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FDA's MedWatch Safety Alerts: October 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.

Online

  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • 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 and ongoing safety reviews prompted by reports FDA has received through MedWatch.

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Recall: Erectile Dysfunction Pills Contain Undeclared Ingredients

Haute Health, LLC is recalling all lots of Virilis Pro, PHUK and Prolifta, products promoted and sold for sexual enhancement in retail stores nationwide and online. Virilis Pro, PHUK and Prolifta have been found to contain sildenafil, which is an active ingredient in the FDA-approved drug Viagra. All three products are sold in capsule form and packaged in blister packs or bottles.

Risk: These pills 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. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

Recommendations

  • Consumers who have these products should stop using them immediately.
  • Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
  • Consumers with questions may contact Michael Carney via email at info@virilispro.com or by phone at 856-404-9474 from Monday to Friday, 11a.m. to 5 p.m. ET. 

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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Recall: Weight-Loss Supplements Contain Undeclared Ingredients

B@B Trade, Inc., Fla., is recalling all lots of Slim Fortune, Lidiy, and Slim Expert. Laboratory analysis showed the products have been found to contain sibutramine, a controlled substance that FDA previously approved for the treatment of obesity. Sibutramine was removed from the U.S. market for safety reasons, making these dietary supplements an unapproved drug.

The product is sold as a natural herb for weight loss. The supplements are packaged in plastic bottles with 30 capsules in each bottle. The products were sold directly to individual customers in Florida, and online at www.lidiy.com, www.slimfortune.com, or www.slimexpert.com.
 

Risk: FDA has identified products containing sibutramine as a potential threat to consumers because the drug substantially increases blood pressure and pulse rate in some patients. These products may pose a significant risk to those with a history of coronary artery disease, congestive heart failure, abnormal heart rhythm or stroke. They may also interact, in life-threatening ways, with other medications a patient is taking.

Recommendations

  • Consumers should not take Slim Fortune, Lidiy, or Slim Expert Dietary Supplements and should contact their physician or health care professional if they have experienced any problems that may be related to taking or using this drug product.    
  • Consumers should return the products immediately to the place of purchase. Consumers with questions should contact B@B Trade Inc. at 305-763-6956 or via e-mail at interincorp@yahoo.com Monday - Friday, 10:00 a.m. - 4:00 p.m., ET.  

For More information

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Electric Vehicles Have Problem Stopping During Operation

Afikim Electric Vehicles is recalling 69 Breeze C Scooters. The Breeze C Scooter may become unresponsive during operation due to an electrical problem from excessive wear. The recalled scooters are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.

Risk: Mobility scooters are often used by disabled or elderly people who have difficulty walking. If the scooter becomes unresponsive it could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.

Recommendations

  • Consumers who have the recalled vehicle should contact the company via telephone Monday through Friday at 800-809-3010 between the hours of 9 a.m. and 5 p.m. ET, or email at dov@afiscooters.com.

For More information

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Recall: Weight-Loss Products Contain Undeclared Ingredients 

FDA is advising consumers not to purchase or use Perfect Body Solutions or Burn 7. FDA lab tests confirmed that Perfect Body Solutions and Burn 7 contain sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Perfect Body Solutions or Burn 7 are promoted for weight loss and sold online and in retail stores.

Risk: These products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some people and can present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  These products can also interact in life-threatening ways with other medications a consumer may be taking.

Recommendation

  • Consumers should stop using these products immediately and throw them away. 
  • Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

For More information

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Drug Safety Labeling Changes

In September 2013, FDA required safety labeling changes to be made to 49 drug products, including medications for hormone therapy, cancer treatment and other conditions. Warnings added included risk of cardiovascular disorders like stroke or heart disease with the hormone therapy, and the risk of hepatitis B virus reactivation while taking the cancer treatment.

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. 2, 2013

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Page Last Updated: 12/02/2013
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