FDA Patient Safety News: Show #20, October 2003

Drug Name Confusion: Zyprexa/Zyrtec/Zantac

Periodically on this program, we point out mix-ups that occur when drug names look or sound alike. This time we're talking about confusions that have occurred between three drugs that all begin with the letter "Z": Zantac, an acid reducer; Zyrtec, an antihistamine; and Zyprexa, an antipsychotic.

First, take Zantac and Zyrtec. FDA has received a number of reports of pediatric medication errors that occurred when Zantac syrup was prescribed, but Zyrtec syrup was dispensed. These two drugs don't have overlapping dosage strengths, but they are both available as a syrup and both are available in amber 1-pint bottles. And the names both look alike and sound alike.

There are also reports of mix-ups between Zyrtec and Zyprexa. The Institute for Safe Medication Practices points out that many of these mix-ups probably occurred when only the first two letters of the drug name were seen by practitioners when reading prescription orders or container labels. Since both drugs are available in 5 mg and 10 mg tablet strengths, this increases the possibility of confusion. ISMP describes a patient who accidentally took Zyprexa instead of Zyrtec, and then suffered a head injury after losing consciousness. In another case, a previously controlled psychotic patient took Zyrtec instead of Zyprexa, and then relapsed. To help alleviate this problem, the manufacturer of Zyprexa has redesigned the product’s label using tall-man lettering to highlight the unique letters in the name.

Here are some ways that you can prevent these kinds of mix-ups. Educate the staff about the medication errors caused by these name confusions. Separate look-alike or sound-alike drugs on the pharmacy shelves. Include the indication for the drug on the prescription. Use name alerts or reminders about the potential for error on computer systems, drug containers and drug storage shelves.

And in situations similar to the Zyrtec and Zyprexa mix-ups, tell patients about the risk of a mix-up and advise them to look at their medication to be sure that it has the right appearance.

Additional Information:

ISMP Medication Safety Alert. October 31, 2001: Action needed to prevent dangerous Zyrtec-Zyprexa mix-ups.
http://www.ismp.org/Newsletters/acutecare/archives/Oct01.asp


Caution on Certain Triple Anti-Retroviral Therapy For HIV

GlaxoSmithKline has notified healthcare providers about a high rate of early virologic non-response in HIV-infected patients receiving a particular three-drug anti-retroviral regimen. The three drugs are Epivir (lamivudine), Ziagen (abacavir) and Viread (tenofovir). This virologic non-response was observed in a company-sponsored clinical trial of HIV-1 infected patients who had not been previously treated with anti-retrovirals.

Based on the clinical study results, GlaxoSmithKline says that abacavir and lamivudine in combination with tenofovir should not be used as a triple antiretroviral therapy when considering a new treatment regimen for either naive or pre-treated patients. Any patient currently controlled on therapy with this combination should be closely monitored and considered for modification of therapy. And any use of this triple combination with other antiretroviral agents should be closely monitored for signs of treatment failure. For more information, go to our website.

Additional Information:

MedWatch Safety Summary – Ziagen (abacavir).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm169490.htm


More Dangerous Misconnections

In a previous story, we described a number of cases where the tubing from a patient's blood pressure monitor was mistakenly connected to the IV port. Some of these cases resulted in the patient dying from an air embolism.

This time we want to draw your attention to a similar case, this time involving the air hose from a sequential compression device that's used with antiembolism stockings. An FDA article in Nursing 2003 describes a report of a confused patient returning from the bathroom. The patient mistakenly attached the air hose from his sequential compression device to his IV tubing, rather than to the antiembolism stocking. Luckily, the compressor was turned off, so air didn't enter the I.V. tubing. If it had, the patient could have sustained an air embolism and died.

Again, the cause of this problem goes back to different devices intended for very different uses having compatible luer connectors that allow them to be attached to one another. The article points out two ways to minimize the risk.

First, if you’re using luer connectors, you should always be alert to the possibility of inadvertent cross-connections. Follow the manufacturer's recommendations and cautions regarding compatibility with other devices, and if you notice potentially dangerous compatibility issues, notify your facility's risk manager and biomedical department.

Second, be aware that confused patients, like the one cited in the article, may be at special risk. It’s important to check on them frequently, and to remind them to call for help if they need to get out of bed.

