The Food and Drug Administration Thursday announced that it wants the federal government to impose tough new restrictions on some of the most widely used prescription painkillers.

 The FDA said it planned to recommend that Vicodin and other prescription painkillers containing the powerful opioid hydrocodone be reclassified from a “Schedule III” drug to a “Schedule II” drug, which would impose new restrictions on how they are prescribed and used.

OxyContin, another opioid painkiller, is already a Schedule II drug, defined by the Drug Enforcement Administration as “potentially leading to severe psychological or physical dependence”.

In a statement posted on its website, the agency said it was taking the step after becoming “increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”

The DEA has been asking the agency to recommend reclassifying the drugs for years, citing soaring numbers of Americans becoming addicted to the drugs and dying from overdoses.

Pain specialists and their patients, however, have been fighting the move, saying that any new restrictions would make it too difficult for those suffering from chronic, debilitating pain to get the drugs they need to survive.

The agency acknowledged the emotional debate, saying it “has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.”

 

Carolyn Tuft and her daughter Kirsten (seen here in 2005) were the victims of a shooting at a Salt Lake City mall in 2007. Kirsten was one of five bystanders killed, and Carolyn was left in severe pain.

Shots – Health News

Painkiller Paradox: Feds Struggle To Control Drugs That Help And Harm

Among other things, reclassifying the drugs would reduce the number of refills patients could get before having to go back to see their doctor. Doctors would not be able to simply call prescriptions into pharmacies.

The FDA said it would submit its recommendation to the Health and Human Services Department by early December, and anticipated that the National Institute on Drug Abuse would concur with the recommendation. That will begin a process that would lead to a final decision by the DEA.

More than 136 million prescriptions for these products are dispensed every year, making them the most widely used prescription drugs in the country. Vicodin is probably the best-known hydrocodone-containing product, but there are many others, sold under brand names such as Lortab and Norco.

While powerful painkillers, opioids are highly addictive and are abused by millions. The number of Americans overdosing from these drugs has been increasing rapidly in recent years, and more than 15,000 now die every year, according to the Centers for Disease Control and Prevention.

Hydrocodone is a key ingredient in the prescription painkiller Vicodin.

Shots – Health News

Across America, The Grip of Prescription Painkillers Tightens

But about 100 million Americans suffer from chronic pain, and many of them and their doctors fear the change would make it difficult, if not impossible, for these patients to get drugs they need.

The move comes after an FDA advisory panel recommended the change in January.

Advocates for pain patients immediately reacted with concern to the announcement.

“The concern we have is that it may unintentionally make access for people with pain even more of a challenge than it is now,” wrote Bob Twillman of the American Academy of Pain Management in an email to Shots. “This could necessitate millions more office visits, with attendant costs approaching a billion dollars a year. The access issues will need to be addressed or we will have a lot more people with a lot more uncontrolled pain.”

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Doctors may soon have two new drug options for patients with hepatitis C, just as the liver-destroying virus becomes a major public health concern for millions of baby boomers.

The Food and Drug Administration holds a public meeting this week to review two experimental medications from Johnson & Johnson and Gilead Sciences. The new drugs, if approved, could offer a quicker, more effective approach to eliminating hepatitis C, a blood-borne disease blamed for 15,000 deaths in the U.S. this year.

In a review posted online Tuesday, the FDA reported that J&J’s drug simeprevir has a slightly higher cure rate than currently available treatments, though it also caused rashes and sunburn in some patients.

On Thursday the FDA will ask a panel of outside experts whether the drug should carry warnings about rashes and sunburn on its label. The agency is not required to follow the panel’s advice, though it often does.

The meeting comes at a time when federal health officials are urging baby boomers to get tested for the virus, which can go unnoticed for decades before causing symptoms.

Between 3 million and 4 million Americans are infected with hepatitis C, and people born between 1945 and 1965 are five times more likely to have it than people of other age groups, according to the Centers for Disease Control and Prevention.

Many baby boomers contracted the virus by sharing needles or having sex with an infected person in their youth. The disease was also spread by blood transfusions before 1992, when blood banks began testing for the virus.

“If something is not done soon, all these people who were infected in the 60s and 70s are going to start experiencing the long-term consequences of liver disease,” said Gaston Picchio, head of hepatitis drug development for J&J’s Janssen Therapeutics unit.

Most people with hepatitis C do not even know they have the virus until after liver damage has occurred, causing abdominal pain, fatigue, itching and dark urine.

