Children’s Motrin Manufacturer Sued for Inadequate Warning!
Source: U.S. District Court of Pennsylvania; Stevens Johnson Syndrome Foundation
The District Courts of Pennsylvania have cleared the way for lawsuits against Children’s Motrin manufacturer Johnson & Johnson for failure to warn of the risk of Stevens Johnson Syndrome. Stevens Johnson Syndrome (SJS) is a severe adverse reaction to medication. It was first discovered in 1922 by pediatricians A.M. Stevens and (perhaps ironically) S.C. Johnson after diagnosing a child with severe ocular and oral involvement to a drug reaction.
While almost any medication can cause SJS, over-the-counter drugs, such as Ibuprofen and Motrin have been added to the list of medications for which SJS is a known complication. A large amount of its victims are children. Recognition of the early symptoms of SJS and prompt medical attention are crucial to minimize the devastating and possible long-term effects of SJS.
Symptoms of Stevens Johnson Syndrome include:
- Rash, blisters, or red splotches on skin
- Persistent fever
- Blisters in mouth, eyes, ears, nose, genital area
- Swelling of eyelids, red eyes
- Conjunctivitis
- Flu-like symptoms
- Recent history of having taken a prescription or over-the-counter medication
SJS is a life-threatening drug reaction. If left untreated, it can result in death. Additional complications can include permanent blindness, dry-eye syndrome, photophobia (light sensitivity), lung damage, chronic obstructive pulmonary disease (COPD), asthma, permanent loss of nail beds, scarring of the esophagus and other mucous membranes, arthritis, and chronic fatigue syndrome. Patient’s literally burn from the inside out, requiring medical treatment often reserved for burn victims.
Drug reactions are one of the leading causes of death in the United States. Yet, less than one percent are reported to the FDA, because there is no mandatory reporting system in effect for postmarketing adverse drug reactions. Although SJS is listed as a “rare disease” it may be more prevalent than previously thought.
For more information, the SJS Foundation was founded to be a resource to SJS victims and their families. Their mission is to provide support services, and compile and distribute valuable information about SJS to the public and medical professionals regarding treatments and therapies that may prove beneficial to SJS sufferers.
Post: Gayle R. Lewis, Esquire
YAZ Contraceptive Health Risks
Source: British Journal of Medicine
While all oral contraceptives include some risk of adverse side effects, Yaz has an unusually extensive list of potential problems. Medical studies have established a clear correlation (link) betweeen women taking Yaz has and the following serious medical conditions:
- Heart attack
- Blood clots
- Stroke
- Pulmonary embolism
- Kidney failure
- Pancreatitis
- Deep vein thrombosis (DVT)
- Hyperkalemia (Elevated potassium)
- Gallbladder disease
- Liver disease and liver tumors
All of these side effects and many more are listed on Yaz packaging and on the Yaz website. According to recent studies, drospirenone, the progestin component in YAZ, Yasmin and Ocella, brings with it’s slick marketing campaign a 2-3x increased risk of blood clots than previous generations of birth control medicine.
Before subscribing to any method of birth control it is important to have a thorough knowledge of any side effects you may experience. If you are taking YAZ, Yasmin or Ocella and are having any of these side effects, let your doctor know.
Post: Gayle R. Lewis, Esquire
Hospitals Exaggerate Benefits of Robotic Surgery
A review of 400 randomly selected hospital websites found out that many may be overestimating the benefits of using robotic surgery at their facilities – - while at the same time ignoring the risks, according to researchers at Johns Hopkins University School of Medicine in Baltimore.
The researchers found that about 41 percent of the examined hospital websites described robotic surgery. Among those, 37 percent presented robotic surgery on their homepages, 73 percent used stock images or text provided by the robot manufacturers, and 33 percent linked to a manufacturer’s website.
At the same time, statements regarding clinical superiority over conventional surgery were made on 89 percent of websites mentioning robotics – - with the most common being less pain (85 percent), shorter recover (86 percent), less scarring (80 percent), and less blood loss (78 percent).
Another 32 percent made reference to improved cancer outcomes. However, none of the websites mentioned risks, the researchers report in an online study of the Journal for Healthcare Quality.
In the past four years, the use of robotics in gynecological, heart, and prostate surgeries – among various common procedures –has grown 400 percent, according to Marty Makary, MD, MPH, an associate professor of surgery at Johns Hopkins and the study’s leader. But many websites, he says, fail to make clear how their facilities or physicians arrived at their conclusions of the robot’s superiority.
“This is a really scary trend,” Makary continues. “Hospitals need to be more conscientious of their role as trusted medical advisers and ensure that information provided on their websites represents the best available evidence.” By Janice Simmons Journal for Healthcare Quality
Coffee ~the next wonder drug for Cancer?
