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FDA’s MedWatch Safety Alerts: May 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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FDA Warns Undeclared Drugs Found in Weight Loss Pills

FDA tests have found that Slim Trim U products contain sibutramine. Sibutramine is a controlled substance that FDA previously approved for the treatment of obesity, but it was removed from the U.S. market in 2010 for safety reasons, and its use in these dietary supplements makes them an unapproved drug.

The products are sold via the Internet, retail stores, spas and fitness centers. In addition, the products have been promoted by licensed health care professionals.

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.

Recommendations

  • Consumers should not purchase or use Slim Trim U.
  • Consumers who have experienced any negative side effects while taking this product should consult a health care professional.

For More Information

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Sleep Aid Drug Can Cause Next-Day Impairment

FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. FDA recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. FDA approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic eszopiclone products will also be updated to include these changes.

Risk: A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary in the Drug Safety Communication). Lunesta users were often unaware they were impaired. The recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.

Recommendations

  • Consumers should continue taking their prescribed dose of Lunesta but ask their health care professionals about the most appropriate dose for them.
  • Health care professionals should follow the new dosing recommendations when starting consumers on Lunesta.

For More Information

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Recall: Dietary Supplements Contain Undeclared Drug Ingredients

Eugene Oregon, Inc. is recalling the following products: African Black Ant, Black Ant, and Mojo Risen. FDA lab tests show that these products contain tadalafil and/or sildenafil, an active ingredient in the FDA-approved prescription drugs Cialis and Viagra. Cialis and Viagra are used to treat erectile dysfunction.

Risk:These undeclared ingredients may interact with nitrates found in some prescription drugs—such as nitroglycerin, used to treat chest pain—and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. Sildenafil and tadalafil can also cause side effects such as headaches and reddening of the skin.

Recommendations

  • Consumers should stop using these products immediately and can return the products to Eugene Oregon, Inc.
  • Consumers with questions regarding this recall can contact Eugene Oregon, Inc. by telephone at 1-800-538-3411, from Monday – Friday, 9:00 a.m. to 5:00 p.m. ET.
  • Consumers should contact their health care professional if they have experienced any problems that may be related to using these drug products.

For More Information

Undeclared Drugs Found in Weight Loss Products

FDA laboratory tests found that Asset Bee Pollen contains sibutramine. Sibutramine is a controlled substance that FDA previously approved for the treatment of obesity, but it was removed from the U.S. market in 2010 for safety reasons, and its use in these dietary supplements makes them an unapproved drug.

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.

Recommendations

  • Consumers should not to purchase or use Asset Bee Pollen and contact a health care professional if they have experienced any problems related to use of this product.

For More Information

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Drug Safety Labeling Changes

In April 2014, FDA required safety labeling changes to be made to 53 drug products, including several extended release - long acting opioid painkillers, an erectile dysfunction and enlarged prostate medicine, and a medicine used to treat migraines.

The labels of multiple extended release – long acting opioid analgesics added boxed warnings about the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. The labels of erectile dysfunction and enlarged prostate medication added warnings that include decreased and permanent loss of vision. The migraine medication labels added warnings that include severe skin reactions.

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.

June 18, 2014

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Page Last Updated: 06/18/2014
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