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.
CDC issues swine flu advisory alert as additional cases are reported
ATLANTA The Centers for Disease Control and Prevention issued a health advisory alert over the weekend concerning the recent outbreak of swine flu, which in addition to confirmed cases in southern California and Texas has been found in Kansas, New York and Ohio, and south of the U.S. border in Mexico.
As of Sunday at 9 a.m., the CDC confirmed 20 swine flu cases — seven in California, two in Kansas, eight in New York City, one in Ohio and two in Texas.
To date, confirmed swine flu cases in the United States have been relatively mild, causing one hospitalization. Swine flu cases in Mexico have been more severe, resulting in 59 deaths so far.
New York Governor David Paterson on Saturday directed the New York State Department of Health to activate its infectious disease, epidemiology, laboratory, disaster preparedness and health systems staff to coordinate efforts across the state, as eight cases of probable swine influenza were identified in New York City earlier in the day.
“I want to reassure all New Yorkers that we are taking appropriate measures to address these probable cases of swine flu,” Paterson said. “The New York State Department of Health is working closely with the CDC, the New York City Department of Health and Mental Hygiene, all local health departments across the State, hospitals, physicians, and other health care providers. [Earlier today], we shipped 1,500 treatment courses of Tamiflu to New York City. These will be used to treat any severely ill probable swine flu cases or household contacts of probable cases who have underlying chronic health conditions, placing them at extra risk.”
Complicating matters is the human influenza virus. While the 2008/2009 season has been winding down, for the week ending April 18 the CDC reported that New York is still measuring outbreaks of human influenza in more than two but less than half of the state’s regions. In California, human influenza is only prevalent in one region and Kansas has reported sporadic activity — small numbers of laboratory-confirmed influenza cases or a single laboratory-confirmed influenza outbreak has been reported, but there is no increase in cases of influenza-like illnesses.
It is not anticipated that the seasonal influenza vaccine distributed for the 2008/2009 flu season will provide protection against the swine flu H1N1 viruses, the CDC stated.
In addition to the CDC, the outbreak is also being tracked by the World Health Organization. WHO on Saturday suggested that the swine flu has the potential of becoming a global pandemic, though it is too early to tell. “WHO … is currently monitoring and assessing the evolution of the events in Mexico and in the United States related to the spread of swine influenza A/H1N1 virus,” the international health agency released in a statement Saturday. “The viruses so far characterized have been sensitive to [Tamiflu] oseltamivir, but resistant to both [older flu medicines] amantadine and rimantadine. … The rapid evolution of the events in Mexico and in the United States calls for a heightened degree of awareness and vigilance of both clinicians and public health professionals to ensure the early detection and management of possibly related events in countries other than Mexico and the United States.”
Persons with a temperature above 100 F accompanied with a severe cough or shortness of breath are being advised to stay home from work or school to avoid spreading the infection. In addition, frequent hand washing can lessen the spread of respiratory illness, the CDC noted.
As of April 25, CDC has confirmed 11 human cases of swine flu in the United States: seven in California, two in Texas and two in Kansas. CDC continues to investigate other suspected cases. Investigations are ongoing to determine the source of the infection and whether additional people have been infected with similar swine influenza viruses.
Illness onsets occurred between March 28 and April 14 for the majority of cases, affecting patients between the ages of 7 and 54.
The specific genetic makeup of the swine viruses has not been reported previously among swine or human influenza viruses in the U.S. or elsewhere, the CDC noted.Swine flu is a respiratory disease of pigs caused by type A influenza that regularly cause outbreaks of influenza among pigs. These viruses do not normally infect humans, however, human infections with swine flu do occur.
Mexico has reported three separate events. In the Federal District of Mexico, surveillance began picking up cases of influenza-like illness beginning March 18. The number of cases has risen steadily through April and as of April 23 there are more than 854 cases of pneumonia from the capital. Of those, 59 have died. In San Luis Potosi, in central Mexico, 24 cases of influenza-like illnesses, with three deaths, have been reported. And from Mexicali, near the border with the United States, four cases of ILI, with no deaths, have been reported.
CDC has not recommended that people avoid travel to affected areas at this time.
Study: UTIs more frequent in women with increased sexual activity, alcohol consumption
LINTHICUM, Md. Increased sexual activity and alcohol consumption were associated with an increased risk of developing urinary tract infections, according to new research presented at the 104th Annual Scientific Meeting of the American Urological Association on Sunday.
From July 2001 through April 2005, researchers studied 181 women with their first UTI who presented to the student health care facility at the University of Florida. The control group consisted of 80 women attending the clinic without a UTI. A clinic nurse administered a survey that addressed lifestyle habits and dietary intake. Results showed that frequency and urgency were the most common symptom, and that UTIs were most commonly found in women who had increased sexual activity and recent alcohol consumption. The use of sanitary napkins during menstruation also increased the risk for a first-time UTI.
Co-existing chlamydia, gonorrhea and yeast infections did not contribute significantly to urinary symptoms.
“If you are experiencing urinary frequency and urgency, you should seek medical attention,” stated Anthony Smith, an AUA spokesman. “A woman experiencing her first UTI might not recognize these symptoms immediately. But, medical attention is necessary because UTIs can lead to kidney infection and even sepsis. So, it is important for women who notice these symptoms to seek medical attention.”