FDA Patient Safety News: Show #18, August 2003

First Intranasal Flu Vaccine

FDA recently approved the first intranasal flu vaccine for marketing in the U.S. It's called FluMist, and it's manufactured by MedImmune Vaccines Inc. FluMist contains the three influenza virus strains recommended by the U.S. Public Health Service for the upcoming flu season.

FluMist is approved for use in healthy children and adolescents ages 5 to 17, and healthy adults ages 18-49. Just as with the injectable flu vaccine, children 5-8 years old need two doses at least 6 weeks apart in their first year of influenza vaccination, and individuals 9-49 years old need one dose.

In clinical trials, FluMist was evaluated in over 20,000 people, including over 10,000 healthy children 5-17 years old. The efficacy of the vaccine in preventing influenza was approximately 87 percent among children included in the trial. In healthy adults between the ages of 18-49, FluMist was effective in reducing the frequency of severe illnesses with fever, and upper respiratory illness with fever which may be caused by influenza infection.

During past flu seasons, there have sometimes been problems with vaccine availability. Having an additional licensed flu vaccine manufacturer could help to prevent shortages. Unlike the injectable flu vaccine, this is a live-attenuated vaccine, and that introduces some special cautions that don't apply to the injectable vaccine. As with other live virus vaccines, Flumist should not be given for any reason to immunosuppressed patients, including AIDS or cancer patients, and patients being treated with immunosuppressive drugs.

Several other groups shouldn't get this vaccine. For example, it’s not been shown to be safe and effective in people under the age of 5 or over the age of 49, or in people with asthma or other reactive airway diseases. And it shouldn’t be given to people with chronic underlying medical conditions that may predispose them to severe flu infections. For these people, the inactivated flu vaccine is indicated.

And finally, people should not receive FluMist, or any other flu vaccine, if they've had an allergic reaction to eggs or to a previous dose of any flu vaccine.

Additional Information:

Product Approval Information – Licensing Action.
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm123753.htm


Two New Cancer Drugs

FDA recently approved two new chemotherapeutic agents to treat cancer. One drug is Iressa, manufactured by AstraZeneca. Its generic name is gefitinib, and it's for patients with advanced non-small cell lung cancer, the most common form of lung cancer in the U.S.

The drug is intended for patients whose cancer has continued to progress despite treatment with existing chemotherapeutic agents. Clinical trials with Iressa have shown no benefit from adding this drug to standard, platinum-based chemotherapy, and so Iressa should be administered alone for those patients who don't respond to standard chemotherapy.

The second drug is Velcade, distributed by Millennium Pharmaceuticals. Its generic name is bortezomib, and it's the first in a new class of chemotherapeutic agents known as proteasome inhibitors. It's intended for multiple myeloma patients whose disease has relapsed after two prior treatments, and who've demonstrated resistance to their last treatment. So far, about 28 percent of patients treated with Velcade have shown a response.

Both of these drugs are intended to be used only when other chemotherapeutic agents have failed. Both can produce side effects, including those common to chemotherapeutic agents, such as nausea, vomiting and diarrhea. In addition, Iressa can cause fatal interstitial lung disease and may harm the fetus if administered to pregnant patients. Although both drugs have been shown to reduce tumor volume in some patients, clinical benefit has yet to be demonstrated.

These drugs were approved under FDA's Accelerated Approval program, designed to make new drugs for life-threatening conditions quickly available when they appear to provide a benefit over existing therapy. Under this program, these two chemotherapeutic agents were approved based on early clinical evidence. The manufacturers will be required to continue clinical testing to demonstrate that the drugs do indeed provide a therapeutic benefit to the patient. If they don't, the Accelerated Approval program also provides a mechanism for withdrawing the product from the market.

Additional Information:

FDA/CDER: Iressa (gefitinib) Information.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110473.htm


Two New Cancer Drugs

FDA recently approved two new chemotherapeutic agents to treat cancer. One drug is Iressa, manufactured by AstraZeneca. Its generic name is gefitinib, and it's for patients with advanced non-small cell lung cancer, the most common form of lung cancer in the U.S.

The drug is intended for patients whose cancer has continued to progress despite treatment with existing chemotherapeutic agents. Clinical trials with Iressa have shown no benefit from adding this drug to standard, platinum-based chemotherapy, and so Iressa should be administered alone for those patients who don't respond to standard chemotherapy.

The second drug is Velcade, distributed by Millennium Pharmaceuticals. Its generic name is bortezomib, and it's the first in a new class of chemotherapeutic agents known as proteasome inhibitors. It's intended for multiple myeloma patients whose disease has relapsed after two prior treatments, and who've demonstrated resistance to their last treatment. So far, about 28 percent of patients treated with Velcade have shown a response.

