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GA, FL, AL: Dilantin and SJS and Purple Glove Syndrome

By Mark Zamora

According to a quarterly report issued in late 2008, the FDA investigated  occurrences where  Dilantin (phenytoin) injections led to a disorder known Purple Glove Syndrome. This condition -named after the discoloration that  often accompanies it, can lead to the need for emergency surgery, and even limb amputation, if it becomes serious.

Phenytoin is an antiepileptic drug. Aside from seizures, it is an option in the treatment of trigeminal neuralgia as well as certain cardiac arrhythmias. In the US, phenytoin is marketed as Phenytek and Dilantin (including Dilantin Kapseals, Dilantin-125 and Dilantin Infatabs).

Phenytoin has been administered intravenously since 1956.  But occasionally, this treatment can lead to a complication called Purple Glove Syndrome.  Purple Glove Syndrome starts as a  pale blue or dark purple discoloration which appears around the intravenous insertion site 2  to 12 hours after the administration of the drug. Progression occurs during the next 12 to 16 hours as developing edema and continued discoloration spread around all sides of  the affected limb.

If a patient is fortunate, the discoloration and edema will gradually fade, and the affected limb will heal within 2 to 4 weeks.  However, Purple Glove Syndrome can sometimes turn quite serious, resulting in the death of affected tissue. When such necrosis occurs, a patient may require surgery to restore blood flow to the affected tissue.  The most severe cases of Purple Glove Syndrome can lead to amputation of the injured limb.

In its report, the FDA did not say how many cases of phenytoin-related Purple Glove Syndrome it was investigating.  But a 1998 study conducted by researchers at the Mayo Clinic found that of 152 patients receiving intravenous Dilantin (phenytoin), 9  (about 5.9%) developed Purple Glove Syndrome.  The study also found that the disorder was more likely to affect the elderly, and people who received more than one dose of phenytoin.

No one yet understands why intravenous Dilantin can cause Purple Glove Syndrome.  The disorder does occur when Dilantin - which has highly alkaline PH - leaks into the interstitial tissue.  But Purple Glove Syndrome is also seen in patients were such phenytoin leakage has not occurred.  Some health practitioners believe this could have something to do with the exact formulation of the phenytoin injection.

 

 

This is news in addition to previous claimed links to SJS.

Dilantin is also commonly used to treat and prevent the onset of seizures after a major brain or spinal surgery. Other names for Dilantin include: Dilantin Infatabs, Dilantin Kapseals, Dilantin-125, Phenytek, and Phenytoin Sodium.

In many instances, the consumer sees visible manifestations of a Stevens Johnson Syndrome reaction within a few days of starting the anti-seizure medication. Others may not see or realize the manifestations of the reaction due to Dilantin until weeks later. Typically the reaction starts out with symptoms such as headaches, sore throat, trouble breathing, itchy or irritated eyes, blistered lips, and/or the onset of a skin rash. In time the condition only gets worse, especially if the ingestion of the inducing drug is not stopped immediately.

Call Mark Zamora at 404 451 7781 , or email him at mark@mzlawyer.com

Full post as published by Trial Lawyer Resource Center on February 28, 2010 (boomark / email).