Dilantin-125 (phenytoin) Oral Suspension Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011
... PRECAUTIONS Drug Interactions (revised) Phenytoin is extensively bound to serum plasma proteins and is prone to competitive displacement. Phenytoin is metabolized by hepatic cytochrome P450 enzymes CYP2C9 and CYP2C19, and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity.
Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes. Serum level determinations for phenytoin are especially helpful when possible drug interactions are suspected.
Dilantin Safety ReviewStevens-Johnson Syndrome (SJS) a condition that causes cell death separation of the epidermis (skin) from the dermis. While a milder form of Toxic Epidermal Necrolysis (TEN), still serious enough result in :
Dilantin, ibuprofen,naproxen, diclofenac, phenobarbitol Penicillins Phenytoins (antiepileptics) and Anticonvulsants: dilantin, phenytek, lamotrigine, carbamazepine, ethosuximide Sulfonamides Enzyme
Pittsburgh, PA: Although cases of Stevens Johnson syndrome, also known as SJS, are rare, they can have a devastating effect on patients.
Some people who developed Stevens Johnson syndrome symptoms have filed lawsuits against the makers of the drugs they say caused the condition, alleging that drugmakers failed to adequately warn about the risk of Stevens Johnson syndrome skin disease.
Now, a federal judge has ruled against Johnson & Johnson in a Stevens Johnson syndrome lawsuit.
Dilantin has a strong connection to Stevens Johnson Syndrome
Phylis Feiner Johnson wrote a warning article for the Epilepsy Foundation highlighting the connection between Dilantin and Stevens Johnson Syndrome (SJS). Dilantin is a commonly prescribed drug to treat seizures including those experienced by epileptics. Johnson has struggled with epilepsy for 20 years and is personally well-versed in a number of drugs related to the disorder. However, when she discovered that Dilantin and SJS had a strong connection, she felt compelled to warn others about the risk...
Symptoms are unexplained widespread skin pain, facial swelling, blisters on your skin and mucous membranes, hives, tongue swelling, a red or purple skin rash that spreads, or shedding of your skin.” Once SJS gets into its most serious stages, the skin sloughs off the body in sheets. Blindness and vision problems are relatively common with SJS survivors because the blisters tend to cluster in wet regions like the eyes, which are sensitive and scarring can lead to vision impairment.
Dilantin Rash Stories
Johnson’s article brought on plenty of empathy. Ruth Brown shares: “I urge everyone with SJS to tell others about what happened. It actually happened to me. When I was six years old, I was diagnosed with epilepsy. I was put on Dilantin. I started out with a rash. It got worse. The rash then broke open and I started losing my skin. My mother took me right away to (a hospital). This was in 1949. They had no treatment for it. They put cold compresses on me to treat me. They thought I was going to die. Somehow, I survived it. It can go into remission and come back later in life. Two years ago, I was diagnosed with it again.”
Drugs Linked to SJS
There is a documented association between phenytoin with concurrent cranial radiation therapy and developmen t of Stevens Johnson Syndrome. Erythema multiforme (EM) linked with phenytoin and cranial radiation therapy (EMPACT ) is the term describing this reaction.