Inadvertent Contact with Evamist Menopause Spray Dangerous to Children and Pets, FDA Warns
Children and pets inadvertently exposed to Evamist spray, a treatment for hot flashes during women’s menopause, are at risk of developing hormone related side effects, said the U.S. Food and Drug Administration (FDA) in an agency advisory.
Evamist is a transdermal spray containing estradiol, an estrogen hormone, applied daily by menopausal women to the forearm between the wrist and elbow to reduce hot flashes.
“Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “It is important that people know to keep both children and pets away from the product to minimize exposure.”
The FDA is currently is reviewing reports of adverse events in children and pets inadvertently exposed to this topical estrogen product. Since the approval of Evamist in 2007, the FDA has received eight reports of children between ages three and five who suffered adverse events including premature puberty, nipple swelling and breast development in females, and breast enlargement in males.
Small pets may be especially sensitive to the estrogen in Evamist. The FDA’s Center for Veterinary Medicine received two reports of secondary exposure in dogs, with such symptoms such as mammary/nipple enlargement and vulvar swelling.
The FDA warns patients using Evamist to prevent children and pets from touching the Evamist area of the arm, by wearing clothing that covers the skin if needed.
Evamist is not the only topical estradiol medication on the market. However, the FDA said it is unknown whether unintended exposure can occur with other topical estrogen products.
22-Year-Old Woman Dies after Silicone Butt Enhancement by Bogus Doctors
A young mother has died after two fake doctors, who police believe are on the run, performed a butt enhancement where they injected silicone into the woman’s buttocks.
According to an ABC7 News article, Mayra Lissette Contreras, 22, went to the Sylmar, CA home of sisters Guadalupe Viveros, 53, and Alejandra Viveros, 50, on the morning of July 23 for a cosmetic procedure. Guadalupe Viveros, who claimed to be a physician in Mexico, and her sister injected Contreras in the buttocks with a silicone, which police believe caused the young woman’s death. The local hospital pronounced Contreras dead the next evening on July 24. An autopsy is underway, but initial reports indicate she died of respiratory distress.
“It’s easy for an injector to hit a vein and the silicon goes to the bloodstream and ends up in the lungs," columnist for The Orange County Register, Colin Stewart, told CNN.
Silicone implants, such as breast implants, are a medical grade silicone-filled capsule, approved as a medical device by the U.S. Food and Drug Administration (FDA), implanted in the body. However, in this case the sisters injected the silicone substance. This can cause a variety of medical conditions ranging from heavy scarring to death, according to AOL News.
The death of Contreras comes three weeks after police arrested Guadalupe Viveros and Alejandra Viveros on June 21 for charges of practicing medicine without a license after other patients reported becoming ill from injections, which in some cases patients developed infections after the substance hardened into solid plastic.
"I’m here to ask the public to help me and my family to bring these people to justice," her husband Gerardo Olvera said at a press conference. "She was very young and my kids are only 2 and 3 years old and they really need her."
Alleged victims or anyone knowing the whereabouts of the Viveros sisters are urged to contact the Los Angeles Police Department detectives at (818) 834-3115.
Underground, unlicensed cosmetic surgeons performing medical procedures such as this on unsuspecting patients are a growing problem.
In March of this year, six women in New Jersey developed infections and other complications after receiving bogus cosmetic injections of hardware-grade caulk, the same used to caulk bathtubs, as butt enhancements.
Toxic BPA Found in Ordinary Store Receipts a Danger to Consumers and Sales Cashiers
An investigation that found extremely high levels of bisphenol A (BPA) on paper used for sales register receipts has revealed a hidden danger for consumers, but sales cashiers are at even greater risk of exposure.
BPA is an industrial chemical used to make a hard, clear plastic known as polycarbonate used in a vast array of consumer products including water bottles and baby bottles. The food industry uses an epoxy resin containing BPA as a liner inside metal canned food cans. Paper manufacturers also use BPA as a coating on thermal paper, such as paper used for sales register receipts.
Researchers now believe that BPA interferes with the endocrine and reproductive systems, and causes cancer. The U.S. Food and Drug Administration (FDA) is supporting reasonable steps to reduce human exposure to BPA while the agency reviews studies on its health effects.
There has been public outcry to ban BPA in food containers such as baby bottles and canned foods.
