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U.S. Department of Health and Human Services

Show #22, December 2003

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Show #22, December 2003

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 New Medical Products

December2003FDA Patient Safety News Homepage
New Class of Antibiotics for Skin Infections (Video, print, and e-mail functions)
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FDA has approved the first drug in a new class of antibiotics called cyclic lipopeptide antibacterial agents, intended to treat serious skin infections. The new drug's name is Cubicin, or daptomycin for injection.

Cubicin is indicated for treating complicated infections of the skin and skin structure caused by susceptible strains of certain staph, strep and enterococcal bacteria. Things like major abscesses, post-surgical wound infections and infected ulcers.

Clinical studies have shown that Cubicin's effectiveness in treating these infections is equivalent to standard treatments such as vancomycin, oxacillin or nafcillin.

Most of the adverse events in these studies were mild to moderate. They included GI disorders, injection site reactions, fever, headache, insomnia, dizziness and rash.

There were also rare reports of muscle injury. In most cases, patients showed no symptoms. The only sign of possible muscle damage was an elevated blood level of CPK. And so the labeling recommends that patients receiving Cubicin be monitored for muscle pain or weakness, and that CPK levels be checked weekly.

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December2003FDA Patient Safety News Homepage
Memantine Approved for Alzheimer's Disease (Video, print, and e-mail functions)
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FDA recently approved the first drug for treating moderate to severe Alzheimer's disease. Previous Alzheimer's drugs have been indicated for patients with mild to moderate disease. The new drug is memantine, and it will be marketed under the trade name Namenda by Forest Labs.

The way memantine works is different from other drugs currently available for treating this disease. It's thought to work by blocking the action of the chemical glutamate in the brain.

Two double-blind studies of memantine, each about six months in duration, were conducted in the U.S, on a total of about 650 patients. In one study, all patients were concurrently taking donepezil. Both studies showed that patients on memantine experienced less mental deterioration than patients treated with placebo. A third study, conducted in nursing homes in Latvia, was a 12-week double blind study in 166 patients with severe Alzheimer's, and it also showed a statistically significant advantage of memantine over placebo. All of the studies had a low incidence of minor side effects.

It's important to note that although memantine helps treat the symptoms of Alzheimer's disease in some patients, there's no evidence that the drug modifies the underlying pathology. Go to our web site for more information.

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 Recalls and Safety Alerts

December2003FDA Patient Safety News Homepage
Roche Diagnostics Recalls CoaguChek PT Test Strips (Video, print, and e-mail functions)
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Roche Diagnostics has issued a recall of CoaguChek PT test strips. These strips are used in clinical settings and by patients at home to monitor anticoagulation therapy.

The problem is a packaging defect that could cause false readings. A small percentage of the foil pouches that hold the strips were not cut properly. When this happens, the "easy open" notch on the side of the pouch cuts through the seal of the pouch, exposing the strips to moisture and air. When that exposure occurs, even for just a few minutes, falsely high or low readings can occur.

Roche Diagnostics says that all lots of both professional use and patient self-testing strips that have a lot number lower than 669 may have this problem. But the company says that test strips in these lots can still be used if these steps are followed:

First, inspect each foil pouch to make sure the "easy open" notch is in the correct position and the pouch is sealed properly. If the notch cuts into the part of the pouch with the test strip in it, don't use any test strips from that box.

Second, even if the pouch looks like it's sealed properly, the company says you should run two tests and compare results, in case there's a defect that couldn't be seen.

For more information, call Roche Diagnostics at 1-800-428-4674 or go to our web site.

Additional Information:

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December2003FDA Patient Safety News Homepage
Caution on Blue Dye with Enteral Feeding (Video, print, and e-mail functions)
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FDA has issued a Public Health Advisory that warns about serious adverse events when a blue dye, FD&C Blue No. 1, is used in enteral feeding solutions as a way to visually detect pulmonary aspiration. Blue No. 1 is allowed by FDA for certain uses in foods, drugs and cosmetics, but FDA hasn't evaluated its safety when it's used in enteral feedings.

FDA has received twenty reports of toxicity associated with the use of Blue No. 1 in enteral feedings. Affected patients showed systemic absorption of the dye, manifested by a blue discoloration of the skin or body fluids.

Some cases were also associated with serious complications such as refractory hypotension and metabolic acidosis. Twelve of the patients died.

The concentration and total amount of dye used in these cases was not unusually high, but these patients did have a distinguishing characteristic: a large proportion of them were likely to have increased gut permeability, including those with sepsis, burns, trauma or inflammatory bowel disease. And so the advisory cautions that patients with these conditions may be at increased risk of absorbing Blue No. 1 from tinted enteral feedings.

Blue No. 1 hasn't definitely been established as the direct cause of these adverse events, but the advisory points out that the safety and utility of using Blue No. 1 in enteral feeding have not been evaluated by FDA.

FDA is not making any recommendations for alternatives to Blue No. 1 for use with enteral feeding. The advisory points out that other blue dyes haven't been evaluated in this setting, and they could be equally or more toxic. So replacing Blue No. 1 with another blue dye wouldn't solve the problem.

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December2003FDA Patient Safety News Homepage
ORLAAM to be Discontinued (Video, print, and e-mail functions)
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Roxane Laboratories is stopping the sale and distribution of the drug ORLAAM. ORLAAM is a synthetic opioid agonist solution used as a second-line therapy to manage opiate dependence.

