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U.S. Department of Health and Human Services

Show #76, June 2008

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Show #76, June 2008

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 Recalls and Safety Alerts

June2008FDA Patient Safety News Homepage
Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps (Video, print, and e-mail functions)
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On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. This letter, which also gave patient management and treatment recommendations, was an update to two earlier communications.

The company's analysis shows that the incidence of inflammatory masses is about five times higher (about 0.5 percent vs. about 0.1 percent) than it was in 2001 and is expected to continue to increase. The masses occurred at or near the distal tip of the intrathecal catheters, and have been reported with a variety of intrathecal infusions, including opioids, baclofen and pharmacy-compounded drugs. The highest incidence was reported with opioid use. High doses or high concentrations of opioids may increase the risk of inflammatory mass, but the exact etiology is not known.

The company's recommendations for managing patients include the following:

• With intrathecal opioids, administer the lowest effective dose and concentration.

• Closely monitor patients to identify the prodromal signs and symptoms of inflammatory mass.

• Consider a neurological consultation and imaging studies to confirm or rule out the presence of an inflammatory mass.

Finally, Medtronic strongly advises physicians to know which intrathecal drugs are approved for use in these devices, including preservative-free morphine sulfate sterile solution, Lioresal® intrathecal baclofen injection, and preservative-free ziconotide sterile solution. The effect of administering other drugs through these devices has not been assessed, and that includes drugs compounded by pharmacies.

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June2008FDA Patient Safety News Homepage
FDA Studying Potential Safety Issues with Several Drugs (Video, print, and e-mail functions)
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FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information is preliminary and there is scientific uncertainty, FDA is not taking regulatory action at this point, and is not advising health care professionals to stop using the drugs. FDA is continuing to evaluate the safety of these products, and will issue updates as more information becomes available.

• CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid)

UPDATE - June 4, 2008: FDA has completed its review of postmarketing reports of PML in patients who took CellCept and Myfortic. The prescribing information for CellCept and Myfortic now includes information on PML in the Warnings and Adverse Events sections. Roche and Novartis issued Dear Health Care Professional Letters on May 29, 2008 outlining the changes to the prescribing information.

One of the ongoing safety reviews concerns two drugs used to prevent organ rejection, CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid). CellCept is approved to prevent heart, liver and kidney transplant rejection. Myfortic is approved to prevent kidney transplant rejection.

This safety review focuses on a potential association between these drugs and a rare, life-threatening CNS disorder called or progressive multifocal leukoencephalopathy (PML). PML occurs when a latent polyoma virus called the JC virus is activated and attacks the myelin sheath surrounding nerve cells. Most adults carry the virus, which becomes activated mainly in immuno-compromised patients. Symptoms of PML include vision changes, apathy, memory loss or confusion, ataxia and muscular weakness.

FDA is reviewing data on the possible association between CellCept and PML. Roche, the manufacturer of CellCept, and Novartis, the manufacturer of Myfortic, have proposed changes in the labeling of these drugs to include information on PML.

Until FDA has more information, healthcare professionals should be alert to the localized neurologic signs and symptoms that could signal PML in patients taking CellCept and Myfortic. They should also consider reducing the amount of immuno-suppression if a patient develops PML.

• Singulair (montelukast)

In another communication, FDA is informing healthcare professionals about a possible association between the use of Singulair and behavior and mood changes, suicidality and suicide. Singulair (montelukast) is used to treat asthma and allergic rhinitis, and to prevent exercise-induced asthma.

Singulair's manufacturer, Merck & Co., has updated the adverse events information in the drug's labeling several times over the past year. Those adverse events include tremor, depression, suicidality and anxiety. Merck plans to highlight these changes to prescribers, and to provide patient information leaflets on the drug.

FDA is reviewing reports of behavior and mood changes, suicidality and suicide in patients on Singulair, and has asked Merck to review its own clinical trial data for more information about suicide and suicidality. FDA will let clinicians and patients know about the results of these evaluations as soon as they're complete. In the meantime, patients on Singulair should be monitored for suicidality and changes in mood or behavior, and they should be instructed not to discontinue the drug without medical advice.

FDA is also reviewing reports of mood and behavioral changes in other asthma drugs, including Accolate (zafirlukast) and Zyflo (zileuton), and will decide whether further investigation is needed.

• Spiriva Handihaler (tiotropium)

In another communication, FDA informed health professionals of a possible increase in the risk of stroke among patients using the Spiriva Handihaler. This product, which contains tiotropium bromide, is used to treat bronchospasm associated with chronic obstructive pulmonary disease.

The manufacturer, Boehringer Ingelheim, conducted a pooled analysis of 29 studies of two tiotropium products, including the Spiriva Handihaler. In this analysis, patients using Spiriva experienced a stroke risk of 8/1000 per year compared with 6/1000 per year for those using a placebo. Pooled analyses like this one have inherent limitations, and so these results must be confirmed by further investigation using other data sources.

