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U.S. Department of Health and Human Services

Show #52, June 2006

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Show #52, June 2006

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 New Medical Products

June2006FDA Patient Safety News Homepage
IMPORTANT NEW INFORMATION -- on Natalizumab (marketed as Tysabri) (Video, print, and e-mail functions)
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IMPORTANT NEW INFORMATION (June 5, 2006)

FDA notified healthcare professionals of the resumed marketing, with a special restricted distribution program of Tysabri (natalizumab), a monoclonal antibody for the treatment of patients with relapsing forms of multiple sclerosis. Tysabri was initially approved by the FDA in November 2004, but was withdrawn by the manufacturer in February 2005 after three patients in the drug’s clinical trials developed progressive multifocal leukoencephalopathy (PML), a serious viral infection of the brain. Tysabri will be available only through the Risk Management Plan, called the TOUCH Prescribing Program. In order to receive Tysabri, patients must talk to their doctor and understand the risks and benefits of Tysabri and agree to all of the instructions in the TOUCH Prescribing Program.

----------------- Original Story from Show #36, February 2005 ----------------------------

FDA recently approved the first monoclonal antibody treatment for patients with relapsing forms of multiple sclerosis. The product, called Tysabri (natalizumab), is intended to reduce the frequency of clinical exacerbations of the disease. Tysabri is marketed by Biogen Idec and Elan Pharmaceuticals.

The product is given intravenously every four weeks in a physician's office.
Tysabri appears to work by targeting part of the underlying inflammatory process in MS by inhibiting adhesion molecules on the surface of leukocytes. It's believed that this interaction prevents immune cells from migrating into the brain, where they can cause damage.

The drug's approval was based on positive results after the first year of treatment in two randomized, double-blind clinical trials. In one of the trials, in which Tysabri was compared to a placebo, it reduced the frequency of relapses by 66 percent. The manufacturer will continue these trials for another year.

Serious but uncommon side effects included infections, severe or life threatening allergic reactions, depression, and gallbladder problems. Common adverse reactions were generally mild and included non-serious infections, headache, and fatigue.

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 Recalls and Safety Alerts

June2006FDA Patient Safety News Homepage
Dangerous Cracks in Diastat Acudial Rectal Applicators (Video, print, and e-mail functions)
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FDA is warning about a serious problem with Diastat AcuDial delivery systems, which are pre-filled syringes that contain diazepam. They're designed to deliver the drug rectally to certain epilepsy patients with acute repetitive seizures, a condition that can lead to status epilepticus if it's not controlled.

The problem is that the base of the applicator tips of the 10 and 20 mg syringes can crack, and this can allow the diazepam gel to leak out while it's being administered. If that happens, the patient could be under-dosed and thus not receive enough of the drug to control seizures. The frequency of cracks has varied, but as many as six percent of syringes in some lots have shown cracks.

The manufacturer, Valeant Pharmaceuticals, is working to fix the problem, but the new version of the product won't be available until this summer. Until then, the current Diastat AcuDial syringes will continue to be sold because there are no other available treatments that can be administered at home.

Because of this, patients and their caregivers must check their syringes carefully to see if the base of the applicator tip is cracked. When inspecting the syringe, it's critical to not remove the applicator cap fully.

Here's how to check the syringes. Hold the syringe in one hand with the large end of the oval pointing up and down. Put your index finger in contact with the cap to apply counterforce when the cap is opened. Grasp the cap firmly with your index finger of the other hand and apply pressure to the seal pin to hold it in place.

With the thumb of your second hand, force the cap apart from the syringe to create a small, quarter-inch opening so that the base of the syringe tip can be inspected. Adjust the angle to give the best view of the syringe tip. While maintaining pressure on the seal pin, reclose the cap. Rotate the syringe 180 degrees and open, inspect the tip, and then reclose the cap in the same way. Remember, the applicator cap should not be fully removed.

If you discover a crack, return the syringe to the pharmacy and exchange it for a new one at no cost. Even if you don't see a crack, the syringes should be re-inspected once a month because these cracks can develop over time.

Valeant Pharmaceuticals has sent letters to physicians caring for epilepsy patients advising them to tell their patients about this problem. The company has also told pharmacists to inspect all of the product on their shelves before dispensing it, and to tell patients they should also inspect the syringes. For more information, contact the company at 1-877-361-2719.

