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FDA Issues Recall of Nizoral, Oral Anti-Fungal Drug by Johnson & Johnson

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In the news recently, another recall of a Johnson & Johnson product. I went to the J&J website to look for their statement on this most recent FDA recall. There is nothing on their blog (http://www.blogjnj.com/), their News page, or the Our Responsibility page about the recalls or their commitment to deal with faulty products. I did find lots of nice images of families that brought back fond memories of their safe, good-for-our-babies products. The online J&J experience is rosy and comforting. A scan of recent news tells a very different story.

In 2013 there have been several notable recalls of Johnson & Johnson products amidst the continuing coverage of the lawsuits over the faulty and defective DePuy hip replacement devices.

In March of 2013, J&J recalled almost 2 million glucose meters used by diabetics. In June, 32 million boxes of contraceptives were recalled. In July, J&J paid out a $23 million dollar settlement related to recalls of medicines for children—40 OTC drugs, including Children’s Tylenol. It was one of the FDA’s biggest recalls of kids’ medicines in the history of the agency.

2012 and 2011 were not much different. J&J has been facing difficulties for several years now. CEO Bill Weldon resigned in 2012, endorsing his successor with the promise of a ‘bright future for Johnson & Johnson’. (CNN Money, 2/21/2012) Apparently the culture at J&J is too deeply ingrained with problems to expect a turnaround this soon. But we do and should expect that the company will take steps to evaluate its product line and do a better job of developing safe products.

Earlier this month the FDA issued a recall of Nizoral, a J&J product manufactured for use with fungal infections. “FDA is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.” (FDA Safety Alert) The product in its topical form, ketoconazole, is used in the treatment of ringworm, jock itch, athlete’s foot and dandruff.

It’s reassuring to see the FDA doing its job, policing the pharmaceutical and medical industries and taking corrective steps when a dangerous product comes to light. But the FDA does not have the resources to police and monitor all products. How do we know a product is safe? Which companies can we count on to reliably manufacture and promote safe products? Which companies will tell us when they discover an unsafe product they have manufactured or marketed? Where does Johnson & Johnson fall on the spectrum? For me, J&J has some work to do to earn my trust.

For resources on safe consumer products, visit some of the following:

http://www.cpsc.gov

http://www.nhtsa.gov

http://www.fda.gov

 

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    They were also recently caught again for fraudulent marketing with Xarelto. Oh, joy, more lawsuits in the works I guess. I have a whole site dedicated to the harms and corruption of JNJ. You might want to check out JohnsonAndToxin to see what I mean. Not spam, just an educational resource.