by Paul Rega, MD — published on March 22nd, 2008
This news article reminds us the importance of asking our patients about vaccinations. There is a new generation of parents concerned about the potential hazardous effects of vaccines and are refusing to subject their kids to them. That’s why we are hearing more and more about measles outbreaks here and abroad.
Studies are showing that many of the anti-depressants that are glutting the market are about as good as placebos. So if you have a patient who is depressed and on Prozac, but is looking at the “sharps” container with a weird smile on his face, you’ll understand.
You’re damned if you do and you’re damned if you don’t. You probably heard about this lady already, but it’s a good reminder that if the Fates are against you, don’t go fishing.
I can’t see how this will impact EM, but the FDA has approved a new compound that should improve burn care. It’s called Artiss and it allows greater flexibility in sealing skin grafts to burn sites.
The FDA is announcing that another company is recalling its heparin products.
by Paul Rega, MD — published on March 22nd, 2008
FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations.
The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 28, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps. Medtronic’s representatives will complete a reply card to document their communication with each doctor regarding this recall, as well as asking the doctors to sign and return a reply card.
Read the complete MedWatch safety summary, including links to the Recall Notice and the “Dear Healthcare Professional” letter, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Neuromodulation
by Paul Rega, MD — published on March 22nd, 2008
B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.
Read the complete MedWatch 2008 safety summary, including a link to the Press Release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#BBraun
