Pfizer is not recalling the products but asking healthcare providers to be vigilant about administering product that looks discoloured as some of the affected vials may also not meet specifications for potency, degradation or impurities.
“Following a thorough assessment, Pfizer believes the probability for serious health consequences is low,” Lauren Starr, a spokeswoman with Pfizer told Outsourcing-Pharma.com. “However, Pfizer is recommending that healthcare professionals refrain from dispensing the product if a color other than that described in the package insert is observed.”
Despite the assurances, the company notes in its letter to healthcare providers that the “effect of these changes to patients is not known. For example, a patient infused with affected product may receive a sub-potent dose and may experience undesired events, such as an insufficient clinical response or adverse events not previously observed,” Pfizer said.
The company added the affected vials can change from “the expected red powder to a brown/black powder” and the discolouration “will also be apparent during the reconstitution process and in the final solution.”
The company expects the shortage to be dealt with by June 30. Wholesalers should disseminate the information on the vials to “all appropriate dispensing staff” and will be reimbursed by Pfizer for forwarding the letter, the company noted.
Other Rifampin Shortages
Drugmakers Akorn and Bedford Laboratories also have announced shortages of their 600 mg vials of Rifampin injections, according to the FDA. Bedford, which is a division of Ben Venue, entered into a consent decree with the FDA after cGMP (current good manufacturing practice) problems surfaced. But the company says that it will still be allowed to manufacture drugs “essential for patient care,” though it’s unknown if Rifampin falls into this category.
But according to the American Society of Health-System Pharmacists, Sanofi-Aventis’ Rifadin injection Akorn’s Rifampin are still available.
TB Drug Shortages
The announcement of the Pfizer shortage comes just a week since Sanofi announced manufacturing delays that caused a shortage of its Rifamate capsules.
That shortage was first announced by the US CDC (Centers for Disease Control) in December 2012. The CDC said at the time that Teva, Sandoz, and VersaPharm should have supplies of the drug.