FDA Watch List: Velcade
Takeda Pharmaceuticals' Multiple myeloma medication Velcade (bortezomib) has found its way onto the Food and Drug Administration’s “Adverse Event Reporting System” list for Q3 2011 because of a potential link between its usage and death when given to patients through intrathecal administration.
Intrathecal administration of a medicine is the clinical term for when a drug is injected into the cerebrospinal fluid through the subarachnoid space of the spinal cord.
Velcade is also used to treat mantle cell lymphoma.
The AERS list documents potential safety risks that were gathered during the final quarter of 2011. The Dosage and Administration and Contraindications sections of the labeling for Velcade were updated in January to better reflect the drug’s potential link with fatal events through intrathecal administration.
It is important to note that the FDA has not yet determined whether or not products listed on the AERS watch list pose a health risk. Instead, it means that additional studies will be undertaken to see if there is a link between the product and a potential health risk. Possible regulatory responses, such as a change in the product’s labeling or a recall, could be pursued by the FDA if such a link is found.