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Consumer Update |
Medicated Patches and MRIs
Reglan and Nervous System Disorder
Raptiva and Brain Infection
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 any problems with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax or by phone.
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.
On March 5, 2009, FDA alerted the public to the risk of skin burns while wearing certain types of adhesive patches during a magnetic resonance imaging (MRI) scan.
The alert applies to adhesive patches that deliver medicines through the skin and contain metal in their backing. (You may not be able to see the metal and the label may not mention that the product contains metal.) These patches include both brand name and generic products and patches purchased over the counter without a prescription.
Adverse events: The metal in the backing of some adhesive patches can overheat during an MRI scan and cause skin burns in the area of the patch.
People at risk: Anyone who wears an adhesive patch that delivers a drug (such as nicotine, pain killer, hormones) during an MRI scan.
Recommendations:
FDA actions: The labeling for most, but not all, medicated patches that contain metal in the backing provides a warning to patients about the risk of burns if the patch is worn during an MRI scan. FDA is reviewing the labeling and structure of all medicated patches to make sure that those made with metal materials provide the appropriate warning.
For more information:
FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01967.html
On Feb. 26, 2009, FDA warned against the long-term use of drugs that contain Reglan (metoclopramide).
Metoclopramide is approved for the short-term (no longer than 3 months) treatment of gastrointestinal disorders, such as gastroesophageal reflux disease (GERD) in people who haven’t responded to other treatments, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines).
The drug is available in a variety of formulations including tablets, syrups, and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.
Adverse events: Frequent and long-term use of metoclopramide has been linked to tardive dyskinesia, a disorder that causes uncontrollable, repetitive movements of the body such as lip smacking, grimacing, tongue protrusion, puckering and pursing of the lips, rapid eye movements or blinking, and rapid movements of the fingers, arms, legs, and trunk.
People at risk: Those at greatest risk include elderly people, especially older women, and people who have been on the drug for a long time.
Recommendations:
FDA actions: FDA is requiring that the drug label carry a boxed warning about the risks of using metoclopramide for a long time or at a high dose. Manufacturers must ensure that patients are given a medication guide that discusses the risks of the drug each time they receive this medication from a pharmacy.
For more information:
FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01963.html
On Feb. 19, 2009, FDA alerted the public to reports of a rare brain infection in people using the psoriasis drug Raptiva (efalizumab). The infection, progressive multifocal leukoencephalopathy (PML), was confirmed in three people, and one more person possibly had it. Three of these people have died. All four were treated with Raptiva continuously for more than three years. No effective way is known to prevent or treat PML, which is caused by a virus that affects the central nervous system.
Adverse events: PML leads to a gradual worsening in the function of the nervous system, which cannot be reversed, and death.
People at risk: People who have taken Raptiva and have severely weakened immune systems are most at risk. Longer, continuous use may further increase the risk.
Recommendations:
FDA actions: In October 2008, FDA required the manufacturer to revise Raptiva’s labeling to carry a boxed warning about the risks of life-threatening infections, including PML. At that time, FDA also directed the manufacturer to ensure that patients are given a medication guide that discusses the risks of the drug each time they receive this medication from a pharmacy.
FDA is reviewing the latest information on Raptiva and reports of PML. The agency will take appropriate steps to ensure that
For more information:
FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01958.html
FDA Public Health Advisory
http://www.fda.gov/cder/drug/advisory/efalizumab.htm
For more safety announcements, visit FDA's MedWatch page at http://www.fda.gov/medwatch/
This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
Date Posted: March 23, 2009
