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FDA’s MedWatch Safety Alerts: August 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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Undeclared Ingredients Found in Appetite Control Capsules

FDA tests have found that Regeneca Worldwide’s RegeneSlim products contain DMAA. DMAA, also known as geranium extract, is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. Lot numbers #823230415, lot #EX0616r 15813, Lot # EX0616R15814, and Lot #11414re5516are being recalled.

RegeneSlim is distributed through direct sales within the United States and Puerto Rico, and through online sales. RegeneSlim is packaged in green and white packets that contain 2 capsules, with the name RegeneSlim displayed prominently on the front.

Risk: FDA has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, an irregular heartbeat, tightening in the chest, and heart attack.

Recommendations

  • Consumers should not purchase or use the recalled RegeneSlim lot numbers.
  • Consumers who have experienced any negative side effects while taking this product should consult a health care professional.
  • Consumers with questions may contact the company at 1-949-281-2600 from Monday – Friday, 9 a.m. to 6 p.m. PDT.

For More Information

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Undeclared Drug Ingredient Found in a Sexual Enhancement Product

FDA is advising consumers not to purchase or use Herbal Vigor Quick Fix, a product sold for sexual enhancement. FDA laboratory analysis confirmed that Herbal Vigor Quick Fix contains tadalafil, the active ingredient in the FDA approved prescription drug Cialis, used to treat erectile dysfunction. This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Herbal Vigor Quick Fix is promoted and sold on various websites and in some retail stores.

Risk: This undeclared ingredient 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. Tadalafil can also cause side effects such as headaches and reddening of the skin.

Recommendations

  • Consumers should not use or purchase Herbal Vigor Quick Fix.

For More Information

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Undeclared Drug Ingredient Found in Sexual Enhancement Product

FDA is advising consumers not to purchase or use Arize, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that Arize contains sulfoaildenafil. Sulfoaildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for erectile dysfunction. Arize is promoted and sold for sexual enhancement on various websites and in some retail stores.

Risk:This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

  • Consumers should stop using these products immediately.
  • 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

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Drug Safety Labeling Changes

In July 2014, FDA required safety labeling changes to be made to 73 drug products, including a medication to treat irritable bowel syndrome, and a treatment for postmenopausal osteoporosis in women.

The label of the IBS medication, Linzess, added boxed warnings about the risks of pediatric use and cautions to avoid use of Linzess in pediatric patients 6 through 17 years of age. The label of the postmenopausal osteoporosis medication, Fortical Nasal Spray, was added a warning for hypocalcemia. Hypocalcemia is the presence of low serum calcium levels in the blood, and leads to muscle cramps, twitching and seizure activity.

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.

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

September 17, 2014

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Page Last Updated: 09/17/2014
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