Pfizer returning ED device to pharmacies

The Caverject Impulse Dual Chamber System, a drug delivery device used to treat erectile dysfunction that was withdrawn by the manufacturer, will return to pharmacy shelves, according to Pfizer, Inc. Pfizer could not say when it will resume production of the device, which it said it withdrew “several months ago.”

The U.S. Food and Drug Administration is consulting with the drugmaker on rewording the device’s instructions and Pfizer is considering changes to the product design, said company spokeswoman Sally Beatty. Beatty said Caverject still can be ordered without the delivery system by pharmacists.

“Pfizer is optimizing the Caverject Impulse to improve its ease of use for patients,” Beatty said. According to a Pfizer Web site, www.caverject.com, the manufacturer is developing and testing more detailed user instructions for the prefilled syringe with a dial for exact dosing.

John Mulhall, MD, an urologist and director of the Male Sexual & Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center in New York, says he understands that Pfizer’s withdrawal of Caverject Impulse is temporary.

“We do have some patients who are on Caverject; they use the regular (syringe) Caverject system at the moment,” he said. “My understanding talking to the Pfizer people not too long ago is that Caverject Impulse is not a discontinued product; it’s going to be available at some point in the future. It’s just a matter of a negotiation between the FDA and Pfizer for a label change regarding the instructions.” FDA spokeswoman Rita Chappelle referred questions to Pfizer. Alprostadil, also known as prostaglandin E1 (PGE1), is the main ingredient in Caverject. While oral ED drugs such as Viagra have become popular in the last few years, alprostadil injections may be the only option for men who are taking other medications that may cause an adverse interaction.

Users of Caverject have other options. Besides a comparable drug known as EDEX, produced by international drugmaker UCB, many consumers have found multi-agent or combination therapies effective, Mulhall said. A majority of his patients at Sloan-Kettering bypass Caverject and EDEX because of pain associated with the injection of prostaglandin, he said. Many compounding pharmacies offer multi-agents that combine two or three chemicals to make a product similar to Caverject.

One, called Bimix, is a blend of papaverine and phentolamine, but does not contain prostaglandin E1 and might be a preferred choice for patients who complain of pain from injections that contain PGE1. Another combination therapy, Trimix, adds PGE1. Beatty said Caverject users should speak with their healthcare providers about continuing to use Caverject with an alternative injection system. EDEX is being delivered to pharmacies as scheduled, according to UCB.

“Production on EDEX has not been halted,” says UCB spokeswoman Anne Kirby.