For Consumers

FDA's MedWatch Safety Alerts for Consumers: November 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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Dietary Product Contains Prescription Antihistamine

FDA laboratory analysis found that Mayhem, a product labeled as a dietary supplement that is promoted to increase appetite and muscle growth, contains dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment. Mayhem is manufactured by Chaotic-Labz and is sold in some retail stores and on various websites.

Risk: Consumers are advised that corticosteroid use can impair a person’s ability to fight infections, cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal glands and cause withdrawal symptoms with abrupt discontinuation. Antihistamines may cause drowsiness and affect mental alertness. In addition, these undeclared drug ingredients in Mayhem may cause serious side effects when combined with other medications.

Recommendations

  • Consumers are urged to immediately consult with their health care provider to safely discontinue use of this product. This risk of withdrawal from corticosteroids should be assessed by a health care professional.

For More Information

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Undeclared Drug Ingredient in Weight Loss Supplement

FDA is advising consumers not to purchase or use V26 Slimming Coffee, promoted and sold as a weight-loss supplement. V26 Slimming Coffee has been found to contain undeclared sibutramine, 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.

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.

Recommendations

  • Consumers should stop using this product immediately.

For More Information

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Children's Supplement Carries Risk of Infection

FDA is alerting the public that Solgar, Inc. is recalling ABC Dophilus Powder due to possible contamination. Tests by the Centers for Disease Control and Prevention found in containers of Solgar ABC Dophilus Powder Rhizopus oryzae, a fungus that may cause Mucormycosis. This is a rare infection that may cause health problems to consumers, particularly pre-mature infants/infants, children, and those with weakened immune systems. It may also occur rarely in people who are otherwise healthy. Product recalled has UPC Code: 0 33984 00010 0; Lot# 074024-01R1, 074024-01, 074024-02; Expiration Date 7/31/15.

Risk: Factors that favor the development of this rare infection include: uncontrolled diabetes; cancer; organ transplant; neutropenia (low white blood cells); skin trauma (cuts, scrapes, punctures, or burns).

Recommendations

  • Consumers who purchased a product with the above lot number and expiration date should dispose of it immediately.

For More Information

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Supplement Contains Undeclared Ingredient

FDA is advising consumers not to purchase or use Black Storm sex pills. FDA laboratory analysis confirmed that Black Storm contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED).

Risk: These pills 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 this product immediately.

For More Information

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Drug Safety Labeling Changes

In October 2014, FDA required safety labeling changes to be made to 37 drug products, including a depression medication and a medication to treat a lack of red blood cells in the body.

The changed labeling of the depression medication, Cymbalta, added a warning that antidepressants increased in short-term studies the risk of suicidal thoughts and behavior in children, adolescents, and young adults. A warning added to the medication used to treat the lack of red blood cells, known as anemia, states there is an increased risk of death, stroke or heart attack while using this medicine.

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.

December 12, 2014

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