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U.S. Department of Health and Human Services

Show #53, July 2006

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Show #53, July 2006

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 Recalls and Safety Alerts

July2006FDA Patient Safety News Homepage
Promethazine Contraindicated in Children Younger than Two (Video, print, and e-mail functions)
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In 2005, Wyeth Pharmaceuticals notified health care professionals that Phenergan brand promethazine hydrochloride was contraindicated in children under the age of two because the drug could cause fatal respiratory depression. Now, the labeling on all products containing promethazine HCl, both brand name and generic, has been changed to reflect these strengthened warnings. Promethazine has a number of uses, including as an antihistamine, a perioperative sedative and antiemetic, and to help control postoperative pain. It is available in several formulations, including syrups, suppositories, tablets or injectables.

Practitioners should also be cautious when using promethazine in older children because respiratory depression can also occur in this age group, even when the dose has been calculated according to the child's weight. This risk may increase when promethazine is used along with other drugs that can cause respiratory depression.

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July2006FDA Patient Safety News Homepage
Safety Recommendations for Baxter Colleague Infusion Pumps (Video, print, and e-mail functions)
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UPDATE: 11 July 2006
FDA notified healthcare professionals that Baxter Healthcare will stop manufacturing and distributing all models of Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until the company corrects manufacturing deficiencies and is in compliance with FDA's current good manufacturing practice requirements and the Quality System regulation for devices. FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. See FDA Press Release "Baxter Healthcare Corp. Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies."

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Over the past year, Baxter Healthcare Corporation has issued four urgent safety notices and recalls for the company’s Colleague infusion pump, specifying steps to be taken to address problems with the pumps. FDA is now recommending that users of Colleague pumps take certain additional safety steps:

• Try not to use the Colleague pumps in situations where delaying or interrupting therapy to reprogram or replace the pump may be life threatening e.g., with critically ill patients being maintained on inotropic infusions, or patients in mobile transfer units.

• Have a contingency plan in case the pump fails e.g., have a backup pump available.

• Monitor patients and check the pumps frequently.

• If a facility relies primarily or entirely on Colleague pumps, that facility may wish to consider evaluating other options for infusion therapy.

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July2006FDA Patient Safety News Homepage
Possible Contamination of Fluoride Rinses (Video, print, and e-mail functions)
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The dental supply company Pascal is recalling the company's anticavity fluoride rinses because they could be contaminated with bacteria that may cause pneumonia, including Burkholderia cepacia and Pseudomonas aeruginosa.

The recall affects all lots and all flavors of NeutraGard 0.05% Neutral Sodium Fluoride Anticavity Treatment Rinse, and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse. Both products are packaged in clear 16 oz plastic bottles.

Dental offices and consumers who have these rinses should stop using them and either destroy the product or return it to the place of purchase. For more information about this recall contact Pascal Company at
1-800-426-8051.

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July2006FDA Patient Safety News Homepage
Renal Failure Associated with Bowel Cleansing Agents (Video, print, and e-mail functions)
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FDA is notifying healthcare professionals about an association between oral sodium phosphates (OSPs) for bowel cleansing and a type of acute renal failure called acute phosphate nephropathy. These occurrences, which are rare but serious, have been associated with both OSP liquids such as Fleet Phospho-soda, and OSP tablets such as Visicol.

Patients at increased risk of acute phosphate nephropathy include the elderly, those with kidney disease, dehydration or decreased intravascular volume, and those using drugs that affect renal perfusion or function. These include diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs), and possibly NSAIDs.

FDA is suggesting several precautions when choosing a bowel cleanser for patients. Here are a few of them:

• Avoid using OSPs in patients with kidney disease, impaired renal function or perfusion, dehydration, or uncorrected electrolyte abnormalities including hyperphosphatemia.

• Use OSPs with caution in patients taking diuretics, ACE inhibitors, ARBs, or NSAIDs.

• Instruct patients to take the correct OSP dose and drink sufficient quantities of fluids during bowel cleansing.

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July2006FDA Patient Safety News Homepage
Oxygen Regulator Fires from Incorrect Use of Seals (Video, print, and e-mail functions)
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FDA and NIOSH are alerting healthcare professionals that incorrect use of certain seals in oxygen regulators can result in fires and are recommending an important precaution to avoid such fires.

FDA has received 12 reports in which regulators used with oxygen cylinders have burned or exploded, in some cases injuring personnel. FDA and NIOSH believe that improper use of gaskets or washers in these regulators was a major factor in causing the fires, although there may have been other contributing factors as well.

Two types of washers, referred to as CGA 870 seals, are commonly used to create the seal where the cylinder valve and the regulator are connected. The type that is recommended by many regulator manufacturers is a metal-bound rubber sealing washer that is designed to be re-used many times. The other common type, often supplied free-of-charge with refilled oxygen cylinders, is a plastic crush gasket that's intended to be used just once.

The re-use of these plastic gaskets appears to be the cause of the problem. These gaskets require higher torque than the metal-bound rubber washers in order to seal the cylinder valve to the regulator, and they require more and more torque each time they're re-used. It is important to understand that the connection between the cylinder valve and the regulator is designed to be hand-tightened. If the plastic gaskets are re-used, the need for more and more torque can require using a wrench or other tool, and this can deform the plastic gasket and damage the cylinder valve and regulator. The deformed plastic gasket can cause oxygen to leak. According to research supported by FDA and NIOSH, the leaking oxygen may produce enough thermal energy to ignite the plastic in the gasket.

