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FDA's MedWatch Safety Alerts: November 2009

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

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 a few of the most recent safety alerts prompted by reports received by FDA from health care professionals and their patients.

 

Early Communication: Safety of Meridia

FDA is reviewing preliminary data from a recent study suggesting that people using the prescription drug Meridia (sibutramine) have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than those using a placebo (sugar pill).

FDA approved Meridia in 1997 for use, together with a reduced calorie diet, for the management of obesity. Meridia is only recommended for obese people with a body mass index (BMI) of 30 or greater, or BMI of 27 or greater with other risk factors such as diabetes, high cholesterol, or controlled high blood pressure. (To determine your BMI, see the BMI calculator.)

This information is part of FDA's effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. FDA will release its findings on Meridia as soon as it completes its review.

The risk: The preliminary data in a study of about 10,000 people show that cardiovascular events were reported in 11.4 percent of those using Meridia compared to 10 percent of those using a placebo. This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the people in the study.

Recommendation: Talk to your health care professional about whether Meridia is right for you.

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Recall: Pai You Guo, Marketed as a Dietary Supplement

Pai You Guo, a weight-loss dietary supplement, has been recalled because FDA
lab analyses found the product contains two undeclared drug ingredients:

  • sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss
  • phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States

FDA has not approved the Pai You Guo product as a drug; therefore, its safety and effectiveness are unknown. The product is sold in either a box of 30 capsules or a 10-gram (g) bag of powder. The affected products were sold and distributed nationwide via the Internet.

The risk: Sibutramine is known to substantially increase blood pressure or pulse rate in some people, and may present a significant risk for individuals with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Phenolphthalein is a suspected cancer-causing agent.

Recommendation: Destroy the products or return them to GMP Herbal Products Inc. (See How to Dispose of Unused Medicines.) For more information, call GMP Tuesday through Saturday at 866-995-8585.

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Recall: Vicks Sinex Nasal Spray

One lot of over-the-counter Vicks Sinex Nasal Spray in the United States has been recalled, along with two other lots in Germany and the United Kingdom.

The recalled U.S. product is Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml, Nasal Spray, lot number 9239028831.

The risk: The bacteria B. cepacia was found in a small amount of the drug made at the manufacturer’s German plant. There have been no reports of illness; however, the bacteria could cause serious infections for people who have a compromised immune system or those with chronic lung conditions, such as cystic fibrosis.

Recommendations:

  • Check to see if you have the U.S. recalled product. The lot number is listed on both the outer carton and the bottle.
  • If you have the recalled product, throw it away. (See How to Dispose of Unused Medicines.)
  • You may call the manufacturer, Procter & Gamble Company, for a replacement coupon or refund at 877-876-7881.

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Unapproved Drugs: RockHard Weekend and Stiff Nights

Two products sold as dietary supplements contain sulfoaildenafil, a form of an FDA-approved drug used as a treatment for erectile dysfunction. The affected products are

  • RockHard Weekend, sold nationwide in single blister packs, and in 3-count and 8-count bottles. This product has been recalled.
  • Stiff Nights, distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Mich. The product is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.

The risk: The presence of sulfoaildenafil makes RockHard Weekend and Stiff Nights unapproved drugs. The undeclared drug ingredient, sulfoaildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Recommendations:

  • If you have unexpected side effects from sexual enhancement products, contact your health care professional.
  • You may return any unused RockHard Weekend for a full refund to RockHard Laboratories; call 800-562-0543 for instructions.

For more information, see Hidden Risks of Erectile Dysfunction "Treatments" Sold Online.

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Recall: Dietary Supplements sold by IDS Sports and Bodybuilding.com

Dietary supplements sold by two companies have been recalled because the products contain undeclared substances that FDA considers to be steroids.

IDS Sports’ recalled products are

  • Bromodrol
  • Dual Action Grow Tabs
  • Grow Tabs
  • Mass Tabs
  • Ripped Tabs TR

The recalled products were distributed in either black boxes containing blister packs of 60 capsules or white bottles with black labels containing 30 or 60 capsules.

Bodybuilding.com’s recalled products include all lots and expiration dates of 65 dietary supplements listed in the company’s press release.

