Tagged Articles

movement disorder 11 articles

Generic drug makers failed to warn about side effects from heartburn drug Reglan

A Missouri appeals court upheld claims by two women that makers of generic versions of the heartburn drug Reglan failed to update their safety labels to warn about side effects associated with long-term use of the medication. Reglan, which is sold generically under the name metoclopramide, has been linked to a movement disorder known as tardive dyskinesia. In 2004, manufacturers of brand-name Reglan updated its safety label with the approval of the Food and Drug Administration (FDA) to warn that “Therapy should not exceed 12 weeks in duration.” Generic manufacturers were required to update their safety labels as well but ... Read More

Experimental drug helps reduce symptoms of tardive dyskinesia

Patients with a movement disorder known as tardive dyskinesia saw a reduction in spasms after taking Neurocrine Biosciences’ experimental drug NBI-98854 for six weeks compared to patients taking a placebo. The drug company says it hopes the promising data will win Food and Drug Administration (FDA) approval to move forward with a late-stage study during the first half of the year. Tardive dyskinesia is a difficult to treat and often incurable neurological disorder that causes involuntary movements such as grimacing, tongue movements, lip smacking and puckering, pursing of the lips, and excessive eye blinking. The condition most often occurs as ... Read More

Study looks at safety of Reglan as treatment for morning sickness

The acid reflux drug metoclopramide may be a safe and effective morning sickness treatment for pregnant women, a new study suggest. Metoclopramide, also known by the brand name Reglan, is used to treat esophageal reflux disease (GERD), nausea, vomiting and diabetic gastroparesis, a condition in which the stomach digests food too slowly. Researchers looked at data from more than 40,000 women who were given metoclopramide while pregnant and found they were no more likely to have a miscarriage or have a baby with birth defects than women who did not take the drug. About half of all pregnant women experience nausea ... Read More

Alabama court rules that makers of brand name drugs can be sued by generic drug users

Generic drugs should carry the same warnings as the brand name drug and, if not, then users of the generic drug can sue the name-brand drug maker for fraudulent misrepresentation, the Alabama Supreme Court ruled. The ruling comes as a response to a certified question from a U.S. District Court, which arose during a case where a plaintiff alleged that a generic version of the prescription heartburn drug Reglan caused him to develop a movement disorder called Tardive Dyskinesia. The plaintiff sued the brand name maker, Wyeth, alleging that the company failed to warn both doctors and patients of the ... Read More

Supreme Court ruling protects generic drug companies

Makers of generic drugs are not required to warn patients if they receive reports of new side effects from the drugs, according to a new Supreme Court decision. This ruling protects generic drug makers from being sued under state liability laws for failing to warn patients of these new dangers. Comparatively, makers of brand-name drugs are required to report any adverse events associated with their medications to the Food and Drug Administration (FDA). These possible side effects are included in an FDA-approved safety label that tells doctors and patients of the possible adverse events. The brand-name drug company has exclusive ... Read More

Heartburn drugs before pregnancy may increase risk for birth defects

Women who use heartburn medication during pregnancy should not be overly concerned about the drugs causing birth defects, but using the drugs before they become pregnant may cause problems for the unborn child, according to a new study from Denmark published in the New England Journal of Medicine. The study looked at nearly 841,000 births registered with national databases from 1996 to 2008. In about 5,000 cases, the mothers had taken PPIs at some point during the four weeks prior to pregnancy through their first trimester. Overall, 3.4 percent of the babies whose mothers took PPIs had a major birth ... Read More

Restless leg syndrome turns out to be movement disorder caused by Reglan

PHOENIX, ARIZONA – Ron, a musician and artist, was having trouble sleeping. His legs would move involuntarily back and forth under the sheets. At first, both Ron and his doctors thought he suffered from restless leg syndrome. But after a battery of tests conducted by neurologists, and a review of his medical history and medications, doctors determined that Ron suffered from a Parkinson’s-like condition known as Tardive Dyskinesia. They say it was caused by the heartburn medication Reglan. Reglan, also known by the generic metoclopramide, is a prescription medication used to treat severe heartburn, acid reflux, gastroparesis and other gastrointestinal ... Read More

Clinical trial seeks diabetics for new gastroparesis treatment

Diabetics who suffer from nausea, vomiting, bloating, or abdominal discomfort after eating may be eligible to participate in a study for an investigational medication to reduce the symptoms associated with delayed stomach emptying, also known as gastroparesis, a condition many diabetics experience. The study is being conducted at institutes in 37 cities in numerous states across the country. Additional criteria to participate includes being 18 years of age or older and free of cancer for five years. Qualified participants will receive all study-related exams and investigational study medication at no cost. Compensation is also provided. Currently, there are few options ... Read More

New Jersey judge calls for consolidation of Reglan lawsuits

A New Jersey judge is calling for a statewide consolidation of all lawsuits filed against the makers of the heartburn medication Reglan that involve claims that the drug caused a serious and debilitating movement disorder known as Tardive Dyskinesia. Judge Eugene J. Codey, Jr., of the Essex County Superior Court, filed the request arguing that the New Jersey court system could better handle the mounting number of lawsuits if they were all centralized in one court. The primary defendant in the lawsuits, Wyeth Pharmaceuticals, is headquartered in New Jersey. In his consolidation request to the administrative director of the courts ... Read More

Why did FDA take so long to place black box warning on Reglan?

In the February 1996 issue of the drug newsletter Worst Pills, Best Pills News, a story was published by the Health Research Group of Public Citizen warning that a drug commonly prescribed for heartburn and slow emptying of the stomach contents, a condition known as gastroparesis, could cause a serious movement disorder known as Tardive Dyskinesia. The condition could cause permanent disability in users, according to the report. However, it took more than a decade for the Food and Drug Administration (FDA) to place a black box warning on the medication, Reglan. A black box warning is the strongest warning ... Read More