immunosuppressive agents, have been associated with cases of pure red cell aplasia. Both drugs are used to prevent organ rejection in transplant patients.

CellCept is made by Roche and Myfortic is made by Novartis. The labeling for these drugs has been changed to reflect the new information.

Pure red cell aplasia is a type of anemia characterized by selective reduction of red blood cell precursors. Patients may present with fatigue, lethargy and pallor. In some cases, reducing the dose or stopping the drug reversed the aplasia, but reducing immunosuppression in transplant patients could place the graft at risk.

Additional Information:

FDA MedWatch Safety Alert. Myfortic (mycophenolic acid). September 3, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181306.htm


Recall of ConMed Linvatec Surgical Handpieces and Cables

The device company ConMed Linvatec is recalling certain surgical handpieces and cables. The handpieces are battery-powered devices used with drills, blades and other cutting devices during surgical procedures.

This action affects certain model and serial numbers of the Power Pro, Power ProMax, and MPower handpieces. These have a switch problem that can cause them to self-activate without the trigger being pushed, or to continue to run after the trigger is released, or to run in the wrong direction. The company intends to service all the affected devices. In the meantime, if a handpiece behaves erratically, stop using it and contact the company. In addition, avoid contact with the movable parts of the handpiece, and follow the manufacturer's handling instructions.

The recall also pertains to certain lots of the company's Universal cables, model number MC5057, which connect certain Linvatec electric handpieces to the power source. The company says there is a possibility that the cables can cause the electric handpieces to self-activate. The company intends to replace the affected cables. Until then, avoid contact with movable parts when the cables are inserted. For more information, contact ConMed Linvatec at 1-800-535-8536.

Additional Information:

FDA MedWatch Safety Alert. ConMed Linvatec - Universal Cables and Power Pro Handpieces. September 10, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181833.htm


TNF Blockers and Cancer in Children

FDA is requiring stronger warnings about an increased risk of lymphoma and other cancers in children and adolescents who are treated with drugs that block tumor necrosis factor. TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab). These drugs are used to treat juvenile rheumatoid arthritis, Crohn's disease, and other inflammatory diseases.

The warnings, which include an updated boxed warning, are based on an FDA analysis of reports of cancer that occurred in children and adolescents treated with TNF-blockers. The cancers, some of which were fatal, occurred after an average of 30 months of treatment. About half of the cancers were lymphomas. The labeling will also include updated information on cases of leukemia and new onset psoriasis associated with TNF-blockers.

Healthcare professionals should monitor patients for development of malignancies during and after treatment with TNF blockers. They should also talk to patients and their families about this risk and tell them to report signs and symptoms of cancer such as unexplained weight loss or fatigue, easy bruising or bleeding, or swollen lymph nodes in the neck, underarms or groin.

Patients should also be monitored for signs or symptoms of new onset psoriasis or worsening psoriasis. The patient Medication Guide will be updated with this new information.

Additional Information:

FDA MedWatch Safety Alert. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). August 4, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm


Portex Uncuffed Pediatric Tracheal Tubes Recalled

Smiths Medical is recalling certain Portex uncuffed tracheal tubes in pediatric sizes. The recall affects several models of 2.5, 3.0 and 3.5 mm tubes manufactured before September 2009.

The internal diameter of some of these tracheal tubes is slightly smaller than stated on the labeling. This could make it difficult to insert or withdraw a suction catheter to remove secretions, which could lead to airway obstruction and an inability to ventilate the patient. The defect could also increase airway resistance, and this too could compromise the ability to ventilate the patient. In September, the company notified customers to return all unused units of the recalled tubes and provided recommendations for managing products that are currently in use.

Additional Information:

FDA MedWatch Safety Alert. Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm). September 11, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182084.htm


Safety Concerns with Philips Medical Alert Pendants

Emergency response help buttons are often worn by seniors to call for help in an emergency. The Philips Lifeline emergency button that is worn around the neck, may pose a choking hazard if the cord becomes accidentally entangled, and this can result in serious injury or death. FDA is aware of three deaths in the U.S. that occurred because of entanglement.

Lifeline pendants are not designed to break away, in order to prevent the button from accidentally falling off the person's body. Entanglement may be most likely in people who use equipment with protruding parts such as wheelchairs, walkers and beds with guard rails.

In a letter sent to all of its Lifeline customers, Philips notes that help-button devices that are worn as wristbands or watches can be used as an alternative to pendant-style buttons. The company says that these styles of help buttons pose less of an entanglement hazard, but they cannot be operated if the person's arm that is not wearing the wristband becomes immobilized-due to a stroke, for example, or the arm becomes trapped under a heavy object.

Since both styles have advantages and drawbacks, FDA and the company are recommending that users consult with their healthcare providers to determine which is most appropriate for them.

Additional Information:

FDA Press Release. Philips Lifeline Issues Safety Alert for Lifeline Pendant Personal Help Buttons. September 22, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183247.htm


Safety Concerns with Philips Medical Alert Pendants

Emergency response help buttons are often worn by seniors to call for help in an emergency. The Philips Lifeline emergency button that is worn around the neck, may pose a choking hazard if the cord becomes accidentally entangled, and this can result in serious injury or death. FDA is aware of three deaths in the U.S. that occurred because of entanglement.

Lifeline pendants are not designed to break away, in order to prevent the button from accidentally falling off the person's body. Entanglement may be most likely in people who use equipment with protruding parts such as wheelchairs, walkers and beds with guard rails.

In a letter sent to all of its Lifeline customers, Philips notes that help-button devices that are worn as wristbands or watches can be used as an alternative to pendant-style buttons. The company says that these styles of help buttons pose less of an entanglement hazard, but they cannot be operated if the person's arm that is not wearing the wristband becomes immobilized-due to a stroke, for example, or the arm becomes trapped under a heavy object.

Since both styles have advantages and drawbacks, FDA and the company are recommending that users consult with their healthcare providers to determine which is most appropriate for them.

Additional Information:

Philips Lifeline Products and Services.
http://www.lifelinesys.com/content/lifeline-products/index.jsp



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