The risk: Severe liver injury is known to be a possible harmful effect of using products that contain steroids. Steroids may cause other serious long-term adverse health consequences in men, women, and children, such as

  • shrinkage of the testes and male infertility
  • development of male sexual characteristics in women
  • breast enlargement in males
  • less than normal height in children
  • a higher predisposition to misuse other drugs and alcohol
  • harmful effects on blood fat (lipid) levels
  • increased risk of heart attack, stroke, and death

Recommendations:

  • Stop using the recalled products immediately.
  • Call your health care professional if you have had any problems that may be related to using these products.
  • Return any unused products from Bodybuilding.com to the company. Call 866-236-8417 or e-mail service@bodybuilding.com for instructions.

For more information, see the video and consumer update, Warning on Body Building Products Marketed As Containing Steroids or Steroid-Like Substances.

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Early Communication: Safety of Negative Pressure Wound Therapy Systems

FDA has received reports of six deaths and 77 injuries associated with Negative Pressure Wound Therapy (NPWT) systems over the past two years.

NPWT systems help to heal open wounds by applying negative pressure (a vacuum) to the wound in order to remove fluids and infectious materials and to draw wound edges together.

Recommendations:

If your doctor has determined that you are a good candidate for using NPWT at home, you or your caregiver should

  • Receive adequate training from your doctor, nurse, or home health care provider so that you understand how to use your NPWT device. Demonstrate to your trainer how to use the device to make sure you are using it properly.
  • Understand the possible complications that may be associated with using your NPWT device. Watch especially for bleeding, which can be life-threatening. If you see signs of bleeding, get medical help right away.
  • Get NPWT patient instructions (labeling) from your doctor, home health care provider, NPWT distributor, or the manufacturer’s Web site. Keep these instructions where you can easily find them.
  • Talk to your health care professional if you do not feel capable of managing the NPWT device at home.

For a full consumer update, see Negative Pressure Wound Devices Draw FDA Notice, Advice.

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Potential Failure of Powerheart and CardioVive Automated External Defibrillators

Cardiac Science Corp. has received multiple complaints related to defective components in some of its automated external defibrillators (AEDs). These devices may not deliver electric shocks, and the devices’ self-test may not detect the defect in advance of their use.

The affected devices are the following models of the G3 series, which were manufactured between August 2003 and August 2009:

  • Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E
  • CardioVive 92531, 92532 , and 9253

These devices are used for emergency treatment of victims with symptoms of sudden cardiac arrest who are unresponsive and not breathing. The devices may be found in public buildings, airports, and other facilities, and are also used by emergency response personnel in hospitals and ambulances.

Recommendations:

  • If alternate AEDs are available, use those AEDs until the Cardiac Science Corp.’s AEDs have been repaired or replaced, or consider obtaining another AED.
  • Contact the company immediately to arrange for repairs or replacements. In the U.S., call 425-402-2000 (press option 1); outside the U.S., call +44-161-926-0011; or e-mail AED175@cardiacscience.com.
  • If an alternate AED is not available, use the Powerheart and CardioVive AEDs if needed, as the units may still be able to deliver the necessary treatment. The consequences of not attempting to defibrillate a patient outweigh the risk that these devices may fail.

FDA continues to investigate this problem and will make available any new information that might affect the use of these AED devices.

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Plavix and Prilosec Drug Interaction

FDA has new data showing that when Prilosec (omeprazole) and Plavix (clopidogrel) are taken together, the effectiveness of Plavix is reduced by almost half. Taking the two medications at different times will not reduce this drug interaction.

Plavix is used to prevent blood clots in people at risk for heart attacks or strokes. Prilosec is available by prescription and as an over-the-counter medication to treat frequent heartburn.

Other drugs that may also reduce the effectiveness of Plavix and should be avoided when taking Plavix include both prescription and non-prescription (over-the-counter) products:

  • cimetidine (such as Tagamet)
  • fluconazole (such as Diflucan)
  • ketoconazole (such as Ketozole, Nizoral, Extina, Xolegel)
  • voriconazole (such as Vfend)
  • etravirine (such as Intelence)
  • felbamate (such as Felbatol)
  • fluoxetine (such as Prozac, Sarafem, Symbyax)
  • fluvoxamine (such as Luvox)
  • ticlopidine (such as Ticlid)

Recommendations:

  • Talk to your health care professional if you use Plavix and are currently taking or considering taking Prilosec. He or she may suggest other available medications to reduce stomach acid.
  • Talk to your health care professional about any prescription or over-the-counter drugs you are taking before starting or while using Plavix.

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

Date Posted: December 1, 2009

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For more about food, medicine, cosmetic safety and other topics for your health, visit FDA.gov/ForConsumers.
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