For most of the last 20 years, the standard treatment involved a grueling one-year regimen of pills and injections that caused flu-like symptoms and cured less than half of patients. Many patients failed to complete the full treatment cycle. Others delayed starting treatment at all in the hopes that more effective treatments would come along.

Two drugs approved in 2011 kicked off a new effort to treat the disease. Research shows that adding the two new drugs — Vertex Pharmaceuticals’ Incivek and Merck & Co.’s Victrelis — to the older drug cocktail can boost cure rates to between 65 and 75 percent.

And the drugs the FDA is reviewing this week have the potential to push cure rates even higher.

J&J’s simeprevir cured 80 percent of patients who had not previously been treated for the disease, according to the FDA’s review. Additionally, the vast majority of patients were able to cut their treatment time in half to 24 weeks, compared with the usual 52 weeks. The New Brunswick, N.J., company is seeking approval to combine the daily pill with the older treatment regimen for patients with the most common form of the virus. J&J developed the drug with Swedish drugmaker Medivir.

On Friday, the same FDA panel will review another hepatitis C drug from Gilead Sciences Inc. that some analysts say will become the first-choice for treating the disease. The pill, known as sofosbuvir, has been shown to cure up to 90 percent of patients after just 12 weeks of therapy, according to one company study. Additionally, analysts believe the drug will eventually be used without interferon, the injectable medication used in the current drug cocktail that causes nausea, diarrhea and other unpleasant side effects.

Gilead is racing against other drugmakers to develop the first all-pill approach to treating hepatitis C, long viewed as the holy grail by drugmakers. Similar efforts are underway from Abbott Laboratories, Bristol-Myers Squibb Co., Vertex Pharmaceuticals and others.

Pharmaceutical industry consulting firm Decision Resources estimates the market for hepatitis C drugs will grow to more than $23 billion by 2018. Sales of the drugs are expected to decline to $17.5 billion by 2021 as more patients are cured of the virus.

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Drug major Ranbaxy Laboratories today said it has received Indian drug regulator’s approval to market SynriamTM for treating malaria caused by Plasmodium vivax parasite. The company has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market SynriamTM in India for the treatment of uncomplicated malaria in adults caused by Plasmodium vivax parasite, Ranbaxy Laboratories Ltd said in a statement. Last year, the Gurgaon-based firm had launched SynriamTM for treatment of uncomplicated Plasmodium falciparum malaria in India.

“Phase III clinical trials for the drug, conducted in India successfully demonstrated the efficacy and tolerability of Synriam as comparable to chloroquine,” the company added. “

The company has also received permission to conduct phase III clinical trials for the paediatric formulation in paediatric patients of uncomplicated Plasmodium falciparum malaria, it said.

“This approval makes SynriamTM one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria,” Ranbaxy CEO and Managing Director Arun Sawhney said.

Ranbaxy is working to make this new treatment available in African, Asian and South American markets where malaria is rampant, he added.

“The company has filed New Drug Applications (NDAs) for marketing SynriamTM in some African countries and will be filing more applications during the year. Once approved, the product will be launched in these markets,” Sawhney said.

According to the World Malaria Report 2012 published by WHO, India witnesses about 13 lakh confirmed cases of malaria each year, about 50 per cent of which are caused by Plasmodium vivax, the second most important species after Plasmodium falciparum.

Shares of Ranbaxy were trading at Rs 402.40 on the BSE in afternoon trade, up 2.93 per cent from its previous close.

Read more at: http://www.firstpost.com/business/ranbaxy-gets-nod-to-sell-malaria-drug-synriamtm-in-india-1184277.html?utm_source=ref_article

Wal-Mart, the country’s largest retailer, recently announced that it would require suppliers to disclose and eventually phase out nearly 10 hazardous chemicals from fragrances, cosmetics, personal care products and household cleaners sold at its stores nationwide.

The company declined to name specific chemicals as it familiarizes suppliers with the new policy, but noted it would apply the same standard to its own line of cleaning products.

This is not because of people like me, who have for years been sounding alarms about the harmful health effects of dangerous chemicals in scores of products used in the home. This is because of you, and millions of other consumers, demanding better with your wallets – because you know better, because you expect better. And now, at least in Wal-Mart, you’ll get better.

Wal-Mart’s announcement comes on the heels of California’s new Safer Consumer Products regulations which will require manufacturers to seek safer alternatives to the harmful chemical ingredients currently found in commonly used products.

Wal-Mart and the state of California might be motivated by different goals (profit versus public health), but their decisions to take on toxic chemicals are similar in scope. California is the most populous state in the country and Wal-Mart is the largest retailer. If manufacturers want to do business with either, they’ll be forced to make some serious changes to their hazardous products currently on the market.