Source: Journal of the National Cancer Institute, BBC Health
Prostate cancer is the most commonly diagnosed male cancer in the USA, and the country’s second biggest cancer killer, after lung cancer. 16 million males worldwide are cancer survivors; 2 million are American.
A recent publicized study now suggests that men who drink six or more cups a day are 20% less likely to develop any form of the disease. They were also 60% less likely to develop an aggressive form which can spread to other parts of the body. The study looked at about 48,000 men in the US who work as health professionals. Every four years between 1986 and 2006, they were asked to report their average daily intake of coffee. Even relatively small amounts of coffee – one to three cups per day – were found to lower the risk of lethal prostate cancer by 30%. No difference was seen between caffeinated and decaffeinated coffee, suggesting caffeine itself was not the cause. So what is it about coffee?
The study’s lead author, Kathryn Wilson is quoted as saying: “At present we lack an understanding of risk factors that can be changed or controlled to lower the risk of lethal prostate cancer. If our findings are validated, coffee could represent one modifiable factor that may lower the risk of developing the most harmful form of prostate cancer.”
Coffee apparently contains several compounds which have been found to regulate insulin, reduce swelling (inflammation), and act as antioxidants – all of which are also beneficial in reducing the risk of prostate cancer.
A recent study of some 6,000 Sweedish women suggests that drinking more than five cups a day halves a woman’s risk of aggressive breast cancer (estrogen receptor negative). Previous studies have also shown that coffee reduces the risk of developing diabetes type 2, gallstone disease, Parkinson’s disease, liver cancer, and cirrhosis of the liver.
Study Highlights:
- Adult males who drank at least six cups of coffee a day had an almost 20% lower chance of developing any type of prostate cancer.
- Those drinking at least six cups of coffee a day had a 60% lower chance of developing the aggressive/lethal form of prostate cancer.
- The risk reduction was seen equally among both drinkers of caffeinated and decaffeinated coffee.
- Moderate coffee drinkers (1 to 3 cups per day) had a 30% lower chance of developing lethal prostate cancer
Obviously the authors add that further studies are needed to confirm their findings. If confirmed, then prostate cancer protection should be added to the benefits of regular coffee drinking. So, maybe those $4 non-fat lattes you’ve been ordering for the past 2 years will finally pay off in unexpected ways.
Post: David M. Schwadron, Esquire
FACING GENERIC RIVALS, MEDS GET PRICE HIKES
Prices have soared from some popular brand-name drugs widely used by older men and women – medications whose patents are close to expiring. Why? Manufacturers tend to hike the prices of those drugs in the year or so before they lose their exclusive marketing rights, according to two new reports. But the silver lining for consumers is that an unprecedented number of top brand-name prescription drugs are due to lose patent protection in the next couple of years – opening the way for generic versions that cost far less. Blockbuster drugs scheduled to go off patent this year include Lipitor (used for high cholesterol) and Xalatan (glaucoma). In 2012 patents set to expire include those for Clarinex (allergies) and Avandia (diabetes). An analysis published in the AARP Rx Price Watch Report finds that cumulatively “the retail price of brand-name drugs that have faced generic competition in 2010 rose by 51 percent…between the end of 2004 and the end of 2009,” which equals an average hike of $762 for one year of therapy between those two dates. “Much of this increase took place in the two years” before lower-cost generic versions appeared on the market, the report adds. Buttressing these findings is a new analysis of prices for the 15 best-selling drugs by Thomson Reuters MarketScan, which found much higher price hikes in 2010 than in earlier years. “The analysis indicates drug makers are scrambling to make as much money as possible from blockbuster drugs before their patents expire, “Reuters reports.
By Patricia Barry for AARP Bulletin
HEALTH CARE COMES RIGHT TO THEIR DOOR
Health care delivery is often inefficient and expensive, but a new clinic in Camden, N.J., may change that. The clinic, which was to open in late April, is located in Northgate II, a public house apartment building where more than 300 low-income residents live. The location was chosen after research data showed that many residents used a hospital emergency room instead of a primary care physician for their medical needs. A part-time nurse practitioner will staff the on-site clinic. “We felt like we could do better with a different model,” says Jeffrey Brenner, M.D., executive director of the Institute for Urban Health at Cooper Hospital, who collected the data. The focus is delivering “better health care at lower cost,” he says. Reliance Medical Group, a private medical practice, will run the operation.
By Cathie Gandel for AARP Bulletin
FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers
The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.
Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.
Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.
“The highest rate of meningococcal disease occurs in children under one year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research.
The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children.
Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.
Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur Inc. of Swiftwater, Pa.
Immediate Release: April 22, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA