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U.S. Department of Health and Human Services

Show #37, March 2005

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Show #37, March 2005

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 New Medical Products

March2005FDA Patient Safety News Homepage
New Genotyping Test to Help Guide Medication Use (Video, print, and e-mail functions)
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FDA has cleared the first laboratory test system that uses DNA microarray technology to provide genetic information that can help select a patient's medications and individualize doses. It's called the AmpliChip Cytochrome P450 Genotyping Test, manufactured by Roche Molecular Systems. FDA clearance of this product paves the way for similar tests to be developed in the future.

Using a blood sample, the new test analyzes an enzyme from one of the genes in the cytochrome P450 family of genes. Variations in this gene can affect the patient's ability to metabolize certain drugs, including some antidepressants, antipsychotics, beta blockers and chemotherapeutic agents.

This test can't be used by itself to determine optimum drug dosages. It's intended to be used along with clinical evaluation and other tools.

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 Recalls and Safety Alerts

March2005FDA Patient Safety News Homepage
Public Health Advisory on NSAIDS (Video, print, and e-mail functions)
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FDA recently issued a public health advisory about the use of NSAIDS, including COX-2 selective agents such as Celebrex and Bextra.

Recently released data from controlled clinical trials suggests that these COX-2 selective agents may be associated with an increased risk of serious cardiovascular events. In these studies, the increased risk was associated with long term use of the drugs, or use in very high risk settings--immediately after heart surgery, for example. The results of these studies are preliminary, and they conflict with other data from studies of the same drugs.

Still, FDA is making some interim recommendations at this time. FDA is advising prescribers of Celebrex or Bextra to consider this emerging information when they're weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal (GI) bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for COX-2 selective agents. Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should also be taken into account for each prescribing situation.

FDA is analyzing the most recent studies of both COX-2 selective and nonselective NSAIDs to determine whether additional regulatory action is needed.

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March2005FDA Patient Safety News Homepage
Recall of Unomedical Airway Adapters (Video, print, and e-mail functions)
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In early December 2004, Unomedical, Inc. recalled certain airway adapters because several were found to be occluded, which could interfere with a patient's ability to breathe. The recalled adapters were used in a number of products, including nebulizer circuits, ventilator circuits, anesthesia circuits, transport circuits and face masks. These products were sold under Unomedical's Hospitak brand name, and also under the names Viasys, Unomedical, Drager and Bio-Med Devices Inc.

Although the recalled products were primarily used in hospitals, some were also sold for home use. Patients and medical health professionals who have Hospitak, Viasys, Unomedical, Bio-Med Devices, Inc. and/or Dräger brand airway adapters should check with Unomedical, Inc. (1-800-634-6003) before using the product. Patients and health care institutions who are not sure of the origin of the airway adapters they have in stock may want to check with their suppliers to make sure that they are not affected by this recall.

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 Preventing Medical Errors

March2005FDA Patient Safety News Homepage
Warning on Liver Injury from Strattera (Video, print, and e-mail functions)
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FDA is advising health professionals about a new warning for the drug Strattera, used to treat attention deficit hyperactivity disorder in adults and children.

The drug's labeling is being updated with a bolded warning about the potential for severe liver injury in patients taking Strattera. The label warns that severe liver injury can progress to liver failure in a small percentage of patients. It cautions clinicians to discontinue the drug in patients who develop jaundice or laboratory evidence of liver injury. It also notes that the actual number of cases of severe liver injury from the drug is not known because of under-reporting.

Strattera's manufacturer, Eli Lilly, has agreed to send a letter to physicians, alerting them to the new information. The company will also update the patient package insert to include information about the signs and symptoms of liver problems.

If you learn of unexpected adverse events with Strattera, including liver damage, please report them, either directly to Eli Lilly, or to FDA's MedWatch program. You'll find the addresses on our web site.

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March2005FDA Patient Safety News Homepage
Reporting Adverse Events for Drugs, Devices, Biologics, and Dietary Supplements (Video, print, and e-mail functions)
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An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they suspect are associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.

Take the example of the antibiotic Zyvox. Within the first six months of Zyvox's marketing, FDA began getting MedWatch reports of myelosupression from clinicians who suspected that the drug might be responsible. After investigating the problem, FDA worked with the manufacturer to change the Zyvox labeling to warn about the potential for myelosuppression.

Sometimes MedWatch reports highlight errors in prescribing or administering medications. For example, FDA received reports of patient injuries due to name confusion between LANOXIN, a heart medication, and what used to be called LEVOXINE, a thyroid medication. As a result, FDA asked the manufacturer to change the name of Levoxine, and now it's known as LEVOXYL, which is less likely to be confused with LANOXIN.

The MedWatch system can also help detect problems with medical products other than drugs. For example, FDA received two reports of pneumococcal eye infections in patients who'd received corneal transplants. An FDA inspection identified numerous manufacturing problems, which led the company to recall the implants.

Of course, MedWatch reports alone rarely confirm a causal relationship between an adverse event and a medical product, since it may take a formal epidemiologic study to do that. Still, MedWatch reports are vital in making sure that medical products are safe, because they provide a rapid signal to FDA that problems may be occurring.