Additional Information:

Nursing 2003, Device Safety Column: Compatible Connections, Incompatible Products.
https://www.nursingcenter.com/library/JournalArticle.asp?Article_ID=421743


Warning on Treating Latent TB with Rifampin and Pyrazinamide

CDC and the American Thoracic Society are now recommending that patients with latent tuberculosis infection not be treated with the combination of rifampin and pyrazinamide because of the risk of severe liver injury. These revised recommendations were published on August 8, 2003 in the MMWR.

In early 2000, CDC and the American Thoracic Society first recommended a 2-month regimen of rifampin plus pyrazinamide for treatment of latent TB infection. Shortly after this, CDC started receiving reports of liver injury in patients on this therapy, and based on these initial reports, CDC cautioned clinicians about using the two drugs in combination and advised additional monitoring of patients.

In the August MMWR issue, CDC reports on 48 confirmed cases of severe liver injury associated with this combination therapy, including 11 deaths. This led to the latest recommendation that the combination of rifampin plus pyrazinamide generally should not be offered to patients with latent TB infection. The preferred regimen for treating latent TB is isoniazid for 9 months. Alternatives are isoniazid for 6 months or rifampin for 4.

CDC notes that this recommendation does not apply to treating active TB disease, where using rifampin and pyrazinamide in multidrug regimens may be appropriate. And CDC continues to emphasize that treatment of latent TB infection is a key component in the effort to eliminate tuberculosis.

Additional Information:

CDC: Adverse Event Data and Revised American Thoracic Society/CDC Recommendations Against the Use of Rifampin and Pyrazinamide for Treatment of Latent Tuberculosis Infection – United States 2003. MMWR 2003;52:773-739.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5231a4.htm


Warning on Treating Latent TB with Rifampin and Pyrazinamide

CDC and the American Thoracic Society are now recommending that patients with latent tuberculosis infection not be treated with the combination of rifampin and pyrazinamide because of the risk of severe liver injury. These revised recommendations were published on August 8, 2003 in the MMWR.

In early 2000, CDC and the American Thoracic Society first recommended a 2-month regimen of rifampin plus pyrazinamide for treatment of latent TB infection. Shortly after this, CDC started receiving reports of liver injury in patients on this therapy, and based on these initial reports, CDC cautioned clinicians about using the two drugs in combination and advised additional monitoring of patients.

In the August MMWR issue, CDC reports on 48 confirmed cases of severe liver injury associated with this combination therapy, including 11 deaths. This led to the latest recommendation that the combination of rifampin plus pyrazinamide generally should not be offered to patients with latent TB infection. The preferred regimen for treating latent TB is isoniazid for 9 months. Alternatives are isoniazid for 6 months or rifampin for 4.

CDC notes that this recommendation does not apply to treating active TB disease, where using rifampin and pyrazinamide in multidrug regimens may be appropriate. And CDC continues to emphasize that treatment of latent TB infection is a key component in the effort to eliminate tuberculosis.

Additional Information:

CDC Fact Sheet: Treatment of Latent Tuberculosis Infection (LTBI) Updated August 7, 2003.
http://www.cdc.gov/nchstp/tb/pubs/tbfactsheets/250110.htm


Warning on Treating Latent TB with Rifampin and Pyrazinamide

CDC and the American Thoracic Society are now recommending that patients with latent tuberculosis infection not be treated with the combination of rifampin and pyrazinamide because of the risk of severe liver injury. These revised recommendations were published on August 8, 2003 in the MMWR.

In early 2000, CDC and the American Thoracic Society first recommended a 2-month regimen of rifampin plus pyrazinamide for treatment of latent TB infection. Shortly after this, CDC started receiving reports of liver injury in patients on this therapy, and based on these initial reports, CDC cautioned clinicians about using the two drugs in combination and advised additional monitoring of patients.

In the August MMWR issue, CDC reports on 48 confirmed cases of severe liver injury associated with this combination therapy, including 11 deaths. This led to the latest recommendation that the combination of rifampin plus pyrazinamide generally should not be offered to patients with latent TB infection. The preferred regimen for treating latent TB is isoniazid for 9 months. Alternatives are isoniazid for 6 months or rifampin for 4.

CDC notes that this recommendation does not apply to treating active TB disease, where using rifampin and pyrazinamide in multidrug regimens may be appropriate. And CDC continues to emphasize that treatment of latent TB infection is a key component in the effort to eliminate tuberculosis.

Additional Information:

CDC: Dear Colleague Letter - August 7, 2003.
http://www.cdc.gov/nchstp/tb/dearcolleague_8_9_03.htm



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