Here's another ripple from the Ben Venue Laboratories splashdown. Sanofi's ($SNY) Genzyme unit has recalled a batch of its leukemia drug Fludara because of worries about its sterility. The 9,380 vials were produced at Ben Venue's troubled plant in Ohio, which is currently shut down for an overhaul.
In its recall notice, the FDA said a joint inspection with European authorities in November sparked concerns the products might not be sterile. Genzyme notified customers of the recall Jan. 31 and Feb. 1, calling it a precautionary measure. "No issue has been identified with Fludara," the company said. "However, defects potentially associated" with the manufacturing shortfalls at Ben Venue "raise the possibility for hypersensitivity reactions" in some patients.
Ben Venue's plant shutdown--and the manufacturing violations leading to it--have sparked a series of drug shortages and recalls. Johnson & Johnson's ($JNJ) cancer drug Doxil had been the most high-profile shortage caused by Ben Venue's shortcomings until this week. Now, a "dire" shortage of methotrexate, used to treat childhood leukemia, has been blamed in part on the shuttered Ben Venue plant.
Other Ben Venue-related supply problems include Vibativ, a Theravance ($THRX) antibiotic marketed by the Japanese drugmaker Astellas. In December, Astellas put a hold on Vibativ distribution and said no new patients should begin treatment. European regulators recalled a number of antivirals and cancer meds in late November on contamination fears, including Pierre Fabre's Busilvex, Johnson & Johnson's Velcade, Celgene's ($CELG) Vidaza and Gilead Sciences' ($GILD) Vistide. Then, in early December, the EMA also pulled Ecalta, a Pfizer ($PFE) antifungal, and recommended that doctors check vials of other drugs for particulate contamination.
- see the Bloomberg piece
- get more from the WSJ