Yourlawyer.com (Purple Glove Syndrome News)

Dilantin Injection Reportedly Causing Purple Glove Syndrome, FDA Says

Tue, 09 Sep 2008 00:00:00 -0700

According to a quarterly report it released last week, the Food & Drug Administration (FDA) is investigating instances were Dilantin (phenytoin) injections led to a disorder known as Purple Glove Syndrome. This condition, which was named for 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.

FDA Now Listing Some Drugs Being Investigated

Mon, 08 Sep 2008 00:00:00 -0700

Effective immediately, the U.S. Food and Drug Administration (FDA) will begin posting a quarterly list of drugs whose safety is under investigation over complaints brought to its attention by drug companies, physicians, and patients. Although the FDA investigates drugs because of data from clinical trials and other studies, those drugs will not be included on the list. FDA officials said they had not yet decided how to inform the public when an investigation clears a drug.

The quarterly list names drugs under review following reports to the AERS program; the first report appears on the FDA Website and covers January 1 to March 31. That report list 20 drugs, four of which are being investigated for problems already announced to the public: Heparin and anaphylaxis reactions; the diagnostic "contrast agent" Definity and cardiopulmonary reactions; Cymbalta and urinary retention; and tumor necrosis factor inhibitors and cancer in children and young adults. Other drugs listed include Tysabri for skin melanoma and phenytoin (Dilantin) injection for its association with a disorder known as Purple Glove Syndrome.

In its quarterly listing, the FDA will name the drug and the nature of its "adverse events." The FDA will not describe the seriousness of the adverse event, nor will it list the number of complaints received, officials said yesterday. Also, being placed on the list is not an indication that the drug is unsafe, rather the list indicates only that the FDA is looking into the drug and the possibility that the drug poses a safety concern. The new policy is required by changes to federal law enacted last year. FDA officials said they realize that the new policy may unintentionally alarm some patients.

Last year, the FDA’s Adverse Event Reporting System (AERS) received 482,154 unsolicited reports of potential reactions to drugs. “The risk is that people will read more into this than what it is, which is a statement that an evaluation is underway," said Paul Seligman of the agency's Center for Drug Evaluation and Research. He added that he hopes patients will not stop taking a medication simply because they saw it on the list. Another official, Gerald Dal Pan, said that the FDA's "post-market surveillance" system is not changing, only the timing and extent to which the public is informed. “I think the public has told us in recent years that 'we want to know what you are working on.' We are telling the public at pretty much the earliest stage what we are working on," he said.

Sometimes rare side effects and interactions are not discovered until after a drug has gone to market and has been taken by many more people than those in pre-market studies. For instance, in recent years, the painkiller Vioxx was found to increase the risk of heart attack and stroke; the diabetes drug Avandia to increase the risk of congestive heart failure; and numerous anti-epilepsy drugs to increase suicide risk. In each of these cases, the drug’s adverse reactions were not fully discovered until well after drug approval.

Dilantin Lawyer Purple Glove Syndrome Phenytoin Attorney Lawsuit

Mon, 08 Sep 2008 00:00:00 -0700

Purple Glove Syndrome Lawyers

Keywords: Dilantin Lawyer Purple Glove Syndrome Phenytoin Attorney Lawsuit

The lawyers and attorneys at our firm are currently offering free case evaluations to victims of Purple Glove Syndrome. This serious condition, which causes the legs/and or arms to become painfully swollen and turn purple, can become serious, and lead to the amputation of the affected limb. If you or a loved one suffered from this condition, we urge you to contact one of our Purple Glove Syndrome lawyers right away to discuss your case.

Dilantin (Phenytoin) and Purple Glove Syndrome

In September 2008, the Food & Drug Administration (FDA) released a list of 20 drugs that were being investigated because of reported adverse reactions. One of the medications on the roster was the antiepileptic drug Dilantin (phenytoin). The FDA said there had been reports that patients receiving intravenous phenytoin had developed Purple Glove Syndrome.

The FDA did not say how many such reports it had received, but our Purple Glove Syndrome lawyers believe a great number of people may have been injured by this drug. A 1998 study found that of 152 patients receiving intravenous Dilantin (phenytoin), 9 (about 5.9%) developed Purple Glove Syndrome. That study, which was conducted by researchers at the Mayo Clinic, concluded that Purple Glove Syndrome is not rare and that elderly patients and individualsreceiving large, multiple doses of intravenous phenytoin are most likely to develop the disorder.

Phenytoin acts to dampen the unwanted, runaway brain activity seen in seizure by reducing electrical conductance among brain cells by stabilizing the inactive state of voltage gated sodium channels. 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). Intravenous phenytoin has been in use since 1956. This treatment is linked to several other serious side effects, including hypotension, arrhythmias and toxicity.

Purple Glove Syndrome

Purple Glove Syndrome was so named because of the discoloration of the skin that often accompanies the disorder. This discoloration is accompanied by pain and edema distal to the site of intravenous administration of phenytoin.

Purple Glove Syndrome progresses in stages. Generally, 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 extremity.

It can take 2-4 weeks for a case of Purple Glove Syndrome to heal. If a patient is fortunate, the discoloration and edema will gradually fade. While the disorder can resolve without incident, our Purple Glove Syndrome lawyers are aware of several cases resulting in necrosis (death of tissue) that have been reported.

No one knows exactly what causes Purple Glove Syndrome. In some cases, it appears to be related to the reaction of the interstitial tissue to leakage of the highly alkaline pH of phenytoin injection. However, not all cases of Purple Glove Syndrome are preceded by such leakage. It is thought that this varying reaction is related to the formulation of phenytoin injection.

Treatment of Purple Glove Syndrome

If a patient exhibits symptoms of Purple Glove Syndrome, there are a number of steps healthcare providers can take to lessen its severity. First and foremost, the administration of phenytoin must be stopped. The application of heat to the affected area can help to relieve pain and to redistribute the phenytoin. The affected extremity will also be elevated to lessen edema.

Severe cases of Purple Glove Syndrome require more intervention. This could include emergency surgery to relieve pressure and restore blood flow. The most severe cases of Purple Glove Syndrome can lead to amputation of the affected limb. For this reason, therapeutic nursing interventions aimed at maximizing healing and promoting comfort are essential.

Legal Help for Victims of Purple Gove Syndrome

If you or a loved one suffered from Purple Glove Syndrome following intravenous administration of phenytoin, you have valuable legal rights. Please fill out our online form, or call 1-800 LAW INFO (1-800-529-4636) to discuss your case with one of our experienced Purple Glove Syndrome Lawyers as soon as possible.