FDA Patient Safety News: Show #58, December 2006

Nerve Agent Treatment Approved for Emergency Use

FDA recently approved the drug product Duodote to treat civilians exposed to life-threatening nerve agents that contain organophosphorus, such as sarin and insecticides. Duodote is atropine and pralidoxime chloride injection. This combination of drugs had been previously approved under a different name for military use to treat troops who had been exposed to toxic nerve agents.

The current approval contains two caveats: that wearing protective clothing is the primary protection against exposure to chemical nerve agents and insecticide poisoning, and that only well-trained emergency medical services (EMS) personnel can administer Duodote to civilians. The manufacturer, Meridian Medical Technologies, Inc., will distribute Duodote directly to EMS organizations or their suppliers.

Additional Information:

FDA Press Release: FDA Approves Treatment for Nerve-Poisoning Agents for Use by Trained Emergency Medical Services Personnel. September 29, 2006.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108749.htm


Alert on Counterfeit “One Touch” Glucose Test Strips

FDA is alerting healthcare professionals and patients about counterfeit blood glucose test strips which are being sold for use with various models of LifeScan’s One Touch blood glucose monitors. LifeScan says that its testing of the counterfeit strips shows erratic test results. These strips could give incorrect blood glucose values, either too high or too low, which might result in a patient taking either too much or too little insulin. This could lead to serious injury or death.

The counterfeit test strips have been identified as certain lots labeled as “One Touch Ultra” or “One Touch Basic/Profile”. To date, the counterfeit product has been limited to 50-count packages for both products.

For the 50-count packages of One Touch Ultra test strips, the counterfeit version will have all three of the following characteristics:

• Lot Numbers 2691191 or 2691261
• Multiple languages - the outer carton is in both English and French.
• No NDC number (normally located on the bottom of the outer carton for US product)

For the 50-count packages of One Touch Basic/Profile test strips with lot numbers 272894A, 2619932 or 2606340, the counterfeit version will have the following characteristics:

• Multiple languages - the outer carton is in English, Greek and Portuguese.
• No NDC number (normally located on the bottom of the outer carton for US product)

For the 50-count packages of One Touch Basic/Profile test strips with lot numbers 2615211 or 227078A, the counterfeit version will have the following characteristics:

• Only English appears on the outer carton.
• Counterfeit vial is labeled “plasma calibrated.”

The counterfeit test strips were distributed to pharmacies and stores nationwide, but primarily in Ohio, New York, Florida, Maryland and Missouri. Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Health care professionals should alert patients who use these test strips about the possibility of counterfeiting. Pharmacists and retailers should check their inventories routinely. For additional information, contact LifeScan at 1-866-621-4855.

Additional Information:

FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips. October 23, 2006.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108774.htm


Alert on Counterfeit “One Touch” Glucose Test Strips

FDA is alerting healthcare professionals and patients about counterfeit blood glucose test strips which are being sold for use with various models of LifeScan’s One Touch blood glucose monitors. LifeScan says that its testing of the counterfeit strips shows erratic test results. These strips could give incorrect blood glucose values, either too high or too low, which might result in a patient taking either too much or too little insulin. This could lead to serious injury or death.

The counterfeit test strips have been identified as certain lots labeled as “One Touch Ultra” or “One Touch Basic/Profile”. To date, the counterfeit product has been limited to 50-count packages for both products.

For the 50-count packages of One Touch Ultra test strips, the counterfeit version will have all three of the following characteristics:

• Lot Numbers 2691191 or 2691261
• Multiple languages - the outer carton is in both English and French.
• No NDC number (normally located on the bottom of the outer carton for US product)

For the 50-count packages of One Touch Basic/Profile test strips with lot numbers 272894A, 2619932 or 2606340, the counterfeit version will have the following characteristics:

• Multiple languages - the outer carton is in English, Greek and Portuguese.
• No NDC number (normally located on the bottom of the outer carton for US product)

For the 50-count packages of One Touch Basic/Profile test strips with lot numbers 2615211 or 227078A, the counterfeit version will have the following characteristics:

• Only English appears on the outer carton.
• Counterfeit vial is labeled “plasma calibrated.”

