Showing posts with label U.S. Food and Drug Administration. Show all posts
Showing posts with label U.S. Food and Drug Administration. Show all posts

Monday

FDA issued stern warning on heartburn drug Reglan

FDA officials warn that the long-term use of metoclopramide, a drug used to treat heartburn, is linked to muscle spasms and tics.

 

Metoclopramide, which comes in a variety of forms including tablets, injections and oral solutions, speeds up the work of muscles used in digestion and subsequently treats gastrointestinal disorders particularly acid reflux and heartburn.

The drug's current labeling mentions the risk of developing the spasms called tardive dyskinesia; health officials, however, urge drug makers to highlight the warning.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, and rapid eye movements or blinking.

Health officials also advise individuals to avoid the chronic use of the drug unless its benefits outweigh the risk.

According to a recently-released FDA statement, using metoclopramide (Reglan) for long periods of time or at high doses leads to involuntary and repetitive movements of the body.


The statement includes the elderly, especially women, and those who have been taking the drug for more than three months in the high-risk group.


The condition is reported to be irreversible in the majority of cases even after stopping the use of the drug.