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FDA's MedWatch Safety Alerts: June 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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Topical Pain Reliever Should Not Be Used on Teething Infants

The FDA is warning parents that prescription drugs such as viscous lidocaine are not safe for treating teething in infants or young children. These products have harmed some children who used them. Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby's mouth within minutes.

FDA has previously recommended that parents and caregivers not use benzocaine products for children younger than 2 years, except under the advice and supervision of a health care professional. Benzocaine—which, like viscous lidocaine, is a local anesthetic—can be found in such OTC products as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase.

Risk: Use of these products can result in seizures, severe brain injury, and heart problems. The use of benzocaine gels and liquids for mouth and gum pain can lead to a rare but serious—and sometimes fatal—condition called methemoglobinemia, a disorder in which the amount of oxygen carried through the blood stream is greatly reduced. And children under 2 years old appear to be at particular risk.

Recommendations

  • Consumers should stop using these products immediately.
  • Use a teething ring chilled in the refrigerator (not frozen).
  • Gently rub or massage the child’s gums with your finger to relieve the symptoms.

For More Information

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Over-The-Counter Topical Acne Products May Cause Hypersensitivity Reactions

The FDA is warning that the use of certain acne products containing the active ingredients benzoyl peroxide or salicylic acid can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. The over-the-counter (OTC) topical (applied directly to the skin) acne products of concern are marketed under brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands. They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.

Based on the information reported to FDA, it cannot be determined if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both. FDA is continuing to monitor and evaluate this safety issue.

Risk: Hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue may occur with use. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use.

These serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, and that are already included in the Drug Facts labels.

Recommendations

  • Before using an OTC topical acne drug product for the first time, apply a small amount to one or two small affected areas for 3 days to make sure you don’t develop any hypersensitivity symptoms. If no discomfort occurs, follow the directions on the Drug Facts label.

For More Information

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Recall: Undeclared Drug Found in Supplement to Treat High Cholesterol

Doctor’s Best Red Yeast Rice has been found to contain undeclared lovastatin, which makes the product an unapproved drug. Lovastatin is a prescription drug for the treatment of high cholesterol. As a result Doctor’s Best is recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles.

Doctor’s Best Red Yeast Rice was distributed nationwide through retail and internet outlets. The product is marketed as a dietary supplement for lowering cholesterol and is packaged in white plastic bottles with an orange flip-top lid, and a clear tamper-evident outer seal. UPC code 753950001183 and expires February 2017.

Risk:Consumers who use supplements found to contain lovastatin in rare cases could experience serious muscle injury, particularly if taking with prescription “statins” such as lovastatin, simvastatin, or atorvastatin. Statins are a class of drug commonly used to lower cholesterol. Patients with pre-existing liver disease may be at an increased risk for liver injury following chronic use of statins.

Recommendations

  • Consumers should stop using any product with lot number 3121005.
  • Consumers with questions regarding this recall can contact Doctor’s Best at 1-844-717-0190 Mon. – Fri. 9 a.m. until 5 p.m. PT.
  • Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For More Information

FDA Warns about Undeclared Drugs Found in Weight Loss Product

FDA is advising consumers not to purchase or use La Jiao Shou Shen, a product 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. Sibutramine 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 this product immediately.

For More Information

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Drug Safety Labeling Changes

In May 2014, FDA required safety labeling changes to be made to 37 drug products, including a sleep aid and a breast cancer medicine.

The sleep aid, Lunesta, added warnings that include the risk of increased next-day impairment if the pill is taken with less than a full night of sleep. The breast cancer medicine, Aromasin (exemestane) tablets, added warnings that include an increased risk of osteoporosis (decreased bone density).

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.

July 11, 2014

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Page Last Updated: 07/11/2014
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