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U.S. Department of Health and Human Services

Show #34, December 2004

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Show #34, December 2004

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 Recalls and Safety Alerts

December2004FDA Patient Safety News Homepage
"Black Box" Warning for Antidepressants (Video, print, and e-mail functions)
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Several previous programs have addressed the increased risk of suicidal thoughts and behavior in children and adolescents being treated with antidepressant medications. FDA recently took several steps to strengthen safeguards for young patients being treated with these drugs.

The manufacturers of certain antidepressants had already changed the product labeling to warn about a possible increased risk of suicidality with these drugs. But now a "black box" warning is being required for all antidepressant drugs. A "black box" warning is the most serious type of warning in prescription drug labeling.

The black box describes the increased risk of suicidality in pediatric patients and emphasizes the need for closely monitoring patients started on these medications. It also describes what uses the drugs have been approved or not approved for in pediatric patients. It doesn't prohibit the use of the drugs in children and adolescents. But it warns of the risk of suicidality, and it encourages prescribers to balance this risk with clinical need.

The previous warnings applied to the SSRIs and several "atypical" antidepressants, based on analyses of placebo-controlled trials of these particular drugs. The new labeling changes apply to the entire category of antidepressant medications --- that's well over 30 drugs. That's because the currently available data are not adequate to exclude any antidepressant drug from the increased risk of suicidality.

A new Patient Medication Guide will also play a role. A "MedGuide" is FDA-approved user-friendly information for patients and it's supposed to be distributed by pharmacists with each prescription or refill of a medication. In the case of antidepressants, it will advise patients and their families about the risk of suicidality and about precautions that can be taken. FDA is working with the manufacturers of antidepressant drugs to make the MedGuides available as soon as possible.

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December2004FDA Patient Safety News Homepage
Caution on Osteonecrosis with Bisphosphonates (Video, print, and e-mail functions)
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Novartis has notified healthcare professionals about new precautions for the company's two bisphosphonate drugs, Zometa (zoledronic acid) and Aredia (pamidronate disodium). These drugs are used to treat hypercalcemia of malignancy and other disease states.

The labeling now cautions about reports of osteonecrosis of the jaw occurring in cancer patients who received bisphosphonates as a component of their therapy. Many of these patients were also receiving chemotherapy, some with corticosteroids, and these are also risk factors for osteonecrosis. The majority of the osteonecrosis cases were associated with dental procedures such as tooth extractions, and many of these patients had signs of local infection, including osteomyelitis.

So the labeling now advises prescribers to consider having patients with these and other risk factors undergo dental evaluation and necessary preventive dental care before starting on Zometa or Aredia treatment.

While on these drugs, high risk patients should avoid invasive dental procedures if possible. If patients do develop osteonecrosis of the jaw while on bisphosphonate therapy, they should avoid dental surgery.

And finally, if patients on bisphosphonates do require dental procedures, there are no data available on whether stopping the drugs reduces the risk of osteonecrosis of the jaw. The clinical judgment of the physician should guide each patient's management, based on an assessment of benefits and risks.

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December2004FDA Patient Safety News Homepage
Recall of Pulmonetic LTV Series Ventilators (Video, print, and e-mail functions)
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Pulmonetic Systems, Inc. has recalled its LTV Series ventilators. The model numbers for the recalled ventilators are 1000, 950, 900 and 800. Over 10,000 of these devices are in use throughout the world, both in hospitals and home care settings.

These ventilators are being recalled because they may fail to operate when the ventilator switches from an external power source to power from an internal battery. This switch is supposed to happen automatically under certain circumstances, for example, when the external power source is removed, fails, is unstable or is inadequate to operate the ventilator. If the switch to battery operation doesn't occur as it should, the ventilator can fail to breathe for the patient.

Pulmonetic Systems is in the process of providing a permanent solution that will correct the problem in all of the existing ventilators. In the meantime, the company sent a Safety Alert and an Information Sheet to customers and users, which explains the problem and provides instructions on how to correct the malfunction if it occurs and continue ventilation.

The company says that if the user follows these instructions, the unit will usually continue to provide ventilation, but they caution that caregivers should still be prepared to provide the patient with an alternate means of ventilation if necessary.

If you have one of these Pulmonetics LTV Series ventilators and the company hasn't yet provided the permanent fix for your unit, you should follow the operating instructions in the Safety Alert and Caregiver Information Sheet that the company sent. If you don't have these documents, you can get them on our web site, or you can call Pulmonetics directly at 1-800-754-1914 extension 2. Likewise, if you have patients who may be using one of these ventilators at home, it would be a good idea to check to be sure that they've been notified by the distributor.

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December2004FDA Patient Safety News Homepage
Preventing Fires in Electrically Operated Beds (Video, print, and e-mail functions)
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FDA has received over 90 reports of fires involving electrically operated hospital beds since 1993. Most of these fires were associated with factors such as overheated bed motors, arcing from ill-fitting plugs, damaged plugs, missing ground pins, fluid leaks that damaged circuit boards, missing components in the wiring, poor maintenance, or failure to follow manufacturers' warnings.

Fortunately, such fires are rare, and a recent FDA article in Nursing 2004 talks about ways to help keep them rare. Most of these tips might sound like common sense, but they're especially important for older beds. Here are just a few of them:

-- Periodically inspect the bed's power cord for damage.

-- Don't use an extension cord or a multiple-outlet strip. Instead, connect the bed's power cord directly into a wall-mounted outlet that's in good working order.

-- Inspect the floor under the bed for buildup of dust and lint, which could clog the motor. Ask housekeeping to clean the area if necessary.

