Dilantin (phenytoin sodium) has been used for many years as an antiepileptic — that is, to control seizures. It helps to control the grand mal and temporal lobe seizures of epilepsy by slowing the brain impulses that trigger them. It is also used to treat trigeminal neuralgia and some kinds of heart arrhythmias.
In 2008, after receiving reports of a condition called Purple Glove Syndrome, the FDA announced that it was going to investigate Dilantin in cases where it was administered intravenously (directly into a vein with a needle or IV line).
What is Purple Glove Syndrome?
Purple Glove Syndrome starts as purple or blue discoloration at the injection site and in less than 24 hours, spreads throughout that arm or leg, causing swelling (edema). The purple or blue is bruising — that is, broken blood vessels. In some cases it all fades in two to four weeks. However, in other cases, it persists to the point where tissue dies for lack of proper blood circulation and the limb may have to be amputated.
Fetal Dilantin Syndrome
There has been another potential side effect also, known as Fetal Dilantin Syndrome. This is a group of birth defects suffered by about one third of the babies born to women who took Dilantin during pregnancy. It mostly features minor face or limb malformations but in some cases involves mental retardation, heart defects, growth problems, cleft lip, or other more serious problems.
Other Side Effects
More recently pinpointed side effects in the FDA’s sights are:
- Stevens Johnson Syndrome (SJS); and
- Toxic Epidermal Necrolysis (TEN).
These are very rare conditions and it has been difficult to determine their frequency. In about half the cases, no cause has been found and in the other half, a link has been made to one or another drug. They start with coughing, fever, and a sore throat. Then bleeding and blisters develop and they can even be fatal.
There is actually a long list of potential Dilantin side effects, none of which are new, and reading it would deter almost anyone from wanting to take the drug. But the important word is potential. Not everyone gets all side effects, and some people may have none.
What is a Defective Drug?
A defective drug is not necessarily inherently defective. It may just have inadequate warnings on its labeling, or may be just inappropriate for some people. It is the manufacturer’s job and the FDA’s job to inform doctors and patients as to who should not take a given drug.
Some side effects may affect everybody, such as edema, but may be minor. When side effects are more serious, such as heart function changes, the FDA determines what warnings must be given to the medical professions and the public. When serious side effects turn out to be more frequent or more serious than the FDA testing phases had suggested, it is usually the manufacturing company who recalls the drug and then notifies the FDA.
Over the years, we have been involved in lawsuits over a great many recalled drugs that caused illness or injury, or even death, before they were recalled. Most drugs have side effects. The safety secret is for you and your doctor to choose only drugs that will be beneficial for you, based on your health needs and the drug’s potential side effects.
However, if you have been harmed by a truly defective drug and would like to know more about your legal position, please contact our law office for a free case evaluation.