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FDA's MedWatch Safety Alerts: February 2014

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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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Recall: Undeclared Drugs Found in Weight Loss Pills

MyNicKnaxs, LLC. announced a recall of: Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction. The pills have been found to contain phenolphthalein, sibutramine or a combination of both. Sibutramine is a controlled substance that FDA previously approved for the treatment of obesity. Sibutramine was removed from the U.S. market in 2010 for safety reasons, making these dietary supplements an unapproved drug. Phenolphthalein, once used in over-the-counter laxatives, is not approved for marketing in the U.S. because of concerns that the substance can cause cancer.

Risk: Products containing sibutramine pose a 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. These products may also interact badly with medications being taken. Consumption of these pills could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

Recommendations

  • Consumers who have purchased these products should stop using them immediately.
  • Consumers may contact MyNicKnaxs at: 1-386-337-8142, Monday – Friday 2 p.m. to 7 p.m. ET, or via e-mail at nicnaxs@yahoo.com.

For More Information

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Recall: Glass Particles Found in Medical Solution

Ben Venue Laboratories is recalling a lot of Acetylcysteine Solution 10 percent because a piece of glass particle was found in a vial. Acetylcysteine is used to help clear abnormal, thick or sticky mucous secretion. It is usually delivered as a mist via a Nebulizer, but can also be delivered through a tracheostomy (an opening in the windpipe) or bronchoscopy (an exploration of the lung’s airways). The recalled lots were manufactured for Roxane Laboratories, NDC #0054-3025-02, with lot number 2005479.

Risk: Glass particles can obstruct the airway, resulting in symptoms such as choking, wheezing, difficulty breathing, coughing and coughing up blood. Use of an inhaled product with glass particles has the potential to cause choking that could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections.

Recommendations

  • Consumers should not use the product lot listed above for patient care and should immediately return the product to their pharmacist or health care professional.

For More Information

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FDA Finds Main Ingredient Missing from Drug Product

Medisca has recalled specific lots of its L-citrulline, used to treat certain rare genetic disorders primarily diagnosed in children. FDA has received reports of health problems associated with potentially less potent L-citrulline. FDA tested samples from recalled lots of Medisca’s L-citrulline product, and found that the samples contain N-acetyl-leucine, which is used to treat a certain type of dizziness. No L-citrulline was found in the samples FDA tested.

Medisca supplies pharmacies nationwide with L-citrulline. The product is sold to pharmacies and clinics in containers filled with powdered L-citrulline, and it may be compounded into tablets, capsules, or liquids by pharmacies, or remain a powder. Testing by Medisca indicated that L-citrulline, lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D do not contain L-citrulline.

Risk: Less potent L-citrulline in patients with certain defects in the urea cycle (a process in which waste is removed from the body) lead to high ammonia levels, which may cause serious damage to the nervous system and can be potentially life-threatening.

Recommendations

  • Consumers should stop using any product with these lot numbers.

For More Information

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Drug Safety Labeling Changes

In January 2014, FDA required safety labeling changes to be made to 23 drug products, including medicine to treat high blood pressure, medicine to treat long-lasting hepatitis C, and a blood thinner that reduces the risk of stroke or blood clots.

The blood pressure drug, Cozaar, added warnings that include possible injury or death to a developing fetus. The hepatitis C drug, Victrelis, added new warnings about use and interactions with other drugs. The blood thinner, Xarelto, added warnings that include an increased risk of bleeding or blood loss.

For More Information

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

March 14, 2014

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Page Last Updated: 03/14/2014
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