FDA Patient Safety News: Show #86, May 2009

FDA Approves First Human Drug from Genetically Engineered Animals

FDA recently approved the first biological product made from genetically engineered animals. The product, called ATryn, is an anticoagulant used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency. These patients can develop blood clots during high-risk situations such as surgery and childbirth. The approval gives patients with this disease an important new treatment option.

ATryn is a therapeutic protein made from the milk of genetically engineered goats. These goats have had a segment of DNA introduced into their genes that causes the female goats to produce human antithrombin in their milk. FDA's approval prohibits using these animals for food or feed, and also ensures that the genetic modification is not harming the animals. The manufacturer will continue to monitor the product's safety, including the possible development of immune responses in patients who receive repeated ATryn treatments. The product is expected to be available in the second quarter of 2009.

Additional Information:

FDA Press Release. FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder. February 6, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm109074.htm


Safety Problems with Baxter Colleague Volumetric Infusion Pumps

Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's letter describes several failure codes that could cause the pump to alarm and stop the infusion, which may lead to serious injury or death. The letter provides new steps for addressing these situations. Baxter advises institutions to have contingency plans, and to verify that back-up pumps are available in case life-sustaining therapies are disrupted.

The letter also says that a higher than expected number of "damaged battery" messages have been reported for some Colleague pumps. Before clearing this message, the user must take the pump out of service and install new batteries with a battery harness. Not doing this may cause unpredictable battery performance and possibly interrupt therapy.

Finally, Baxter’s letter says that improper cleaning has led to electrical short circuits and caused the pump to overheat, creating a fire hazard. In one case, hospital staff needed medical evaluation because of smoke exposure. The letter reminds pump users to follow the cleaning instructions in the manual.

Additional Information:

Baxter Healthcare Corporation. Press Release. March 11, 2009.
http://www.baxter.com/about_baxter/news_room/news_releases/2009/03_11_09_colleague.html


Warning on Metoclopramide

FDA is requiring that manufacturers of metoclopramide add a boxed warning to the label about the risk of tardive dyskinesia if the drug is used for long periods of time or at high doses. Metoclopramide stimulates motility in the upper GI tract and its uses include diabetic gastroparesis and gastroesophageal reflux disease. Metoclopramide is marketed as a generic and under several trade names, including Reglan.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, as well as grimacing, rapid blinking and impaired movement of the fingers. The risk of tardive dyskinesia associated with metoclopramide is increased among long-term users of the drug, and also among elderly patients, especially women. There is no known treatment, and the symptoms, which are rarely reversible, may persist even after the metoclopramide is discontinued. However, in some patients, the symptoms may lessen or resolve when the drug is stopped.

FDA's advice to practitioners is to avoid the chronic use of metoclopramide except in rare cases where they believe the benefit outweighs the risk. FDA is requiring manufacturers of the drug to develop a medication guide explaining the risks, which will be provided to patients with each prescription.

Additional Information:

FDA MedWatch Safety Alert. Metoclopramide-Containing Drugs. February 26, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm106942.htm


Recall of Pediatric Tracheostomy Tubes

Covidien, formerly known as Tyco HealthCare, has recalled certain lots of Shiley 3.0PED cuffless pediatric tracheostomy tubes. This is because of difficulties in inserting the obturator that is used to place the tube in the trachea, as well as problems inserting a suction catheter into the tracheostomy tube, which may require replacing the tube.

Covidien's original advice to users, issued in a letter dated January 14, 2009, was to make sure that the obturator and suction catheter fit properly into the tube before using the device on a patient. However, in a letter dated March 6, the company revised its recommendations and instructed users to remove all of the affected products from their inventory and return them for replacement or credit. The company can be contacted at 1-800-635-5267.

Additional Information:

FDA MedWatch Safety Alert. Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc. March 10, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127774.htm


Recall of Pediatric Tracheostomy Tubes

Covidien, formerly known as Tyco HealthCare, has recalled certain lots of Shiley 3.0PED cuffless pediatric tracheostomy tubes. This is because of difficulties in inserting the obturator that is used to place the tube in the trachea, as well as problems inserting a suction catheter into the tracheostomy tube, which may require replacing the tube.

