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What is Dilantin?

Dilantin is manufactured by Pfizer and received FDA approval in 2001. Since then, it has been added to the FDA’s Potential Signals of Serious Risks List and has been associated with serious conditions including Stevens-Johnson Syndrome and Purple Glove Syndrome.

Dilantin, also know as phenytoin, is an antiepileptic drug, or anticonvulsant, prescribed to control certain types of seizures including grand mal seizures and temporal lobe seizures. Grand mal seizures feature a loss of consciousness and violent muscle contractions while those suffering from temporal lobe seizures experience odd feelings such as euphoria, fear, déjà vu, and hallucinations.


Stevens-Johnson Syndrome, also known as SJS, is a serious, life-threatening disorder in which your skin and mucous membranes react severely to a medication or infections. Stevens-Johnson Syndrome often begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed.

Stevens-Johnson Syndrome is an emergency medical condition that typically results in hospitalization. In addition, if it is caused by a drug, such as Dilantin, patients are required to permanently discontinue the medication and all others related to it.

Some serious side effects of Stevens-Johnson Syndrome include:

  • Facial swelling
  • Tongue swelling
  • Hives
  • Skin pain
  • A red or purple skin rash that spreads within hours to days
  • Blisters on your skin and mucous membranes, especially in your mouth, nose and eyes
  • Shedding (sloughing) of your skin

If you or a loved one have experienced any of these extreme side effects, seek medical attention immediately.

Possible complications of Stevens-Johnson Syndrome include:

  • Secondary skin infection (cellulitis). This acute infection of your skin can lead to life-threatening complications, including meningitis — an infection of the membrane and fluid surrounding your brain and spinal cord — and sepsis.
  • Sepsis. Sepsis occurs when bacteria from a massive infection enter your bloodstream and spread throughout your body. Sepsis is a rapidly progressing, life-threatening condition that can cause shock and organ failure.
  • Eye problems. The rash caused by Stevens-Johnson syndrome can lead to inflammation in your eyes. In mild cases, this may cause irritation and dry eyes. In severe cases, it can lead to extensive tissue damage and scarring within your eyes that can result in blindness.
  • Damage to internal organs. Stevens-Johnson syndrome can cause lesions of your internal organs, which can result in inflammation of your lungs (pneumonitis), heart (myocarditis), kidney (nephritis) and liver (hepatitis).
  • Permanent skin damage. When your skin grows back following Stevens-Johnson syndrome, it may have abnormal bumps and coloring (pigmentation). Scars may remain on your skin, as well. Lasting skin problems may cause your hair to fall out, and your fingernails and toenails may not grow normally.


In September of 2008, the FDA released a quarterly report indicating that they were investigating instances where Dilantin (phenytoin) injections led to a disorder known as Purple Glove Syndrome. However, the FDA did not say exactly how many instances had been reported.

Earlier in a 1998 study, the Mayo Clinic found that of 152 patients receiving Dilantin injections, 9 (about 5.9%) developed Purple Glove Syndrome. That study concluded that Purple Glove Syndrome was not rare and that elderly patients and individuals receiving large, multiple doses of Dilantin are most likely to develop the disorder.

Purple glove syndrome is a skin disorder in which the extremities become swollen, painful and discolored due to IV injections of Dilantin. The condition begins as a blue or purple discoloration around the injection site and then spreads around all sides of the extremity or limb.

If you have noticed any discoloration around the injection site, you should seek medical attention right away.

In some cases it can take 2-4 weeks for the condition to resolve; however, the discoloration may not ever fade. In other cases, Purple Glove Syndrome can result in the premature death of cells and living tissue, known as necrosis. Necrosis is almost always detrimental and can be fatal.


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