Neurontin - Recent News

On January 31, 2008, the U.S. Food and Drug Administration (FDA) issued a warning about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions. The drugs that are subject to the warning include Neurontin. FDA analysis of recent studies showed patients taking antiepileptics had about twice the risk of suicidal thoughts and behaviors, compared with patients receiving placebo. Read the FDA Press Release.

A number of lawsuits have been filed alleging that Neurontin causes suicidal or suicidal thoughts (called "suicidality"). Plaintiffs in these cases allege that Neurontin-maker Pfizer Pharmaceuticals failed to disclose the risk of suicidality.

Pfizer has responded to the allegations, stating that there is no scientific evidence linking Neurontin to suicide. In December 2005, Pfizer changed the Neurontin prescribing information to include "suicide" and "suicide attempt" as infrequent adverse events.

In 2004, Pharmaceutical manufacturer Warner-Lambert, a subsidiary of Pfizer Pharmaceuticals, agreed to plead guilty and to pay more than $430 million to resolve criminal charges and civil liability in connection with the illegal and fraudulent promotion of unapproved uses for Neurontin. Click here to read more from the FDA.

Neurontin Precautions

The follow precautions should be observed before, while, and/or after taking Neurontin:

• Children between the ages of 3 and 12 may be sensitive to the effects of Neurontin. This may increase the chance of side effects during treatment. For patients between the ages of 12 and 18, Neurontin has not been shown to cause different side effects or problems than found in adults.

• Because Neurontin is removed from the body more slowly in elderly people than in younger people, higher levels of Neurontin in the blood can occur. This can increase the chance of unwanted effects. Elderly patients may receive different Neurontin doses than younger people.

• When taking Neurontin, it is important that your healthcare professional check your progress at regular visits, especially during the first few months of treatment. This is necessary to allow for dose adjustments and for the reduction of any unwanted effects.

• Stopping Neurontin suddenly may cause seizures to return or to occur more often. Talk to your healthcare professional about gradually reducing your dose of Neurontin first before stopping it completely.

• Because Neurontin may cause blurred or double vision, clumsiness, unsteadiness, dizziness, drowsiness, or trouble thinking, you should make sure you know how you react to Neurontin before you drive, use machines, or perform any activity that requires alertness, good coordination, or the ability to think and see well.

• Tell your healthcare professional that you are taking Neurontin before having any medical tests. Neurontin can affect the results of dipstick tests for protein in the urine.

What Should I Tell My Healthcare Professional?

You should tell your healthcare professional if you:

• have or have had any unusual or allergic reaction to Neurontin (gabapentin), or if you are allergic to any other substances (foods, preservatives, or dyes)

• are pregnant, may become pregnant, or are breast-feeding. Although Neurontin has not been studied in pregnant women, animal studies have shown that Neurontin may cause bone or kidney problems in offspring when the mother is given doses larger than the human dose. Neurontin passes into human breast milk and may cause unwanted effects in nursing infants.

• have kidney disease

Neurontin Side Effects

Tell your healthcare professional if any of the following side effects associated with Neurontin use are severe or persistent:

• drowsiness
• tiredness or weakness
• dizziness
• headache
• shaking of a part of your body that you cannot control
• double or blurred vision
• unsteadiness
• anxiety
• memory problems
• strange or unusual thoughts
• unwanted eye movements
• nausea
• vomiting
• heartburn
• diarrhea
• dry mouth
• constipation
• weight gain
• swelling of the hands, feet, ankles, or lower legs
• back or joint pain
• fever
• runny nose, sneezing, cough, sore throat, or flu-like symptoms
• ear pain
• red, itchy eyes (sometimes with swelling or discharge)

Call your healthcare professional immediately if you experience any of the following side effects of Neurontin use:

• rash
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty swallowing or breathing
• seizures