Defective Simponi Injectable Devices Recalled

February 23, 2011

Simponi injectable pens, used commonly to help treat symptoms of rheumatoid arthritis, have been recalled due to defective manufacturing.

Simponi injectable pens, used commonly to help treat symptoms of rheumatoid arthritis, have been recalled due to defective manufacturing.

A defect in almost 900 injectable pens caused a massive recall of SmartJet autoinjectors, reported Arthritis Today; after it was discovered that the defect in the pen could prevent the proper administration of Simponi, the pens were pulled off the shelves.

Simponi, or golimumab, contains a TNF-alpha inhibitorused to treat rheumatoid arthritis, as well as psoriatic arthritis and ankylosing spondylitis.

Monica Neufang, a spokesperson for the drug’s marketer, Centocor Ortho Biotech Inc., stressed that the vast majority of the injectable pens were nabbed before they ever hit the retail market, and most of the defective pens were never in the hands of a patient.

“Nearly 80 percent of the affected unit was quarantined at the wholesale level, and we are working with wholesalers and distributors to recapture the remaining 165 affected units,” Neufang explained.

Neufang also said that “what’s important to note is it’s a defect in the autoinjector. It has nothing to do with the Simponi medication.”

At some stage in a regular quality testing, the defect was discovered in one lot (containing 839 pens) of 50 mg single dose SmartJect autoinjectors, which were distributed beginning January 26, 2011. The lot number is 09D071.AC and can be located on the lower left hand corner of the carton’s back panel.

There is still one safeguard against patients giving themselves multiple insufficient doses with the defective devices: according to Neufang, the self-injectable pen will display a yellow marker in the “viewing window” after the injection is complete. If the yellow marking does not appear, then the dose was not completed and the patient should be able to conclude that something is wrong.

Should this occur, Neufang suggested that patients consult their practitioner before administering another dose.

While there is a fleeting shortage of the autoinjector pens due to the recall—according to the Simponi website—there is a prefilled syringe version of the drug, which Neufang recommended patients use if they require medication immediately.

“There might be a chance that patients might have to use a prefilled syringe for one month’s therapy, but we will have autoinjectors back for physicians and patients by the end of March,” Neufang said.

While patients will still be able to get the medication they require, using the prefilled syringe means that patients will be forced to see the needle, something that many patients dislike and choose the autoinjector specifically for.

“The autoinjector is structured in a way that you don’t see the needle entering the skin,” Neufang says. So some people prefer that because it’s less noticeable that they are giving themselves an injection, but there’s no difference in terms of the medication. It’s simply the route of administration.”