Health Highlights: Jan. 25, 2008
FDA Repeats Notice of Recalled Heparin and Saline Flushes Camera in Pill Detects Signs of Esophageal Cancer Recalled Fish May Contain Bacteria: FDA FDA Wants Greater Presence in Developing Nations Scientists Discover Why Bird-Flu Virus Hasn't Infected More People
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Repeats Notice of Recalled Heparin and Saline Flushes
Pre-filled syringes containing either the anti-clotting agent heparin or normal saline solution may be contaminated with a dangerous bacterium and are being recalled by the manufacturer, the U.S. Food and Drug Administration repeated Friday.
Both types of pre-filled syringe are manufactured by North Carolina-based AM2 PAT Inc. The products were distributed nationwide under two brand names, Sierra Pre-Filled Inc. and B. Braun.
The company voluntarily recalled these products on Jan. 18 after confirming contamination with Serratia marcescens bacteria. Infections with Serratia marcescens are capable of causing life-threatening illness or death, the FDA said.
Consumers or facilities who have any of the recalled products should stop using them immediately and return them to the distributor or place of purchase, the agency said.
The following products and codes are affected:
|NDC #||CATALOG #||Product Name|
|Sierra Pre-Filled Products|
|64054-1003-02||1003-02||Heparin Lock Flush 100units/ml 5ml|
|64054-1003-01||1003-01||Heparin Lock Flush 100units/ml 3ml|
|64054-3005-02||3005-02||Heparin Lock Flush 10units/ml 5ml|
|64054-3003-02||3003-02||Heparin Lock Flush 10units/ml 3ml|
|64054-3003-06||3003-06||Heparin Lock Flush 10units/mL 3ml (6ml syringe)|
|64054-3005-06||3005-06||Heparin Lock Flush 10units/mL 5ml (6ml syringe)|
|64054-0910-2||0910-12||Normal Saline Flush 10ml|
|64054-0905-2||0905-12||Normal Saline Flush 5ml|
|64054-0903-2||0903-12||Normal Saline Flush 3ml|
|B. Braun Products|
|64054-3005-02||513610||Heparin Lock Flush 10units/mL 5mL|
|64054-1003-01||513611||Heparin Lock Flush 100units/mL 3mL|
|64054-1003-02||513612||Heparin Lock Flush 100units/mL 5mL|
|64054-0903-2||513584||Normal Saline IV Flush 3mL|
|64054-0905-2||513586||Normal Saline IV Flush 5mL|
|64054-0910-2||513587||Normal Saline IV Flush 10mL|
Any adverse reactions associated with use of these products should be reported to the FDA at 1-800-FDA-1088.
Camera in Pill Detects Signs of Esophageal Cancer
A tiny camera that fits inside a pill that can be swallowed to assess people for warning signs of esophageal cancer has been developed by University of Washington researchers. They say it's more comfortable and less expensive than current endoscopy methods.
The camera in the pill is designed to take high-quality, color photos in confined spaces, CBC News reported. Patients don't have to be sedated to swallow the pill, which is tethered to a 1.4 millimeter wide cord.
Its first use to scan for signs of esophageal cancer in a human will be reported in an upcoming issue of the journal IEEE Transactions on Biomedical Engineering.
"Our technology is completely different from what's available now. This could be the foundation for the future of endoscopy," lead author Eric Seibel, a professor of mechanical engineering, said in a prepared statement, CBC News reported.
A condition called Barrett's esophagus, marked by changes in the lining of the esophagus, often precedes cancer. Detection of Barrett's esophagus can help prevent cancer. But the expense of screening means that many people aren't diagnosed until they have esophageal cancer, which has a survival rate of less than 15 percent, the report said.
"These are needless deaths. Any screen that detected whether you had a treatable condition before it turned into cancer would save lives," Seibel said.
Recalled Fish May Contain Bacteria: FDA
Bags and bulk boxes of frozen salted/dried yellow croaker fish that may be contaminated with dangerous Clostridium botulinum bacteria are being recalled by Seoul Shik Poom Inc. of Hillside, N.J., the U.S. Food and Drug Administration said.
This type of bacteria can cause botulism, a potentially fatal form of food poisoning that includes symptoms such as trouble speaking and swallowing, difficulty breathing, abdominal distention, constipation, general weakness, dizziness, and double-vision.
The recall includes bags and boxes of frozen salted/dried yellow croaker ranging from 2.2 pounds to 30.83 pounds that were distributed in New York, New Jersey and Maryland and sold to consumers through retail stores, the FDA said.
Routine testing detected the possibility of contamination. To date, there have been no reported illnesses related to the recalled fish.
Anyone with these products should return them to the place of purchase for a full refund. For more information, contact Seoul Shik Poom Inc. at (908) 810-7230.
FDA Wants Greater Presence in Developing Nations
U.S. Food and Drug Administration Commissioner Dr. Andrew C. von Eschenbach wants to post agency inspectors at U.S. embassies and consulates in developing nations in an attempt to improve the quality of food and medicines imported from those areas into the United States.
In a briefing with reporters Thursday, von Eschenbach said he wanted to have "boots on the ground" in nations such as India and China and in regions such as the Middle East and Central and South America, The New York Times reported.
The FDA already sends inspectors to dozens of countries each year to examine clinical trial sites and pharmaceutical plants. But the commissioner said he wants the FDA's presence in developing nations to be on an "ongoing and continuous basis rather than episodic and periodic."
As amounts of foreign-produced foods and drugs sold in the United States have risen, the FDA has struggled to ensure the safety of those products. For example, the agency inspects less than one percent of imported foods, the Times reported.
The proposal to boost the presence of FDA inspectors abroad is still in the early stages. Details about funding and how those inspectors would interact with other federal agencies still need to be worked out, von Eschenbach said. He also noted that host nations would have to request the inspectors' presence.
Scientists Discover Why Bird-Flu Virus Hasn't Infected More People
U.S. scientists have discovered a major reason why the H5N1 bird flu virus hasn't yet become a major human health threat, BBC News reported.
The virus has infected mostly birds and relatively few people who have been in close contact with infected poultry. But experts have repeatedly voiced concerns that the virus could mutate into a form that's easily transmitted between people, triggering a pandemic.
Researchers at the Massachusetts Institute of Technology discovered that in order for this scenario to materialize, the H5N1 virus must first pick a very specific type of chemical "lock" in order to enter human respiratory cells, BBC News reported.
The finding, published in the journal Nature Biotechnology, may improve efforts to monitor changes in H5N1 and lead to better ways to fight the virus, the researchers said.
This work has "changed our view of flu viruses and how they must adapt to infect us," said Dr. Jeremy Berg, of the U.S. National Institutes of Health. The NIH funded the research, BBC News reported.