FDA’s MedWatch Safety Alerts: May 2013

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After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.
FDA encourages health care professionals and consumers to report problems with medical products, including

unexpected and undesirable side effects
quality problems, such as a drug with an unusual odor or color, or a device with defective parts
unclear or confusing instructions
failure to deliver the expected benefit.

Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

Online
Regular Mail: FDA form 3500B
Fax: 800-FDA-0178
Phone: 800-332-1088

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.
Here are some of the most recent safety alerts prompted by reports FDA has received through MedWatch.
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Recall: FreeStyle InsuLinx Blood Glucose Meters May Show Incorrect Result

The FreeStyle InsuLinx Blood Glucose Meter measures sugar (glucose) in blood drawn from the fingertips of people with diabetes to monitor blood sugar levels. At very high blood glucose levels of 1024 mg/dL and above, the meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured results.
For example, at a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL (1066 mg/dL – 1024 mg/dL = 42 mg/dL.
Risk: Though rare, blood glucose levels that are 1024 mg/dL or higher are a serious health risk that requires immediate attention.
Recommendations
If you are using the FreeStyle InsuLinx Meter, you should immediately take one of the following actions:

Access a software update to install on your meter to resolve the issue at: www.freestyleinsulinx.com/swupdate . The software update will allow you to maintain settings and historical data on your meter.
Contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of your FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send a meter to you immediately upon request.
Until you are able to update the meter software or until your requested replacement meter arrives, you may use the current FreeStyle InsuLinx meter. However, if you experience symptoms that are not consistent with your readings, you should contact your health care professional and follow his or her treatment advice.

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FDA Requires Lower Recommended Doses of Products Containing Zolpidem

FDA has approved label changes specifying new dosing recommendations for widely prescribed zolpidem products (Ambien, Ambien CR, and Edluar), because of the known risk of next-morning impairment with these drugs.
The agency is also warning that patients who take the sleep medication zolpidem extended-release (Ambien CR)―either 6.25 mg or 12.5 mg―should not drive or engage in other activities that require complete mental alertness the day after taking the drug because zolpidem levels can remain high enough the next day to impair these activities.
Risk: New data shows that blood levels of zolpidem, a widely prescribed insomnia drug, may be high enough the morning after use to impair activities that require alertness, including driving.
For zolpidem products, data show the risk of impairment is highest for patients taking the extended-release forms of Ambien CR and generics. Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men. Impairment from sleep drugs can be present despite feeling fully wake.
The recommended doses of Intermezzo, a lower-dose zolpidem product approved for middle-of-the-night awakenings, are not changing. When Intermezzo was approved in November 2011, the label already recommended a lower dosage for woman than for men.
Recommendations

For women, the recommended dose of zolpidem should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).

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Recall: Xymogen Recalls Dietary Supplement Due to Potential Allergic Reaction

The company Xymogen has recalled Atriphen, a product sold for the support of healthy joint function, because it contains the undeclared allergens soy and milk.
Risk: People who have an allergy or severe sensitivity to either milk or soy run the risk of a serious or life-threatening allergic reaction if they consume this product. To date, no one has reported allergic reactions or adverse events in connection with the product.
Recommendations

Consumers are urged to return this product for a full refund.
More information is available at www.xymogen.com . Consumers may email pr@xymogen.com for comments or inquiries.

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Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy

Drug Safety Labeling Changes

In April 2013, FDA required safety labeling changes to be made to 48 drugs including a warning about an increased risk of osteonecrosis of the jaw—in which bone is exposed—with certain bisphosphonate drugs used to treat osteoporosis.
In general, changes were made to the prescribing information and in some cases, to the patient package inserts and medication guides (paper handouts for patients that come with many prescription medicines) to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.
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