It's important to keep the MedWatch system working, and FDA needs your help. Here are the kinds of reports that should be submitted:

First, report any serious adverse event that might be associated with a drug, biologic, medical device, or dietary supplement, particularly serious adverse events that are not listed in the product labeling. "Serious" means fatalities, hospitalizations, and medically significant events.

Secondly, report therapeutic failures - cases in which the drug or device failed to work as it should (e.g., if a patient has to switch from one brand of a drug to another because the original one was ineffective).

Third, report cases of use errors with medications or devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.

Finally, report product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.

FDA encourages reporting these problems to MedWatch even if you're not sure that the product was the cause. It's easy to report by internet, phone, fax, or mail.

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March2005FDA Patient Safety News Homepage
Warning on Severe Hepatotoxicity with Remicade (Video, print, and e-mail functions)
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Centocor has notified healthcare professionals about new warnings for Remicade, a drug used to treat rheumatoid arthritis and Crohn's disease. The new safety information describes rare but severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis in patients being treated with Remicade. These reactions occurred between two weeks to more than a year after Remicade treatment was started. Some of these cases were fatal or resulted in liver transplants.

Centocor advises that patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. Remicade should be discontinued if patients develop jaundice, or if liver enzymes become elevated to a level that's 5 or more times the upper limit of normal.

The company also notes that Remicade, like other immunosuppressive drugs, has been associated with reactivation of hepatitis B in chronic carriers of this virus. The company says that these patients should be evaluated and monitored before and during treatment with Remicade.

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March2005FDA Patient Safety News Homepage
More on Preventing Fatal Gas Mix-Ups (Video, print, and e-mail functions)
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Previous reports have described patient deaths from medical gas mix-ups, where patients were accidentally given the wrong gas, such as nitrogen or CO2, instead of oxygen. These types of fatalities could be prevented by not using adapters, and not changing the connectors or fittings on gas containers to make them fit the oxygen connector on the patient's gas delivery system.

Fatalities continue to occur. The Institute for Safe Medication Practices recently received a report about an oxygen flow meter being forced into a nitrous oxide wall outlet that was immediately adjacent to the oxygen outlet in a radiology suite. Instead of receiving oxygen, the patient received nitrous oxide, and died.

Two factors played a part in this incident. First, because the room was dimly lit in preparation for a CAT scan, the technician wasn't able to distinguish the blue color of the nitrous oxide connector from the green color of the oxygen connector. And second, the pin index safety system on the oxygen flow meter was broken at the time. Since the pin system is designed to prevent incorrect connections, a flow meter with a broken or missing pin should never be used.

ISMP points out that the opportunity for errors of this kind may increase as general anesthesia is used more often outside the OR. For example, more invasive procedures with general anesthesia are being conducted in radiology, and general anesthesia is used in bronchoscopy, cardiac cath and endoscopy.

Here are some of the things ISMP recommends to help reduce the likelihood of this kind of gas mixup error:

First, standardize the type of flow meters, regulators and connectors used throughout your facility, and use only those with indexing systems to help prevent misconnections.

Second, make sure that the labeling of all gas connections and sources is visible during actual use conditions, such as in dim light, or under crowded conditions.

Third, if a patient doesn't respond to treatment with supplemental oxygen, consider the possibility that the wrong gas is being administered, and immediately check the connections. Using an oxygen saturation monitor can provide an early alarm of hypoxic gas delivery to the patient.

Finally, be sure that biomedical engineering staff perform regular preventive maintenance on gas delivery systems, and that only trained and certified personnel are allowed to use or service this equipment.

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March2005FDA Patient Safety News Homepage
More on Brethine-Methergine Mix-ups (Video, print, and e-mail functions)
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Institute for Safe Medication Practices previously reported on dangerous mix-ups between two drugs whose packaging looks similar. Brethine (terbutaline sulfate) and Methergine (methylergonovine maleate) are frequently used in labor and delivery settings, but they're pharmacologic opposites used for very different clinical reasons.

Brethine is used off-label to treat preterm labor, and Methergine is used primarily after delivery of the placenta to treat hemorrhage and failure of the uterus to contract. Methergine should not be used in pregnancy except after the delivery of a newborn, and it's especially dangerous to a patient in preterm labor. Despite previous warnings, ISMP recently reported on another error that occurred because the ampuls of these two products look alike.

Both drugs continue to be available as 1 mL ampuls, packaged in amber plastic tubs covered by a foil label with the product name in tiny print, which makes them difficult to tell apart. Both ampuls also have similar colored "rings" around their necks, and that makes them look even more alike.

The manufacturer of Brethine, aaiPharma, now packages the drug in vials, instead of ampuls, to reduce the chance of mix-ups. But ISMP says that even though Brethine ampuls were last shipped in January 2004, the ampuls may still be available in the supply chain. So ISMP recommends that hospitals and birthing centers that still have Brethine ampuls immediately replace them with vials.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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