Science News reports that last year, green chemist John Warner argued that his data suggested store receipts could be a — if not the — leading source of BPA exposure in Americans.
The Environmental Working Group (EWG) initiated the BPA receipt investigation, gathering receipts from a variety of retail and service businesses across seven states and the District of Columbia, then commissioned testing by the University of Missouri Division of Biological Sciences laboratory, one of the world’s foremost research facilities in its capability to detect environmentally relevant amounts of BPA.
Laboratory tests found high concentrations of BPA in at least one of several samples from Chevron, McDonalds, CVS, KFC, Whole Foods, Safeway, the U.S. Postal Service, Walmart and the U.S. House of Representatives cafeteria. 40% of receipt samples contained BPA, some at 250 to 1,000 times the level of BPA found in the controversial canned foods, and that the chemical rubs off during contact with the paper. Testing showed no BPA in receipt samples from Target, Starbucks, Bank of America ATMs and the U.S. Senate cafeteria.
“We’ve come across potentially major sources of BPA right here in our daily lives,” Sonya Lunder, senior analyst at EWG, told The Washington Post. “When you’re carrying around a receipt in your wallet for months while you intend to return something, you could be shedding BPA into your home, into your environment. If you throw a receipt into a bag of food, and it’s lying there against an apple, or you shove a receipt into your bag next to a baby pacifier, you could be getting all kinds of exposure and not realize it.”
Dermal exposure happens when BPA is absorbed through the skin after contact with a receipt. People may also encounter BPA when the receipt contacts food or a person touches food or their mouth with BPA on their hands from handling a receipt.
While consumers may be at risk every time they make a purchase, sales cashiers who handle BPA containing register receipts as part of their work activity are at even greater risk. Occupational Employment Statistics by the U.S. Department of Labor show that cashiers and retail salespersons are were the two largest occupations in May 2009, representing 1 out of every 17 jobs.
“A typical employee at any large retailer who runs the register could handle hundreds of the contaminated receipts in a single day at work,” said Jane Houlihan, EWG Senior Vice-President for Research in a release. “While we do not know exactly what this means for people’s health, it’s just one more path of exposure to this chemical that seems to bombard every single person.”
The EWG recommends the following tips to reduce exposures to BPA in receipts:
- Minimize receipt collection by declining receipts at gas pumps, ATMs and other machines when possible.
- Store receipts separately in an envelope in a wallet or purse.
- Never give a child a receipt to hold or play with.
- After handling a receipt, wash hands before preparing and eating food (a universally recommended practice even for those who have not handled receipts).
- Do not use alcohol-based hand cleaners after handling receipts. A recent study showed that these products can increase the skin’s BPA absorption (Biedermann 2010).
- Take advantage of store services that email or archive paperless purchase records.
- Do not recycle receipts and other thermal paper. BPA residues from receipts will contaminate recycled paper.
- If you are unsure, check whether paper is thermally treated by rubbing it with a coin. Thermal paper discolors with the friction; conventional paper does not.
The Environmental Working Group is a non-profit research group whose goal it is to prevent human exposure to toxic contaminants and influence government policies to promote conservation and sustainable development.
Doctors across U.S. implanting Unapproved IUDs and Placing Patients Health at Risk
A nationwide problem of medical practitioners implanting unapproved intrauterine devices (IUDs) has prompted the U.S. Food and Drug Administration (FDA) to issue a warning to consumers to notify them of the risks of such devices and the ongoing problem.
An intrauterine device, or IUD, is a medical device implanted in the uterus as a long-term birth control method. The FDA warns that patients who received an unapproved IUD could be at an increased risk for unwanted pregnancy.
The FDA released the consumer update entitled FDA Cautions Against Using Unapproved IUDs to inform consumers about a warning letter sent today reminding health professionals that using unapproved IUDs raises concerns about effectiveness and safety—as well as the potential for fraud and counterfeiting.
The FDA’s major concerns with the use of unapproved IUD/IUS’s are:
- the potential lack of safety and efficacy, and especially the risk of reduced efficacy for preventing pregnancy;
- the negative public health impact from the import and use of unapproved IUD/IUS’s that can be from unknown sources or foreign locations, and may not have been manufactured, transported or stored under conditions required as part of the FDA approval process; and
- the use of and subsequent billing for unapproved medical products, which raises the possibility of insurance fraud, particularly Medicaid fraud.
