Evrysdi (risdiplam) 0.75 mg/mL powder for oral solution (PfOS).

Summary:

• Complaints were reported from a pharmacy in Germany regarding insoluble foreign particles in constituted Evrysdi® 0.75 mg/mL oral solution for Batches B2033B03 and B2035B09.
  The potential presence of particles in additional batches cannot be excluded. This includes finished-product batches labeled with batch numbers starting with one of the following numbers: B2033, B2034, B2035, B2036, B2037, B2038 and B2039. No additional batches are in scope.
• Investigations of the MAH have shown that these particles consist of white Polytetrafluorethylene (PTFE-Teflon). PTFE is a chemically inert, non-toxic material that is expected to pass through the gastrointestinal tract unchanged without systemic absorption. Based on the identification of PTFE particles measuring 0.3 mm to 2.7mm, the clinical risk to the patient population is considered low as the presence of these small particles does not pose a specific or heightened risk to patients with SMA when compared to the general risk associated with the administration of liquids or food.
• None of the complaints received in this context were associated with adverse events
• A review of relevant post-marketing spontaneous adverse event reporting data shows no evidence of safety signals causally related to this product complaint. The events reported in the review were typical for this patient population and consistent with underlying disease progression. 
• A review of the company safety database during the reporting interval following the release of the batches in scope and routine signal management identified no new signals regarding gastrointestinal obstruction, respiratory distress, respiratory failure or mortality.