Covidien's original advice to users, issued in a letter dated January 14, 2009, was to make sure that the obturator and suction catheter fit properly into the tube before using the device on a patient. However, in a letter dated March 6, the company revised its recommendations and instructed users to remove all of the affected products from their inventory and return them for replacement or credit. The company can be contacted at 1-800-635-5267.

Additional Information:

Tyco Healthcare Press Release. Tyco Healthcare Group LP Initiates a Nationwide Voluntary Recall. March 6, 2009.
http://www.nellcor.com/legal/prodnotices.aspx


Alert on Metabolic Acidosis from Zonisamide

FDA has alerted healthcare professionals that the drug zonisamide can cause metabolic acidosis in some patients. Zonisamide is marketed as Zonegran and in generic form. It is used as an adjunctive therapy in treating partial seizures in adults with epilepsy. Zonisamide is not approved for pediatric use.

Zonisamide-induced metabolic acidosis is characterized by hyperchloremia and decreased serum bicarbonate. It generally occurs early in treatment, but can also arise later. The risk appears to be increased in those taking high doses of the drug, but acidosis has been observed with doses as low as 25 mg daily. Patients at higher risk also include those with renal disease, severe respiratory disorders, diarrhea and a ketogenic diet, as well as those taking certain other drugs. Children are also at higher risk. Note that zonisamide can be passed to nursing infants through the breast milk of mothers taking the drug.

Although patients with persistent metabolic acidosis may exhibit symptoms such as hyperventilation, fatigue, anorexia and cardiac arrhythmias, they are often asymptomatic. If left untreated, metabolic acidosis may increase the risk of kidney stones, nephrocalcinosis and bone abnormalities, and it can reduce growth rates in children and affect fetal development.

Here are FDA's recommendations for healthcare professionals:

• Measure serum bicarbonate before starting zonisamide treatment and periodically thereafter, even in the absence of symptoms.

• If metabolic acidosis develops and persists, consider either reducing the dose or discontinuing the drug and modifying the patient's anti-epileptic treatment.

• If a patient with metabolic acidosis is to continue on zonisamide, consider treatment with alkali.

Additional Information:

FDA MedWatch Safety Alert. Zonisamide (marketed as Zonegran, and generics). February 23, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm106934.htm


Welch Allyn Automated External Defibrillators (AED) Recalled

The device company Welch Allyn is recalling about 14,000 automated external defibrillators. The affected models are AED 10 and MRL JumpStart defibrillators manufactured between October 3, 2002 and January 25, 2007.

A number of problems have been reported with these defibrillators. They include devices that deliver less defibrillation energy than they were programmed for, susceptibility to electromagnetic interference, and unexpected shutdown during use. These problems could prevent a patient in cardiac arrest from being defibrillated, which could be fatal.

The company has sent a letter to its customers about the recall, giving them instructions to return their units without delay so they may be repaired or replaced.

Customers in the U.S. and Canada may either exchange their AED 10 for a similar device at no cost, or purchase a new AED 10 directly from Welch Allyn at a reduced cost. International customers will be offered exchange AED 10 devices.

For more information, contact the company at 1-888-345-5356.

Additional Information:

FDA MedWatch Safety Alert. Welch Allyn AED 10 and MRL JumpStart Defibrillators. March 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127781.htm


Safety Problems with Baxter Colleague Volumetric Infusion Pumps

Baxter Healthcare Corporation has alerted customers to several safety problems with the company's Colleague infusion pumps. The problems apply to Colleague Single and Triple Channel Volumetric Infusion Pump Models Mono, CX and CXE. The company's letter describes several failure codes that could cause the pump to alarm and stop the infusion, which may lead to serious injury or death. The letter provides new steps for addressing these situations. Baxter advises institutions to have contingency plans, and to verify that back-up pumps are available in case life-sustaining therapies are disrupted.

