Automated Procedure to Detect West Nile in Blood, Organ Donors Approved
A system that automatically screens for West Nile virus in human donors' blood tissue and organs has been approved by the U.S. Food and Drug Administration.
Called the Procleix WNV Assay on the Procleix TIGRIS system, the procedure is an automated way to detect the presence of West Nile virus in people who are donating an organ or plasma, the FDA says in a news release. However, the TIGRIS system will not be used for cord blood specimens or as an aid in the diagnosis of West Nile virus infection, the agency adds.
"The capability of full automation can reduce the potential for human error while accelerating donor screening and enhancing the safety of blood and tissues," said Dr. Jesse Goodman, the director of FDA's Center for Biologics Evaluation and Research. "This is the latest step forward in what has been a very successful industry-government effort to keep blood safe from the emerging threat of West Nile virus."
West Nile virus can be fatal to humans. It is spread by mosquitoes and first began appearing in the U.S. human population in 1999. According to the U.S Centers for Disease Control and Prevention, severe symptoms can include high fever, headache, neck stiffness, stupor, disorientation, coma, tremors, convulsions, muscle weakness, vision loss, numbness and paralysis.
Milder symptoms include fever, headache, and body aches, nausea, vomiting, and sometimes swollen lymph glands or a skin rash on the chest, stomach and back. According to the FDA, between 1 and 3 million Americans have been infected with West Nile Virus. Since 1999, about 1,100 human fatalities have been reported.
Illnesses at Oyster Festival Prompt FDA Investigation
An outbreak of flu-like symptoms in 25 people at a Maryland oyster festival in early February has prompted a U.S. government probe into whether the illnesses were caused by contaminated oysters from Texas,.
The U.S. Food and Drug Administration announced late Friday that it is investigating whether the outbreak, believed to be caused by a norovirus-associated illness linked to eating raw oysters, came from oysters harvested in early February from San Antonio Bay, Tex., about 55 miles northeast of Corpus Christi. The Maryland festival was called the Bull and Oyster Event and was held Feb. 9.
This particular norovirus usually lasts for about 48 hours, and its symptoms include low-grade fever, chills, headache, muscle aches and a general sense of tiredness. It is not usually associated with more serious illnesses.
The FDA is asking anyone who may have experienced the gastrointestinal symptoms after the first weekend in February to contact his or her healthcare provider and the local health department. The oyster beds in question have been shut down while the investigation proceeds, the FDA says in a news release, and recalls have been issued for all oysters with the tag, "Gal 1, 2/2/07."
Bush Orders Review of U.S. Military and Veteran Hospitals
U.S. President George W. Bush on Friday ordered a thorough review of conditions at all American veteran and military hospitals. The review was prompted by revelations about poor care for wounded troops at Walter Reed Army Medical Center in Washington, D.C.
Bush will name a bipartisan commission to investigate whether the problems uncovered at Walter Reed are also present at other facilities, the Associated Press reported.
On Thursday, the Pentagon said it had fired Walter Reed commander Army Maj. Gen. George W. Weightman. The situation at Walter Reed was made public by The Washington Post, which found that bureaucratic issues prevented many troops from receiving adequate care and that some outpatients were enduring squalid living conditions, the AP reported.
The commission to be appointed by Bush will be separate from a panel named by Defense Secretary Robert Gates to study outpatient care at Walter Reed and the National Naval Medical Center in Bethesda.
FDA Outlines Approach to Informing Public About Drug Safety
The U.S. Food and Drug Administration on Friday issued final guidance on the agency's approach to communicating drug safety information to the public and the factors that influence when drug safety information is given to the public.
The FDA said the guidance affirms the agency's commitment to provide important drug safety information in a timely manner through: public health advisories; patient information sheets; health care professional information sheets; and alerts posted on public health advisories and patient and health care professional sheets. These are all available through the FDA Web site.
Drug product labeling is another method of providing the public and health professionals with important drug safety information, the FDA said.
"Our goal is to make emerging drug safety information available in a balanced, impartial manner so that health care professionals and patients can consider the information when making decisions about medical treatments despite uncertainties in the data," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.
Create Global Bird Flu Stockpile: WHO Official
A global stockpile of bird flu vaccine needs to be established in order to help guarantee that poor countries have access to vaccine if a global pandemic erupts, the World Health Organization's leading flu official said Friday.
Currently, up to 500 million doses of bird flu vaccine can be produced, which is far below what would be needed if bird flu starts to infect large numbers of people around the world, the Associated Press reported.
A number of developing countries fear they won't be able to get the vaccine if there is a pandemic, said Dr. David Heymann. He suggested the creation of a "virtual" stockpile, where richer countries agree to donate a percentage of their vaccine supplies to poorer nations if there is a pandemic.
"What we need to do and want to do is develop mechanisms that will permit countries to have access to vaccines if they need it," Heymann told the AP.
That would cover the short term. The long-term goal is to provide developing nations with the technology and expertise to produce their own vaccines, he said.
FDA Warns 20 Companies About Illegal Migraine Drugs
Twenty drug companies have been sent warning letters that they're selling unapproved and potentially dangerous migraine medicines, the U.S. Food and Drug Administration said Thursday.
The illegal prescription medicines contain ergotamine tartrate, which is derived from a rye fungus called ergot. Ergotamine is a vasoconstrictor, which means that it narrows blood vessels, the Associated Press reported.
Labeling on these unapproved drugs doesn't warn consumers about potentially dangerous interactions if the medicines are taken with other drugs, including some HIV medicines, anti-fungal agents and antibiotics, the FDA said.
"Because these drugs don't have approval, we don't know how they were formulated or manufactured. We don't know if they are safe or effective," Deborah Autor, director of the office of compliance at the FDA's Center for Drug Evaluation and Research, told reporters.
Companies that received the warning letters included: a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. of Israel, the world's largest manufacturer of generic drugs; Actavis of Iceland; and Sandoz Inc., part of the Swiss company Novartis AG.
In the warning letters, the FDA told the companies that they have 60 days to stop making the drugs and 180 days to halt distribution. If they don't meet the demands, the companies will be subject to seizure or injunction, the AP reported.
The FDA told the companies that they could seek agency approval for the drugs.