Drugs

FDA Requires New Seizure Warning for Parkinson’s Drugs

FDA is requiring updated safety warnings for a widely used class of Parkinson’s disease treatments, citing evidence that they can cause vitamin B6 deficiency and, in some cases, seizures. The agency has notified manufacturers of all drug products containing carbidopa/levodopa to revise prescribing information to include the new warning. The change applies to commonly used therapies such as Sinemet, Rytary, Duopa, and Stalevo, among others.

Carbidopa/levodopa therapies are a common treatment for Parkinson’s, a progressive condition characterized by tremors, rigidity, and slowed movement. FDA’s review found that the medications can deplete vitamin B6 levels through multiple mechanisms, potentially leading to serious neurological complications. As a result, the agency is directing health care providers to check patients’ vitamin B6 levels before starting therapy, monitor them periodically during treatment, and provide supplementation when needed.

The safety action follows an FDA analysis of 14 reported cases of vitamin B6 deficiency–associated seizures in patients taking carbidopa/levodopa products. Most cases involved high daily doses of levodopa, typically exceeding 1,000 milligrams. In several instances, patients developed severe seizure activity, including progression to status epilepticus.

Notably, FDA says the seizures often did not respond to standard anti-seizure medications but resolved after patients received vitamin B6 supplementation. Among nine patients treated with vitamin B6, all experienced seizure resolution. Two deaths were reported in patients with documented vitamin B6 deficiency and poorly controlled seizures, it says.

Additional symptoms linked to vitamin B6 deficiency included depression, confusion, inflammation of the lips and tongue, and nerve damage causing numbness, tingling, or muscle weakness.

The agency emphasizes that while cases were identified primarily in patients using certain oral and enteral formulations, there is biological plausibility that the risk could extend across all carbidopa/levodopa-containing products.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome