Articles Posted in FDA Information

Last year, vaccine injury lawyers Larry Cohan and David Carney achieved a $9 million settlement with a lifetime payout of $40 million on behalf of a child who developed encephalopathy after receiving the varicella (chicken pox) vaccine.

Encephalopathy is a life-threatening medical emergency that requires hospitalization. Patients who suffer encephalopathy after a vaccine may suffer a seizure, brain damage, or temporary or permanent loss of consciousness.

Vaccine injury victims who develop encephalopathy after receiving a vaccine may never be the same again. Patients with encephalopathy may experience a significant change in mental status such as confusion, delirium or a coma. They may not be able to make eye contact or respond to their environment.

On June 16, the Philadelphia Trial Lawyers Association (PTLA) elected Lawrence Cohan of Anapol Weiss as the new President of the organization.

For more than 50 years, PTLA has sought to protect the rights of all individuals, and it has become a growing force in the community. The organization is made up of more than 1,000 trial lawyers who aim to preserve the legal system and create new laws to protect the rights of the community.

“Because of the Trial Lawyers, the workplace in Pennsylvania is safer,” Cohan said. “Products are safer because manufacturers know we hold them responsible, and perhaps we have also helped make it safer to be a patient in a hospital in Pennsylvania.”

Vaccine injury lawyers Lawrence Cohan and David Carney settled a $4.5 million case for a young woman who suffered Guillain-Barre Syndrome (GBS) as a reaction to the flu shot. The settlement is expected to have a lifetime payout of $11.6 million to cover past and future medical expenses incurred as a result of the serious vaccine reaction.

For the 20-year-old nurse employed by a hospital in Lehigh County Pennsylvania, getting a flu shot was a job requirement. Less than a week later, Sarah Behie had a reaction to the flu shot. The young woman went to the emergency room with flu-like symptoms, but she was discharged. A few weeks later, she returned to the hospital, unable to walk. She was admitted and diagnosed with Guillain-Barre Syndrome from the flu shot.

The young woman eventually went to a rehabilitation center, where she received constant care for her injuries. Four years later, she has regained the use of her arms, but still cannot walk. She remains bed and wheelchair bound. Unfortunately, there is no cure for GBS, but certain therapies can help lessen the severity of the condition.

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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Some people — especially people needing certain drugs to prolong their lives or end severe pain – think that the FDA drug approval process is slow and tiresome. According to a recent study, the FDA approves drugs faster than either Canada or Europe. Does this surprise you?

Is that good news or bad news?

The Prescription Drug User Fee Act (PDUFA) of 1992 was passed to expand the FDA resources devoted to reviewing applications for novel therapeutics for humans and to ensure drug safety. The FDA is able to collect user fees for each new drug application in order to support what is needed as part of the review process. Nevertheless, performance standards have been associated with higher rates of black box warnings and drug withdrawals.

Topamax (generic topiramate) is an anti-seizure medication that is also used to prevent migraine headaches. Off-label, Topamax is prescribed to treat mood instability, weight loss, Parkinson’s, stroke, and psychiatric disorders. Off-label means when a prescription medicine is used to treat a disease or condition for which the drug has not been approved by the FDA. While the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor’s ability to prescribe the medication for different conditions, in different doses, or for different lengths of time.

Topamax when taken during the first trimester of pregnancy may cause birth defects such as oral clefts.

Some women taking Topamax for seizures and preventing migraine headaches also tout that they have lost weight while on the drug. Weight loss is a side effect of Topamax. Some people are thrilled and others concerned. What is concerning is that taking Topamax while pregnant (when women don’t even know they’re pregnant yet) has devastating side effects on the unborn fetus.

Why would any doctor prescribe Topamax for weight loss?
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Topamax (generic topiramate) is an anti-seizure medication that is also used to prevent migraine headaches. Off-label, Topamax is prescribed to treat mood instability, weight loss, Parkinson’s, stroke, and psychiatric disorders. Off-label means when a prescription medicine is used to treat a disease or condition for which the drug has not been approved by the FDA. While the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor’s ability to prescribe the medication for different conditions, in different doses, or for different lengths of time.

Topamax when taken during the first trimester of pregnancy may cause birth defects such as oral clefts.

Some women taking Topamax for seizures and preventing migraine headaches also tout that they have lost weight while on the drug. Weight loss is a side effect of Topamax. Some people are thrilled and others concerned. What is concerning is that taking Topamax while pregnant (when women don’t even know they’re pregnant yet) has devastating side effects on the unborn fetus.

Why would any doctor prescribe Topamax for weight loss?
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As consumers, we assume that the products we use are safe. This is never more applicable than in our consumption of food. According to a nj.com article, a long-awaited bill proposed by the Senate to overhaul the food safety system set forth by the Food and Drug Administration has been unanimously approved. However, it still needs to go for a floor vote, which is speculated to not take place until sometime in 2010. The bill will allow the FDA to recall tainted food rather than simply make a request to the manufacturer of the food to do so, and will also require food manufacturing plants, especially high-risk facilities, to be regularly inspected.

Currently, the FDA is responsible for safeguarding nearly 80% of the food supply in the U.S. However, safeguarding against food-borne illness does not always prevent the public from falling ill due to tainted food. Currently, it is estimated that nearly 76 million Americans are affected each year by food-borne pathogens. According to the Centers for Disease Control, 5,000 people die annually due to such illness.
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