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Dilantin labels show serious side effects

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The U.S. Food and Drug Administration on March 6 approved Pfizer’s new labeling for the antiepileptic drug Dilantin (phenytoin). One change added several drugs to the list of those that “may decrease phenytoin levels.”

Nevertheless, significant labeling remains intact. Although Dilantin has been FDA-approved since the mid-1950s, a couple of increased risks noted on Dilantin’s 21st century labeling have not changed.

One pertains to the drug’s fetal effect and it reads, “If you take Dilantin during pregnancy, your baby is at risk for serious birth defects. … Infant breast feeding is not recommended for women taking this drug because phenytoin appears to be secreted in low concentrations in human milk.”

Expounding on this warning, “The babies of women taking phenytoin have a greater than usual number of major birth defects like cleft lip, cleft palate, and heart malformations,” according to the Epilepsy Foundation’s Epilepsy Therapy Project.

If they become pregnant, Dilantin patients should be encouraged by their physicians to enroll in the North American Antiepileptic Drug Pregnancy Registry, according to labeling in effect since 2009. The registry provides information on the effects of in-utero exposure to Dilantin, and it collects information “about the safety of antiepileptic drugs during pregnancy.” One may visit the registry online at www.aedpregnancyregistry.org and enroll by calling its toll-free number, which is 1-888-233-2334.

Here is another labeled potential Dilantin side effect: “Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with phenytoin treatment.” These are conditions that consist of extensively excruciating skin detachment and blistering, with TEN being a more severe form of SJS.

Although studies conducted in Thailand and in Taiwan suggest a relationship between the human leucocyte antigen and phenytoin-induced Stevens-Johnson syndrome, the British Epilepsy Association in 2011 published evidence in Seizure, the European Journal of Epilepsy, that such susceptibility is related to “other genetic markers or nongenetic factors.”

The FDA in November 2008 announced that among those with the antigen it was “investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis from phenytoin therapy.” Dilantin labels have warned about the risks of these conditions since 2009.

In Dilantin lawsuits, victims claimed that the manufacturer should have known about, should have properly warned sooner about, and should have abated the drug’s increased risks.

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The Dilantin attorneys at Reich & Binstock (www.reichandbinstock.com) have specialized skill and experience in handling these types of pharmaceutical injury lawsuits. For a free attorney consultation, call the law firm, which operates in every state, toll-free at 1-866-LAW-2400.