The Food and Drug Administration (FDA) has issued a warning to consumers not to use Hydroxycut products due to the risk of serious liver damage. The FDA says that “Consumers who use a Hydroxycut dietary supplement and who experience signs of illness associated with liver disease should immediately consult their health care provider. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Non-specific symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, itching, and loss of appetite. FDA has also identified several other serious adverse events associated with Hydroxycut, including cases of seizures, rhabdomyolysis (a type of muscle damage that can lead to other dangerous problems, such as kidney failure), and cardiovascular problems, ranging in severity from irregular heart beat to a heart attack.” [click to continue…]
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The FDA has announced that it will require a “Black Box” warning on Botox and its competitors due to serious adverse side-effects. Many of the side-effects have been reported when Botox has been used as an off-label treatment for children with cerebral palsy. Side-effects in children have included difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression. Serious case reports described hospitalizations involving ventilatory support and reports of death. The majority of the adult postmarketing case reports occurred following use of botulinum toxin for the treatment of spasticity (an unapproved use) or cervical dystonia. Some cases resulted in hospitalization, including several cases that required placement of a gastric tube or mechanical ventilation.
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The FDA announced yesterday that Genentech was withdrawing the psoriasis drug Raptiva because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. There is no known effective treatment for PML. About 2,000 people in the U.S. are believed to be taking the drug.
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