The counterfeit test strips were distributed to pharmacies and stores nationwide, but primarily in Ohio, New York, Florida, Maryland and Missouri. Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Health care professionals should alert patients who use these test strips about the possibility of counterfeiting. Pharmacists and retailers should check their inventories routinely. For additional information, contact LifeScan at 1-866-621-4855.

Additional Information:

LifeScan OneTouch. Updated December 1, 2006.
http://www.lifescan.com/company/about/press/counterfeit/


New Labeling Stresses Bleeding Risk from Coumadin

A boxed warning has been added to the labeling for Coumadin (warfarin sodium) tablets and injection which reminds practitioners that patients may experience major or fatal bleeding from this drug. A new Medication Guide that instructs patients on precautions to be taken during treatment must also be distributed when prescriptions for Coumadin are dispensed.

The new labeling for practitioners stresses that bleeding is more likely to occur when Coumadin therapy is being started, with higher doses, and with long periods of treatment. Other risk factors for bleeding include elevated or highly variable INR’s, older age, a history of GI bleeding, hypertension, cerebrovascular disease, serious heart disease, anemia, malignancy, trauma or renal insufficiency, and taking concomitant drugs that may compromise clotting.

The warning states that INR should be monitored regularly during treatment with Coumadin, and that patients judged to be at higher risk for bleeding may benefit from more frequent monitoring, careful dose adjustment, and a shorter duration of therapy. The Medication Guide alerts patients to warning signs of bleeding, instructs them to get regular tests for clotting, and lists the foods and drugs that may promote bleeding.

Additional Information:

FDA MedWatch Safety Alert - Coumadin (warfarin sodium). October 6, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150518.htm


Possible Association between Lamictal and Cleft Lip/Palate

FDA is alerting health care professionals and patients that infants exposed to Lamictal (lamotrigine) during the first trimester of pregnancy may have an increased risk of being born with a cleft lip or palate. Lamictal is used to treat certain patients with seizures or bipolar disorder. FDA’s caution was based on preliminary data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

In this particular registry, the prevalence of cleft lip and palate if the mother took Lamictal was about 9/1000. That compares with about 0.5/1000 to 2/1000 in other studies that looked at non-epileptic women not taking the drug. Although cleft lip and palate are often part of a broader syndrome that includes other congenital anomalies, the defects in this registry were not part of a larger syndrome. Also, the increased prevalence of cleft lip and palate hasn’t been seen in other pregnancy registries of similar size, so the clinical significance of these findings is still uncertain.

FDA has identified several points that practitioners should take into account when they consider prescribing Lamictal during pregnancy. First, if the epilepsy or bipolar disorder isn’t treated, this can expose the woman and her unborn child to significant health risks. These risks have to be weighed against the risks of taking Lamictal, one of which may be an increased risk of cleft lip and palate, although this remains unconfirmed at this point.

The number of pregnant women in the NAAED and other pregnancy registries exposed to several of the other new antiepileptic drugs is too small to establish an estimate of comparative risk among the newer antiepileptic drugs.

Patients need to know that seizures and bipolar disorder are serious conditions that continue to need treatment during pregnancy. FDA advises women who take Lamictal and are pregnant or are thinking of becoming pregnant to talk to their physicians. And physicians should warn patients to consult with them before they start or stop using the drug.

Additional Information:

FDA MedWatch Safety Alert – Lamictal (lamotrigine). September 29, 2006.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150637.htm


Roche Diagnostics Recalls CoaguChek PT Test Strips

In October 2006, Roche Diagnostics recalled all of the company’s CoaguChek® PT test strips because a possible defect in the test strips may cause falsely elevated test results. These strips are used in clinical settings and by patients at home to monitor anticoagulation therapy.

Although only a small percentage of the test strips may be affected by this problem, falsely high INR results could cause the patient to receive the wrong dose of anti-coagulant or unnecessary corrective measures to reduce the effect of circulating anti-coagulants. Both of these incorrect treatments could put patients at risk for blood clots.

The company is working on a permanent fix for this problem. In the meantime, Roche Diagnostics is notifying home users and healthcare professionals about this problem. Patients who use these products in their homes should take the following steps: immediately stop using these strips, discard any unused product and consult their health care professional about alternate testing options.

Health care professionals may continue to use these strips in their facilities, but to reduce the chance for inaccurate results, they should conduct duplicate testing on their patients using CoaguChek PT test strips from two different lot numbers. Patients and health care professionals who have questions can call Roche Diagnostics at 1-800-820-0995.

