May 6, 2010: Johnson and Johnson Children's Medicine Recall Update: Bacteria Identified

The FDA identified the recently unconfirmed bacteria that was found in the drums used to transport the raw materials used to make the recalled childrens' drugs.  The bacteria, Burkholdaria cepacia (B-cepacia), is not generally harmful to a healthy individual, but can be harmful to persons with weakened immune systems.  Johnson and Johnson claimed that the drums containing the contaminated raw material never made it to the Fort Washington, PA factory, where the drugs were being produced.   The FDA and Johnson and Johnson hold opposing claims on the contaminated drums; Marc Boston, spokesman of Johnson and Johnson, stating that "Remaining drums from that lot were sent to us, all of which tested negative for bacteria. Samples of the finished product also tested negative", while the 17 page FDA report stated that some drums at the For Washington, PA plant were found to be contaminated with B-cepacia.

I conducted some further research of my own on B-cepacia and found the following facts:

• B-cepacia is a nonfermentative, aerobic, gram-negative bacillus formerly classified as Pseudomonas. Unlike Pseudomonas aeruginosa, B-cepacia is an organism of low virulence with a limited ability to cause infection in humans.
• B-cepacia can generally be found in antiseptic soaps and hand lotion, respiratory equipment or fluids, intravenous lines or fluids, pressure monitoring devices and in urine
• In rare cases, B-cepacia can be the cause of nosocomial pneumonia
• B-cepacia iss resistant to many antibiotics and can be very difficult to treat. It does not pose a threat to most healthy adult, but those who are at risk can become severely ill, suffer long-term damage to their health, and even die from the disease.
• B. cepacia infection does not always show symptoms. The symptoms mimic any other lung infection, putting those with lung disease at risk for delayed diagnosis. Symptoms include cough, wheezing, shortness of breath, congestion, and fever. A culture is necessary for diagnosis.
• t is difficult to avoid exposure to B. cepacia, but there are some things that can minimize the risk. Awareness and avoidance of people who are infected as well as contaminated substances is first and foremost. Of course, proper hand washing and cleaning of surfaces is a must.