FDA Patient Safety News: Show #90, September 2009

New Warnings on Propoxyphene Overdoses

FDA is taking action to reduce the risk of fatal overdoses in patients taking the pain medication propoxyphene, an ingredient in drugs such as Darvon and Darvocet. Some European studies have indicated that propoxyphene may be more lethal than other pain medications when taken in higher-than-recommended doses. Because of these concerns, FDA is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, to emphasize the danger of overdosing. Manufacturers will also be required to develop a Medication Guide to be given to patients with each prescription, that stresses the importance of using the drugs only as directed.

Based on the available evidence, FDA believes that the benefits of using propoxyphene for pain relief outweigh the risks when it is taken at recommended doses. But FDA also recognizes that more safety information is needed about propoxyphene's effects at higher doses, especially on the heart. And so the manufacturer will be required to conduct a safety study to provide more information on this potential risk. FDA will also work with other Federal agencies to explore additional sources of data for comparing propoxyphene's safety with other pain medications.

In the meantime, physicians and patients need to be aware of the possible danger involved if propoxyphene is taken at doses higher than those in the labeling.

Additional Information:

FDA MedWatch Safety Alert. Propoxyphene-containing Products. July 7, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170763.htm


Fire Hazard with Stabilet Infant Warmers

Hill-Rom Stabilet Infant Warmers were recalled in July because they might pose a fire risk. An infant lying under one of these devices in a hospital nursery suffered second and third degree burns when a fire occurred in the infant's bassinet. The infant was receiving supplemental oxygen at the time. The fire was likely caused by a hot particle falling from the warmer's heating element into the area near the infant's head, which contained a high concentration of oxygen.

Draeger Medical Company, the firm that acquired the Stabilet product line from Hill-Rom, says that the recalled warmers should be taken out of service as soon as it is feasible. All of the affected warmers were manufactured before 1999. For more information, call Draeger at 1-800-543-5047, ext 2349.

Additional Information:

FDA MedWatch Safety Alert. Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]. July 20, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173239.htm


Fire Hazard with Stabilet Infant Warmers

Hill-Rom Stabilet Infant Warmers were recalled in July because they might pose a fire risk. An infant lying under one of these devices in a hospital nursery suffered second and third degree burns when a fire occurred in the infant's bassinet. The infant was receiving supplemental oxygen at the time. The fire was likely caused by a hot particle falling from the warmer's heating element into the area near the infant's head, which contained a high concentration of oxygen.

Draeger Medical Company, the firm that acquired the Stabilet product line from Hill-Rom, says that the recalled warmers should be taken out of service as soon as it is feasible. All of the affected warmers were manufactured before 1999. For more information, call Draeger at 1-800-543-5047, ext 2349.

Additional Information:

Minnesota Hospital Association Patient Safety Alert. Bassinet Fire Investigation Complete. January 15, 2009.
http://www.mnhospitals.org/inc/data/pdfs/Alert_Advisory_1-15-09.pdf


Warning on Neuropsychiatric Effects from Smoking Cessation Drugs

FDA is requiring that two drugs used to help people stop smoking carry new warnings about the risk of serious neuropsychiatric effects. The drugs are Chantix (varenicline) and Zyban (bupropion). The same warnings will be required for other bupropion products such as Wellbutrin, which are used to treat depression and seasonal affective disorder.

FDA's analysis of adverse event reports shows that when neuropsychiatric symptoms occur, they usually develop during drug treatment, but symptoms can also develop after the drug is stopped. Some patients on these drugs who had no history of psychiatric illness experienced suicidal ideation and behavior for the first time. The drugs have also been associated with a worsening of symptoms in patients with pre-existing psychiatric disorders.

Healthcare professionals should advise patients to stop taking Chantix or Zyban and contact a healthcare provider immediately if they experience agitation, hostility, depressed mood, atypical changes in thinking or behavior, suicidal thoughts or suicidal behavior. If the drugs are stopped because of neuropsychiatric symptoms, patients should be monitored until the symptoms resolve.

Family members and caregivers also have an important role. They should watch for changes in mood or behavior in the person taking the drug, and contact the healthcare provider if they notice those changes. But it is also important for patients and caregivers to realize that nicotine withdrawal itself can cause behavioral changes, even in people who are not taking these drugs.

It's important to remember that Chantix and Zyban can be effective in helping people to stop smoking, which can have significant health benefits. So these benefits have to be weighed against the small but potentially serious risk of neuropsychiatric effects from the drugs.

Additional Information:

FDA MedWatch Safety Alert. Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics). July 1, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm


Recall of Medtronic Mini-Med Paradigm Quick-Set Infusion Sets

In July, Medtronic recalled certain infusion sets which are used with the company's Mini-Med Paradigm insulin pumps to deliver insulin to diabetic patients. Because of a manufacturing error, the vents on these sets may clog and then fail to equalize the air pressure in the reservoir compartment with the surrounding atmosphere. If this happens, the pump could deliver too much or too little insulin to the patient, and that could lead to serious injury or death.

