Johnson & Johnson became the target of the FDA’s wrath on Friday due to a delayed recall of approximately 500 lots of drugs like Tylenol, Motrin, and Benadryl.
Apparently J&J had received many complaints from consumers early in 2008 stating that some of there medications had a moldy, mildew-like odor. J&J chose to overlook these complaints, until late in 2008 when the FDA issued a warning letter to J&J stating that failure to rectify the problem could result in legal action and seizure.
Despite knowing that they were selling sub par products, a recall was not initiated until last month, drawing public criticism from the FDA on Friday.
McNeil (sub company of J&J) should have acted faster,” said Deborah Autor, director of the FDA’s Office of Compliance, of the arm of Johnson & Johnson that manufactures Tylenol products, adding “When something smells bad, literally or figuratively, they must aggressively investigate and solve the problem.”
The FDA further criticized J&J for not adequately responding to complaints, noting the extremely long length of time from when they had first received complaints of the odor, to when action was taken to remedy the problem.
The recall has been made on the Tylenol Arthritis medication that was the original source of the problem, as well as Tylenol Extra Strength, Rolaids, and a number of children’s medicines that appear to have the same problem.
If the tainted medicine is taken, individuals may experience a number of side affects including nausea and vomiting.
If you have purchased any of these tainted J&J medications, the company advises consumers to stop using them and contact McNeil for information about how to get a refund or a replacement. The company provided the address for its Web site, www.mcneilproductrecall.com, as well as a toll-free number: (888) 222-6036.
Nicorrette has helped many smokers kick the habit. Revia (Naltrexone) has helped many alcoholics relieve their dependency. Sabril (vigabatrin) reduces cocaine cravings and has helped many kick the addiction.
What’s next, a drug to help users kick their Facebook addiction? Not likely…but, you never know.
The New York Times recently reported that many teens, the majority girls, are forming Facebook support groups to deal with their addiction.
“It’s like any other addiction,” psychologist Kimberly Young, the director of the Center for Internet Addiction Recovery in Bradford, Penn., told The Times. “Its hard to wean yourself.”
According to the article, one boy even said that “Facebook wasn’t merely a distraction, but it was really confusing him about who he was,” and he decided to spend his senior year away from the service. He was apparently burned out trying to live up to his own descriptions of himself.
Facebook also doesn’t let you quit so easily, teens that wish to give the axe to Facebook must check off six reasons why they want to quit. And if they have a weak moment and decide to reactivate their account, all they have to due is simply sign in with their original login and password information and pick up right where they left off.
Last week, Sen. Byron Dorgan a Democrat from North Dakota introduced a piece of legislation that would save consumers over a $100 billion dollars by allowing them to order their drugs from several other countries.
According to the Bangor Daily News
a North Dakota Democrat, introduced legislation to allow consumers to buy drugs from several other countries. As a safeguard, only medication approved by the U.S. Food and Drug Administration and produced in facilities approved by the FDA could be purchased by U.S. residents. The measure was co-sponsored by Sen. Olympia Snowe.
Sen. Dorgan estimated the legislation would save consumers about $100 billion over the next decade.
The article goes on to say the only thing stopping the legislation is the FDA and PhRMA. The FDA won’t support the importation of drugs because they are protecting the pockets of the big pharmaceutical companies, and PhRMA is the pharmaceutical companies lobbying group.
Senators have verified that the drugs are safe, the only hold up is they don’t want YOU to save money on your prescriptions. The good news is you don’t have to wait on them. You can order the medications you need like Actos and Lexapro right now.
Don’t let lobbyists and bureaucrats to decide when you can save money on your prescription medication, join ePharmacies.com today.
The cost of brand name drugs can be nothing less that ridiculous, and why? The answer is simple: because big pharma wants to take as much money from the consumer as possible. Even worse, the government is allowing them to do it.
That leaves everyone trying to save money on their brand name medication asking the same question, how can I save on my meds?
The first thing I would suggest is to see if there is a generic equivalent available. If you don’t want to use a generic, or even want if you want to find the generic version cheaper, then you should give ePharmacies.com a shot. Here is an example of the type of savings you can expect.
The rising cost of health care is an issue that America must deal with. And one of the main factors for the rising cost of health care is prescription drugs. Medications can improve quality of life, treat life threatening conditions, and help prevent costly hospitalizations. The bottom line is that health care consumers must educate themselves about less expensive alternatives to brand name medications.
Depending on what your body needs and the problems you are experiencing will determine what type of cholesterol medication your doctor will prescribe for you. These medications will help by:
Lowering your LDL (bad) cholesterol
Decreasing your triglycerides, a type of fat in the blood that also increases the risk of heart disease
increasing your HDL (good) cholesterol which helps protect against heart disease.
One of the most common classes of cholesterol medication are statins. Statins decrease LDL and triglycerides and slightly increase HDL. Altoprev, Crestor, Lescol, Lipitor, Mevacor, Pravachol, and Zocor can all be found in this class.
Some of the side affects that you should look out for when using any of these statins are constipation, nausea, diarrhea, stomach pain, cramps, and muscle soreness.
According to the Mayo clinic
most cholesterol medications are well tolerated, but effectiveness varies from person to person. If you decide to take cholesterol medication, your doctor may recommend periodic liver function tests to monitor the medication’s effect on your liver. Also remember the importance of healthy lifestyle choices. Medication can help control your cholesterol — but lifestyle matters, too.
I think the main thing to remember when taking cholesterol medication is that it is not an end- all cure- all, and should be used in conjunction with a healthy diet. Often times once the user changes his diet, the medication can be decreased or is no longer needed.
Today Novartis AG announced that they will pay $200 million to market Vanda’s new schizophrenia drug in the United States and Canada.
Outside of the US, Vanda will retain rights to the drug, Fanapt. Novartis does however have the option to co-commercialize or receive royalties on sales outside the US as well as the right to develop and release a long lasting injectible version of the drug.
According to Rueter’s
Fanapt, known chemically as iloperidone, was approved in May, contrary to the expectations of many industry experts and analysts. The drug was initially rejected by the U.S. Food and Drug Administration, but Vanda resubmitted its application and the agency, to the astonishment of investors, changed its mind.
Many believe the new drug will still have a relatively small role in the large and already over-saturated antipsychotic market. In clinical trials, it was shown to be about as effective as Pfizer Inc’s Geodon…the worst-performing drug in the antipsychotic market. The major drugs that dominate the market are AstraZeneca’s Seroquel, Eli Lilly & Co’s Zyprexa, Johnson & Johnson’s Risperdal and Bristol Myers Squibb Co’s Abilify.
Although it is unlikely that Novartis’ new drug will overthrow Zyprexa which brings in $4.7 billion a year, the new drug is expected to sell about the same amount as Geodon, which had over 1$ billion in sales last year. That is a good chunk of change, but meager in comparison Zyprexa.
Orexigen Therapeutics Inc. reports that the a mid-stage trial of Empatic met its goal of demonstrating significant weight loss.
This news comes at a great time. America is getting bigger by the day; roughly two-thirds of adults in the United States are overweight, and almost one-third are obese.
An ongoing giant study of American nurses showed that only about 10 percent who made it to age 70 could be considered in top shape. Women who steadily gained weight from age 18 on ended up in the worst shape, the researchers said.
Most had some kind of physical or mental limitation, and more than a third had both chronic diseases and also mental or physical limitations.
Currently there are only a few options for weight loss aids deemed safe by the FDA: Meridia, Xenical, and Alli.
The good news is that results from the preliminary trails on Empatic look promising. Orexigen said
the 729-patient trial found that 60.4 percent of obese people given the highest dose of the drug lost at least 5 percent of their body weight, compared with 14.7 percent of patients given a placebo.
The 24-week trial also found that patients treated with Empatic had mean weight loss of 7.5 percent, compared with 1.4 percent for the placebo group — a percentage point difference of 6.1.
Empatic must still receive final approval by the FDA, but early estimates have it ready for market in 12 to 18 months.
The arrival of the H1N1 pandemic has everyone on edge and eagerly awaiting the new vaccination to fight against the new deadly strain of influenza. However many are debating if the new vaccination has been rushed to market to fast, and if safety has been overlooked in order to meet the demand of the public.
The new vaccine will be administered in two shots in addition to the regular flu shot. The Centers for Disease Control and Prevention is recommending pregnant women, people between 6 months and 24 years old and non-elderly individuals who have underlying conditions be vaccinated as soon as the shot becomes available in mid-October. Also, the CDC recommends people living in households with infants under 6 months of age should be immunized, because the infant is too young to be vaccinated.
But with the vaccination comes concerns, and rightfully so. According to the U.S. Food and Drug Administration and a preliminary report published earlier this month by the New England Journal of Medicine, 45 percent of the 240 people vaccinated experienced mild-to-moderate side effects.
