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tardive dyskinesia 102 articles

First treatment for tardive dyskinesia gains FDA approval

The Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules, the first drug to treat the neurological disorder tardive dyskinesia. Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips. Some people affected by the condition also experience involuntary movement of the extremities or difficulty breathing. Not only is the condition disabling, it can further stigmatize patients with mental illness, as it is caused by antipsychotic medications, especially older drugs, taken for long periods of time to treat chronic conditions ... Read More

NJ Supreme Court allows state lawsuits against makers of generic Reglan to proceed

The New Jersey Supreme Court unanimously upheld a lower court’s 2014 ruling that consumers with state law claims blaming the manufacturers of generic versions of the heartburn drug Reglan for not adequately warning about neurological side effects, are not preempted by federal law. The lawsuits claim that generics manufacturers, including Pliva Inc., Actavis Elizabeth LLC, and Teva Pharmaceuticals USA Inc., delayed changing the labels of generic Reglan, known chemically as metoclopramide so that it conformed with the brand-name version of the drug. The New Jersey Supreme Court said that by not changing the labels to match that of the brand-name drug, the ... Read More

Judges decide not to dismiss lawsuits against generic Reglan makers

A three-judge panel has found that failure-to-warn claims against makers of generic versions of the heartburn drug Reglan could move forward because the companies failed to update their warning labels when the brand name product’s label was changed to include new side effect warnings. The ruling affects a large number of the roughly 650 lawsuits consolidated in Middlesex County, where they were transferred from Atlantic County last month. The panel of judges wrestled with the 2011 ruling in Pliva v. Mensing that state tort claims against makers of generic drugs alleging inadequate warnings should be overridden by federal law, which ... Read More

Makers of generic Reglan hoping federal law preempts lower court’s ruling

Drug companies Pliva Inc., Actavis Elizabeth LLC, and Teva Pharmaceuticals USA Inc., hope the New Jersey Appellate Division will find that federal law overrides a lower court’s ruling that consumers can sue makers of generic versions of the heartburn drug Reglan (metoclopramide) who they claim failed to update their labels to include new warnings on the brand name drug’s label. Reglan, known generically as metoclopramide, is used to treat gastric esophageal reflux disease (GERD). It is also used to treat nausea and vomiting, and heartburn caused by a stomach problem known as gastroparesis in diabetic patients. The issue stems from a ... Read More

Janssen agrees to pay $5.9 million for concealing Risperdal side effects

Johnson & Johnson unit Janssen Pharmaceuticals agreed to pay $5.9 million to settle a lawsuit brought by Montana’s attorney general alleging the company downplayed or hid Risperdal side effects while marketing the bipolar drug to doctors. “This settlement is not only significant in terms of the amount of money Montana will receive, but also in that it protects our citizens from being prescribed Risperdal based on the types of false statements Janssen previously made to our health care providers,” Attorney General Tim Fox said in a statement issued by his office. Janssen is admitting no wrongdoing. However just four months ... 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

Lesser expensive generic drugs soon available, but are they safe?

The patents for several of the best-selling prescription medications will be expiring over the next two years, paving the way for drug companies to manufacture and sell less expensive generic versions of the drugs. Among the medications that will likely be matched by a generic competitor are the cholesterol-lowering Lipitor and the blood thinner Plavix. On average, generic drugs cost as much as 20 to 80 percent less than their brand-name equivalents. Generic drugs are what the Food and Drug Administration calls “copies of brand name drugs that have exactly the same dose, intended use, side effects, route of administration, ... 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