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U.S. Department of Health and Human Services

For Consumers

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FDA's MedWatch Safety Alerts: February 2010

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After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor that product for unexpected and undesirable side effects (adverse events).

Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.

  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • Fax: 1-800-FDA-0178
  • Phone: 1-800-332-1088

MedWatch reports can signal a safety problem and lead to an FDA action to protect the public from harm, serious illness, or even death.

Here are a few of the most recent safety alerts prompted by reports received by FDA from health care professionals and their patients.

 

Recall: OneTouch SureStep Test Strips

Eight lots of OneTouch SureStep Test Strips have been recalled. The test strips, a product of LifeScan Inc., are used by people with diabetes to measure their blood glucose levels at home.

Lot numbers are located on the outer carton and test strip vial. The recalled lots are

# 2969251100-ctOneTouch SureStep
# 2969798100-ctOneTouch SureStep
# 2982369100-ctOneTouch SureStep
# 2983467100-ctOneTouch SureStep
# 296979550-ctOneTouch SureStep
# 298256650-ctOneTouch SureStep
# 296948150-ctMedicare/Mail Order
# 299819350-ctMedicare/Mail Order

The risk: The test strips may provide falsely low glucose results when the glucose level is higher than 400 milligrams per deciliter (mg/dL). Based on these false results, patients may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

Recommendations:

  • Continue to test your blood glucose.
  • If you have access to a meter that does not use the recalled test strips, use this other meter to test your blood glucose until LifeScan sends you a replacement product.
  • If an alternate meter is not available, continue to test using the recalled test strips. However, if your glucose results are above 400 mg/dL, contact your health care professional for further instructions.
  • If you have test strips from the recalled lots, call LifeScan at 800-574-6139 or visit www.surestep.com to request a replacement product.

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Ongoing Safety Review of Invirase

FDA is reviewing data from studies in people about a potentially serious effect on the heart from the use of two antiviral medications given together to treat HIV infection.

The risk: The data suggest that when Invirase (saquinavir) is used in combination with Norvir (ritonavir), the two drugs may affect the electrical activity of the heart, increasing the risk for abnormal heart beats that can trigger dangerous and irregular rhythms.

This information is part of FDA's commitment to communicate with the public about its ongoing safety review of drugs. The agency will update the public as soon as it completes its review.

Recommendations:

  • Don’t stop taking prescribed antiviral medications without talking to your health care professional.
  • Discuss any questions or concerns you have about Invirase with your health care professional.

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Ongoing Safety Review of Avandia

FDA is reviewing data submitted in August 2009 from a large, long-term study in people on possible heart-related risks with the diabetes drug Avandia (rosiglitazone).

FDA’s review is ongoing. No new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time.

After FDA completes its review, the agency will hold a public meeting in July 2010 to present heart-related safety data on rosiglitazone along with an update on the risks and benefits of the drug to treat type 2 diabetes.

Recommendations:

  • Don’t stop taking your medication without talking to your health care professional.
  • Read the Medication Guide that comes with each rosiglitazone prescription to better understand the risks and benefits of your medication.
  • Discuss any questions or concerns you have about rosiglitazone with your health care professional.

For a full Consumer Update, see Safety Review of Avandia (Rosiglitazone).

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Risk of Serious Injuries with Ear Candles

FDA warns consumers not to use ear candles because they can cause serious injuries.

These "candles" are hollow cones about 10 inches long made from a fabric tube soaked in beeswax, paraffin, or a mixture of the two. Sellers of the products claim that a burning ear candle draws ear wax and “impurities” or “toxins” out of the ear canal and provides relief from a variety of conditions—from sinus infections, to flu, to cancer.

FDA has found no valid scientific evidence of any medical benefit from the use of ear candles.

The risk: FDA has received reports of burns, perforated eardrums, and blockage of the ear canal, which required surgery, from the use of ear candles. Children are likely at increased risk for injuries and complications if they are exposed to ear candles.

For a full Consumer Update, see Don't Get Burned: Stay Away From Ear Candles.

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Maalox Product Mix-Ups

Serious medication errors have occurred when consumers used Maalox Total Relief when they had intended to use a Maalox liquid antacid product. Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription, but are not interchangeable and are intended to treat different medical conditions.

Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products (Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength) are antacids.

The risk: Maalox Total Relief is not appropriate for people who want to use an antacid, since it contains bismuth subsalicylate. This ingredient is chemically related to aspirin and may cause serious side effects such as bleeding. Maalox Total Relief should not be used in people who have had gastrointestinal ulcers or a bleeding disorder. It also should not be taken by children and teens if they are recovering from a viral infection, nor by people who are taking certain medications.

Recommendations:

  • Check the active ingredients in the “Drug Facts” label before you buy a Maalox product. If your health care professional recommended you take Maalox antacid, do not get Maalox Total Relief.
  • Ask your pharmacist or other health care professional for help if you’re unsure of which product is right for you.

For a full Consumer Update, including photos of Maalox product labels, see Avoid Maalox Mix-Ups.

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Tysabri Label Update

New safety information will be included in the Tysabri (natalizumab) drug label and patient Medication Guide: The risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received.

PML is a rare brain infection that usually causes death or severe disability. This new safety information is based on reports of 31 confirmed cases of PML received by FDA as of Jan. 21, 2010.

The drug label will also include information about the occurrence of immune reconstitution inflammatory syndrome (IRIS) in people who developed PML and then stopped using Tysabri. IRIS is a rare but severe inflammatory response that can cause worsening of multiple sclerosis.

Tysabri is approved to treat relapsing forms of multiple sclerosis, and moderately to severely active Crohn’s disease. (PMS has not been reported in people treated with Tysabri for Crohn’s disease.)

At this time, FDA believes that the benefits of Tysabri continue to outweigh the potential risks.

Recommendation: If you take Tysabri, call your health care professional right away if you get any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems) that have lasted over several days. 

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: March 17, 2010

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