FDA has asked for more information from Boehringer Ingelheim, and is also reviewing adverse event reports for this product. The company has conducted a large, four-year study of the Spiriva Handihaler which should provide more information on the potential risks of this product. Results are expected soon. At that point, FDA will analyze all of the data and report its results to health professionals and the public. In the meantime, patients should not stop using the Spiriva Handihaler without talking to their doctors.

Again, these communications are preliminary information, and they're in keeping with FDA's commitment to inform the public about its ongoing drug safety reviews. FDA urges healthcare professionals and patients to report adverse reactions from any of the products discussed here through FDA's Medwatch program at 1-800-FDA-1088 or at the link below.

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June2008FDA Patient Safety News Homepage
Neupro Patches Recalled (Video, print, and e-mail functions)
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Schwarz Pharma recalled Neupro (rotigotine) transdermal patches at the end of April 2008. These patches are used to treat early stage Parkinson's disease.

The problem is that rotigotine, the active ingredient, may crystallize in the patch. If that happens, less drug is available to be absorbed through the skin and so the efficacy of the products may vary. The crystallized drug may cause a patch to have snowflake-like patterns. The more snowflakes, the greater the chance that the patch won't work properly.

Because of this, new patients should not be started on Neupro. Patients already using the patch should be slowly titrated off it, and started on an alternative treatment as needed. Patients should not abruptly discontinue treatment with Neupro. The down-titration should proceed according to guidelines in the labeling, using patches that are unaffected or minimally affected by the crystallization.

Patients should be told to look at their patches and only use those that have a minimal amount of crystals. (See link below for picture.) For more information, contact the company at 1-800-477-7877 (option 9).

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June2008FDA Patient Safety News Homepage
Avoid Using ReadyMED Infusion Pumps with Cubicin (Video, print, and e-mail functions)
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In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to treat certain bacteremias and complicated skin infections.

The company's letter says that a potentially significant impurity has been isolated from reconstituted Cubicin that was stored in ReadyMED pumps. The impurity, 2-mercaptobenzothiazole (MBT), is used in rubber manufacturing. MBT has been reported to leach into medical products from rubber stoppers and syringe components in the past.

The impurity was discovered during lab studies evaluating the stability of reconstituted Cubicin when it was stored in two types of elastomeric infusion pumps: the Ready MED pump and the Eclipse, which is a pump made by I-Flow Corporation. Stability results were acceptable for both types of pumps, but MBT was detected in the samples from the ReadyMED pumps. It was not found in the Eclipse pump samples or control samples. Cubist recommends not using Cubicin with ReadyMED pumps until the impurity issue has been addressed.

The company says it has not identified MBT in reconstituted Cubicin that was stored in the other types of standard infusion systems that were tested. But the company also points out that Cubicin's stability hasn't been evaluated in infusion pumps other than the Eclipse and ReadyMed.

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 Advice for Patients

June2008FDA Patient Safety News Homepage
Getting the Most Out of Blood Glucose Meters (Video, print, and e-mail functions)
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Keeping glucose levels under control can help people with diabetes feel better and also lower the risk of blindness, kidney disease, and nerve damage. Very high or very low blood sugar can have serious consequences.

Although blood glucose meters are fairly simple to operate, many things can go wrong if the user isn't careful. Here are some tips that can help people with diabetes get accurate results from their glucose meters.

• Be prepared before you do the test. Carefully read all instructions for your meter and test strips. Calibrate the meter or test it to be sure it's calibrated before you use it.

• Be sure that you're using test strips that are specified to work with your meter. Even if an incorrect test strip fits in your meter, it could give you the wrong results. Don't use test strips from a cracked or damaged bottle and don't use test strips that have passed their expiration date.

• Once you're ready to test, wash your hands, because even a little bit of food or sugar can affect the results. Make sure the drop of blood is the right size. Let the blood flow freely; don't squeeze your finger, since that can affect the results. Always use a whole test strip and insert it into the meter until you feel it stop against the end of the meter guide.

• Storage and maintenance are important, too. Be sure to keep your meter clean, and test it regularly with control solution. Have extra batteries charged and ready. Heat and humidity can damage test strips, so replace the bottle cap promptly after removing a strip. And store your meter and supplies according to manufacturer instructions.

What about glucose meters that allow you to use blood from places other than fingertips, such as the upper arm, forearm, base of the thumb, and thigh? This can give you more options. But blood from a finger stick shows changes in glucose levels more quickly than blood from other parts of the body. That means that glucose levels from these other places may not always be as accurate as readings from the fingertips, particularly when glucose levels are changing rapidly, including after a meal, after taking insulin, during exercise, or when you're ill or under stress. During these times, you should use blood from a finger stick. You should also use fingertip blood if you think your blood glucose is low, if you don't usually have symptoms when your blood glucose is low, or if the result from the alternative site doesn't match how you feel.

Glucose meters are generally reliable, but they're not as accurate as testing done in your doctor's office. So take your meter with you when you visit your doctor so you can compare it with your laboratory results. Finally, if your meter gives a normal reading but you still suspect your glucose is too low or too high, contact your doctor immediately.

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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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