Pfizer has recalled two lots of RELPAX (eletriptan HBr) due to possible bacterial contamination. At this time, no injuries or adverse events have been reported, and Pfizer is voluntarily recalling the pharmaceuticals after becoming aware of the contamination risk. RELPAX is a popular migraine treatment designed to treat acute migraine headaches in adults.
While no adverse events have been reported at the time of this writing, bacterial contamination does pose a risk to patients. According to the recall notice, Pfizer has detected the potential presence of Genus Pseudomonas and Burkholderia. Anyone who consumes oral medication contaminated with microorganisms is at risk of bacterial dissemination from the gut to the bloodstream. This can result in gastrointestinal distress (without serious infection) as well as potentially resulting in serious, life-threatening infections. These risks are fairly low for the general population. However, individuals who may be particularly vulnerable because of compromised immune systems, such as those with cystic fibrosis, chronic granulomatous disease, or those undergoing chemotherapy, there may be the potential for serious adverse events including life-threatening infections.
The presence of bacteria in pharmaceuticals may happen more often than we might think. One of the most high profile cases of microbial contamination in recent years was the Synvisc-One knee injections. In the fall of 2017, Sanofi Genzyme, the manufacturer of Synvisc-One became aware of possible contamination. The company issued an urgent voluntary recall of one lot of the injections. The FDA later issued a Class 2 Recall for the vials related to the lots identified as contaminated. A Class 2 recall is issued when the FDA has identified a product that might cause serious injury or temporary illness. Adverse events were reported by patients who had been injected by the contaminated vials. Patients reported various injuries, including severe pain and swelling of the knee.
The Pfizer recall involves RELPAX (eletriptan hydrobromide) 40-mg tablets with lot numbers AR5407 and CD4565. These lots were distributed to wholesalers, retailers, hospitals, and healthcare providers across the United States and Puerto Rico during June and July of 2019. Pfizer is instructing any individuals with an existing inventory of these recalled lots to immediately stop use and to immediately quarantine the medication. Retailers, hospitals, and healthcare providers that have dispensed the medication to patients are instructed to notify these patients of the recall. If you think you may have some of the recalled medication, or you would like more information about the recall, visit the FDA’s recall announcement.
About the Author