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FDA's MedWatch Safety Alerts: November 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 regulated 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.

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 and ongoing safety reviews prompted by reports FDA has received through MedWatch.

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Dietary Supplements Linked to Liver Illness

USPlabs LLC, has recalled specific OxyElite Pro dietary supplement products, marketed as an aid to losing weight and building muscles. The company announced this after receiving a letter from FDA stating that the products have been linked to liver illnesses. FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.

FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

Risk: FDA reviewed 46 medical records, submitted by the Hawaii Department of Health, and found that 27 patients had taken a dietary supplement labeled as OxyElite Pro before becoming ill. Seventeen of the patients reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.

Recommendations

  • Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner. 
  • In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1. 

For More information

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Chemotherapy Drug Linked to Risk of Clots, Narrowing of Blood Vessels

FDA has asked, and Ariad Pharmaceuticals has agreed, to suspend marketing and sales of Iclusig (ponatinib), a leukemia chemotherapy drug, because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Iclusig is a prescription medicine used to treat adults diagnosed with certain kinds of leukemia who are no longer benefiting from previous treatment or who did not tolerate other treatment. FDA will continue to evaluate the drug to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks.

Risk: Data from clinical trials and postmarket reports show that some patients treated with Iclusig have suffered heart attacks resulting in death, worsening coronary artery disease, stroke, narrowing of large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to restore blood flow.

Recommendations

  • Patients currently receiving Iclusig should discuss with their health care professionals the risks and benefits of continuing treatment with the drug.  
  • Patients taking Iclusig should seek immediate medical attention if they experience symptoms suggesting a heart attack such as chest pain or pressure, pain in their arms, back, neck or jaw, or shortness of breath; or symptoms of a stroke such as numbness or weakness on one side of the body, trouble talking, severe headache or dizziness. 

For More information

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Glucose Test Strips Give Erroneously Low Results

Abbott is recalling 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips. These test strips may produce incorrect low blood glucose (sugar) results when used with both "FreeStyle Blood Glucose Meter" and "FreeStyle Flash Blood Glucose Meter,” as well as the OmniPod Insulin Management System. The affected test strips are from lots with expiration dates between May 2014 and March 2015.

Risk: Low glucose readings can cause people to consume sugar in an effort to raise their glucose levels, and could lead to hyperglycemia (high sugar levels). Having too much sugar in the blood for long periods of time can cause serious health problems. Hyperglycemia can damage the vessels that supply blood to vital organs, which can increase the risk of heart disease and stroke, kidney disease, and vision problems.

Recommendations

  • Consumers who have these products should stop using them immediately.
  • Consumers with recalled test strips should call Abbott's diabetes care customer service at 888-736-9869 for a replacement of the affected test strips at no charge.

For More information

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Eyeliner Contains High Levels of Lead

New Reliance Traders, Inc. is recalling all lots of Hashmi Surma Special Eyeliner because it was found to contain high levels of lead. The eyeliner is packed within a 12 gram gold bottle, enclosed within blue packaging with English translation on the front and a foreign language character on the back. The recall was initiated after it was discovered that product contained high levels of lead based on laboratory testing conducted by the Connecticut Department of Consumer Protection.

Risk: The high levels of lead can cause health problems, particularly for infants, small children and pregnant women. Lead interferes with many processes in the body, and is toxic to organs, including the heart, bones, kidneys and nervous system. Recent analysis found that the products contained lead levels high as 167,387 parts per million.

The Hasmi Surma Special Eyeliner was distributed to retail stores in Connecticut, Pennsylvania, Maryland and Rhode Island.

Recommendations

  • Consumers who have these products should stop using them immediately.
  • Consumers with questions may contact New Reliance Traders at 718-894-2927 Monday - Friday 9 a.m. – 5 p.m. ET.

For More information

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Recall: Sexual Enhancement Products Contain Undeclared Ingredients

Tendex is recalling lots of its NatuRECT and P-Boost products, promoted and sold for sexual enhancement online and in some retail stores. They are packaged in one-capsule packs or five, 10, 20 or 40-capsule bottles. FDA lab tests show that the products contain tadalafil, an active ingredient in the FDA-approved prescription drug Cialis.

Risk: These undeclared ingredients may interact with nitrates found in some prescription drugs—such as nitroglycerin, used to treat chest pain—and may lower blood pressure to dangerous levels or cause loss of consciousness. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Recommendation

  • Consumers that have product being recalled should stop using it and return it to the place of purchase.
  • Consumers with questions can contact Tendex at 800-984-0341, from Monday - Friday, 9:00 a.m. – 5:00 p.m. PT.
  • Consumers should contact their physician or health care professional if they have experienced any problems that may be related to taking or using these drug products.

For More information

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Antibiotic Traces Found in Protein Products

Sequel Naturals Inc., doing business as “Vega,” is recalling multiple lots of its Vega One Nutritional Shakes and Sports Performance Protein products. Laboratory analysis showed the products contain trace amounts of chloramphenicol, an antibiotic. Chloramphenicol is a prescription drug commonly used to treat typhoid fever and eye infections world-wide.

Risk: Those who have severe sensitivity or allergies to chloramphenicol may have an allergic reaction if they consume these products.  The antibiotic should only be used under medical supervision. Pregnant or lactating women should avoid this medication.

Recommendation

  • Consumers who have purchased a product from any of the lot codes affected by this recall may call Vega for a full refund at 866-839-8863.

For More information

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Anti-Seizure Drug Linked to Skin Discoloration, Vision Loss

FDA is warning consumers that the anti-seizure medication Potiga can cause skin discoloration and changes in eye color. Potiga is approved for the treatment of seizures in adults when combined with other medications. The skin discoloration has been reported as a blue color on or near the lips and in finger or toe nails. Discoloration on the eyelids and the white of the eye has also been reported.

Risk: FDA approved changes to the drug label, alerting consumers to the skin and eye discoloration, as well as potential vision loss. Pigment changes in the retina  can cause eye disease and loss of vision, all of which may be permanent. FDA is working with the manufacturer to evaluate these reported side effects.

Recommendations

  • Consumers should have a baseline eye exam and periodic eye exams. More in-depth testing should be discussed as well.
  • Consumers should not stop taking Potiga without talking to their health care professional.  Stopping such treatment suddenly can cause serious and life-threatening medical problems such as recurrence of seizures.
  • Consumers who are taking Potiga and develop any changes in their vision or any discoloration of their skin should contact their health care professional right away.

For More information

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Drug Safety Labeling Changes

In October 2013, FDA required safety labeling changes to be made to 68 drug products, including oral contraceptives and a medicine countering the side effects of narcotics. Warnings added include a greater risk of heart attack when using the medicine to combat narcotic side effects, and increased risk of heart problems and high blood pressure when smoking while on the contraceptives.

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.

For More Information

Monthly Safety Labeling Changes

This article appears on FDA's Consumer Updates page20, which features the latest on all FDA-regulated products.

Dec. 20, 2013

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Page Last Updated: 12/20/2013
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