Manufacturing Pain

Apparently the European Medicines Agency (EMEA) got tired of waiting for Johnson & Johnson (NYSE: JNJ  ) to figure out what happened with a bad lot of its pain relieving drug delivery system, Ionsys, because the agency pulled the company's marketing authorization yesterday.

Ionsys hasn't been on the European market since September when Johnson & Johnson voluntarily recalled all the systems after one manufacturing lot was found to have corrosion that could result in an overdose of pain medication. The electronic system allows the patient to push a button to deliver the drug, but is set up to limit the amount of drug delivered. Corrode the innards and the patient might get more medicine than bargained for, which would lead to bad things. No one at Johnson & Johnson has yet figured out why the corrosion happened, so the agency pulled its marketing authorization to make sure it gets a full explanation before the product goes back on the market.

In case you were wondering, the system hasn't made it onto U.S. shelves.

Fentanyl, the pain killer delivered by the Ionsys, has been a real pain in the neck for Johnson & Johnson. In February, Johnson & Johnson and Novartis (NYSE: NVS  ) had to pull their patches that deliver fentanyl, because the patient might get exposed to all the drug at once rather than through a slow release as designed. The recall has helped boost sales of Mylan's (NYSE: MYL  ) own fentanyl patch, which didn't have that problem.

Recalls in the drug industry aren't all that common, but they seem to happen more often with delivery systems; Shire (Nasdaq: SHPGY  ) and Noven Pharmaceuticals (Nasdaq: NOVN  ) had to recall their ADHD treatment patch last year.

Fortunately for Johnson & Johnson, the company is big enough that these issues aren't a major problem. Investors just need to keep an eye on them to make sure they're isolated incidents and not symptomatic of a larger problem.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.


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