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FDA's MedWatch Safety Alerts: July 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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Weight Loss Product Contains Undeclared Ingredient

FDA is advising consumers not to purchase or use Mix Fruit Slimming, Lingzhi Cleansed Slim Tea, 24 Ince, Lipo 8 Burn Slim Capsules, Sliming (sic) Diet By Pretty White, and Trim-Fast Slimming Softgel, products promoted and sold for weight loss. The product has been found to contain undeclared phenolphthalein, sibutramine or a combination of both, which makes it an unapproved drug. Sibutramine is a controlled, FDA-approved substance for the treatment of obesity which was removed from the U.S. market in 2010 for safety reasons. 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 the consumer may be taking. Consumption of these pills could also cause potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

Recommendations

  • Consumers should stop using these products immediately.

For More Information

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Drug Alert: Lack of Sterility Assurance

The FDA is alerting health care professionals and consumers not to use drugs marketed as sterile and produced by Downing Labs LLC, also known as NuVision Pharmacy, in Dallas, because they may be contaminated. FDA investigators inspected NuVision facility and observed insanitary conditions that result in a lack of sterility assurance of the company’s purportedly sterile drug products, which puts patients at risk. The inspection revealed sterility failures in 19 lots of drug products intended to be sterile; endotoxin failures in three lots of drug products; and inadequate or no investigation of these failures. NuVision’s products were distributed nationwide. Most of the product labels include: NuVision Pharmacy, Dallas TX. 75244 1-800-914-7435.

Risk: Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure, and in other circulatory functions. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

Recommendations

  • Consumers who have received any drug product produced by NuVision and have concerns should contact their health care professional.

For More Information

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Recall: Visible Particles Found in Anesthetic

FDA is warning consumers of a recall by Hospira, Inc.of a lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-dose Vial, Preservative-Free due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide.

Lidocaine is packaged 10 units per carton /180 units per case in single-dose glass fliptop vials. This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from June 2013 through July 2013. The affected lot bears number25-550-DD, expiring 1JAN2015 and NDC 0409-2066-05.

Risk:An undetected particle - depending on its size and number -- could block the administration of the drug to the patient, causing a delay in therapy. Particulates may be able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.

Recommendations

  • Consumers should immediately stop using and quarantine any affected product.
  • Consumers can call Stericycle at1-855-827-6586 Mon. – Fri. 8 a.m. until 5 p.m. ET.

For More Information

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Drug Safety Labeling Changes

In June 2014, FDA required safety labeling changes to be made to 52 drug products, including a testosterone and a cancer medicine.

The changed labeling of the testosterone products added warnings that include formations of a blood vessel clot that breaks loose and is carried by the blood stream to plug another vessel. The labeling of the cancer medicine, Sutent capsules, added a warning of kidney filtering problems.

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

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

August 19, 2014

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Page Last Updated: 08/20/2014
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