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FDA's MedWatch Safety Alerts: October 2012

Posted Nov 29 2012 11:35am

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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 medical 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.

  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500 (http://www.fda.gov/medwatch/report.htm)
  • Fax: 800-FDA-0178
  • Phone: 800-332-1088

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.

 

Several updates were posted on MedWatch in October related to the outbreak of fungal meningitis associated with sterile injectable drugs produced by the New England Compounding Center (NECC) in Framingham, Mass. To help inform medical facilities and health care professionals about NECC products shipped to them since May 21, 2012, FDA made available two lists of customers who received products after that date, one organized by state and the other organized alphabetically by customer name.

Risk: According to the Centers for Disease Control and Prevention (CDC), there are 510 cases in 19 states tied to this outbreak of fungal meningitis and other infections among patients who received contaminated steroid injections from NECC. FDA and CDC are investigating the outbreak.

Recommendations
The agency reiterated and updated its previous recommendations that follow-ups with patients be done when these conditions are met:

  • The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution, often used in cardiac surgery,
  • The medication was shipped by NECC on or after May 21, 2012, and
  • The medication was administered to patients on or after May 21, 2012.

For More Information

 

Zi Xiu Tang Success, LLC, is recalling four lots of Classic Zi Xiu Tang Bee Pollen Capsules, and three lots of Ultimate Formula Capsules found to contain sibutramine, an appetite suppressant pulled from the U.S. market in October 2010 because of safety concerns. These capsules are marketed nationally as weight-loss aids.

Risk: Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of heart disease. These products may also interact in life-threatening ways with other medications.

The affected Classic Zi Xiu Tang with UPC 6937000700019 includes the following lot numbers—04/15/2012, 05/15/2012, 06/15/2012 and 07/15/2012.

The affected Ultimate Formula with UPC 793573041401 includes the following lot numbers—05/25/2012, 07/29/2012 and 08/05/2012.

Recommendations

  • Consumers who have these recalled products should stop using them and return them to Zi Xiu Success, LLC, at (800) 764-0120 or info@zixiutangsuccess.com Monday - Friday from 9:00am-5:00pm EST.
  • Consumers should contact their health care professional if they have experienced any problems that may be related to taking this drug product.

For More Information

 

FDA is warning the public that young children can become seriously ill if they swallow over-the-counter eye drops and nasal decongestant sprays. There have been cases in which children age 5 and younger have been hospitalized after ingesting these products, a small amount of which could make them very sick. The products are sold under various brand names, such as Visine, Dristan and Mucinex, as well as in generic and store brands.

Risk: These products are safe when used in the eyes and nose as directed. However, when swallowed, their active ingredients—tetrahydrozoline, oxymetazoline, or naphazoline—can have effects that include nausea, lethargy, decreased respiration and even a coma. No deaths have been reported.

Most of these redness-relief eye drops and nasal decongestant sprays are not packaged with child-resistant closures.

Recommendations

  • Consumers should store these products out of reach of children at all times.
  • If a child accidentally swallows OTC redness-relief eye drops or nasal decongestant spray, call your local poison control center (1-800-222-1222) immediately. Experts are available 24 hours a day, seven days a week at these centers.

For More Information

 

In September 2012, FDA required safety labeling changes to be made to 61 drug products, including to 19 blood-pressure medications that include Accupril and Cozaar, and to 10 proton-pump inhibitors that include Nexium and Prevacid.

The safety concern with the hypertension medications is that they could interact badly with other drugs prescribed to diabetics, with side effects including an increased risk of kidney failure.

The concern with the proton pump inhibitors—used to reduce levels of stomach acid—is that they may increase the risk of diarrhea be associated with Clostridium difficile, especially in hospitalized patients. Clostridium difficile is a potentially life-threatening bacterial infection.

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.

For More Information

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

November 29, 2012

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