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Reglan 117 articles

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

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

AL Supreme Court rules: Brand name drug makers liable for warnings on generic drug counterparts

Makers of brand-name medications can be held liable for warnings on generic drugs even if the generic was produced by another drug company, the Alabama Supreme Court ruled. A majority of the nine-member court upheld a 2013 decision, which was viewed as a defeat by business leaders in this mostly Republican state. The ruling is based on a federal lawsuit filed by Danny and Vick Weeks against five current and former drug makers alleging that long-term use of the heartburn drug metoclopramide, which was also sold under the brand name Reglan, caused a debilitating movement disorder known as tardive dyskinesia. ... 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

Recall is just the latest in string of manufacturing mishaps for Hospira

Drug maker Hospira Inc.’s announced this week that it was recalling some injectable drugs because glass strands were found the vials, and if used could cause a host of complications from minor vein inflammation to serious organ failure. The recall is one of nearly a half-dozen manufacturing mishaps involving the company’s products so far this year. This week’s recall involved metoclopramide (Reglan), used to treat severe acid reflux, and ondansetron (Zofran), used to prevent nausea and vomiting in cancer patients. The drugs were distributed nationwide to wholesalers, hospitals and pharmacies from June to September. Hospira blamed the issue on its glass ... Read More

Injectable Reglan, Zofran recalled due to hazardous vial defect

Some injectable medications used to treat severe acid reflux and other gastrointestinal conditions are being recalled because tiny strands of glass were found in some vials. If the glass comes loose and is injected in to patients, it could cause serious and potentially life threatening consequences. The nationwide recall involves one lot of metoclopramide injection and two lots of ondansetron injection. Metocloparmide is known by the brand name Reglan and is used to treat gastric esophageal reflux disease (GERD), and a heartburn condition known as gastroparesis in diabetics. Ondansetron, known by the brand names Zofran and Zuplenz, prevents nausea and vomiting ... 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