The recall applies to the MiniMed Paradigm Quick-Set infusion sets with reference numbers MMT-396, MMT-397, MMT-398 or MMT-399 and with lot numbers starting with the number "8." [Example: 8xxxxxx]. The lot number can be found on both the box label and on each infusion set package.

The firm is advising patients who have the recalled infusion sets to stop using them and to return them to the company for replacement at no additional charge. For more information contact Medtronic at 800-345-8139.

Additional Information:

Medtronic Diabetes website. “Lot 8” Quick-set® Infusion Sets. July 13, 2009.
http://www.medtronicdiabetes.com/lot8


Possible Cancer Risk with Lantus

FDA is investigating the possibility that Lantus (insulin glargine) may be associated with an increased risk of cancer. Three of four observational studies published recently in the journal Diabetologia suggested an increased cancer risk associated with Lantus. All of the studies had drawbacks or inconsistencies that preclude drawing any firm conclusions about whether the drug is actually associated with an increased risk of cancer.

FDA is reviewing many sources of safety data for Lantus, including these four newly published studies, to better understand whether this drug poses a cancer risk. The agency is also deciding whether any additional safety studies will be needed. FDA will keep practitioners and patients informed as new information becomes available.

In the meantime, FDA is cautioning patients not to stop taking their insulin without consulting a physician, since uncontrolled blood sugar levels can have serious immediate and long-term effects.

Additional Information:

FDA MedWatch Safety Alert. Lantus (insulin glargine). July 1, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170089.htm


FDA Studying Cleaning Procedures for Arthroscopic Shavers

FDA is investigating a situation in which pieces of tissue were found within certain arthroscopic shavers even after they were reportedly cleaned according to the manufacturer's instructions. Arthroscopic shavers are devices used in certain orthopedic surgical procedures. If these devices retain tissue after they are cleaned, the entire sterilization process could be compromised.

Multiple manufacturers of these devices have notified their customers about this situation and reiterated the importance of following proper cleaning procedures. FDA is continuing to work with the manufacturers to evaluate this situation and determine its potential public health impact. FDA will provide an update when more information is available.

In the meantime, facilities that use arthroscopic shavers should evaluate the adequacy of their cleaning procedures, and should ensure that the personnel who clean and sterilize these devices follow all the steps in the manufacturer's cleaning instructions prior to sterilization. They should also consider inspecting the inside of the devices after cleaning to ensure that they have been cleared of any tissue or fluids.

FDA is asking facilities that find tissue in these devices after they have been cleaned according to the manufacturer's instructions to file a report through FDA's MedWatch program.

Additional Information:

FDA MedWatch Safety Alert. Ongoing Safety Review of Arthroscopic Shavers. July 7, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170730.htm


Update on Cefepime Safety Data

FDA is updating healthcare professionals about its continuing review of safety data for cefepime, a broad-spectrum cephalosporin antibiotic sold as Maxipime and generics. In 2007, a meta-analysis published in the literature concluded that patients taking this drug experienced increased mortality compared with those taking other cephalosporin antibiotics.

FDA has analyzed additional data, and at this time has not found an increased death rate in patients taking cefepime. FDA will continue to review the possibility of increased mortality with cefepime, to include a study based on hospital discharge data. The results will be reported approximately a year from now.

Additional Information:

FDA MedWatch Safety Alert. Cefepime (marketed as Maxipime) Update of Ongoing Safety Review. June 17, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm167427.htm


Preventing Skin Burns from Surgical Microscopes

A recent FDA article in the publication "OR Nurse 2009" recommends several ways to prevent skin burns from surgical microscopes, which are used to illuminate and magnify internal structures during surgical procedures. The lights on these devices can generate enough heat to burn a patient's skin, especially during procedures that require high light intensity and magnification-for example, where the operative structure is small and deep within the body.

The skin is most vulnerable to microscope-induced burns because it is closest to the microscope's light. Patients particularly sensitive to this type of injury include those with thin or delicate skin, such as infants or the elderly, and those with poor circulation, which can compromise the tissue's ability to dissipate heat.

The FDA article describes a number of ways to avoid these skin burns, including:

• Start the microscope with minimal light and increase it gradually. Avoid maximum intensity or use it for as little time as possible.

• Focus the light only on the surgical area, and turn it off as soon as it is not needed.

• Keep the surgical incision site cool with wet sponges or towels, and hydrate with repeated irrigations.

• Minimize the use of metal instruments, since they absorb heat and can burn surrounding tissue. When metal instruments are necessary, keep them moist throughout the procedure and protect the skin with wet sponges.

• Avoid or minimize the injection of vasoconstrictive drugs into the surgical site.

• Take special care when treating high-risk patients such as children and the elderly.

Additional Information:

Mirsaidi, N. Reduce the Risk of Skin Burns with Microscopes. OR Nurse 2009. May 2009. Volume 3, Number 3.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm169604.htm


Patient Deaths from Injection of Topical Epinephrine

The Institute for Safe Medication Practices (ISMP) recently cited a report from the ISMP Canada Safety Bulletin about the death of a patient who was accidentally injected with topical epinephrine. The attending surgeon and nurse mistakenly thought the syringe they were using contained lidocaine with epinephrine 1:100,000.

