Defective Drugs: Provigil

Drug Recall Attorneys

Provigil, also known as modafinil, is a stimulant that has a use of helping patients who suffer from sleep disorders such as shift work disorder, narcolepsy, and obstructive sleep apnea/hypopnea syndrome. The exact mechanism of how this drug works is generally unknown, but CNS stimulants are known to increase alertness and wakefulness. CNS stimulants can also cause insomnia, nervousness, and tension in large doses. Typically, somebody taking Provigil will take it in tablet form at 200mg.

Who has Provigil been prescribed for? The FDA originally approved it for adolescents over age 16 and adults who suffered from narcolepsy, obstructive sleep apnea, and shift work sleep disorder. In recent studies, Provigil was also used to treat ADHD in children at times, but there have been conflicting studies about such. Some studies have indicated that it was helpful, while others found that it had no effect on symptoms surrounding ADHD. Sometimes, Provigil is used third-line as a treatment for ADHD.

A Warning Issued

In 2007, the Food and Drug Administration (FDA) issued a warning to physicians and consumers surrounding Provigil and certain findings. The drug ran the risk of causing Stevens Johnson Syndrome, which is a rare disorder that causes the skin and mucous membranes to become sensitive to medication or infection. Along with that, the FDA also found that Provigil was linked to other psychiatric disorders such as anxiety, mania, hallucinations, and suicidal ideation. In some instances, patients also experienced unfortunate fatal complications of Stevens Johnson Syndrome, which includes lesions on the internal organs and organ failure caused by sepsis.

The FDA urged patients to contact their doctors immediately if they were to develop a skin rash or any other skin irritation while taking the drug. Provigil was manufactured by Cephalon Incorporated. Many believe that Cephalon failed to properly warn consumers and physicians of the risks associated with Provigil, and as a result, some victims of the drug have filed personal injury claims against Cephalon seeking compensation for the harm sustained.

In-Depth Knowledge of Stevens Johnson Syndrome

The very unfortunate news is that there is no standardized treatment known for Stevens Johnson Syndrome. This makes it extremely difficult to manage for patients who develop serious cases. In many instances, physicians focus on replacing fluids lost due to skin loss and take other measures like applying cold compresses to heal the blisters they may experience. Patients who have severe cases may require skin grafting, a procedure which removes sections of skin from one area of the body and attaches them to another area.

Compensation for Provigil Side Effects

Patients who develop Stevens Johnson Syndrome as a result of taking Provigil may be able to receive compensation for the costs of their medical expenses, lost income, or more. In many cases, patients find themselves in a situation where they need to take time off from work in order to properly care for their disease. In the event that a victim dies from serious side effects from this drug, his or her family can file a survival action or wrongful death claim as well against the manufacturer.

If you believe that you have a claim for the defective drug, Provigil, you can call WTW to speak to an experienced attorney about your case! We will work with you to answer any questions you might have.

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