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June2006FDA Patient Safety News Homepage
Fungal Keratitis Infections and Contact Lenses (Video, print, and e-mail functions)
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FDA and CDC are alerting healthcare practitioners and contact lens wearers about an increasing number of reports of a rare but serious eye infection caused by the Fusarium fungus. The infection can cause significant vision loss and require corneal transplant.

Susceptibility to Fusarium infection may be increased by using a Bausch and Lomb product called ReNu with Moisture Loc Contact Lens Solution, and so the company is permanently removing this product from the market. Consumers should stop using ReNu with MoistureLoc immediately.

FDA is advising that when clinicians evaluate a patient with microbial keratitis, they keep in mind that a fungal infection may be involved, and that they consider referring the patient to an eye care professional to obtain a specimen for laboratory analysis. FDA is also asking that clinicians report these infections and the agency will share this information with CDC.

Clinicians should instruct patients to take precautions to prevent contamination of the lenses and the products used to maintain them. This includes washing the hands with soap and water before handling the lenses, keeping the contact lens case clean and replacing it every three to six months, wearing and replacing the lenses according to the prescribed schedule, and following the cleaning and storage guidelines provided by the doctor and the manufacturer. Patients should be warned that if they experience symptoms of infection, they must immediately remove the lenses and consult their doctor.

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June2006FDA Patient Safety News Homepage
Recall of ACCU-CHEK Ultraflex Infusion Sets (Video, print, and e-mail functions)
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Disetronic Medical Systems is recalling all ACCU-CHEK Ultraflex infusion sets, which are used with insulin pumps, because the set's tubing could separate at the luer lock connection. This could cause a leakage of insulin, resulting in hyperglycemia. Remember that patients using any pump with a standard luer lock may be using these ACCU-CHEK Ultraflex infusion sets.

Under the recall, patients have several choices. They can continue to use the set, in which case the company says that they must check the luer lock tubing connection at least every three hours and at bedtime. Or they can receive an exchange Ultraflex infusion set. In this case, the company notes that separation at the luer lock connection can still take place as a result of normal daily use. Or patients can replace their Ultraflex infusion sets with ACCU-CHEK Tender or Rapid-D infusion sets.

In any case, the company's notification states that it's a good practice for patients on insulin pump therapy to check their blood glucose levels one to three hours after changing the infusion set system, and continue to check during the day.

To find out more about the recall and how to get a replacement infusion set, healthcare practitioners and patients can call Disetronic at 1-800-688-4578.

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June2006FDA Patient Safety News Homepage
Anaphylaxis with Macugen (Video, print, and e-mail functions)
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Pfizer Pharmaceuticals has alerted healthcare professionals that severe allergic reactions have occurred in patients treated with Macugen. Macugen (pegaptanib sodium injection) is used to slow vision loss in people with the neovascular or “wet” form of age-related macular degeneration.

In rare cases, anaphylaxis or anaphylactoid reactions, including angioedema, have been reported after patients received Macugen along with other medications used to prepare for the injection. A direct relationship hasn't been established between these reactions and Macugen or any of the other drugs. However, the company says that the patient's history should be evaluated for hypersensitivity reactions before giving the treatment.

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June2006FDA Patient Safety News Homepage
New Information on Preventing Patient Entrapment in Hospital Beds (Video, print, and e-mail functions)
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FDA has received hundreds of reports of deaths and injuries in patients who became entrapped in hospital beds-sometimes through the bars of a side rail, or through the space between split side rails, or between the bed rail and the mattress, the headboard, or the footboard. Some of these patients strangled. Elderly patients are most vulnerable to entrapment, especially those who are frail, confused, restless, or who have uncontrollable body movements.

To help reduce the hazard, FDA has released new guidelines that will help manufacturers design safer beds, and health care facilities assess the risk of patients being entrapped in the beds they're using.

FDA developed the guidelines along with other government agencies, the healthcare community and the medical bed industry. The guidelines describe which body parts are at risk for entrapment and which bed openings are potential entrapment areas. For manufacturers, they recommend dimensional criteria for new hospital bed systems, and describe how to assess the gaps in hospital beds.

What's most important for healthcare facilities is that the new guidelines describe how to get a Bed Safety Entrapment Kit. The kit includes an instructional video on how to measure beds, a measurement device that will help test the four critical entrapment areas of a bed system and explains how to modify existing beds to help reduce the risk of entrapment.

