FDA to require NSAID manufacturers to revise labeling
ROCKVILLE, Md. The Food and Drug Administration issued a final rule Tuesday that requires manufacturers of over-the-counter pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these drugs.
Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs. NSAIDs include aspirin, ibuprofen, naproxen and ketoprofen.
The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with such other ingredients, as cold medicines containing pain relievers or fever reducers.
“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ stated Charles Ganley, director of FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”
Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.
The new rule requires all manufacturers to relabel their products by April 28, 2010.
However, many analgesic manufacturers are already in compliance with the new labeling rules, Barbara Kochanowski, VP regulatory affairs for the Consumer Healthcare Products Association, stated Tuesday.
“CHPA member companies voluntarily have begun implementing many of the label changes included in the final rule that will publish April 29, 2009, well ahead of the April 28, 2010, implementation deadline,” she said. “These label changes are designed to provide consumers with a greater understanding of some of the risks that could be associated with the misuse of these medications.”
An FDA Advisory Committee meeting will convene on June 29 and 30 to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.
Researchers discover protein can inhibit colorectal cancer cells
MILWAUKEE, Wis. Medical College of Wisconsin Cancer Center researchers in Milwaukee have learned that a protein, CXCL12, that normally controls intestinal cell movement, has the potential to halt colorectal cancer from spreading.
These studies represent a potential mechanism by which CXL12 may slow cancer spreading. Controlling this process could lead to new biological therapies for colorectal cancers.
“Colorectal cancer ranks third in cancer-related deaths in the United States in 2008,” stated principal investigator Michael Dwinell, professor of microbiology and molecular genetics. “Finding therapies to prevent its spread to secondary organs would increase patient prognosis considerably.”
The abstract was presented at the American Association for Cancer Research meeting in Denver, April 21.
Normal intestinal cells stick to underlying proteins, which provide survival signals to maintain cell health. If they become unstuck, the floating cells undergo a programmed cell death. In cancer, cells have acquired genetic changes that allow them to survive during loss of attachment. Previously, the researchers found that colorectal cancer cells lacked CXCL12 expression. In these studies, they re-introduced CXCL12 expression in colorectal cancer cells which prevented their ability to adhere to underlying proteins.
Obama administration mobilizes flu meds, declares public health emergency
WASHINGTON The Obama administration mobilized government stockpiles of flu medicines Sunday afternoon, declaring a public health emergency, following an update from the Centers for Disease Control and Prevention earlier in the morning that confirmed 20 U.S. cases of swine flu to date.
“President [Barack] Obama is very concerned about the recent cases of swine flu that have been identified in the United States, as well as the outbreak in Mexico,” stated John Brennan, assistant to the President for Homeland Security and Counterterrorism, during a special press conference Sunday afternoon. “At this point a top priority is to ensure that communication is robust and that medical surveillance efforts are fully activated. This will enable both the rapid identification and broad notification of any new cases that may occur in the U.S., as well as in Mexico.”
A public health emergency was declared by the Department of Health and Human Services as a way to free up federal, state, and local agencies and their resources for prevention and mitigation. “It allows us to use medication and diagnostic tests that we might not otherwise be able to use, particularly on very young children; and it releases funds for the acquisition of additional antivirals,” Janet Napolitano, the Secretary of Homeland Security, told reporters Sunday.
The government currently has approximately50 million treatment courses of antiviral drugs — Tamiflu and Relenza — in the strategic national stockpile, Napolitano said. “We are releasing 25% of those courses, making them available to all of the states, but particularly prioritizing the states where we already have confirmed incidents of the flu. In addition, the Department of Defense has procured and strategically prepositioned 7 million treatment courses of Tamiflu.”
The government expects the number of swine-flu related cases to grow from the initial 20 identified so far.
“As we look for cases of swine flu, we are seeing more cases of swine flu,” stated Richard Besser, acting director of the CDC. “We expect to see more cases of swine flu.”
In New York City, where there’s been a cluster of swine-flu related disease in a school, that school has been closed for Monday, Besser reported.
“There’s a similar situation in Texas,” he said. “If there are other communities where we saw cases in a school, we would be recommending that they take those actions as well.”
Besser noted that the swine flu outbreak in the United States has been relatively mild — of the 20 cases identified, 19 have recovered and only one person has been hospitalized.
“What we know about this virus is it looks to be the same virus as is causing the situation in Mexico. And given the reports out of Mexico, I would expect that over time we’re going to see more severe disease in this country,” Besser cautioned.
As part of its response, CDC is already moving forward on the possible development of a vaccine.
“We’ve created that seed stock, we’ve identified that virus, and discussions are underway so that should we decide to work on manufacturing a vaccine, we can work towards that goal very quickly,” Besser said.