Dilantin and Stevens-Johnson Syndrome (SJS)
Dilantin (generic name “phenytoin sodium”) has been used for a long time to control seizures. It is an anti-epileptic and helps to control grand mal and temporal lobe seizures.
Phenytoin sodium is also sold as:
- Phenytek (by Mylan Laboratories);
- Eptoin (in India by Abbott Group); and
- Epanutin (in Israel and the UK by Parke-Davis, which is now part of Pfizer)
How Does Dilantin Work?
A seizure is a condition where the brain’s neural activity is greatly speeded up, which can cause the person to go unconscious and fall, to stiffen, make uncontrolled jerky movements, and bite hard on the tongue.
There are different degrees of seizure ranging from simple partial seizures (involving a small part of the brain) to generalized seizures (involving the entire brain). Epilepsy is the best-known condition that involves seizures. It is not curable but can be managed with medications such as Dilantin.
Dilantin works to slow down the brain’s neural activity, reducing the severity of the seizure or preventing a seizure. It reduces electrical movement between brain cells (neurons), which can fire as many as 500 times per second during a seizure. A normal rate is about 80 times per second.
FDA Planning an Investigation
Research has found a human leukocyte (white blood cell) antigen allele (type of DNA sequence) called HLA-B*1502. This is found mostly in people from eastern Asia (Han Chinese, Malaysians, Filipinos, South Asian Indians, and Thais). When a person with this allele is given phenytoin (Dilantin), there is an elevated risk of severe skin problems.
In 2008, the FDA (Food and Drug Administration) announced that it planned to investigate Dilantin when it was given intravenously, that is, directly into a person’s vein using a needle or an IV line.
A side effect of Dilantin that has been reported to the FDA is Stevens-Johnson Syndrome. It is an emergency condition requiring immediate hospitalization. It has another form also, called Toxic Epidermal Necrolysis (TEN). They both feature lesions on the mucous membranes (mouth, lips, eyes, anal and genital areas) and a skin rash with blisters.
The rash has a purple or red color and spreads, causing the upper skin layer (epidermis) to die and peel off. This creates severe pain and danger of infection and the patient is treated in a hospital burn unit. Stevens-Johnson Syndrome (SJS) can be fatal.
The FDA is advising medical professionals to avoid using Dilantin for patients who test positive for HLA-B*1502, and to use carbamazepine instead (sold under many trade names, such as Tegretol, Biston, and Calepsin).
Other Dilantin Side Effects
It is not surprising that Dilantin would have many potential side effects, since it works on the brain, modifying electrical communication between brain cells. Some of the other possible side effects are:
- Slurred speech
- Difficulty with learning
- Numbness in the hands or feet
- Difficulty with breathing
- Unusual bruising or bleeding
Not everyone has all possible side effects. As with most FDA-approved drugs, most people have few side effects and SJS is very rare. However, it is severe and potentially lethal and the FDA wants better communication to medical professionals and patients about who should avoid Dilantin.
Frequency in the U.S. is estimated at between 2 and 7 cases per million person-years although Germany estimates it at one case per million person-years. Mortality rate appears to be from one to three percent of cases according to some sources and five percent according to others. It occurs among all races and in all countries. It appears that more females have SJS than males although estimates range between one-third and two-thirds female. The average age of patients has been found to be 25 years in a large study and 47 years in a small study.
At The Florida Firm, our personal injury attorneys represent SJS victims and other people who have suffered severe side effects caused by defective drugs. If we take your case, you will owe us no fees until and unless we win compensation for you.