Also many parents are concerned that the vaccine contains thiomersal, a mercury-containing agent that preserves vaccines, but has been alleged to have a link to autism in children.
Only time will tell whether the vaccine is truly affective and safe. Whether or not you choose the vaccine for yourself or your family, don’t forget the practical things you can do in your everyday routines recommended by the Center for Disease Control to help prevent catching and spreading H1N1 like:
Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
Wash your hands often with soap and water, especially after you cough or sneeze. If soap and water are not available, use an alcohol-based hand rub.*
Avoid touching your eyes, nose or mouth. Germs spread that way.
Stay home if you get sick. CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.
Hopefully the H1N1 scare is more hype than fact, but remember, it is always better to error on the side of caution.
The anticonvulsant Sabril (vigabatrin) was approved by the FDA last Friday for the treatment of epilepsy and infantile spasms. The drug was already available in Canada, the U.K., Denmark and Mexico.
The Los Angeles Times reports that Sabril is the first drug approved in the United States for infantile spasms, a terrible disease that can cause babies to have hundreds of spasms in a day.
The onset of infantile spasms usually occurs between the ages of four and eight months. The seizures are characterized by a sudden bending forward of the body and a stiffening of the arms and legs. U.S. doctors have used prednisone to treat the condition to date, with limited success.
Here’s video of a baby named Kailani having infantile spasms:
Although infantile spasms generally clear up by age 5, patients are prone to other forms of epilepsy later in life.
In addition to infantile spasms, Sabril is approved to treat epilepsy sufferers with so-called “complex partial seizures,” which affect about 1 million Americans.
As the Times points out, there are reasons the FDA took its time to OK Sabril:
The drug … is not perfect. As many as 30% of those who use it suffer from a loss of peripheral vision, although it does not affect central vision and such tasks as reading. Patients who use the drug will have to be monitored very closely for loss of vision…
The Times adds that many U.S. parents have been buying Sabril from Canadian pharmacies for years to treat infantile spasms.
Millions of Americans take oral ibuprofen (in products like Advil) for pain relief. What’s great about ibuprofen is that it is chemically similar to aspirin but easier on the stomach. So if you have body aches and pains that acetaminophen (Tylenol) can’t treat, ibuprofen is a great solution for ailments like arthritis, sunburns, sprains, etc.
Since people associate ibuprofen with the relief of body aches, it was probably inevitable that drugmakers would market it in topical ointments. And indeed, numerous ibuprofen creams and gels are now available.
Late last week, however, the FDA announced that it has issued warnings to eight makers of these over-the-counter products, telling them to take their products off the market.
The FDA said in its announcement:
Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products … Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.
The specific products whose manufacturers received warning letters are called Emuprofen, BioEntopic 15% Ibuprofen Crème, Ibunex Topical Ibuprofen, LoPain AF 15% Ibuprofen Crème, IB-RELIEF, Profen HP, IbuPRO-10 Plus, and IBU-RELIEF 12.
Interestingly, other topical ibuprofen products, such as those by Mentholatum, were not mentioned in the announcement.
The FDA did not comment on whether topical ibuprofen actually works. It only said that these products need to earn FDA approval before being sold.
So, does topical ibuprofen work?
Some people swear by it. For example, when a questioner on Yahoo! Answers asked, “How good is topical ibuprofen?”, one respondent answered:
I use ibuprofen gel on my neck when I get a tension headache – its about the only thing that works!
But another person responded:
Topical ibuprofen is of limited use as it only penetrates about 0.5cms, this means it can’t really reach the knee joint if you rub it in.
We did find some medical studies that argued the effectiveness of topical ibuprofen. The maker of the ibuprofen cream Ibunex states its case this way:
Topical supplementation is the best way for addressing soft tissue and joint pain because it is applied directly to the target area that is causing the pain or discomfort. Over 80% of oral medicines and supplements are filtered out by the digestive system, thus minimizing their effect in the easing of pain … Ibunex is a unique, topically applied formula. One pump (.2 grams) contains Ibuprofen (10 mg) plus Glucosamine (4 mg), Chondroitin (4 mg), MSM (5 mg) and Bromelain (5 mg). Recent clinical research has found that 5% topical Ibuprofen resulted in comparable effectiveness relative to 400 mg oral Ibuprofen.
In the wake of the FDA warning letters, the continued availability of these products at your local drugstore is obviously in question. In the meantime, if you currently use topical ibuprofen, ask your doctor to recommend alternatives.
The anticonvulsant 
Millions of Americans take oral 
