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CASEY GERRY SCHENK FRANCAVILLA BLATT & PENFIELD, LLP
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Metoclopramide
Metoclopramide and Tardive Dyskinesia Overview
In February 2009, the US Food and Drug Administration announced that it will require a boxed warning on prescribing literature for the digestive drug metoclopramide, which is marketed under many trade names, including Reglan, Octamide, and Maxolon. The warning describes the increased risk of Tardive Dyskinesia that occurs with long-term use of this powerful drug.
Tardive Dyskinesia (“TD”) is a serious neurological disorder, characterized by involuntary body movements including: lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers, as though the patient were playing an invisible piano. The uncontrollable movements are continuous, stopping only when the person sleeps. Tardive Dyskinesia may persist for months, even years after metoclopramide has been discontinued, and is usually not reversible. There is no known treatment for TD.
Metoclopramide increases the stomach’s ability to empty digested food and move it on to the small intestine. Many users of metoclopramide are diabetics, since slowed stomach-emptying is a common problem for diabetics. Metoclopramide is also used in the treatment of heartburn associated with gastroesophageal reflux, as well as the management of nausea and vomiting resulting from either migraines or cancer treatment. The risk of TD with prolonged use of metoclopramide has long been known, and the prescribing literature has recommended time-limited use, four to twelve weeks.
The FDA’s announcement cited studies in which more than 20% of patients using metoclopramide (Reglan, Octamide, and Maxolon) were kept on it for three months or more. The risk of developing TD increases with the length of time a person has taken the drug, and the size of the dose. Increased exposure to this dangerous drug can lead to an increased risk of developing Tardive Dyskinesia. The elderly are at greater risk; women more so than men.
Metoclopramide is one of a number of drugs, including some psychotropic medications, whose long term use increases the risk of TD. Neurologists who study drug-induced movement disorders now see more cases of TD associated with metoclopramide (Reglan, Octamide, and Maxolon) than with any other drug.
A black-box warning is the FDA’s strongest warning, used to alert prescribing physicians to significant risks associated with a drug. Here is the FDA’s warning for metoclopramide:
---------------------------------------------
WARNING: TARDIVE DYSKINESIA
Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. The elderly, especially elderly women are most likely to develop this condition.
Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, in some patients symptoms may lessen or resolve after metoclopramide treatment is stopped.
Prolonged treatment (greater than12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia. See WARNINGS
---------------------------------------------
If you or a loved one has taken metoclopramide (Reglan, Octamide, Maxolon) and has developed symptoms of Tardive Dyskinesia, you should consult the prescribing physician as soon as possible. If you or a loved one has been diagnosed with TD, you should immediately consult an experienced pharmaceutical attorney who handles dangerous drug cases for review of a potential claim against the manufacturer.
Most states have laws called statutes of limitation which specify how long after an event you may file a claim or a lawsuit related to the event. Because of these statutes, it is urgent that if you or a loved one believes you have a claim, you will want to contact an experienced plaintiff’s attorney so that your claim can be evaluated before the time limit is reached.
Pharmaceutical litigation lawyer, Gayle Blatt can be reached by email gmb@cglaw.com. Her associate, Wendy Behan, can be reached at wbehan@cglaw.com
Casey Gerry’s phone number is 619 238 1811, the fax is 619 544 9232, and the firm’s mailing address is 110 Laurel Street, San Diego CA 92101. You may also use the contact form available on the website.
In February 2009, the US Food and Drug Administration announced that it will require a boxed warning on prescribing literature for the digestive drug metoclopramide, which is marketed under many trade names, including Reglan, Octamide, and Maxolon. The warning describes the increased risk of Tardive Dyskinesia that occurs with long-term use of this powerful drug.
Tardive Dyskinesia (“TD”) is a serious neurological disorder, characterized by involuntary body movements including: lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers, as though the patient were playing an invisible piano. The uncontrollable movements are continuous, stopping only when the person sleeps. Tardive Dyskinesia may persist for months, even years after metoclopramide has been discontinued, and is usually not reversible. There is no known treatment for TD.
Metoclopramide increases the stomach’s ability to empty digested food and move it on to the small intestine. Many users of metoclopramide are diabetics, since slowed stomach-emptying is a common problem for diabetics. Metoclopramide is also used in the treatment of heartburn associated with gastroesophageal reflux, as well as the management of nausea and vomiting resulting from either migraines or cancer treatment. The risk of TD with prolonged use of metoclopramide has long been known, and the prescribing literature has recommended time-limited use, four to twelve weeks.
The FDA’s announcement cited studies in which more than 20% of patients using metoclopramide (Reglan, Octamide, and Maxolon) were kept on it for three months or more. The risk of developing TD increases with the length of time a person has taken the drug, and the size of the dose. Increased exposure to this dangerous drug can lead to an increased risk of developing Tardive Dyskinesia. The elderly are at greater risk; women more so than men.
Metoclopramide is one of a number of drugs, including some psychotropic medications, whose long term use increases the risk of TD. Neurologists who study drug-induced movement disorders now see more cases of TD associated with metoclopramide (Reglan, Octamide, and Maxolon) than with any other drug.
A black-box warning is the FDA’s strongest warning, used to alert prescribing physicians to significant risks associated with a drug. Here is the FDA’s warning for metoclopramide:
---------------------------------------------
WARNING: TARDIVE DYSKINESIA
Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. The elderly, especially elderly women are most likely to develop this condition.
Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, in some patients symptoms may lessen or resolve after metoclopramide treatment is stopped.
Prolonged treatment (greater than12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia. See WARNINGS
---------------------------------------------
If you or a loved one has taken metoclopramide (Reglan, Octamide, Maxolon) and has developed symptoms of Tardive Dyskinesia, you should consult the prescribing physician as soon as possible. If you or a loved one has been diagnosed with TD, you should immediately consult an experienced pharmaceutical attorney who handles dangerous drug cases for review of a potential claim against the manufacturer.
Most states have laws called statutes of limitation which specify how long after an event you may file a claim or a lawsuit related to the event. Because of these statutes, it is urgent that if you or a loved one believes you have a claim, you will want to contact an experienced plaintiff’s attorney so that your claim can be evaluated before the time limit is reached.
Pharmaceutical litigation lawyer, Gayle Blatt can be reached by email gmb@cglaw.com. Her associate, Wendy Behan, can be reached at wbehan@cglaw.com
Casey Gerry’s phone number is 619 238 1811, the fax is 619 544 9232, and the firm’s mailing address is 110 Laurel Street, San Diego CA 92101. You may also use the contact form available on the website.
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