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U.S. Department of Health and Human Services

Show #44, October 2005

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Show #44, October 2005

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 New Medical Products

October2005FDA Patient Safety News Homepage
New Therapy for HIV Patients with Advanced Disease (Video, print, and e-mail functions)
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FDA recently approved a new drug for patients with advanced HIV disease. The drug, called Aptivus (tipranavir) is an HIV protease inhibitor. It's intended to be given in combination with ritonavir and other antiretroviral drugs to patients who have limited treatment options. Aptivus is made by Boehringer Ingelheim Pharmaceuticals.

In clinical trials, Aptivus, when used in combination with ritonavir and other antiretroviral agents, was shown to be effective in patients who had HIV strains highly resistant to other drugs.

The product labeling will carry a boxed warning that Aptivus can cause serious liver problems, especially in patients with liver disease. Because of the potential for serious drug interactions, certain drugs are contraindicated in patients taking Aptivus plus ritonavir. They include certain antiarrhythmics, antihistamines, ergot derivatives and herbal products.

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 Recalls and Safety Alerts

October2005FDA Patient Safety News Homepage
Avoiding Fatal Overdoses with Fentanyl Patches (Video, print, and e-mail functions)
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FDA has issued a public health advisory about deaths and serious injuries that have occurred when pain-relieving transdermal patches containing fentanyl, such as Duragesic, were misused. This has caused fatal overdoses of the drug.

The Institute for Safe Medication Practices describes an incident where a patient's caregiver placed the fentanyl patch on the patient's buttock, which was the site of her pain. When the patient went to bed, she also used a heating pad at the same place. The patient was discovered dead two days later. According to ISMP, neither the prescribing physician nor the pharmacist had counseled her on how to use the patch properly, and they hadn't told her to avoid applying heat over the patch.

There have also been cases where children have gotten hold of the patches, with tragic results. In one case, a mother found her 4-year old son dead next to an overturned trash can that held torn wrappers and used patches. The boy had applied a patch to his body, either a discarded one from the trash, or one he opened from a box of new patches. ISMP also describes a case where a child was accidentally exposed to a patch that fell off a family member, and another one where a child removed his grandmother's patch and applied it to himself.

It's important to instruct patients how to safely store and dispose of the patches. Used patches, or those that are no longer needed, should be folded in half so that the sticky side of the patch sticks to itself, then flushed down the toilet. And of course, warn patients to keep the patches out of the reach of children.

Absorption of the drug can also be increased by exposing the patch to heat sources such as heating pads, electric blankets or long, hot baths. A high fever can also increase absorption. In addition, using other CNS depressants, including alcohol, can have an additive effect on a patient using fentanyl.

The advisory says to counsel patients and their caregivers to recognize the signs of fentanyl overdose. These include trouble breathing, extreme sleepiness, or the inability to think, talk or walk normally. If these signs occur, patients or their caregivers should get medical help right away.

It’s important to recognize that the indications for these patches are somewhat limited. The advisory reminds practitioners that these patches should only be used by patients who have chronic pain that's not well controlled with shorter-acting painkillers, and who are tolerant to opiates. Fentanyl patches should NOT be used to treat short-term, intermittent, or post-operative pain. And they should always be prescribed at the lowest dose needed for pain relief.

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October2005FDA Patient Safety News Homepage
Caution on Power Injection of MRI and CT Contrast Media (Video, print, and e-mail functions)
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FDA is reminding radiology personnel about the potential for serious patient injury when vascular access devices that are not designed to withstand high pressures are used for power injection of CT or MRI contrast media.

FDA has received approximately 250 reports over the past few years where vascular access devices have ruptured under high pressure, sometimes causing fragmentation that required surgical intervention. The ruptured devices included central venous catheters, implanted ports, extension tubing and I.V. administration sets. Ruptures occur when the injection pressure is too great for the vascular access device to withstand.

To help prevent these ruptures, FDA recommends that radiology personnel check the labeling of each vascular access device for its maximum pressure and flow rate. If this information isn't available, you should assume that the device is not intended for power injection and don't use it for this purpose.

If you do know the maximum pressure that the vascular access device can withstand, be sure to adjust your power injector so that it doesn't exceed this limit. It's important to understand that if the recommended pressure for a vascular access device is exceeded, the device could be weakened even though no rupture is evident, and the weakened device could fail to operate properly when it is used again.

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October2005FDA Patient Safety News Homepage
New Safety Information for Mifepristone (Video, print, and e-mail functions)
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FDA recently announced further labeling changes for Mifeprex (mifepristone) also known as RU-486, an orally administered drug used for the termination of early pregnancy. Earlier labeling changes had warned health care practitioners and patients to be on the alert for rare but serious risks, including infection, bleeding and ectopic pregnancy.

The latest labeling changes describe four deaths from sepsis that occurred in women who had used mifepristone with vaginally administered misoprostol. In two of the cases, the bacterium was identified as Clostridium sordelli.

Also, the Medication Guide for patients now alerts them to seek medical attention if they develop certain symptoms more than 24 hours after taking misoprostol. They include general malaise, abdominal pain and discomfort, weakness, diarrhea, nausea and vomiting, with or without fever.