Because of this, FDA and NIOSH are recommending that plastic crush gaskets never be reused.

There are also other, general safety precautions that you should follow to avoid explosions, tank ruptures and fires from oxygen regulators. Here are some of them:

• Before attaching the regulator to the valve, inspect the regulator and the seal to insure that they're in good condition, and be sure that the regulator has just one of the CGA-870 seals.

• Tighten the T-handle firmly by hand, but don't use wrenches or other tools that may over-torque the handle.

• Open the cylinder valve slowly while maintaining a grip on the valve wrench so that it can be closed quickly if gas escapes between the regulator and the valve.

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July2006FDA Patient Safety News Homepage
Generic Acetaminophen Recalled for Labeling Error (Video, print, and e-mail functions)
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The distributor IVAX Pharmaceuticals is recalling certain lots of 500 mg acetaminophen tablets and capsules because there's an error on the product label.

The label incorrectly says, "Do not exceed 12 tablets or capsules in a 24 hour period," when it should have said, "Do not exceed 8 tablets or capsules in 24 hours." Although no serious illnesses or injuries have been reported at this time, a patient who takes more than eight 500 mg tablets or capsules in a 24 hour period may increase the risk of liver toxicity.

The recall affects Goldline brand Extra Strength Genapap 500mg Caplets and Tablets, and Extra Strength Genebs 500mg Caplets and Tablets. A list of the recalled lot numbers can be found by calling IVAX Pharmaceuticals at 1-866-262-1243.

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July2006FDA Patient Safety News Homepage
Paxil and Increased Risk of Suicidality in Young Adults (Video, print, and e-mail functions)
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GlaxoSmithKline is notifying healthcare professionals about new warnings on the risk of suicidality with Paxil (paroxetine) and Paxil CR. These labeling changes relate to adult patients, especially young adults, ages 18 to 24.

The company recently conducted a meta-analysis of clinical trials in adult patients taking paroxetine that looked at suicidal behavior and ideation. These patients had a variety of psychiatric disorders, including Major Depressive Disorder (MDD), other depression, and non-depressive disorders such as obsessive-compulsive disorder.

This analysis showed a higher overall frequency -- two in a hundred versus one in a hundred -- of suicidal behavior in young adults aged 18 to 24 treated with Paxil compared with placebo. This was not observed in older adults.

For adults with MDD, the frequency of suicidal behavior was higher for patients of all ages treated with paroxetine compared with placebo -- about 30 in 10,000 versus 5 in 10,000. However, the majority of suicide attempts in these patients were in those aged 18 to 30. This suggests that the higher frequency of suicidality seen in younger patients across psychiatric disorders may extend beyond the age of 24.

As a result of these findings, the company says that it is important that all patients, especially young adults, be carefully monitored during paroxetine therapy regardless of the condition being treated.

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 Preventing Medical Errors

July2006FDA Patient Safety News Homepage
FDA/ISMP Campaign to Eliminate Dangerous Abbreviations (Video, print, and e-mail functions)
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FDA and the Institute for Safe Medication Practices (ISMP) have launched a nationwide educational campaign to eliminate the use of potentially harmful abbreviations in all forms of medical communications. That includes written medication orders, computer-generated labels, pharmacy entry screens, and commercial medication labeling, packaging, and advertising.

It is important not to use error-prone abbreviations, even in printed materials for several reasons. First, they can still be misinterpreted. Second, they could be copied into handwritten orders, where they are liable to be confused. And finally, using these abbreviations in print perpetuates the idea that they are acceptable.

As part of the campaign message, FDA and ISMP are recommending that whenever medical information is communicated, individual practitioners and institutions refer to the “do not use” list of abbreviations, symbols, and dose designations -- those are the ones most often associated with medication errors. Here are some of the items on that list.

First, the abbreviations "U" and "IU". The "U" can easily be mistaken as the number "0", particularly when the "U" is written too closely after the number. This can lead to tenfold overdoses. And "IU" can be mistaken for "IV" or the number "10". So instead of using "U" and "IU", use the terms "unit" and "international unit".

Next, there's "q.d.", meaning every day, and "q.o.d.", meaning every other day. "q.d." can be mistaken as "q.i.d.", meaning four times a day, especially if the period after the "q" or the tail of the "q" is misunderstood as an "i". Conversely, "q.o.d." can be mistaken for "q.d." or "q.i.d." if the "o" is poorly written. The solution is to write out "daily" or "every other day".

Then there's the possible confusion with dose designations that include decimal points. A trailing zero after a decimal point can make "1.0 mg" look like "10 mg" if the decimal point isn't seen. Similarly, ".5 mg" can look like "5 mg". So don't use trailing zeros for doses expressed in whole numbers, and be sure to use a leading zero when the dose is less than a whole unit.

Finally, some drug names should never be abbreviated. For example, confusion between the abbreviations for magnesium sulfate (MgSO4) and morphine sulfate (MSO4 or MS) has led to serious errors. Here, write out "magnesium sulfate" or "morphine sulfate". The ISMP list has many more examples of potentially dangerous abbreviations.

FDA and ISMP also have several recommendations on how healthcare practitioners can help eliminate use of error-prone abbreviations. For example, provide staff with a “do not use” list in an easy-to-reference format; post reminders in patient care areas, your intranet, and internal newsletters; and work with software vendors to make changes in computer programs for order entry, labeling and medication printouts.

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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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