“Federal law requires that IUD/IUSs (intrauterine systems) be FDA-approved prior to marketing. This law is designed to protect patients from products that are unsafe and ineffective,” Theresa Toigo, FDA’s liaison with health professionals, says in the letter. “The recent issue with patients in Rhode Island unknowingly receiving imported, unapproved IUD/IUSs highlights the unacceptable risk patients may be exposed to when a product’s identity, purity, source, handling and storage cannot be verified.”
According to Examiner.com, the use of illegal IUDs in Rhode Island was so prevalent that health department officials have cited about 10% of the state’s obstetricians and gynecologists.
The investigation into the use of unapproved products in Rhode Island has expanded into a broader investigation of the purchase, use and distribution of unapproved intrauterine devices (IUD) and intrauterine systems (IUS) by some medical practices throughout the United States. The investigation has found unapproved versions of FDA-approved products such as Mirena, Implanon, Copper-T and ParaGard; as well as products not approved for use in the United States, such as T-Safe.
The FDA says doctors, nurses, midwives—and possibly patients themselves—might buy unapproved products from Canadian or other foreign websites in a bid to save money.
“Purchasing medical products from websites that are outside of the U.S. may be illegal and may increase the risk of receiving a potentially harmful product, since many websites sell products that are not FDA-approved and could be manufactured in other countries,” the FDA warns.
Legitimate Internet pharmacies will display a seal from the National Association of Boards of Pharmacy—known as VIPPS seal or Verified Internet Pharmacy Practice Sites. Consumers and health professionals can verify if a pharmacy website is VIPPS verified by entering the pharmacy’s web address here.
FDA says women should not try to remove IUDs by themselves. The agency is advising women who think they may have an unapproved IUD to use another form of birth control—such as condoms, birth control pills or the patch—and contact their health care professional.
Grand Jury Subpoenas Toyota Steering Defect Docs
The federal grand jury investigating Toyota’s vehicle sudden acceleration and braking issues has now subpoenaed documents relating to faulty steering rod components.
According to The New York Times, Toyota revealed that the grand jury in the Southern District of New York has demanded documents about defective steering relay rods, which were the subject of a massive 2005 recall.
Toyota issued a recall in Japan in 2004 for the defective steering rods, telling U.S. regulators that the recall was limited only to vehicles in Japan. In late 2005, Toyota told the National Highway Traffic Safety Administration (NHTSA) that the defective parts were in U.S. vehicles and issued a recall of about 977,000 model year 1989 to 1998 SUVs and pickups to correct the problem.
Since the recall in 2005, documents filed by Toyota with the government show only a fraction of the recalled vehicles fixed, reports The Washington Post.
The faulty rod connects the steering wheel to the wheels and can break, causing the driver to lose control of the vehicle. The NHTSA has found the defective steering relay rods to blame for at least fifteen crashes, three deaths and seven injuries.
In May 2010, The NHTSA opened an investigation into whether Toyota complied with U.S. regulations, which require notification of a defect to the agency within five days. The Los Angeles Times reports that Toyota received may complaints about the defect as early as 2000.
The company faced a criminal investigation in Japan over its actions regarding the defective steering relay rods.
In April, Toyota agreed to pay a $16.4 million fine for delaying the recall for “sticky” gas pedals in its vehicles.
Breast Cancer linked to Cleaning Products and Air Fresheners, but not Pesticides says Study
Researchers of a new study found a correlation between women with breast cancer and their use of household cleaning products and air fresheners, but found no link to pesticide exposure.
Researchers from the Silent Spring Institute, of Newton, MA, and the Boston University School of Public Health’s Department of Epidemiology in Boston, MA performed the study. It appears in this month’s journal of Environmental Health.
Study researchers conducted telephone interviews with 787 women diagnosed with breast cancer and 721 women in a control group without the disease in Cape Cod, MA. Interviewers asked the participants a series of questions regarding their past use of household cleaners, including mold and mildew products and air fresheners, and their usage or exposure to a variety of pesticides. They also asked participants how much they thought factors of heredity, diet, chemical and pollutants in the air or water, or a woman’s reproductive or breastfeeding history contributed to breast cancer development.
