May 31, 2012 — Johnson & Johnson, one of the largest health companies in the world, has been sent a warning letter from the U.S. Food and Drug Administration (FDA). The letter cites numerous problem with J&J’s K-Y Liquibead Vaginal Moisturizer product, as well as J&J’s ongoing failures to respond or report serious adverse events associated with several of its products.
Most of the allegations concern K-Y Liquibead Vaginal Moisturizer. The lubricant is a soft ovule that is supposed to dissolve inside the vagina and provide additional moisture and comfort. Despite the fact that this design differs significantly from other vaginal lubricants, J&J never submitted an application to the FDA for approval or review. They also never informed the FDA that they would be selling a new type of medical device.
Many people have reported that the Liquibead product does not dissolve or provide extra comfort. J&J received 227 complaints between June 2010 and December 2011, including 68 medical complaints. The FDA cited J&J for failing to establish a system for filing, reviewing, responding to, or reporting complaints.
By law, companies that sell medical devices must have a system to manage, address, and report medical complaints to the FDA. During a previous inspection of a facility in Skillman, N.J., in 2009, the FDA found that the facility lacked a reporting system. The fact that they still do not have this system in place suggests a failure to take corrective action.
The FDA was also concerned that the K-Y Liquibeads might not be compatible with latex condoms. Despite the fact that the label specifically assures customers that the product is compatible with latex condoms, J&J never conducted a safety study to test this assertion. The shell of the Liquibead contains coconut oil ingredients. Experts warn not to use oil-based lubricants during intercourse because they are known to degrade latex condoms, which increases the risk of condom breakage.
Another problem is that the study which assessed the shelf-life of the Liquibead product had major flaws. Most notably, the study failed to establish the temperature at which the product is supposedly stable.
The FDA also found serious problems with the way the J&J facility handled adverse event reports for other products. This included failing to tell the FDA about a woman who had toxic shock syndrome after using O.B. Tampons and a man who lost a tooth after using J&J dental floss.
J&J has 15 days to respond to the warning letter with information on how the company will address the problems. If they fail to respond, the company may face fines and seizure of its products from store shelves.
This is just the latest issue to face the beleaguered health company. In 2010, J&J issued nine major product recalls, including the largest drug recall in history — 136 million bottles of Tylenol, Motrin, Zyrtec, and Benadryl. In 2011, the company faced lawsuits from 100 women who were seriously injured from the company’s vaginal mesh products, which have been plagued with safety issues.
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