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U.S. Department of Health and Human Services

For Consumers

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FDA's MedWatch Safety Alerts: January 2010

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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.

 

Beware of Counterfeit Weight-Loss Drug, Alli

Counterfeit Alli 60 mg capsules (120-count refill kit) are being sold over the Internet. FDA laboratory tests showed that the counterfeit Alli has a different active ingredient, a stimulant found in a prescription weight-loss drug. People using the counterfeit Alli may be taking three times the usual daily dose of the stimulant if they are following the dosing directions for Alli, and may be at risk for a stroke or heart attack. The counterfeit Alli looks similar to the authentic product, with a few notable differences (see photos).

To read a full consumer update article, see “Warning: Counterfeit Alli.”

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Recall: Over-The-Counter Products From McNeil Consumer Healthcare

A December 2009 recall of a Tylenol product has been expanded to include other other-the-counter medications distributed by McNeil Consumer Healthcare.

The recalled products include some forms of the following brand names:

  • Tylenol
  • Motrin
  • Benadryl
  • Rolaids
  • Simply Sleep
  • St. Joseph

See the McNeil Web site for a full list of the recalled products, lot numbers, and photos.

Some previously recalled products were reported to have an unusual moldy, musty, or mildew-like odor that was related to nausea, stomach pain, vomiting, and diarrhea. The odor is caused by a compound believed to result from the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.

McNeil has now applied broader criteria to identify and remove all product lots that it believes may be potentially affected, even if there are no consumer complaints about them.

The risk: The health effects of the compound believed to cause the symptoms have not been well studied. To date, all of the observed events reported were temporary and not serious.

Recommendations:

  • If you purchased a recalled product, stop using it.
  • Contact McNeil Consumer Healthcare at 888-222-6036 or at www.mcneilproductrecall.com for instructions on how to get a refund or replacement, and how to return or dispose of the product.
  • Contact your health care professional if you have medical concerns or questions.

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Recall: Insulin Syringes

Nipro Medical Corp. has recalled all GlucoPro Insulin Syringes with expiration dates before 2011-11 (November 1, 2011). The recall does not include the GlucoPro syringe specific for use with the Amigo Insulin pump.

The risk: These syringes may have needles that detach from the syringe. The needles can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.

Recommendations:

  • Stop using GlucoPro Insulin Syringes and return them to the place of purchase for reimbursement.
  • If you have questions, call Nipro Medical Corp. at 305-599-7174, ext. 249.

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Recall: HAPPYTOT and HAPPYBABY Pouch Meals

Nurture Inc. has recalled selected varieties and date codes of HAPPYTOT Stage 4 and HAPPYBABY Stage 1 and Stage 2 pouch meals with date codes expiring between October 2010 and January 2011. The meals are packaged in plastic pouches with plastic caps (see photos).
The recalled products (with UPC codes) are

  • HAPPYTOT Green bean, pear & peas, NET WT. 4.22 OZ. (120g), UPC 8 52697 00127 9
  • HAPPYTOT Sweet potato, carrot, apple & cinnamon, NET WT. 4.22 OZ. (120g), UPC 8 52697 00128 6
  • HAPPYTOT Spinach, mango & pear, NET WT. 4.22 OZ. (120g), UPC 8 52697 00129 3
  • HAPPYTOT Butternut squash & apple, NET WT. 4.22 OZ. (120g), UPC 8 52697 00130 9
  • HAPPYTOT Banana, peach, coconut & prunes, NET WT. 4.22 OZ. (120g), UPC 8 52697 00131 6
  • HAPPYTOT Banana, peach & mango, NET WT. 4.22 OZ. (120g), UPC 8 52697 00132 3
  • HAPPYBABY Mango, NET WT. 3.5 OZ. (99g), UPC 8 52697 00134 7
  • HAPPYBABY Spinach Mango Pear, NET WT. 3.5 OZ. (99g), UPC 8 52697 00139 2
  • HAPPYBABY Apricot Sweet Potato, NET WT. 3.5 OZ. (99g), UPC 8 52697 00136 1

The risk: A packaging defect could cause contamination with bacteria, possibly leading to illness.

Recommendations:

  • To find out if a specific product is part of this recall, examine the product packaging for expiration date codes between October 2010 and January 2011. These date codes are printed as the first seven characters of a 15-character string.
  • If anyone in your family has become sick after eating these products, call your health care professional immediately and report the illness to FDA's Consumer Complaint Coordinator for your geographic area and to the company, Nurture Inc., at 212-374-2779.
  • If you see swelling, leaking, or packaging problems in any HAPPYTOT Stage 4 or HAPPYBABY Stage 1 or Stage 2 pouched baby food product, throw it out in a way that will keep children and pets from getting into it. Wash your hands thoroughly after handling the packages.

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Meridia Risky for People With Heart Disease

The label of the weight-loss drug Meridia (sibutramine) will include new information stating that the drug is not to be used in people with a history of disease involving the heart or blood vessels (cardiovascular disease), including

  • coronary artery disease (for example, heart attack or angina)
  • stroke or mini-stroke (transient ischemic attack, or TIA)
  • slow, fast, or irregular heartbeat (heart arrhythmia)
  • congestive heart failure
  • plaque build-up in the arteries (peripheral arterial disease)
  • uncontrolled high blood pressure (for example, greater than 145/90 mmHg)

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.)

The risk: FDA’s review of data indicates an increased risk of heart attack and stroke in people using Meridia who have a history of cardiovascular disease.

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

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

Date Posted: February 3, 2010

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