Study results found that women who reported the highest combined cleaning product use had a doubled risk of breast cancer compared to those with the lowest reported use. Use of air fresheners and products for mold and mildew control were associated with increased risk.
“Pesticides, household cleaners and air fresheners are of interest in breast cancer research because many contain ingredients that are mammary gland carcinogens in animals or endocrine disrupting compounds (EDCs), including compounds that affect growth of estrogen-sensitive human breast cancer cells or affect mammary gland development,” study authors said. “To our knowledge, this is the first epidemiological study to suggest an association between cleaning product use, in particular air fresheners and products for mold and mildew control, and elevated breast cancer risk.”
Critics claim the study is biased and study authors themselves recognized the potential for bias in their results. The study relied on the women’s self-reporting of products used and exposures over their lifetimes.
“Simply put, this research is rife with innuendo and speculation about the safety of cleaning products and their ingredients,” said Richard Sedlak, Senior Vice President of Technical and International Affairs of The American Cleaning Institute (ACI). “This is all based on the most cursory look at the scientific literature and the recollection of breast cancer survivors as to the products they used 15 to 20 years ago.”
When women are diagnosed with breast cancer, they often think about what happened in the past that might have contributed to the disease,” Julia Brody, Executive Director of Silent Spring Institute, said of the potential bias. “As a result, it may be that women with breast cancer more accurately recall their past product use or even over-estimate it. Or, it could also be that experience with breast cancer influences beliefs about its causes.”
Study Links Zinc Cold Remedies to Loss of Smell
A new study has linked the use of nasal remedies containing zinc gluconate with the loss of the sense of smell.
Zinc gluconate is a dietary supplement marketed as a homeopathic remedy to shorten the duration of the common cold.
Study authors Terence M. Davidson, MD and Wendy M. Smith, MD, of the University of California, San Diego, evaluated the relationship between over-the-counter intranasal zinc gluconate therapy and anosmia. Their study results showed that intranasal zinc gluconate therapy causes hyposmia, a reduced ability to smell and to detect odors, and anosmia the total loss of smell.
The study appears in the July 2010 issue of the Archives of Otolaryngology – Head & Neck Surgery.
In June of 2009, the U. S. Food and Drug Administration (FDA) advised consumers not to use Zicam Cold Remedy Nasal Gel or Zicam Cold Remedy Nasal Swabs, which contained zinc gluconate, due to more than 130 reports of loss of sense of smell associated with the use of the three Zicam products. The FDA issued Matrixx Initiatives, maker of the Zicam products, a warning letter telling the company that it could not market the products without FDA approval.
“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”
The FDA warned that loss of the sense of smell may cause serious problems, such as failing to smell smoke, a gas leak, or spoiled food. In addition, loss of the sense of smell is often linked with a loss of the sense of taste. People who cannot taste could unintentionally eat spoiled food and not appreciate flavors, and lose much of the pleasure of eating.
In response to the FDA’s June 2009 warning letter, Matrixx Initiatives said the company “vigorously disagrees with the FDA’s allegations” and that the FDA’s actions were “unwarranted,” but agreed issue a voluntary recall and to withdraw the products from the market.
According to Matrixx, the company sold more than 35 million retail units, representing over 1 billion doses, since they first introduced Zicam Cold Remedy intranasal products to the market in 1999. These products constituted approximately 40% of the Company’s net sales in 2009.
The FDA allegations in 2009 were not the first report of Matrixx Initiatives’ Zicam Cold Remedy Nasal Gel and Swabs affecting consumer’s sense of smell. According to the company’s own literature, allegations of such adverse effects from their zinc gluconate nasal products began in 2003 and continued for years before the FDA issued the warning letter. In 2006, the company agreed to settle 340 lawsuits resulting from their products’ adverse effects on the sense of smell at a cost of about $12 million and then continued to sell the products without warning consumers of the danger.
Matrixx Initiatives said in a January 2007 release, “The decision by Matrixx to settle some lawsuits was a business and economic decision. It was not based on any perception that the claims are legitimate.”
The company cited two studies, one from 2000 and another from 2003, it says proved the effectiveness of the products.
