Purple Glove Syndrome Warnings Urged for IV Phenytoin

Intravenous phenytoin, a seizure drug approved in 1956, has at least one unusual adverse reaction. Although phenytoin has been linked to hypotension, arrhythmias, and toxicity, the emerging <"http://www.yourlawyer.com/topics/overview/purple-glove-syndrome">Purple Glove Syndrome has been reported recently, said the Mayo Clinic.

A relatively rare complication, Purple Glove Syndrome can have significant complications including fasciotomies (incision into the connective tissue to relieve pressure), amputations, and permanent loss of the hand and forearm, explained Mayo Clinic. The Body Odd said that lingering pain and even death have been connected to the syndrome.

Although its exact cause is not yet known, experts do know that three stages of the syndrome exist: Appearance, progression, and resolution, said the Mayo Clinic.

It is in the second stage of progression that the severity of the syndrome is determined, noted the Mayo Clinic. And, while some cases do disappear with elevation; dry, mild heat; and other measures, more serious cases could mandate surgery to restore normal blood flow and ameliorate the pressure, added the Mayo Clinic.

In one case of Purple Glove Syndrome following treatment for a massive stroke, the patient and her family blame an injection of intravenous phenytoin, said the Body Odd. Following treatment with intravenous phenytoin, the patient’s hand swelled significantly and turned a deep purple color; the family claims a bungled injection, said the Body Odd.

“With the Purple Glove Syndrome, she can’t do all the things with her hands she used to do,” Jeff Garvin, the patient’s husband said, quoted the Body Odd. “Her biggest complaint from the stroke is a speech impediment—and the pain in her hand,” Garvin added.

In response to the adverse reaction reports, an advisory committee of the U.S. Food and Drug Administration (FDA) recommended that IV phenytoin, which is also marketed as Dilantin, contain label warnings about Purple Glove Syndrome, wrote the Body Odd. The group also voted against pulling phenytoin from the market, added the Body Odd.

The syndrome—also known as PGS—first began being reported in the 1980s, noted the Body Odd.

To date, said the FDA, 43 cases have been reported; it is believed the syndrome is underreported, said the Body Odd. Some studies suggest that severe cases occur in about six percent of patients receiving IV phenytoin; less severe cases occur in about 25 percent of the patients, wrote the Body Odd.

Some experts believe PGS occurs when the “toxic” medication does not reach a vein, but is injected into hand tissue, with some damage being permanent, said the Body Odd.

Fosphenytoin (brand name: Cerebyx) seems to control seizures equally as well as phenytoin and also carries some PGS risks; however, the FDA panel could not definitively link the medication to the disorder, said the Body Odd. Both fosphenytoin and phenytoin have similar risks for established side effects, added the Body Odd.

The FDA is looking into recommendations from a collaborative meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, reported the Body Odd.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.