News Tagged ‘FDA black box warning

Clinical trial seeks diabetics for new gastroparesis treatment

gastroparesis sleepy stomach 150x150 Clinical trial seeks diabetics for new gastroparesis treatmentDiabetics 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.

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Salix stock soars despite FDA warning letter

salix pharmaceuticals 150x150 Salix stock soars despite FDA warning letterSalix Pharmaceuticals stock rose 5 percent last week despite news that the company received a warning letter from the Food and Drug Administration (FDA) urging the company to clarify information about its new orally dissolving heartburn treatment, , according to Local Tech Wire. The FDA said that some of the drug’s marketing materials are “false or misleading because they omit and minimize risk information, broaden the indication of , and contain unsubstantiated comparative and other claims.”

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Participants needed for clinical trial on new GERD treatment

Researchers from the North Alabama Research Center based in Athens, Ala., are looking for people to participate in clinical trials for a potential new medication to treat gastrointestinal disease, also known as . Persons age 18 to 70 who are still suffering from symptoms of despite treatment with prescription medications are welcome to participate in the clinical trial. Participants must live within 50 miles of the clinic. Those interested can sign up at the Clinical Connection Web site here.

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Reglan may stop hiccups, but may cause more serious problems

Most people who take the medication Reglan (metoclopramide) are prescribed the drug to treat heartburn, , or gastroparesis, also known as slow emptying of the stomach. But metoclopramide may also halt persistent hiccups.

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Women suffering from movement disorder sues Reglan maker Wyeth

Elizabeth Conte was prescribed Reglan, a brand-name of metoclopramide used to treat gastrointestinal conditions such as heartburn, and gastroparesis. For four years she took the medication, unaware that she was slowly developing a debilitating and incurable movement disorder known as Tardive Dyskinesia. What she soon found out is that her involuntary head jerks and facial twitches were caused by long-term use of metoclopramide.

More and more cases of consumers taking metoclopramide and subsequently developing Tardive Dyskinesia were reported to the Food and Drug Administration (FDA), and by early 2009, the agency had ordered a be placed on the medication. New warnings and precautions were written into the drug’s packaging that included an up to 20 percent risk of patients developing Tardive Dyskinesia during long-term use of the medication.

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Anti-nausea drugs carry black box warnings

Patients who suffer from nausea and vomiting are often given medication to stop their symptoms. But many of those drugs carry serious side effects that have earned them black box warnings from the Food and Drug Administration (FDA). A indicates that use of the drug carries a significant risk of serious or life-threatening adverse effects.

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Procedure shows promise versus drugs for children with gastroparesis

Surgeons have implanted a pacemaker in the abdomen of a 16-year-old patient to help treat a debilitating stomach condition that can cause symptoms such as nausea and bloating and result in malnourishment and significant weight loss. This is the first time the procedure has been performed in a child at Nationwide Children’s Hospital, one of the few medical centers that will perform the procedure on pediatric patients.

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