FDA Patient Safety News: Show #12, February 2003

New Rapid HIV Test Kit

FDA recently approved a rapid HIV diagnostic test kit that provides results in as little as 20 minutes. Using a fingerstick blood sample, this new test can quickly and reliably detect antibodies to HIV-1, with greater than 99.6 percent accuracy.

Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be used outside of traditional laboratory or clinical settings. It's called the OraQuick Rapid HIV-1 Antibody Test and it's manufactured by OraSure Technologies, Inc.

Each year, thousands of HIV-infected people come to public clinics for HIV testing, but don't come back to get their results. This test will help resolve that problem because it can provide results without a waiting period. It will also help identify pregnant HIV-infected women who are going into labor but were not tested during pregnancy, so that steps can be taken to block their newborns from being infected with HIV.

To perform the test, a fingerstick sample of blood is collected from an individual and transferred to a vial where it is mixed with a developing solution. The test device, which resembles a dipstick, is then inserted into the vial. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device.

Two points to keep in mind. First, as with all screening tests for HIV, if the OraQuick test gives a preliminary positive result, this must be confirmed with a more specific test. And second, the OraQuick test has not been approved to screen blood donors.

Additional Information:

Premarket Approval Information: OraQuick Rapid HIV-1 Antibodies Test.
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091994.htm


New Rapid HIV Test Kit

FDA recently approved a rapid HIV diagnostic test kit that provides results in as little as 20 minutes. Using a fingerstick blood sample, this new test can quickly and reliably detect antibodies to HIV-1, with greater than 99.6 percent accuracy.

Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be used outside of traditional laboratory or clinical settings. It's called the OraQuick Rapid HIV-1 Antibody Test and it's manufactured by OraSure Technologies, Inc.

Each year, thousands of HIV-infected people come to public clinics for HIV testing, but don't come back to get their results. This test will help resolve that problem because it can provide results without a waiting period. It will also help identify pregnant HIV-infected women who are going into labor but were not tested during pregnancy, so that steps can be taken to block their newborns from being infected with HIV.

To perform the test, a fingerstick sample of blood is collected from an individual and transferred to a vial where it is mixed with a developing solution. The test device, which resembles a dipstick, is then inserted into the vial. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device.

Two points to keep in mind. First, as with all screening tests for HIV, if the OraQuick test gives a preliminary positive result, this must be confirmed with a more specific test. And second, the OraQuick test has not been approved to screen blood donors.

Additional Information:

Frequently Asked Questions About the OraQuick® Rapid HIV-1 Antibody Test.
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm091996.htm


Counterfeiting of Procrit

Occasionally on this program, we'll alert you to the existence of counterfeit medical products. This time we're talking about the counterfeiting of Procrit, marketed by Ortho Biotech Products, L.P. Procrit is used primarily to treat anemia associated with chemotherapy, chronic renal failure, and AZT treatment. It's also used in some patients undergoing elective surgery. Other products similar to Procrit have also been counterfeited.

In a letter to health care professionals, Ortho Biotech said that the counterfeit product comes in four-pack boxes and is labeled as 40,000 units/ml Procrit. The company stated that the implicated vials appear to be intact, and they contain a clear liquid with some active ingredient. But Ortho Biotech says that counterfeiters may be acquiring 2,000 units/ml vials and relabeling them with counterfeit Procrit labels that say 40,000 units/ml. And so it's possible that patients could be under-dosed as a result of this mislabeling. In addition, other potential health risks can't be ruled out at this time.

Ortho Biotech says that three lot numbers have been implicated to date. These lot numbers appear on your screen and can also be found on our website. Authentic Procrit was also distributed under these lot numbers. But Ortho Biotech's letter points out that based on historical usage patterns and inventory practices, it's likely that all authentic Procrit with these lot numbers has already been used. So the company says that any product that still has these lot numbers should be considered suspect and not used.

Ortho Biotech has noted that there are a few subtle differences between the features of authentic and counterfeit Procrit. For example, some of the printing on the counterfeit box wraps around the corner of the panel, leaving no space between the printing and the edge of the box. Authentic Procrit has a space between the printing and the edge of the box.

Ortho Biotech has also begun to use color-shifting seals on Procrit cartons to make possible tampering more evident. Seals will shift color from green to silver when viewed at different angles.

If you receive any product that you suspect is counterfeit, do not use it. Store it properly and promptly contact the FDA. Be sure to go to our web site for more complete information on how to identify this counterfeit product.

Additional Information:

Updated Information : Counterfeiting of Procrit® (Epoetin alfa).
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM173866.pdf


New Warnings on Bextra Label

FDA and Pharmacia are advising health care professionals about new warnings in the product labeling for drug Bextra. Bextra is an NSAID used to treat osteoarthritis, rheumatoid arthritis and dysmenorrhea. Its generic name is valdecoxib.

Since its introduction, this drug has been associated with serious skin and hypersensitivity reactions. These reactions occurred in patients with and without a history of allergy to sulfa-containing products. Although these adverse events are rare, some of the patients required hospitalization.

Based on these reports, FDA has approved labeling changes that include a warning for serious skin reactions. The labeling also states that the drug is contraindicated in patients who are allergic to sulfonamides. Since these reactions can be life threatening, Bextra should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Additional Information:

FDA MedWatch Safety Information Summary: Bextra.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154472.htm


Warning About Methotrexate Overdoses

The Institute for Safe Medication Practices has issued an alert about methotrexate overdoses that occur when this drug is accidentally taken daily rather than weekly, as intended.

