Beware of these side effects from narcolepsy drug
Because severe rash and psychiatric adverse effects have been reported with the use of Provigil, FDA adds new warning on the narcolepsy drug's label
The FDA has added new warnings to the labeling of Provigil (modafinil), which is used to improve the wakefulness of patients with narcolepsy. The agency said it has received reports of patients developing severe rash-including Stevens-Johnson syndrome and toxic epidermal necrolysis-and psychiatric symptoms, such as hallucinations and suicidal ideation. Patients who develop a rash from taking the drug should stop using it, according to the FDA. The agency also cautioned that the drug is not approved for use in children. More information is available at:
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