However, a 2006 study of the effectiveness of such zinc nasal treatments found no effect on the common cold. “We contend that it is unethical to introduce any potentially permanent anosmia-inducing agent such as zinc or other heavy metals into the interior of the nose in a manner that could result in contact with the olfactory region to treat a temporary discomfort such as a common cold or allergy,” the study said. “We found no reason to recommend intranasal zinc gluconate or zinc orotate lozenges in treating common colds.”
Read When every scent disappeared from my world, a woman’s account of the adverse effects she suffered from Zicam in 2005.
The study released this month linking nasal remedies containing zinc gluconate with the loss of smell is important because it is the first study to find a definite link. In the Zicam cases that have come before the court, judges have found little scientific evidence to support the claim that zinc-containing Zicam nasal products caused loss of smell.
Despite Matrixx Initiatives’ withdrawal and recall of Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Nasal Swabs, and the fact that it is illegal to sell recalled products, consumers can still find these products in the marketplace.
Very few people realize what it’s like to lose their sense of smell, and this is the time for people to stop for a moment and see how much smell means to them," Dr. Davidson told AOL Health. "It’s Christmas, loved ones, pines trees and food. It’s one of our most basic senses."
Those Using Illegal Circle Lenses to Get “Lady Gaga” Eyes are Placing Their Vision at Risk
Contact lenses called circle lenses are becoming popular in the United States, especially with teenagers and young adults, but can damage eyes and cause blindness.
Circle lenses have been in the news a lot recently since musical artist Lady Gaga released her music video “Bad Romance” that portrayed the artist with huge eyes generated by computer special effects. People wear circle lenses as a cosmetic enhancement to achieve a doll-like or doe-eyed appearance similar to Japanese anime or cartoon illustration. They make the iris of the wearer’s eye appear larger because they have a color or pattern that extends beyond the natural iris and covers part of the whites of the eye.
Released in Asian markets in 2009 and popular in Japan and South Korea, circle lenses are illegal in the United States.
In 2005, the Food, Drug and Cosmetic Act was amended to classify all contact lenses—including decorative ones—as medical devices under the U.S. Food and Drug Administration’s (FDA) regulatory authority. The FDA requires that contact lenses only be sold by an eye care professional’s prescription. Contact lenses distributed without appropriate involvement by eye care professionals are misbranded devices under this law.
Decorative contact lenses such as circle lenses carry the same risks as those that correct vision, including conjunctivitis (pink eye), corneal ulcers, corneal abrasion and vision impairment or blindness. The FDA has produced a consumer guide and video warning of the dangers of decorative contact use.
Americans are purchasing illegal and potentially dangerous circle lenses on the internet for between $20 and $40. They come in prescription strengths and as zero-powered non-corrective lenses
“I’ve noticed a lot of girls in my town have started to wear them a lot,” a 16-year-old girl who owns 22 pairs of circle lenses told The New York Times.
“Consumers who purchase lenses without a prescription or without consultation from an eye doctor put themselves at risk of serious bacterial infection, or even significant damage to the eye’s ability to function, with the potential for irreversible sight loss,” said Dr. Barry Eiden, chair of the American Optometric Association’s (AOA) Contact Lens and Cornea Section.
Millions of Huber Needles Recalled
Earlier this year, the FDA recalled 2 million Huber needles manufactured between January 2007 to August 2009 by Nipro Medical Corporation and distributed by Exelint International Corporation.
The Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for infusion of medication, among other things. They are used to treat diseases ranging from sickle cell anemia to breast cancer to osteoporosis. The needles can cut into ports and possibly send slivers of the material in the port into the body. This is a very serious product defect and could cause grave damage to persons, according to Alan Ripka, Esquire.
The needles subject to recall include the following:
Exel/Exelint Huber needles;
Exel/Exelint Huber infusion sets; and
Exel/Exelint Securetouch+ safety Huber infusion sets.
A class 1 level recall is the strongest recall level issued by the FDA. Inspections conducted in October 2009 of the Nipro facilities in Japan found that 60% to 72% of tested needles demonstrated “coring,” according to the FDA alert sent Tuesday from MedWatch, the FDA’s safety information and adverse event reporting program.
The FDA advises healthcare professionals to take the following precautions when using any type of Huber needle (ie, not just those manufactured by Nipro) in conjunction with normally operating ports:
Avoid flushing the syringe when confirming patency of the needle on accessing the port, as it may introduce a silicone core into a patient’s body.