The letter also says that a higher than expected number of "damaged battery" messages have been reported for some Colleague pumps. Before clearing this message, the user must take the pump out of service and install new batteries with a battery harness. Not doing this may cause unpredictable battery performance and possibly interrupt therapy.

Finally, Baxter’s letter says that improper cleaning has led to electrical short circuits and caused the pump to overheat, creating a fire hazard. In one case, hospital staff needed medical evaluation because of smoke exposure. The letter reminds pump users to follow the cleaning instructions in the manual.

Additional Information:

FDA MedWatch Safety Alert. Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter. March 12, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127777.htm


Welch Allyn Automated External Defibrillators (AED) Recalled

The device company Welch Allyn is recalling about 14,000 automated external defibrillators. The affected models are AED 10 and MRL JumpStart defibrillators manufactured between October 3, 2002 and January 25, 2007.

A number of problems have been reported with these defibrillators. They include devices that deliver less defibrillation energy than they were programmed for, susceptibility to electromagnetic interference, and unexpected shutdown during use. These problems could prevent a patient in cardiac arrest from being defibrillated, which could be fatal.

The company has sent a letter to its customers about the recall, giving them instructions to return their units without delay so they may be repaired or replaced.

Customers in the U.S. and Canada may either exchange their AED 10 for a similar device at no cost, or purchase a new AED 10 directly from Welch Allyn at a reduced cost. International customers will be offered exchange AED 10 devices.

For more information, contact the company at 1-888-345-5356.

Additional Information:

Welch Allyn Website. Welch Allyn AED 10 Recall Information. February 2009.
http://www.welchallyn.com/support/customer/AED_lookup.jsp


Removing Insulin from Cartons

The Institute for Safe Medication Practices (ISMP) warns that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen. If the vial is accidentally returned to the wrong carton after being used, that sets the stage for a serious insulin mix-up.
That is because the next person looking for a particular insulin product could read the label on the carton, assume that it accurately reflects what is inside, and end up administering the wrong product.

So ISMP recommends that the cartons be discarded, either in the pharmacy before the insulin is dispensed, or when it is received at the nursing station. The bottom line? Do not dispense or store insulin vials in their cartons on patient care units.

Additional Information:

ISMP Medication Safety Alert! Remove Vials from Cartons. Volume 13, Issue 9. May 8, 2008.
http://www.ismp.org/newsletters/acutecare/articles/20080508-1.asp


Don’t Share Insulin Pens Between Patients

FDA is reminding health care professionals not to use a single insulin pen and cartridge on more than one patient. Even if needles are changed between patients, reusing these products on multiple patients may transmit blood-borne pathogens such as hepatitis or HIV between patients.

Insulin pens are injector devices that contain either an insulin reservoir or an insulin cartridge, usually with enough insulin for several doses.

More than 2,000 diabetic patients in two hospitals may have recently been put at risk of infection when insulin pens were used for more than one patient. Although staff changed the pen's disposable needle between patients, the pen itself was reused. Patients who were exposed to the shared insulin pens are being contacted and offered testing for hepatitis and HIV. Some of the patients have reportedly tested positive for hepatitis C, although it is not known whether the pens were responsible for transmitting the virus.

The Institute for Safe Medication Practices points out that air bubbles and pathogenic contaminants can enter the cartridge after injection while the needle is still attached to the pen. ISMP cites studies showing that up to half of all insulin pen cartridges are contaminated after being re-used, and warns that facilities shouldn't assume that everyone understands the importance of following the "one pen, one patient" practice.

Here are some of FDA's recommendations for the safe use of insulin pens.

• Remember that insulin pens containing multiple doses are meant for only one patient, and should not be shared between patients.

• Label the insulin pen with the patient's name and other identifiers, but be sure that this doesn't obstruct the dosing window or other product information.

• Eject and discard the needle after each use and attach a new needle for each new injection.

