For Consumers

FDA’s MedWatch Safety Alerts: April 2014

MedWatch Logo

Red envelope icon for Govdelivery Get Consumer Updates by E-mail

RSS feed orange symbol Consumer Updates RSS Feed

 On This Page:

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.

back to top 

FDA Warns Undeclared Drugs Found in Weight Loss Pills

FDA tests have found that Zi Xiu Tang Bee Pollen products contain phenolphthalein and/or sibutramine. Zi Xiu Tang Bee Pollen is manufactured by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd., in China. Sibutramine is a controlled substance that FDA previously approved for the treatment of obesity. Sibutramine was removed from the U.S. market in 2010 for safety reasons, making these dietary supplements an unapproved drug. Phenolphthalein, once used in over-the-counter laxatives, is not approved for marketing in the U.S.

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

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. Consumption of these pills could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.

The FDA is investigating the distribution of Zi Xiu Tang Bee Pollen products in the United States and may issue warning letters or take enforcement action, such as seizures, injunctions and/or criminal charges.

Recommendations

  • Consumers who have purchased these products should stop using them immediately.
  • Consumers who have experienced any negative side effects while taking this product should consult a health care professional.

For More Information

back to top 

Public Notification: Weight-Loss Supplement Contains Undeclared Substance

FDA is advising consumers not to buy or use Infinity, a weight-loss supplement. The product tested positive for sibutramine, a controlled substance that FDA previously approved for the treatment of obesity. Sibutramine was removed from the U.S. market in 2010 for safety reasons, making these dietary supplements 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.

The products were distributed nationwide via retail stores and the Internet.

Recommendations

  • Consumers should stop using the product immediately. 

For More Information

back to top 

Public Notification: Sexual Enhancement Products Contain Undeclared Ingredients

FDA is advises against using S.W.A.G, a product sold online and in some retail stores for sexual enhancement. FDA lab tests show that the product contains sildenafil, an active ingredient in the FDA-approved prescription drug Viagra.

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.

Recommendations

  • Consumers should stop using the product immediately and throw it away.
  • Consumers should contact their health care professional if they have experienced any problems that may be related to taking or using these drug products.

For More Information

Recall: Undeclared Drugs Found in Pain Relief Capsules

Nano Well-being Health Inc. announced a recall of Super Arthgold pills for pain management. The product has been found to contain the active pharmaceutical ingredients chlorzoxazone, diclofenac and indomethacin, making it an unapproved drug. Super Arthgold is marketed as a dietary supplement for joint pain and arthritis. The product comes in bottles of 120 pills and was distributed nationwide.

Risk: Chlorzoxazone, indomethacin and diclofenac may cause unexpected side effects or an allergic reaction because the ingredients are not listed on the product. Diclofenac is a nonsteroidal anti-inflammatory drug and patients may already be taking a product in this class, increasing the risk of heart attack and stroke, ulcers, bleeding, or holes in the stomach or intestine. These problems can develop without symptoms and can cause death.

The recall includes the following lots:

L1P1-6100/Expiration date June 25, 2016

L1P2-6000/Expiration date Sept. 16, 2016

Recommendations

  • Consumers should stop using these products immediately and contact a health care professional if they have experienced any problems related to use of these pills.
  • Consumers with questions regarding this recall can contact Nano Well-being Health Inc. at 714-515-4600, Monday – Friday 10:00 a.m. to 5:00 p.m. PT., or e-mail at nanowellbeingh@gmail.com.

For More Information

back to top 

Drug Safety Labeling Changes

In March 2014, FDA required safety labeling changes to be made to 30 drug products, including a medicine used to treat seizure disorders and to prevent migraine headaches, and an estrogen spray.

The seizure medication Stavzor added warnings that include fatal liver problems. The estrogen spray Evamist added reactions that include rash, skin and nipple discoloration.

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

back to top

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

May 29, 2014

back to top 

Page Last Updated: 06/03/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.