ISMP noted an earlier case in which a child died from cardiac arrest after his ear was infiltrated with a syringe containing epinephrine 1:1,000 that had been filled from an open cup. The physician mistakenly assumed that the solution in the cup contained lidocaine with epinephrine 1:100,000.

ISMP recommends several steps that can help prevent fatal accidents of this kind, including:

• Supply epinephrine for topical use in a pour-bottle so that it is not likely to be injected. If these bottles are not available from the manufacturer, require the pharmacy to prepare ready-to-use doses in pour bottles or topical syringes.

• Never withdraw a topical medication into a parenteral syringe and, conversely, do not place a solution intended for injection, such as a local anesthetic, into an open container.

• Be sure that the word "topical" appears on any container holding a solution intended for topical use.

• Keep local anesthetics for injection in their original vials until they are going to be used. Then withdraw the medication into a syringe and label it immediately.

• And if possible, prepare pledgets of topical epinephrine before each procedure, which can eliminate the need for topical epinephrine in vials.

Additional Information:

ISMP Medication Safety Alert! Fatal outcome after inadvertent injection of topical Epinephrine. March 26, 2009.
http://www.ismp.org/Newsletters/acutecare/articles/20090326.asp


Patient Deaths from Injection of Topical Epinephrine

The Institute for Safe Medication Practices (ISMP) recently cited a report from the ISMP Canada Safety Bulletin about the death of a patient who was accidentally injected with topical epinephrine. The attending surgeon and nurse mistakenly thought the syringe they were using contained lidocaine with epinephrine 1:100,000.

ISMP noted an earlier case in which a child died from cardiac arrest after his ear was infiltrated with a syringe containing epinephrine 1:1,000 that had been filled from an open cup. The physician mistakenly assumed that the solution in the cup contained lidocaine with epinephrine 1:100,000.

ISMP recommends several steps that can help prevent fatal accidents of this kind, including:

• Supply epinephrine for topical use in a pour-bottle so that it is not likely to be injected. If these bottles are not available from the manufacturer, require the pharmacy to prepare ready-to-use doses in pour bottles or topical syringes.

• Never withdraw a topical medication into a parenteral syringe and, conversely, do not place a solution intended for injection, such as a local anesthetic, into an open container.

• Be sure that the word "topical" appears on any container holding a solution intended for topical use.

• Keep local anesthetics for injection in their original vials until they are going to be used. Then withdraw the medication into a syringe and label it immediately.

• And if possible, prepare pledgets of topical epinephrine before each procedure, which can eliminate the need for topical epinephrine in vials.

Additional Information:

ISMP Canada Safety Bulletin. Alert: Fatal Outcome after Inadvertent Injection of Epinephrine Intended for Topical Use. March 5, 2009.
http://www.ismp-canada.org/download/safetyBulletins/ISMPCSB2009-2-InadvertentInjectionofEpinephrineIntendedforTopicaUse.pdf


Nephropathy with Certain Organ Transplant Drugs

FDA is requiring that the labeling for several immunosuppressant drugs used to prevent organ rejection after transplants be updated with a warning that these drugs increase the risk of nephropathy associated with the BK virus, which can lead to transplant loss.

The stronger warnings apply to the following drugs:
• Sirolimus, marketed as Rapamune
• Cyclosporine, marketed as Sandimmune and generics
• cyclosporine modified, marketed as Neoral and generics
• mycophenolate mofetil, marketed as Cellcept and generics
• mycophenolic acid, marketed as Myfortic

In FDA's analysis, BK virus-associated nephropathy was primarily seen in kidney transplant patients. Clinicians should carefully monitor transplant patients, and consider adjusting their immunosuppressant therapy if they develop BK virus-associated nephropathy.

FDA is continuing to review the safety of these drugs, and will provide updates as they are available.

Additional Information:

FDA MedWatch Safety Alert. Immunosuppressant Drugs: Required Labeling Changes. July 14, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm


Recall of Medtronic Mini-Med Paradigm Quick-Set Infusion Sets

In July, Medtronic recalled certain infusion sets which are used with the company's Mini-Med Paradigm insulin pumps to deliver insulin to diabetic patients. Because of a manufacturing error, the vents on these sets may clog and then fail to equalize the air pressure in the reservoir compartment with the surrounding atmosphere. If this happens, the pump could deliver too much or too little insulin to the patient, and that could lead to serious injury or death.

The recall applies to the MiniMed Paradigm Quick-Set infusion sets with reference numbers MMT-396, MMT-397, MMT-398 or MMT-399 and with lot numbers starting with the number "8." [Example: 8xxxxxx]. The lot number can be found on both the box label and on each infusion set package.

The firm is advising patients who have the recalled infusion sets to stop using them and to return them to the company for replacement at no additional charge. For more information contact Medtronic at 800-345-8139.

Additional Information:

FDA MedWatch Safety Alert. Medtronic Paradigm Quick-Set Infusion Sets. July 13, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171686.htm



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