Consider aspirating blood after accessing the port and then discard the syringe with its contents. This step may recapture the silicone sliver. If the needle becomes clogged, use a new one.
Watch for indications of damage to the port’s septum. These include medication leakage, resulting in inadequate dosing as well as tissue damage, and localized erythema.
No adverse events related to silicone foreign bodies released in patients from Huber needle coring have been reported yet. “The agency received only reports of port leakage,” they state in a written release. “However, because it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, there may be under-reporting of events.”
If you or a loved one feel you may have been harmed from using a needled that has “cored,” you may be entitled to compensation. The professional team of lawyers at Napoli Bern Ripka Law Firm can evaluate your situation and determine the next steps to gain justice for you and your family. Napoli Bern Ripka, LLP has fought against large companies in other matters and will fight for you if we believe you have a potential case for medical malpractice, products liability, personal injury, and is prepared to go to court and have a trial if necessary. Please fill out the form and submit or call and ask for Alan Ripka, one of our partners.
Popular NSAID Pain Relievers Increase Risk of Heart Attack and Stroke
A new study has found that healthy people who take certain NSAID (Nonsteroidal anti-inflammatory drugs) pain relievers may increase their risk of heart attack and stroke.
People commonly use NSAIDs, especially OTC formulations, to reduce fever and relieve pain caused by conditions such as arthritis, headache, toothache, back pain, muscle pain, menstrual cramps or minor injury.
Previous studies linked NSAIDs and cardiovascular risks in persons with other high risk factors or established heart disease, however this study is the first to measure the increased cardiovascular risk caused by NSAIDs in healthy people.
“We conducted this study to answer whether any specific NSAID carried a risk of cardiovascular adverse events among healthy individuals and to explore if there were safer alternatives within the group of NSAIDs,” study authors said.
Researchers in Denmark studied 1,028,437 healthy Danish individuals with an average age of 39 from January 1, 1997 to December 31, 2005 for increased cardiovascular morbidity and mortality with the use of rofecoxib (Vioxx), diclofenac, celecoxib, naproxen and ibuprofen.
Rofecoxib, marketed as the brand name Vioxx, is no longer available in the United States. Merck voluntarily withdrew the drug from the market in 2004 after studies showed an increased risk of heart attack and stroke. Vioxx was widely used in the U.S. before its withdrawal, generating $2.5 billion in sales revenue in 2003.
Diclofenac, marketed as brand names Cambia, Cataflam, Voltaren, Voltaren-XR and Zipsor, and Celecoxib marketed as Celebrex are only available by prescription in the U.S., while consumers can purchase ibuprofen over-the-counter (OTC) as brand names such as Advil, Motrin, Midol and Nuprin. Naproxen is available by prescription, but consumers can also purchase naproxen (Aleve) over-the-counter.
According to Healthday News, compared to people who took no NSAIDs, researchers of the study found that patients taking diclofenac had a 91% higher risk of death from heart attack and stroke, much higher than the 66% increased risk for those taking rofecoxib (Vioxx). People taking the largest doses of diclofenac saw risk of heart attack doubled and for those taking the largest doses of rofecoxib (Vioxx) risk tripled.
Perhaps the most relevant study finding for U.S consumers self-medicating with OTC ibuprofen products is that ibuprofen showed a 29% higher risk of stroke.
Researchers found no increased risk of heart attack or stroke with use of naproxen. Their analyses of celecoxib were not conclusive.
“Because treatment with NSAIDs is so widely distributed in the general population, it is also of great importance that a safe alternative is found when NSAID treatment cannot be avoided. The safety of naproxen has been much debated, but it is widely accepted that naproxen is probably the NSAID with the safest cardiovascular risk profile, and our results support this assumption,” the researchers said. “Our results suggest that naproxen could be a safer alternative when NSAID treatment is required.”
The study appears in the June 8, 2010 issue of Circulation: Cardiovascular Quality and Outcomes, a Journal of the American Heart Association.
The U.S. Food and Drug Administration (FDA) requires drug labels for NSAIDs to warn of increased risk of heart attack or stroke associated with long-term continuous use of the drug. The Denmark study population had a median exposure time to NSAIDs of 14 days, indicating short-time exposure in most individuals.
