Kecia Neal

Last month, Neal filed suit against Teva Pharmaceutical, Schwarz Pharma and Wyeth Inc., makers of Reglan and its equivalent metoclopramide, after she began experiencing involuntary and repetitive movements of her body and face known as tardive dyskinesia. The condition is debilitating, and often continues even after the medication has been discontinued.

In February 2009, the Food and Drug Administration (FDA) ordered Reglan’s manufacturers to provide an additional boxed warning that “chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement that is often irreversible.” The new warnings state that “prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases,” however those warnings came far too late for Neal.

According to the lawsuit, patients who take Reglan for more than 12 weeks are at a 100 times greater risk for developing the disorder and other side effects.

Neal, who was on Reglan for more than a year, says she did not have access to the warnings about taking Reglan long-term. As a result, she is suffering from permanent and debilitating injuries. The lawsuit seeks damage for past and future medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, disability, psychological injury, loss of ability to provide household services, loss of earnings, and loss of earning capacity.

The case is expected to become part of a multi-district litigation.

Source: Southeast Texas Record

SOURCE: Reglan Side Effects › Woman files suit against Reglan for causing serious movement disorder

“He has been sick ever since he was born,” writes Sam Weber. Karter was diagnosed with infantile spasms when he was just two months old, and has been on the medication Reglan for digestive problems since he was just two days old. He was recently taken off Reglan, and tested for West Syndrome, a seizure disorder, but the tests came out negative. “I have a feeling that he may have TD,” Sam Weber writes. “He continues to spasm and cry and stiffen up like he is in pain.”

The Weber’s concerns about Tardive Dyskinesia may be warranted. The Food and Drug Administration (FDA) recently issued a black box warning on Reglan and its generic metoclopramide after receiving reports that long-term use of the medication has been linked to an increased risk of Tardive Dyskinesia. Individuals with Tardive Dyskinesia develop involuntary movements of their muscles. Those movements include lip smacking, tongue thrusting, head jerking, facial grimacing, and involuntary movements of the fingers.

There is no known cure for Tardive Dyskinesia, and symptoms may persist even after the medication is discontinued.

SOURCE: Reglan Side Effects › Family asks, ‘Is this Tardive Dyskinesia?’

Shirley Brinkley was prescribed Reglan by her physician in 1992 to treat a stomach ailment. According to the complaint, her physician referred to the Physician’s Desk Reference (PDR) and the medication’s package inserts and prescribed the medication for long-term use. She took the medication until April 2007.

Brinkley claims that even though the Food and Drug Administration (FDA) had approved the long-term use of Reglan, taking the medication for the prolonged period caused her to suffer from uncontrolled movements associated with Tardive Dyskinesia. Because of the condition, she has and will continue to experience medical and related expenses, loss of ability to provide household services, disfigurement, disability, pain and suffering, and psychological injury.

“Because of the misleading information that the Defendants provided to physicians and the FDA about the true risks associated with the use of Reglan and because of the failure of the Defendants and each of them to adequately inform physicians generally, including Plaintiff’s physicians, about the true risks associated with the use of Reglan, her physicians never informed her of any side effects associated with Reglan or that Reglan was only approved for short term use (up to 12 weeks),” the complaint states.

Wyeth, A.H. Robins Company Inc., and Schwarz Pharma are named in the product liability suit.

Source: Madison-St. Clair The Record

SOURCE: Reglan Side Effects › Woman with Tardive Dyskinesia sues makers of Reglan

Diabetes is just one of the known causes of gastroparesis. The condition is generally treated through dietary changes and medications including metoclopramide, which is commonly found under the brand names Reglan, Maxolon or Clopra and is traditionally available in the form of a tablet,  oral solution or injection.

The clinical trail on Questor’s Emitasol metoclopramide nasal spray showed encouraging results in terms of safety and preliminary evaluation of efficacy in the treatment of diabetic gastroparesis. No serious adverse events were reported during the trial.

In recent months, the Food and Drug Administration (FDA) placed a black box warning on the drug metoclopramide – the strongest warning required by the FDA – after a serious condition called Tardive Dyskinesia was reported in a number of patients who took the drug. Tardive Dyskinesia is a Parkinson’s-like condition in which a person develops involuntary movements of his muscles, including lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, lip puckering and involuntary movements of the fingers. The condition can be permanent, even after the drug has been discontinued.

Questor says it plans to begin Phase III of the Emitasol study as soon as possible.

Source: PR Newswire

SOURCE: Reglan Side Effects › Clinical trial underway for metoclopramide nasal spray

Laura received a letter late last month from her GI’s office notifying her that the Food and Drug Administration (FDA) had placed a “Black Box Warning” on Reglan because it carried a risk of a rare but Parkinson’s-like condition known as known as Tardive Dyskinesia. There is no treatment for Tardive Dyskinesia, and it is often irreversible even after the medication has been discontinued.

