Articles Posted in FDA Information

The U.S. Food and Drug Administration (FDA) is expected to issue a proposed rule about electronic cigarettes very soon.

There is currently a relative lack of regulations on the use of e-cigarettes. The case-by-case handling by employers and municipalities across the country could change, but that depends on whether the FDA decides to regulate e-cigarettes as a tobacco product.

The agency is concerned about public health issues because most e-cigarette products give users a nicotine fix.

Meningitis is an infection of the meninges, the membranes that surround the brain and the spinal cord. Meningitis can come from a virus, (viral meningitis), a fungus (fungal meningitis) or bacteria (bacterial meningitis). Meningitis can be acute or chronic, mild or severe. No matter what type of meningitis you may have, you should see a doctor immediately if you experience signs of meningitis as the results can be fatal.

Individuals with a weak immune system, such as AIDS patients or cancer patients are more at risk for contracting the disease. Patients who are taking medications known to weaken the immune system are also at a higher risk for developing meningitis than those without a compromised immune system. However, meningitis is not limited to those individuals. Anyone can be diagnosed with any of the three types of meningitis: fungal, bacterial or viral.

Fungal meningitis is not contagious and is less common than bacterial meningitis. This rare form of meningitis is caused by a fungus spreading through the bloodstream from somewhere else in the body to the spinal cord and into the central nervous system.

The fungus can be transmitted by inhaling contaminated soil. Such contaminates include bird droppings, bat droppings and decaying organic matter. Fungal meningitis can also be contracted intradermally, as with the recent outbreak in which the contaminant was directly injected into the body. More than 200 patients who received a tainted injection of the steroid methylprednisolone acetate have been diagnosed with fungal meningitis. An additional 13,000 patients are potentially at risk. Patients sickened by the contaminated steroid may be eligible to file a fungal meningitis lawsuit.
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On June 28th, 2012, During the Second Day of the FDA’s Orthopedic Surgery and Rehabilitations Device Panel, the Administration presented on Local and Systemic Complications for different types of orthopedic devices.

Dr. Katherine S. Squibb, PhD of the University Of Maryland School Of Medicine presented the panel with an Overview of the Toxicity of cobalt and chromium metals found in metal on metal hip implants.

There are four major determinants of metal toxicity: Chemistry of the metal, the exposure dose, route of exposure, and the duration of exposure.

Chemistry: The metal’s chemistry is affected by the solubility, the oxidation state, and the preferred ions or molecules bound to the central metal atom.

Exposure Dose: The severity of the dose is determined through absorption, tissue distribution, metabolism, and excretion.
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