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U.S. Department of Health and Human Services

For Consumers

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FDA's MedWatch Safety Alerts: August 2010

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After the Food and Drug Administration (FDA) approves a product and it is on the market, the agency continues to monitor that product for unexpected and undesirable side effects (adverse events).

Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • Fax: 1-800-FDA-0178
  • Phone: 1-800-332-1088

MedWatch reports can signal a safety problem and lead to an FDA action to protect the public from harm, serious illness, or even death.

Here are some of the most recent safety alerts prompted by reports FDA has received from health care professionals and patients.

Risky Sexual Enhancers

Prolatis, Novacare LLC Products, Mr. Magic Male Enhancer, TimeOut Capsules, and Revivexxx Extra Strength, marketed as dietary supplements for sexual enhancement, contain undeclared ingredients. Novacare LLC Products are sold under the names of Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear).

The undeclared chemicals in these products may lower blood pressure to dangerous levels if taken with nitrate-containing prescription drugs, such as those used to treat diabetes, high cholesterol, and other conditions.

Recommendations

  • Stop using these products immediately.
  • If you have experienced any bad side effects while using these products, report them to your health care professional.

For More Information

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Dangerous Weight Control Pills

Solo Slim and Solo Slim Extra Strength products contain an undeclared ingredient to reduce appetite that should be used only in drugs prescribed by a doctor. The ingredient may present a significant health risk for patients with a history of various heart diseases.

Recommendations

  • Stop using these products immediately, and return them to the store for a refund.
  • If you have experienced any bad side effects while using these products, report them to your health care professional.

For More Information

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Poorly Performing Tourniquets

Suspected counterfeit Combat Application Tourniquets (C-A-T®) have a weak tension rod that breaks or bends before the strap can be sufficiently tightened to stop the blood flow.

The resulting excessive blood loss can endanger the victim’s life and ultimately lead to death.

Recommendations

  • Use only C-A-T® tourniquets manufactured by Composite Resources and purchased from an authorized distributor.
  • If you have C-A-T® tourniquets you suspect may be counterfeit, replace them with the genuine devices.
  • If you suspect your tourniquet is counterfeit, contact FDA’s Office of Criminal Investigations (OCI): Alex Alvarado, special agent - (240) 276-9407.

For More Information

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Infected Blood-Testing Devices

There has been an increase in blood infections (mostly of hepatitis B) transmitted by reusable fingersticks and other skin-puncturing devices such as blood glucose meters, anticoagulation meters, and cholesterol testing devices that are used to draw small blood specimens for testing. When used on more than one patient, these devices may not be safe because it is difficult to clean and disinfect them enough to remove all of the blood.

Recommendation

  • Blood-lancing devices should be used only by one patient and should not be shared.
  • If that's not feasible, the devices should be thoroughly cleaned and disinfected as described in the labeling.

For More Information

Fingerstick Devices To Obtain Blood Specimens -- Initial Communication -- Risk of Transmitting Blood Pathogens

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

Posted September 2010

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