-- Inspect the covering of the patient's bed control panel. Look for signs of damage where liquids could leak in.

-- Test the bed and its controls, including patient lockout features, to ensure that the bed can move freely in both directions without pulling or rubbing on cords.

-- And finally, tell staff about any unusual sounds, burning odors, or unusual movement of a bed.

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December2004FDA Patient Safety News Homepage
New Warnings on Rituxan (Video, print, and e-mail functions)
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Biogen Idec and Genentech have notifed health professionals about new warning information in the labeling for the drug Rituxan (rituximab), which is used to treat certain patients with non-Hodgkins lymphoma. The new labeling warns of hepatitis B reactivation in some patients, which has led to fulminant hepatitis, hepatic failure and death.

The warning says that patients at high risk of HBV infection should be screened for the presence of HBV before initiating treatment with Rituxan. Those found to be carriers of HBV should be closely monitored for signs of active HBV infection or hepatitis, both during the treatment and for several months afterwards.

If a patient develops viral hepatitis while being treated with Rituxan, the drug should be discontinued, along with any concomitant chemotherapy, and treatment should be started, including antiviral therapy. There's currently insufficient information about whether it's safe to resume Rituxan therapy in patients who developed hepatitis due to HBV reactivation while they were being treated with the drug.

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December2004FDA Patient Safety News Homepage
Monitoring Steam Sterilizers (Video, print, and e-mail functions)
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When you're using steam sterilizers for medical instruments, physical, chemical and biological monitors help assure that sterilization has taken place. In a recent article, FDA cites several reports of problems with these monitors.

In one case, the liquid growth media in the self-contained biological monitor had dried out. In another case, one chemical indicator failed to change color, even though another one in the same sterilizer cycle did change. And in a third case, a physical monitor showed that the required temperature wasn't reached, and yet the sterilizer didn't warn that this had happened.

The article suggests several ways to address these kinds of events. For example, for self-contained biological indicators, always check the level of the growth media before and after sterilization, and don't use indicators with low levels of media.

If a biological or chemical indicator gives unexpected results, this could be because the sterilizer was overloaded or improperly loaded, so that steam couldn't penetrate or circulate to reach the indicator. Or it could be that the sterilizer isn't delivering good quality steam.

The article also cautions that if you program your sterilizer to operate at other than the manufacturer's settings for time and temperature, you should develop a system to be sure that these are set properly by the staff. For example, you might require that a second person verify the settings before the sterilizer is returned to service.

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 Preventing Medical Errors

December2004FDA Patient Safety News Homepage
Mix-ups Administering Lotrisone Lotion (Video, print, and e-mail functions)
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Here's a caution for patients who are prescribed Lotrisone lotion, a combination of betamethasone and clotrimazole that's used to treat fungal infections of the skin such as athlete's foot, jock itch, and ringworm. FDA has received several reports of patients who used this product in their eyes or ears, rather than on their skin. Fortunately, none of these patients had permanent injuries, but all required medical attention.

One factor contributing to these mistakes might be how the product is packaged. Lotrisone lotion comes in containers that look like ophthalmic, otic, and nasal drug products and the plastic tip looks like a dropper. That may contribute to the confusion, and it also makes it easier to put the lotion in the eyes or ears as compared to a tip that's blunted or flat.

The label does say "FOR TOPICAL USE ONLY", but that statement may be difficult to spot because of its size and placement among other words on the label. FDA is working with the manufacturer to change the labeling and packaging. In the meantime, here are some suggestions to help reduce the chance of these mix-ups.

Counsel patients on proper use of the product and tell them about the potential for confusion.

Advise patients who also use otic or ophthalmic preparations to store Lotrisone lotion where it's unlikely to be confused with the other products.

And if possible, circle or highlight the "FOR TOPICAL USE ONLY" statement on the product package and container.

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 Advice for Patients

December2004FDA Patient Safety News Homepage
Advising Patients on OTC Defibrillators (Video, print, and e-mail functions)
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FDA recently cleared for marketing an automatic external defibrillator that can be sold over-the-counter to the general public. It's called the HeartStart Home Defibrillator, and it's made by Philips Medical Systems. This product was already available for use at home with a doctor's prescription, but now it can be purchased without a prescription. So some of your patients may be curious about these devices, when they should be used, and how they work.

Like other defibrillators, the device administers an external electric shock through the chest wall to the heart to help restore normal heart rhythm to patients in ventricular fibrillation. The device analyzes and interprets the patient's heart rhythm and advises the user on whether to deliver a shock.

Consumers should know that the Heart Start device is supposed to be used only on people believed to be in sudden cardiac arrest who don't respond when shaken and aren't breathing normally. It should only be used on adults, or on children who are at least eight years old or who weigh at least 55 pounds. Special small pads for younger children and infants are available by prescription.

In the training video that comes with the device, users dealing with a person in cardiac arrest are advised to first call 911. Then they should get the defibrillator. Pulling the device's cartridge handle starts voice instructions to guide the user through each step. The user is instructed to remove all clothing from the patient's chest. When the patient's chest is bare, the user removes the protective cover, takes out the white adhesive pads, and attaches them to the victim's chest exactly as shown in the pictures on the pads. Once the pads are in place, the defibrillator analyzes the victim's heart rhythm and decides if a shock is needed. If a shock is needed, the defibrillator says to push the flashing orange button. If a shock isn't needed the device says so, and instructs the user to begin CPR if necessary. The flashing blue i-button lets the user know that more information is available. Pushing that button gives step-by-step coaching on performing CPR.

Although the HeartStart Home Defibrillator is designed for use by virtually anyone, people who may be using this device are also advised to take CPR training in case that's needed instead of a shock.

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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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