The basic message is that although entrapment in hospital beds is rare, it is preventable.

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June2006FDA Patient Safety News Homepage
Importance of Monitoring Liver Function with Tracleer (Video, print, and e-mail functions)
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Based on recent reports of hepatotoxicity, the drug company Actelion has reminded healthcare professionals about the importance of monitoring liver function in patients receiving Tracleer (bosentan).

Tracleer is a limited-access drug that's used in certain patients with pulmonary arterial hypertension to improve exercise ability and decrease the rate of clinical worsening.

The company's notification underscores the need to continue monthly liver function monitoring for the entire time a patient is being treated with Tracleer, and to follow the dosage adjustment and monitoring guidelines in the product labeling.

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 Preventing Medical Errors

June2006FDA Patient Safety News Homepage
Accidental Intrathecal Administration of IV Vincristine (Video, print, and e-mail functions)
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A recent Institute for Safe Medication Practices safety alert warns about the danger of accidentally administering IV vincristine by the intrathecal route. ISMP cites a recent case where a syringe containing vincristine was accidentally delivered to the wrong patient's bedside. A physician, believing it was a different medication intended for intrathecal use, delivered the vincristine intrathecally. The patient died three days later.

In the past, FDA and USP have urged that extemporaneously prepared IV syringes be labeled “Fatal if given intrathecally, for IV use only,” and be over-wrapped with a similar warning label. The ISMP alert again stresses the importance of using this kind of labeling for intrathecal medications to prevent confusion with IV medications.

ISMP recently asked several hundred hospitals what they do to avoid accidental intrathecal administration of IV vincristine. In addition to the warning labels, here are some of the methods these institutions reported using:

• Some hospitals only deliver IV vincristine to areas where intrathecal drugs are prohibited.

• Others use distinctive packaging, such as unique overwraps, for intrathecal medications.

• Some dilute IV vincristine in a plastic minibag before use, which helps distinguish it from syringes of intrathecal medications.

• Some have two health professionals independently check IV vincristine doses before administration, and others continually monitor the patient at the bedside when delivering IV vincristine.

• For patients receiving medications by both routes, some hospitals verify that the IV medication has been administered before administering the intrathecal medication, and vice versa.

ISMP stresses that patients usually die slowly and painfully when IV vincristine is accidentally administered intrathecally, and that their deaths can be prevented with relatively simple precautions like these.

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June2006FDA Patient Safety News Homepage
Dangerous Confusion with Color-coded Wristbands (Video, print, and e-mail functions)
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A recent ISMP report, along with an advisory from the Pennsylvania Patient Safety Authority, points out the danger of misinterpreting the meaning of color-coded wristbands worn by patients. The confusion is often caused by certain colors having different meanings in different facilities.

In one case, a hospitalized patient was given a green wristband to show that he was allergic to latex. He was later transferred to another facility where the staff wasn't familiar with this particular color coding. They performed a test with latex-containing devices, and the patient suffered an anaphylactic reaction.

In another case, a nurse wanted to signify that a patient had a restricted extremity, so she placed a yellow wristband on him. Because she worked in several hospitals with different color coding schemes, she didn't realize that in this particular facility, yellow meant “do not resuscitate.” Luckily, the mistake was caught before any damage was done.

Mistakes can also happen if you don't remove the colored wristbands that some people wear for non-medical reasons, such as to signify charitable contributions.

Here are some of the recommendations listed by ISMP and the Pennsylvania Patient Safety Authority:

• Limit the number of colors used on patient wristbands.

• Use only primary and secondary colors, and don't use shades of the same color to convey different messages.

• Use wristbands that are pre-printed with text that tells what the band means. This can reinforce the color coding system for new clinicians, help caregivers interpret the meaning of the band in dim light, and also help those who may be color blind.

• Consider removing colored non-medical wristbands that patients may be wearing when they present to the facility. If that can't be done, you can cover the band with a bandage or medical tape.

• Explain the purpose of the wristband to the patient and family members, which provides another opportunity to prevent errors.

If your facility uses pediatric wristbands that correspond to the Broselow color coding system for pediatric resuscitation, take steps to reduce any confusion between these Broselow colors and the colors on the wristbands used elsewhere in the facility.

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