In 1997, the Food and Drug Administration (FDA) issued nationwide warnings regarding Levaquin (an antibiotic medication for the treatment of serious, life-threatening bacterial infections) and Provigil (a drug prescribed for narcolepsy). Both were found to cause the same severe side effect – toxic epidermal necrosis (TEN). Rare and potentially fatal, toxic epidermal necrosis is a serious skin condition in which the outer layer of the skin (the epidermis) detaches from the layers beneath.
In addition to alerting consumers and medical professionals about the dangers and risks of Levaquin and Provigil, during its 1997 warning, the FDA also mandated that Omnicare (the division of Johnson & Johnson that makes Levaquin) and Cephlon (the manufacturer of Provigil) include black box warnings on all drug packaging and advertising to highlight the serious risk of developing TEN.
Symptoms of TENS
Both Levaquin and Provigil patients should be aware of the risk and symptoms of toxic epidermal necrosis so they know when to seek emergency medical care. Symptoms of TEN include:
- blisters in the mouth that make eating difficult
- infection of the upper respiratory tract
- inflammation of the mucous membranes in the eyes, mouth, nose, and genitals.
- loss of vision
- rash and sagging/sloughing of the skin.
To determine whether a patient has developed toxic epidermal necrosis, doctors must examine a tissue specimen under a microscope. Those who have TEN will be immediately transferred to an intensive care or burn unit for immediate treatment (which may include IV therapy, and anti-inflammatory medications).
Because the significant loss of skin associated TEN will increase the chances of developing serious infections (such as sepsis), the prognosis for the condition is grim. There is a 30 to 40 percent mortality rate for patients suffering from toxic epidermal necrosis.
Levaquin and Provigil Lawsuits
Patients who have taken Levaquin or Provigil and have TEN may have a legal claim against Omnicare or Cephlon. They may be entitled to compensation for their injuries and losses. Defective drug attorneys invite injured parties to learn more about their legal rights and entitlements at no charge.
If you or a loved one have used Levaquin or Provigil and suffers from TEN should contact us immediately for a free and confidential case review. You may be entitled to compensation and we can help.