• Tell patients to never share their insulin pens with another person, because this could result in transmission of hepatitis or other blood-borne diseases.

• Remember that the same risk may exist with any multiple-dose injector device, not just insulin pens.

Additional Information:

FDA MedWatch Safety Alert. Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use. March 19, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm127783.htm


Don’t Share Insulin Pens Between Patients

FDA is reminding health care professionals not to use a single insulin pen and cartridge on more than one patient. Even if needles are changed between patients, reusing these products on multiple patients may transmit blood-borne pathogens such as hepatitis or HIV between patients.

Insulin pens are injector devices that contain either an insulin reservoir or an insulin cartridge, usually with enough insulin for several doses.

More than 2,000 diabetic patients in two hospitals may have recently been put at risk of infection when insulin pens were used for more than one patient. Although staff changed the pen's disposable needle between patients, the pen itself was reused. Patients who were exposed to the shared insulin pens are being contacted and offered testing for hepatitis and HIV. Some of the patients have reportedly tested positive for hepatitis C, although it is not known whether the pens were responsible for transmitting the virus.

The Institute for Safe Medication Practices points out that air bubbles and pathogenic contaminants can enter the cartridge after injection while the needle is still attached to the pen. ISMP cites studies showing that up to half of all insulin pen cartridges are contaminated after being re-used, and warns that facilities shouldn't assume that everyone understands the importance of following the "one pen, one patient" practice.

Here are some of FDA's recommendations for the safe use of insulin pens.

• Remember that insulin pens containing multiple doses are meant for only one patient, and should not be shared between patients.

• Label the insulin pen with the patient's name and other identifiers, but be sure that this doesn't obstruct the dosing window or other product information.

• Eject and discard the needle after each use and attach a new needle for each new injection.

• Tell patients to never share their insulin pens with another person, because this could result in transmission of hepatitis or other blood-borne diseases.

• Remember that the same risk may exist with any multiple-dose injector device, not just insulin pens.

Additional Information:

FDA Consumer Update. Insulin Pens are Not for Sharing. March 25, 2009.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm129955.htm


Don’t Share Insulin Pens Between Patients

FDA is reminding health care professionals not to use a single insulin pen and cartridge on more than one patient. Even if needles are changed between patients, reusing these products on multiple patients may transmit blood-borne pathogens such as hepatitis or HIV between patients.

Insulin pens are injector devices that contain either an insulin reservoir or an insulin cartridge, usually with enough insulin for several doses.

More than 2,000 diabetic patients in two hospitals may have recently been put at risk of infection when insulin pens were used for more than one patient. Although staff changed the pen's disposable needle between patients, the pen itself was reused. Patients who were exposed to the shared insulin pens are being contacted and offered testing for hepatitis and HIV. Some of the patients have reportedly tested positive for hepatitis C, although it is not known whether the pens were responsible for transmitting the virus.

The Institute for Safe Medication Practices points out that air bubbles and pathogenic contaminants can enter the cartridge after injection while the needle is still attached to the pen. ISMP cites studies showing that up to half of all insulin pen cartridges are contaminated after being re-used, and warns that facilities shouldn't assume that everyone understands the importance of following the "one pen, one patient" practice.

Here are some of FDA's recommendations for the safe use of insulin pens.

• Remember that insulin pens containing multiple doses are meant for only one patient, and should not be shared between patients.

• Label the insulin pen with the patient's name and other identifiers, but be sure that this doesn't obstruct the dosing window or other product information.

• Eject and discard the needle after each use and attach a new needle for each new injection.

• Tell patients to never share their insulin pens with another person, because this could result in transmission of hepatitis or other blood-borne diseases.

• Remember that the same risk may exist with any multiple-dose injector device, not just insulin pens.

Additional Information:

ISMP Medication Safety Alert! Reuse of Insulin Pen for Multiple Patients Risks Transmission of Bloodborne Disease. Volume 14, Issue 3. February 12, 2009.
http://www.ismp.org/newsletters/acutecare/articles/20090212-2.asp



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