Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has fired off a warning letter to drug maker Salix Pharmaceuticals arguing that some of its marketing materials for Metozolv, an orally dissolving form of metoclopramide for the treatment of acid reflux conditiosn, “are false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”

The letter goes on to say that “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

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More and more doctors are diagnosing fussy infants with gastroesophageal reflux disease, or GERD, leaving some critics worrying that doctors are over-diagnosing the condition to soothe exasperated mothers.

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Millions of people turn to medication to treat the annoying and painful symptoms of heartburn. But doctors say that people who use medications to treat their symptoms should use them with caution and limit use if at all possible.

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Last month, a 12-year-old girl’s mysterious sneezing illness promoted a flurry of attention after her story was told on MSNBC’s Today show. Lauren Johnson sneezes 10 times a minute – up to 12,000 of times a day – and doctors have no clue why. Weeks later she was diagnosed with Paediatric Autoimmune Neuropsychiatric Disorder Associated with Streptoccus, or PANDAS. Her parents say that antibiotics have improved her disorder, but that she is at risk of showing symptoms again in the future.

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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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When Joey* was two months old, he was prescribed Reglan (known generically as metoclopramide) and took the medication for two years. When Joey turned 5, he began blinking his eyes uncontrollably. Less than two years later, he was still blinking uncontrollably but he also began jerking his head. “The doctors at first thought my son had Tourette’s syndrome,” says Joey’s mother on a post on iGuard about Reglan. “But now after knowing the side effects of Reglan they are starting to think he has permanent Tardive Dyskinesia.”

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Patients with Huntington disease (HD), a rare degenerative disorder of the central nervous system, have often been prescribed Reglan (metoclopramide) for the treatment of gastric problems even though the medication’s label says people with a history of depression, Parkinson’s disease or a movement disorder, and epilepsy or other seizure disorder should not take the drug.

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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.

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Kecia Neal of Arkansas was prescribed Reglan in 2005 to help her overcome a medical condition that involved the paralysis of stomach muscles. What she didn’t expect is for the medication to make her even sicker.

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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.

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