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FDA's MedWatch Safety Alerts: September 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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Risk of Lead Poisoning from Cold Therapy

FDA warns parents and caregivers not to use “Bo Ying compound” manufactured by Eu Yan Sang (Hong Kong) Ltd. due to the potential lead poisoning risk associated with the product.

FDA learned of this risk from the New York City Department of Health & Mental Hygiene after the product was tested and found to contain high levels of lead. FDA has received one adverse event report of lead poisoning in an 18-month-old child who was given this product. The powdered product is marketed in retail outlets and online for use in infants and children for treatment of a variety of conditions including influenza, fever, sneezing, and nasal discharge. The product is labeled in Chinese and English.

Risk: Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.


  • Consumers are advised to not purchase or use this product.
  • Anyone using this product or providing it to a child should immediately consult a health care professional.

For More Information

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Updated Drug Alert: Lack of Sterility Assurance

The FDA has issued a formal request to Downing Labs for an immediate recall of all lots of its purportedly sterile products currently on the market that are not expired. In the letter, the FDA outlined the practices and facility conditions that raise concerns about the sterility assurance of drug products made at the Downing Labs facility.

FDA investigators inspected the firm’s NuVision facility in Dallas, Texas in July, and observed insanitary conditions that result in a lack of sterility assurance that 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, which are substances found in certain bacteria, cause a wide variety of serious reactions such as fever, shock, and changes in blood pressure and 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.


  • 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 of Mole Product Causes Safety Concerns

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:A mole should be removed under the supervision of a dermatologist. Dermatend is not FDA approved, and has not been shown to be safe and effective for the uses suggested in the labeling. Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer.


  • Consumers should immediately stop using these products and consult their physician.
  • Consumers can call Solace International, Inc. at 1-775-323-1413 Mon. – Fri. 8 a.m. until 5 p.m. PT.

For More Information

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Drug Safety Labeling Changes

In In August 2014, FDA required safety labeling changes to be made to 32 drug products, including an anti-blood clotting medicine, a severe pain treatment and a migraine drug.

The changed labeling of the anticoagulant medicine, Eliquis, added warnings that include possible formation of blood vessel clots if a patient has stopped taking it without medical consent. A warning added to the pain medicine states the prolonged use of Zohydro ER during pregnancy can result in neonatal opioid withdrawal syndrome in newborns. This may be life-threatening if not recognized and treated. A warning for the migraine drug, Axert states that overuse of migraine medication may lead to medication overuse headaches. These headaches can occur when migraine medication is used more than 10 days per month.

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.

October 14, 2014

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Page Last Updated: 10/14/2014
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