Shortly after being prescribed Reglan (metoclopramide), Laura’s health began to decline. Her tongue started moving out of control and she began smacking her lips. She didn’t immediately make the connection between her condition and Reglan. When she contacted her physician and said she was experiencing tremors, he ordered her to cut the Reglan in half.

“Why didn’t my gastroenterologist warn me? Why didn’t he give me a choice?” she asks.

Even though she has stopped taking the medication, she still suffers from uncontrolled movements of her tongue, which cause sores on her tongue, lesions in her mouth and inflamed gums. “It’s nerve wracking,” she says. Even more concerning is that her pregnant daughter was given a prescription for Reglan to treat morning sickness. “She told (her doctor) ‘No way,’ recalling what happened to me.”

Patients who have taken Reglan in the past or are currently taking Reglan are advised to contact their health care provider even if they have not experienced any side effects from the medication. Negative side effects should be reported to the FDA online at www.fda.gov/medwatch, or by phone at 1-800-FDA-1088.

Source: RGJ.com

SOURCE: Reglan Side Effects › Woman harmed by Reglan wants to know why she was never warned

The FDA recently issued a boxed warning for Reglan after recent studies revealed that people on the medication can develop a serious Parkinsons-like condition called Tardive Dyskinesia.

Jennifer’s daughter only had three doses of the medication before Jennifer took her off the drug. She was never diagnosed with Tardive Dyskinesia, however the medication did cause her to become irritable and she started “flailing her arms, twitching with stiff movements and screaming uncontrollably,” Jennifer said. “As soon as we discontinued Reglan she went back to her normal behaviors.”

While Jennifer vowed to never use the drug again, she caved with her second daughter after her severe reflux nearly caused her to aspirate. The younger daughter didn’t have the same reaction to Reglan and the little girl stayed on the medication for more than a year. She did suffer developmental delays, which Jennifer’s pediatrician says was likely caused by the prolonged use of Reglan.

“I would NEVER presume to tell anyone whether to use Reglan or not,” Jennifer said. “What I will tell you is that this is not a medication that should be taken without doing research.”

Source: Health Central

SOURCE: Reglan Side Effects › Mother says FDA’s Reglan warning is long overdue

The drug is primarily used in infants to treat gastroesophageal reflux and in children and adults to treat heartburn or nausea and vomiting caused by other medications. But Reglan has a side effect of increasing the prolactin in the brain. Prolactin is the milk-making hormone. Coupled with frequent and regular breast pumping, Reglan has been shown to increase breast milk production. A small amount of the mother’s dose will transfer to her breast milk, but studies indicate that there have been no side effects to infants.

However, some reports of other, serious side effects from the use of Reglan have made breastfeeding advocates leery of the medication. Some mothers have reported feeling fatigued, irritable or depressed while taking the medication. Reglan is in a class of medications known as dopamine-blockers, which includes several antipsychotic and some antidepressants. The Food and Drug Administration (FDA) recently issued a black box warning to consumers and health care providers warning of the risk of a neurological disorder called tardive dyskinesia with the long-term or high-dose use of Reglan.

As an alternative medication to Reglan, breastfeeding experts recommend Motillium (domperidone), to increase breast milk production. Motillium does not pass the blood-brain barrier and as a result has fewer side effects.

Source: Breastfeeding Online

SOURCE: Reglan Side Effects › Breast milk-increasing medication linked to neurological disorder

Tardive dyskinesia is an often irreversible condition that is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers.

It is likely the Supreme Court decision will cost the pharmaceutical drug market “billions of dollars,” according to one attorney quoted by Bloomberg. “There’s no way to quantify it, but the number has as many zeroes in it as attacked Pearl Harbor.”

SOURCE: Reglan Side Effects › Supreme Court ruling could cost pharmaceutical industry ‘billions’

While several antipsychotic and some antidepressants have been linked to the condition, more drugs are being added to the list of possible culprits. Recently, the Food and Drug Administration (FDA) issued a black box warning to consumers and healthcare providers warning of the risk of tardive dyskinesia with the long-term or high-dose use of metoclopramide, more commonly known as Reglan, a medication prescribed for the treatment of disorders like heartburn caused by gastroesophageal reflux disease. Elderly patients, especially women, are at an increased risk of developing the condition while using Reglan.

The medicines that can cause tardive dyskinesia affect how nerve impulses are transmitted across gaps between nerve cells. This is done in part by blocking a chemical made by the body called dopamine. (Reglan is considered a dopamine receptor blocking agent.) Over time, the nerves seem to become hypersensitive to dopamine, causing abnormal movements.

There is currently no cure for the condition, however in some patients, symptoms may lesson or resolve after coming off the medication. The FDA has advised physicians to avoid long term use of Reglan except in rare cases where the benefit outweighs the risks.

SOURCE: Reglan Side Effects › Dopamine-blocking medications linked to tardive dyskinesia