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October2005FDA Patient Safety News Homepage
Complications with Metallic Tracheal Stents (Video, print, and e-mail functions)
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FDA has issued a Public Health Notification cautioning healthcare professionals about the use of metallic tracheal stents in patients with benign airway disorders. Using metallic stents in these patients may preclude their receiving alternative therapies in the future.

According to the Notification, complications from the metallic stents have included obstructive granulation tissue, stenosis, stent migration, and infection. And removing the stent can result in mucosal tears, severe bleeding, re-obstruction and respiratory failure.

The Notification recommends that metallic tracheal stents not be used in patients with benign airway disorders until all other treatment options, such as surgical procedures or silicone stents, have been explored. Also, using metallic stents as a bridge to other therapies is not recommended, because removing the stent can cause serious complications.

If a metallic tracheal stent is the only option for a patient, the Notification says that it should be inserted by a physician trained or experienced in metallic tracheal stent procedures. Likewise, if it's necessary to remove the stent, this should be done by a trained or experienced physician.

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October2005FDA Patient Safety News Homepage
New Warning for Raptiva (Video, print, and e-mail functions)
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Genentech has notified healthcare professionals about serious blood-related disorders and infections that have been associated with the drug Raptiva (efalizumab) used to treat certain patients with plaque psoriasis.

The labeling for Raptiva now warns about immune-mediated hemolytic anemia, which can become apparent several months after starting treatment, and cautions prescribers to discontinue the drug if this occurs. The new labeling also includes expanded warnings about serious infections and thrombocytopenia associated with Raptiva.

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October2005FDA Patient Safety News Homepage
Certain Oral Drops for Infants Recalled (Video, print, and e-mail functions)
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Perrigo Company has recalled certain oral drops for infants because they're packaged with a dosing syringe that could lead to improper dosing for infants under two years old, including overdosing. Perrigo makes OTC products sold under many different store brand names, including Target, CVS, and Walgreens. The recalled drops are for pain, coughs and colds.

The oral dosing syringe has only one marking, at "1.6 mL". That's the right dose for children 2-3 years old who weigh 24-35 pounds. However, these drops are also intended for children younger than two years old who weigh less than 24 pounds. For these younger children, the labeling directs consumers to ask a doctor for dosing directions. But even if the consumer knew the correct dose for these younger children, the syringe isn't marked to deliver it.

The affected products are:

• Cherry and Grape Flavor Infant Pain Reliever 160 mg Acetaminophen,
• Cherry Flavor Cough and Cold Infant Drops, and
• Cherry Flavor Decongestant and Cough Infant Drops.

These products were sold nationally through several dozen retail chains and grocery stores under the store brand names.

Parents who want to use these products for children under two years old should discuss how to determine and measure the proper dose with their doctor.

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October2005FDA Patient Safety News Homepage
Preventing Injuries from Laparoscopic Trocars (Video, print, and e-mail functions)
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Each year, more than 2 million patients in this country undergo laparoscopic procedures, ranging from cholecystectomies to sterilization. During these procedures, trocars, or access ports, are inserted into the abdominal cavity to allow entry of the laparoscopic instruments.

Although the vast majority of these surgeries are performed safely, it's possible to cause a life-threatening injury when inserting a trocar. In fact, between 1997 and mid-2002, FDA received more than 1300 injury reports, including approximately 30 deaths. Complications most likely to result in death included vascular injury and infection secondary to bowel injury.

FDA recently issued a report on patient injuries from trocars used in during laparoscopic surgery. It's based on FDA adverse event reports, published literature, product recalls, trocar labeling, and patient educational brochures, and it outlines recommendations to prevent patient injuries

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 Preventing Medical Errors

October2005FDA Patient Safety News Homepage
Mix-ups Involving Lindane (Video, print, and e-mail functions)
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In 2003, FDA issued an advisory on the potential neurologic toxicity of lindane, a topical second-line treatment for scabies and lice. The advisory noted the importance of limiting the use of lindane to just one application and specified that lindane must be dispensed only in single-use containers of one or two ounces. This was intended to reduce the possibility that patients would apply an excess amount of the product, or that they'd re-apply it.

A recent article in MMWR cautions about a different problem related to lindane. The article reported on 870 cases of illness from 1998 to 2003 that were caused by the unintentional ingestion of lindane. In a number of these cases, lindane was mistaken for a liquid oral medication, such as cough syrup.

The article notes that before the changes in 2003, bottles of bulk lindane were sometimes repackaged by pharmacies into smaller bottles that looked like those used for oral medications such as cough syrup, and that could have contributed to many unintentional ingestions. And because bottles of bulk lindane already in use weren't recalled from pharmacies after the 2003 advisory, some repackaging might still be occurring, even today. Also, some consumers might still have repackaged lindane in their homes. So, although the use of lindane appears to be declining, cases of accidental ingestion are continuing to occur.

The article points out several important reminders about the appropriate use and packaging of the product. First, lindane is a second-line therapy for scabies and lice, and should be used only if other treatments have failed or are intolerable. It shouldn't be used in children and small adults who weigh less than 110 pounds. Because of the risk of toxicity, lindane treatment should not be repeated.

Pharmacists should not transfer lindane to other containers. And they should dispense lindane only in the 1- or 2-ounce single use containers provided by the manufacturer.

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