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FDA's MedWatch Safety Alerts: January 2010

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.

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Albuterol Inhalers: Time to Transition

Albuterol is a quick-relief medication that's used to open up the airways so that it's easier to breathe. The medication is used by people with certain airway diseases, such as asthma and chronic obstructive pulmonary disease (COPD), a group of lung diseases that includes chronic bronchitis and emphysema. One method of delivering albuterol is the metered dose inhaler, a hand-held device that delivers a specific amount of medication directly into the lungs. Traditionally, inhalers have contained...

Read the Albuterol Inhalers: Time to Transition article > >

  • Online 1
  • Regular Mail: Use postage-paid, pre-addressed FDA form 35002
  • 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 threetimes 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 photos3).

To read a full consumer update article, see “Warning: Counterfeit Alli4.”

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 photos5.

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.

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