Additional Information:

Company Press Release - Roche Diagnostics Announces Nationwide Recall on Medical Device Used to Determine Blood Clotting Time. October 19, 2006.
http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2006/ucm112057.htm


Severe Tissue Injury with IV Promethazine

The Institute for Safe Medication Practices recently warned that administering promethazine parenterally may cause more severe tissue injuries than previously recognized. Promethazine, which is commonly sold under the trade name Phenergan, has many uses including as an antihistamine, a sedative and an antiemetic.

ISMP points that out promethazine is a known vesicant which is highly caustic to the intima of blood vessels and surrounding tissue. Deep intramuscular injection into a large muscle is the preferred parenteral route of administration, and is least likely to cause damage. But promethazine is also given by slow IV push in many hospitals. The IV route, along with inadvertent intra-arterial or subcutaneous administration is most likely to result in significant complications, ranging from burning and pain to paralysis, tissue necrosis, and gangrene. Sometimes surgical intervention such as fasciotomy, skin graft or even amputation is needed.

ISMP describes several recent cases where severe tissue damage occurred following IV administration of promethazine. For example, in one case a 19-year-old woman who went to the emergency department with flu-like symptoms was given Phenergan IV. During the injection, she cried out in pain, and after the injection she told the nurse that her arm was still in significant pain and that she felt “something was wrong.” The nurse reassured her and then left the room. The patient’s arm and fingers became purple and blotchy and then over the next several weeks eventually turned black and shriveled. Her thumb, index finger, and top of her middle finger eventually had to be amputated.

ISMP points out that the product labeling makes several recommendations to reduce the risk of these adverse events. They include giving the drug in concentrations no greater than 25 mg/mL, administering the drug at a rate no greater than 25 mg/minute, injecting the drug through the tubing of an infusion set that’s running and known to be working satisfactorily, and stopping the injection immediately if the patient reports burning in order to investigate whether there might be intra-arterial placement or perivascular extravasation.

In addition to the manufacturer’s recommendations, ISMP lists about a dozen other strategies to prevent or minimize tissue damage when giving IV promethazine. Here are several suggestions.

• Stock promethazine only in the 25 mg/mL concentration (not the 50 mg/ml) since this is the highest concentration of promethazine that can be given IV.

• Consider 6.25 to 12.5 mg of promethazine as the starting IV dose, especially for elderly patients.

• Give the medication only through a large-bore vein and check the patency of the access site before administering.

• Administer IV promethazine through a running IV line at the port furthest from the patient’s vein.

• Consider administering IV promethazine over 10-15 minutes.

• Before administering the drug, tell patients to let you know immediately if burning or pain occurs during or after the injection.

Additional Information:

ISMP Medication Safety Alert! Serious Action needed to prevent serious tissue injury with IV Promethazine. August 10, 2006.
http://www.ismp.org/Newsletters/acutecare/articles/20060810.asp


Preventing Fatal Heparin Overdoses

The Institute for Safe Medication Practices recently cited a case in which three premature infants died after receiving an overdose of heparin. According to ISMP, this may have occurred because heparin vials containing 10,000 units/mL were placed in an automated dispensing cabinet where vials containing 10 units of heparin per ml were normally kept. The vials looked somewhat similar, and the nurses did not notice that the ones that were taken from the cabinet actually contained 10,000 times more heparin than they expected.

ISMP notes that errors in filling automated dispensing cabinets are common, and so it is important to double-check the contents of these cabinets before they leave the pharmacy. The ISMP Alert lists several other steps to help prevent these kinds of errors. For example:

• Consider which medications might be removed from automated dispensing cabinets for safety’s sake, especially in those cabinets that are used for high-risk patients such as neonates and children.

• Take steps to minimize look-alike packages and labels. When possible, do not stock items on nursing units that require further preparation before administration.

• Consider bar coding for medication administration management systems throughout the hospital, if not already in place. Even if bedside scanning is not being used, dispensing cabinet vendors provide bar code systems to make sure the right medications are stocked in these cabinets.

Additional Information:

ISMP Medication Safety Alert! Infant Heparin Flush Overdose. September 21, 2006.
http://www.ismp.org/Newsletters/acutecare/articles/20060921a.asp



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