The company has received increasing reports of severe cardiac-related adverse events since the drug was first introduced in 1995. In 2001, these adverse events led to extensive labeling changes in the U.S., and removal from the market in Europe. Since these changes, the use of ORLAAM has decreased dramatically. In a recent letter to healthcare professionals, Roxane Laboratories now says that the risks of using the drug no longer outweigh its benefits, given that less toxic treatments are available.

The company estimates that the current inventory of ORLAAM will be gone by February 2004, so no new patients should be started on ORLAAM therapy. The company says that current ORLAAM patients should be transferred to alternative treatments such as methadone and the recently approved buprenorphine as soon as possible before ORLAAM becomes unavailable. For more information, go to our web site.

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 Preventing Medical Errors

December2003FDA Patient Safety News Homepage
Store IV Bags in Their Overwraps (Video, print, and e-mail functions)
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Here's a reminder about the importance of keeping premixed IV bags covered in their plastic overwraps. The Institute for Safe Medication Practices describes how the protective overwrap serves an important purpose - to control the amount of water vapor that escapes from an IV solution. When you see water droplets forming inside a protective overwrap, that's the water vapor moving from the 100 percent humidity within the bag to the lower humidity in the overwrap. Once IV bags are removed from their overwraps and exposed to room air, the rate of evaporation increases. And over time, the drug's concentration will increase because the amount of drug in the bag stays the same while amount of fluid decreases.

You can actually lose a large proportion of the liquid in an IV bag this way. ISMP cites a case where half the liquid in the bag was lost. In this case, a patient was supposed to receive 40 mEq of potassium chloride in 100 mL over an hour, but the bag was empty in half an hour. That's because the overwrap had been removed from the bag and over time, half of the water had evaporated, leaving 40 mEq of potassium in just 50 mL of solution.

Manufacturers do have recommendations on how long an IV bag can be used after the overwrap is removed, but they vary a great deal. Some companies say that certain bags should be discarded after several days if they don't have an overwrap. Others say discard them after a few months. The time span depends on the material used for the IV bag, the volume of solution, and drug in the solution.

To simplify things and resolve the uncertainty, ISMP recommends that all IV bags be stored in their overwraps until they're used. But of course that’s not always possible. Sometimes bags are removed from their overwraps but not used right away. ISMP encourages nurses to talk to their pharmacist about the best way to handle bags that have been removed from their overwraps.

One solution may be to send them to the pharmacy, so they can be sent to a unit where a patient is currently receiving the solution and they can be used right away. ISMP also cautions against writing an expiration date directly on the bag, because volatile chemicals from the ink may leach into the solution.

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 Recalls and Safety Alerts

December2003FDA Patient Safety News Homepage
Fire Precautions with Alcohol-Based Hand Rubs (Video, print, and e-mail functions)
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CDC has issued an update on alcohol based hand rubs and fire safety. These hand rubs are an important tool in improving hand hygiene practices and reducing nosocomial infections, and they're becoming more and more widely used in hospitals.

But alcohol is flammable, and so there's some concern that if stored or used improperly, these hand rubs could ignite. To keep that from happening, CDC recommends three things.

First, when using these products, be sure to rub your hands until the alcohol has evaporated and your hands are dry.

Second, keep your dispenser of alcohol-based hand rub away from high temperatures or flames.

And third, store your excess supplies of this product in cabinets or areas approved for flammable materials.

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 Preventing Medical Errors

December2003FDA Patient Safety News Homepage
More on the Danger of Giving Sterile Water Intravenously (Video, print, and e-mail functions)
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In an earlier show, we summarized an article from the Institute for Safe Medication Practices that warned about potentially fatal hemolysis if sterile water for injection were given intravenously. ISMP cited a case in which a physician gave a patient an IV infusion of sterile water for injection because he mistakenly believed it would correct the patient's hypernatremia.

Sterile water for injection is supposed to be used just in the pharmacy, to prepare various IV infusions. In this case, the physician apparently prevailed upon the hospital pharmacy to supply a bag of this product. But the new article by ISMP points out that there are other ways that plastic bags of sterile water for injection can find their way into patient care areas.

Sometimes they turn up in dispensing cabinets. In one case, a supplier mistakenly stocked the cabinets with sterile distilled water instead of 5 percent dextrose solution. In another case, the hospital's purchasing department placed liter bags of sterile water in the cabinets because pour bottles of the water weren't available at the time. ISMP recommends ensuring that sterile water can't be stocked or ordered in patient care areas without special permission and precautions.

Sometimes bags of sterile water are included in emergency boxes to treat malignant hyperthermia, where they're used to dilute IV Dantrium. They may later end up being mistakenly hung as an IV solution during emergency treatment. ISMP suggests using 50 mL vials of sterile water for this purpose instead of the one liter bags.

Also, some humidification devices require bags of sterile water, and so those bags end up in the patient's room, too. Although they're usually labeled “Sterile Water for Inhalation,” these bags can still look like IV solutions.

ISMP suggests several ways to avoid mixups.

You can use humidification devices that don't require using bags of sterile water. If you have to use bags of inhalation water, warn staff members not to leave unopened bags in the patient's room, and not to hang them from IV poles. You can also consider using 2 liter bags for the inhalation water, which helps distinguish them from the 1 liter IV bags.

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