Tuesday, February 22, 2011

How Much Medication is Your Autoinjection Device Delivering?

Sometime last year, I remember discussion online about a new autoinjection device for Rebif.  It was set-up so that you didn't even need to see the needles and several doses were included in one device.  Rebif isn't the only MS medication which offers an option aside from manual injection.

Medications for RA also have similar autoinjection devices, however they are more commonly referred to as "pens."  Simponi is one such medication which is available in a pre-filled syringe which you would manually inject or a pre-filled pen which delivers the medication.

Last week, Johnson & Johnson (makers of Simponi) have recalled two lots of pre-filled pens due to the potential delivery of reduced doses.  I assume that they mean not all of the medication gets injected.  The European Medicines Agency released a Q&A paper regarding the recalled Simponi pens.  You can read the Reuters article below.

When I first started using Copaxone, I used the injection device.  It is simply how my MS nurse taught me to inject.  There was one period of time where I would think the injection was complete, but when I removed the device more medication would squirt out.  I thought that the spring on my autoinjector was wearing out so I started injecting manually.  I later discovered that there were a few lots of syringes in which the rubber stoppers were too stiff and provided too much resistance for the device.  I continued to inject manually until I stopped using Copaxone in October 2009.

I do not use Simponi and do not have an opinion on the medication itself.  I just find the topic of autoinjection devices interesting and wanted to share the news.

J&J recalls two lots of Simponi injection devices
Fri Feb 18, 2011 2:27pm EST
* Injection devices may deliver less than full dose
* No problems found with medicine
* 165 in U.S., 230 in Europe being recalled from market
By Bill Berkrot
NEW YORK, Feb 18 (Reuters) - Johnson & Johnson (JNJ.N) said it has recalled two lots of Simponi injection devices -- one in the United States and one in Europe -- after discovering they may deliver less than a full dose of the rheumatoid arthritis medicine.

The potential defect was discovered by the company during regular quality testing and the voluntary recall was initiated earlier this week.

J&J, which has been beset by recalls of more than 250 million bottles of its consumer healthcare medicines as well as other products due to manufacturing and quality control problems, has stepped up inspections at plants across its business universe.

"There is no issue with the Simponi drug product. It is merely the drug delivery device that has a manufacturing issue," Monica Neufang, a business communications spokeswoman for J&J, said of the latest recall.

From the affected U.S. lot of 839 pre-filled injection devices, nearly 80 percent were quarantined at the wholesaler level, the company said of the recall.

"We're working with wholesalers and distributors to recapture the remaining 165 affected units that are in the market," Neufang said.

The percentage fail rate among the affected injection devices is 0.5 percent, the company said.

"If you apply that rate to the 165 units, potentially one device in the marketplace has a defect," Neufang said.

The pre-filled injection devices were manufactured at J&J's Janssen Biologics plant in Switzerland.

The affected lot in Europe was discovered in Germany during part of ongoing quality checks, J&J spokesman Brian Kenney said.

From that lot, 1,890 units were quarantined as a precaution and 230 units made it to market and are being recalled, Kenney said.

J&J is working with Merck & Co (MRK.N), which holds European sales rights to Simponi, to make sure healthcare professionals in Germany are aware of the recall, he added. (Reporting by Bill Berkrot, editing by Gerald E. McCormick)

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