Both of these drugs are intended to be used only when other chemotherapeutic agents have failed. Both can produce side effects, including those common to chemotherapeutic agents, such as nausea, vomiting and diarrhea. In addition, Iressa can cause fatal interstitial lung disease and may harm the fetus if administered to pregnant patients. Although both drugs have been shown to reduce tumor volume in some patients, clinical benefit has yet to be demonstrated.

These drugs were approved under FDA's Accelerated Approval program, designed to make new drugs for life-threatening conditions quickly available when they appear to provide a benefit over existing therapy. Under this program, these two chemotherapeutic agents were approved based on early clinical evidence. The manufacturers will be required to continue clinical testing to demonstrate that the drugs do indeed provide a therapeutic benefit to the patient. If they don't, the Accelerated Approval program also provides a mechanism for withdrawing the product from the market.

Additional Information:

FDA/CDER: Velcade (bortezomib) Information.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106494.htm


Caution on Pediatric Use of Paxil

FDA is reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents being treated with Paxil for major depressive disorder. Although our evaluation of these reports is still underway, FDA is recommending that Paxil not be used to treat depression in patients younger than 18. At this time, there's no evidence that Paxil is effective for this indication and it's currently not approved by FDA for any use in children.

Despite these new possible safety concerns, patients should not abruptly discontinue the use of Paxil. Any changes in these patients' drug regimen must take place under medical supervision.

In adults, Paxil is approved for several indications, including obsessive compulsive disorder, major depressive disorder and panic disorder. For adults, there's no evidence that Paxil is associated with an increased risk of suicidal thinking, so FDA's advice hasn't changed for these patients.

Additional Information:

FDA Talk Paper: FDA Statement Regarding the Anti-Depressant Paxil for Pediatric Population.
http://www.fda.gov/NewsEvents/Testimony/ucm113265.htm


Dangerous Misconnections Between BP Monitors and IV Ports

The Institute for Safe Medication Practices has reported on a number of cases where the tubing from a patient's blood pressure monitor was mistakenly connected to the IV port. These misconnections have been fatal when the air that was supposed to inflate the blood pressure cuff instead entered the patient's vascular system and created an air embolism. ISMP points out that although these kinds of mixups may be rare, the hazard exists at many hospitals.

The mix-ups occurred because the tubing that led from the monitor's blood pressure cuff inflator had a male Luer connector that fit into a female connector on the cuff. ISMP says that these misconnections are more likely to occur at the Y-site of needleless IV tubing, since the misconnection requires no manipulation of the tubing.

Although the color of the tubing on the blood pressure cuff is different than the color of the IV tubing, ISMP points out that you can’t rely on that. They cite one case in the literature where a nurse accidentally connected the tubing from a BP monitor to what looked like the white tube on the BP cuff. But in fact, the drug propofol, which is white and opaque, had been infusing through the patient's IV line, making it look like the white tube on the cuff, and that's how the mistake occurred.

Some manufacturers are taking steps to try to prevent these errors. Some of them have warned their customers about the problem, or provided warning labels for the monitors and tubing. And some plan to require dedicated tubing with non-Luer connectors. And in some cases biomedical engineering departments have alerted clinical managers about the problem. But as long as disposable BP cuffs are available with female Luer connectors, tubing from the BP monitor could be connected to an IV, with potentially lethal results.

ISMP’s primary recommendation is to switch blood pressure equipment, if necessary. What they're suggesting is to replace all BP monitoring equipment to ensure that the tubing from the monitor is not compatible with Luer connections. Until that happens, they recommend making it a practice to place BP cuffs on a different arm than the IV site, and to remove IV catheters as soon as they're no longer needed. They say that using labels on the tubing can help, but they warn not to rely on labeling alone to solve the problem.

Additional Information:

ISMP Medication Safety Alert. "Blood pressure monitor tubing may connect to IV port" - June 12, 2003.
http://www.ismp.org/MSAarticles/blood.htm


New Consumer Brochure on Safe Medication Use

There's a new brochure available that helps consumers use medications safely. It's called “Your Medicine: Play it Safe,” and it's been issued by the Agency for Healthcare Research and Quality, along with the National Council on Patient Information and Education.

It teaches people the importance of communication between patient and healthcare provider, and covers such things as knowing what the medication is for, asking questions, taking a full course of antibiotic treatment, and keeping medication records. Go to our web site to find out how to get free copies of the brochure, or how to purchase bulk quantities.

Additional Information:

AHRQ Press Release - AHRQ and the National Council on Patient Information and Education (NCPIE) Produce New Tool to Help Consumers Reduce Medication Errors.
http://www.ahrq.gov/news/press/pr2003/safemedpr.htm



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