The use of methotrexate is well established in oncology. It's also prescribed in low doses for immunomodulation in such conditions as rheumatoid arthritis, asthma, and inflammatory bowel disease. When it's used for these purposes, the dose is administered weekly or twice a week, as opposed to the daily doses that physicians and patients are accustomed to. This has led to serious and sometimes fatal mistakes.

For example, in one case, a physician prescribed methotrexate 15 mg daily rather than weekly for a 79-year-old patient. The patient received nine doses before the error was discovered and the patient later died. Another patient died after he misread the directions on a prescription bottle and took 10 mg every "morning" instead of every "Monday."

Because of the number of fatalities from errors with oral methotrexate, it should be considered a high alert medication regardless of the indication.

Here are some of ISMP's recommendations to help reduce the risk of an error.

Since oral methotrexate CAN be prescribed daily in oncology, prescribers should include the clinical indication within prescription directions. That way, if daily dosing is ordered for an autoimmune disease, the pharmacist will be alert to the possibility of error.

If the indication isn't included in the order or the prescription directions, the pharmacist should speak directly with the prescriber to determine the reason for use of methotrexate, and to verify the proper dosing schedule.

Electronic prescribing systems and pharmacy computers should have built in alerts to warn clinicians whenever oral methotrexate is entered, so that the indication and the dose can be checked.

Patients should receive written material that contains clear advice about taking the drug weekly, not daily. The instructions should name a specific day of the week for taking the drug. When possible, avoid choosing Monday since it could be misread as "morning."

Patients should understand that taking extra doses is dangerous. Encourage feedback to ensure that the patient understands the weekly dosing schedule and that the medication should not be used "as needed" for symptom control.

Additional Information:

ISMP Medication Safety Alert December 3, 2002: Methotrexate overdose due to inadvertent administration daily instead of weekly.
http://www.ismp.org/hazardalerts/ha.pdf


Warning About Methotrexate Overdoses

The Institute for Safe Medication Practices has issued an alert about methotrexate overdoses that occur when this drug is accidentally taken daily rather than weekly, as intended.

The use of methotrexate is well established in oncology. It's also prescribed in low doses for immunomodulation in such conditions as rheumatoid arthritis, asthma, and inflammatory bowel disease. When it's used for these purposes, the dose is administered weekly or twice a week, as opposed to the daily doses that physicians and patients are accustomed to. This has led to serious and sometimes fatal mistakes.

For example, in one case, a physician prescribed methotrexate 15 mg daily rather than weekly for a 79-year-old patient. The patient received nine doses before the error was discovered and the patient later died. Another patient died after he misread the directions on a prescription bottle and took 10 mg every "morning" instead of every "Monday."

Because of the number of fatalities from errors with oral methotrexate, it should be considered a high alert medication regardless of the indication.

Here are some of ISMP's recommendations to help reduce the risk of an error.

Since oral methotrexate CAN be prescribed daily in oncology, prescribers should include the clinical indication within prescription directions. That way, if daily dosing is ordered for an autoimmune disease, the pharmacist will be alert to the possibility of error.

If the indication isn't included in the order or the prescription directions, the pharmacist should speak directly with the prescriber to determine the reason for use of methotrexate, and to verify the proper dosing schedule.

Electronic prescribing systems and pharmacy computers should have built in alerts to warn clinicians whenever oral methotrexate is entered, so that the indication and the dose can be checked.

Patients should receive written material that contains clear advice about taking the drug weekly, not daily. The instructions should name a specific day of the week for taking the drug. When possible, avoid choosing Monday since it could be misread as "morning."

Patients should understand that taking extra doses is dangerous. Encourage feedback to ensure that the patient understands the weekly dosing schedule and that the medication should not be used "as needed" for symptom control.

Additional Information:

ISMP Medication Safety Alert! April 3, 2002: Beware of erroneous daily oral methotrexate dosing.
http://www.ismp.org/MSAarticles/Beware.htm


West Nile Virus and Blood Safety

In 2002, a major outbreak of West Nile virus infection occurred in many parts of the U.S., in animals as well as humans. Although the most common means of transmission, by far, is from mosquito bites, your patients may have heard about cases of people acquiring West Nile virus infections from blood transfusions. They may wonder about whether they could become infected from a transfusion and about the safety of the blood supply.

Although investigations are still underway, it's highly likely that the virus can be transmitted by transfusions, although the degree of risk is uncertain. Since about 80% of people infected with the virus will remain asymptomatic, laboratory screening of blood and plasma donors probably will be needed to protect blood safety if the West Nile epidemic continues.

There's currently no such test approved and available for donor screening or clinical diagnosis of the virus. But FDA is actively encouraging the development of these tests, and we're working with industry to facilitate the development of commercial blood-donor screening tests that can be used on a large scale.
In the meantime, FDA has developed guidance for blood establishments to help protect the safety of the blood supply against West Nile virus. Because no screening tests are currently available for the virus, this guidance is especially important in answering a number of questions.

For example, how should blood establishments decide which potential donors should be deferred? And what should blood establishments tell donors about reporting fever and flu-like symptoms that occur after they've donated blood?

Be sure that your patients understand two very fundamental things. First, that they cannot acquire the West Nile virus by donating blood. And second, that in situations where a blood transfusion may be life-saving, the benefits of receiving the transfusion outweigh the risk of West Nile Virus infection.

Additional Information:

FDA West Nile Virus Information.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072128.htm



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