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FDA's MedWatch Safety Alerts: October 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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Baby Wipes May Contain Bacteria

Nutek Disposables, Inc. is recalling all lots of baby wipes it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to Oct. 21, 2014, to the following retail stores: Walgreens, Sam's Club, Family Dollar, Fred's, and Diapers.com.

After receiving several complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of the bacteria Burkholderia cepacia (B. cepacia), in some of these products.

Risk: This bacteria poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. As of Oct. 3, 2014, the date of the original withdrawal, the company had received only one report of irritation. Numerous reports of complaints have since been received by the company that include rash, irritation, infections, fever, gastro-intestinal issues, and respiratory issues, though these reports have not been confirmed to be related to the use of these products.

Recommendations

  • Consumers should stop using this product immediately.
  • Consumers with questions may contact the company at 855-646-4351, Monday through Friday, 10 a.m. – 4 p.m. ET.

For More Information

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FDA Warns About Undeclared Drugs Found in Weight-Loss Product

FDA is advising consumers not to purchase or use Sit and Slim II, promoted and sold as a dietary supplement with weight loss claims. Sit and Slim II has been found to contain undeclared phenolphthalein, sibutramine or a combination of both, which makes it an unapproved drug. Sibutramine was a controlled, FDA-approved substance for the treatment of obesity until it was removed from the U.S. market in 2010 for safety reasons. Phenolphthalein, once used in over-the-counter laxatives, is also 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 this product immediately.

For More Information

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Possible Salmonella Contamination

Solace International, Inc. is recalling all lots of Dermatend Original and Dermatend Ultra, in all sizes and dosage forms. Dermatend Original and Dermatend Ultra products were promoted to remove moles, warts and skin tags. Consumers who purchased Dermatend Original and Dermatend Ultra to remove moles and warts should immediately discontinue use and consult their physician. Dermatend Original and Dermatend Ultra are packaged in flexible plastic tubes labeled with the product name in blue letters. All units and lots are affected by the recall.

Risk: Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, an infection of the exterior lining of the heart and arthritis.

Recommendations

  • Consumers who purchased these products should dispose of them immediately and may request a refund by calling 866-758-7222, Monday through Friday, 9:00 am – 5:00 p.m. CT.
  • Consumers who are experiencing any unusual or severe symptoms such as those described above should go to an emergency room immediately or contact their physician for immediate advice.

For More Information

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Pain Reliever Packaging Mix Up

Contract Packaging Resources, a drug repackaging company, is recalling 11,640 boxes of Assured brand Naproxen Sodium tablets because some cartons actually contain bottles of ibuprofen, a different pain reliever. The affected products are: boxes of Assured brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685] containing bottles of ibuprofen softgels in 200mg strength.

Risk: Consumers who intentionally avoid using ibuprofen due to allergy or other medical conditions, are advised that they may have inadvertently purchased ibuprofen 200mg softgels, believing it was Naproxen Sodium 220mg tablets. Allergic reactions can range from mild irritation or hives to serious reactions such as anaphylaxes that may be life-threatening. The firm has not received any reports of adverse events related to this recall.

Recommendations

  • Consumers may return the recalled products to the place of purchase or contact the firm by phone at 336-252-3422, on Monday – Friday from 8:00 a.m. – 4:00 p.m. ET.

For More Information

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Drug Safety Labeling Changes

In September 2014, FDA required safety labeling changes to be made to 55 drug products, including a chronic hepatitis C medicine, an arthritis tablet and a nicotine addiction treatment.

The changed labeling of the hepatitis C medicine, Pegasys, added warnings that include possible birth defects, fetal death and behavioral reactions. A warning added to the arthritis medicine, Arthrotec, states using Arthrotec with other non-steroidal anti-inflammatory drugs, such as aspirin, should be avoided. A warning for the nicotine addiction medication, Chantix, states that there have been reports of seizures and increased intoxicating affect while taking the drug.

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.

November 14, 2014

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Page Last Updated: 11/14/2014
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