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black box warning 220 articles

Colon hydration offers alternative to OSP for bowel prep

Some hospitals across the country are choosing an alternative method of prepping the bowel before colonoscopies that does not require patients to drink a gallon of liquid laxatives the day before the procedure, according to EndoNurse. The new procedure is called colon hydrotherapy and involves infusing the colon with warm, filtered, chemical-free water to effectively clear it. The colon hydration is administered by a trained technician in a private room at a spa and takes about 45 minutes. During that time, the patient lies on a table on his back and sides. The method offers a more soothing environment than ... Read More

C.B. Fleet wants to put recalled products back on market

Maker of bowel cleansing products and laxatives C.B. Fleet wants to sell its over-the-counter oral sodium phosphate (OSP) solutions to consumers even though the company recalled them six months ago after the Food and Drug Administration (FDA) issued black box warnings on prescription OSPs and raised serious concerns over the over-the-counter OSP products. The FDA had received numerous reports of a serious form of kidney injury known as acute phosphate nephropathy following the use of OSP. Currently, C.B. Fleet faces 38 lawsuits that allege the pharmaceutical company did not do enough to warn consumers and health care providers of the ... Read More

Patients with gastroparesis should weigh treatment options

Gastroparesis, also known as delayed gastric emptying, is a disorder that affects people with both type 1 and type 2 diabetes in which the stomach takes too long to empty its contents. It is caused when the vagus nerve to the stomach becomes damaged or stops working. When not working properly, this nerve is unable to send a message to the muscles that move food through the digestive tract, and food is either slowed or stopped in the process. Diabetes can cause damage the vagus nerve when blood glucose levels remain high over a long period of time by damaging ... Read More

Family asks, ‘Is this Tardive Dyskinesia?’

Karter’s parents want to know if their infant son has Tardive Dyskinesia (TD). The little guy thrusts his body around and cries constantly for several minutes as his family watches helplessly. They posted this video, called Is this Tardive Dyskinesia, just four weeks ago on YouTube seeking answers. “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 ... Read More

Clinical trial underway for metoclopramide nasal spray

Questcor Pharmaceuticals Inc. has just released the study results of its Phase II clinical trial on a metoclopramide nasal spray for the treatment of diabetic gastroparesis, a condition in which contents remain in the stomach for a longer period of time than normal. Left untreated, gastroparesis can lead to fluctuations in blood glucose, general malnutrition, intestinal obstruction and bacterial infection. 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 ... Read More

Woman harmed by Reglan wants to know why she was never warned

Laura Tennant wants answers. The former editor of the Leader-Courier was prescribed Reglan more than a year ago to treat a digestive disorder. Now she appears to be suffering from what she calls “permanent central nervous system damage.” 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 ... Read More

Mother says FDA’s Reglan warning is long overdue

The FDA’s “black box warning” on the acid reflux drug Reglan is long overdue, according to Jennifer Rackley. Both her daughters as infants were on the medication. Her first had severe GERD and was categorized by doctors as “failure to thrive.” Her pediatrician prescribed Reglan, a brand name of metaclopramide. “At the time we were not aware of the side effects nor did we have any major qualms about using the medication,” Jennifer said. “Boy was that about to change!” The FDA recently issued a boxed warning for Reglan after recent studies revealed that people on the medication can develop ... Read More

Breast milk-increasing medication linked to neurological disorder

Nursing mothers who have difficulty establishing or maintaining breast milk production may be prescribed medication to increase the amount of breast milk they produce. One popular choice has been metoclopramide, most commonly known as Reglan. 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 ... Read More

Dopamine-blocking medications linked to tardive dyskinesia

This is a YouTube user’s wife. She suffers from tardive dyskinesia as a result of being over-prescribed the atypical antipsychotic Geodon. Tardive dyskinesia is a condition in which a person develops involuntary movements of their muscles, which can include lip smacking, tongue thrusting, eye blinking and buldging, head jerking, facial grimacing, pucker and pursing of the lips, and involuntary movements of the fingers. 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 ... Read More

Family says nursing home didn’t reveal black box warning

The black box warning on the anti-psychotic drug Risperdal says it all: “Increased mortality in elderly patients with dementia-related psychosis.” But Bruce Bowman’s children claim they were never told by the nursing home staff that cared for their father that the medication he was being given could kill him. “I’d never give any kind of consent for any of that,” says Martin Bowman, Bruce’s son and legal guardian, to the Milwaukee-Wisconsin Journal Sentinel. Martin approved all his father’s medication but said he was never told that the drug given to control his father’s agitation and physical aggression could kill him. ... Read More