This is cause for celebration, but also for continued concern – why aren’t more local or state governments following suit? Of even greater concern – why isn’t the federal government leading the way? If elected officials took this issue seriously and banned certain known carcinogens found in everyday products, it would send a message not only to manufacturers but also to citizens that just because a product lines the shelves at a popular store like Wal-Mart, it’s not necessarily safe.

Instead, Wal-Mart has stepped up, and for this they are to be commended, particularly in light of a report released last month by the American College of Obstetricians and Gynecologists. Among other recommendations, the report suggests doctors ask mothers-to-be about their exposure to different chemicals, and urges health care professionals to teach women how to avoid substances considered most worrisome during pregnancy.

Let’s hope more retailers follow in Wal-Mart’s footsteps, and that Wal-Mart delivers on its substantial promise. Meanwhile, be your own regulator. a list of dangerous chemical ingredients that will help you interpret confusing product labels as you navigate the aisle in your local drugstore.

For now, you have to do the work – but being a smarter, more informed consumer will pay dividends in the long run.

Read more at http://www.i4u.com/2013/10/wal-mart/takes-lead-toxins-fighting-whos-wal-mart-next#XUypEYqo5wbBpEWQ.99

Novartis AG said on Thursday it had overhauled management operations and sanctioned key staff in Japan after a scandal involving research into its Diovan blood pressure drug in the country.

The Swiss company’s pharmaceutical head David Epstein said the episode would not have a significant impact on the group’s profits, although he acknowledged sales of the drug had fallen.

“Overall Diovan is a relatively small part of our portfolio, given the breadth of the medicines that we have, so the impact should not be significant,” Epstein said.

Epstein told a news conference that oversight at its Japan unit had fallen short and, as a result, Novartis was setting up a compliance advisory panel to prevent future such problems.

“Clearly there should have been more control as well as better training in Japan,” Epstein said. “Unfortunately that was not the case. Those controls are now in place so that this cannot happen again.”

He also acknowledged, in response to a reporter’s question, that the company should have paid more attention to questions raised by some outside experts about the studies into Diovan.

A Japanese health ministry panel this week called for the ministry to investigate Novartis Pharma, the company’s Japanese arm, saying it may have violated the law when it cited studies based on allegedly manipulated data.

Japan accounted for around a quarter of Diovan’s global sales before the scandal and, overall, it made up 9 percent of total group sales in 2012, or $5.36 billion.

Diovan was once Novartis’ top-selling product but its importance is declining and the patent on the medicine is due to expire in Japan this year.

Several Japanese hospitals have stopped offering Diovan after two Japanese universities retracted papers regarding the drug’s efficacy in reducing the incidence of stroke and angina.

While Novartis has said a former employee who assisted in the trials had acted inappropriately, the interim report said the case involved the company as a whole.

Epstein said the report left unclear who manipulated data and for what purpose, but acknowledged potential damage from the scandal to the company’s reputation.

“Clearly if something happens in one market and impacts our reputation, that’s something that we feel acutely all around the world. So we will work very hard to regain your trust,” he said.

Epstein said the company was setting up a panel of seven to nine members, including outside experts, to advise the Japan unit on how to prevent further such problems.

Novartis global Chief Commercial Officer Eric Cornut will be transferred from headquarters to serve as Japan unit’s chairman. The previous head of the unit left the company as of Monday and two other senior executives are taking a 30 percent pay cut until the case is resolved.

Japan’s pharmaceutical lobby group, the Japan Pharmaceutical Manufacturers Association, said on Thursday it was suspending Novartis’s membership rights in the organisation.

Source:

For some healthy adults, getting sick enough to require medication is only half of the problem. The other is getting that pill to go down. Stephen Cassivi, a thoracic surgeon at the Mayo Clinic in Rochester, Minn., who specializes in esophageal disorders, offers one explanation for why some people find it difficult to swallow pills.

Fear Factor

Cassivi says the reasons some people can’t even get a baby aspirin to go down the esophagus are varied. “People who have underlying swallowing difficulties, called dysphagia, may have trouble swallowing pills, but that is generally the result of other problems, such as stroke or surgery or gastroesophageal reflux,” he says.

For the rest of the population, Cassivi notes, pill-swallowing difficulty is usually related to a fear of gagging, which might come from a bad experience with taking a pill. “Fear of gagging is pretty prominent” and a bad experience can cause one to think a pill is harmful and thus cause the throat muscles to tighten, he says. To swallow pills without worry, one has to “get over the mental hump” and relax the muscles.

It’s Just a Phase

There are three phases to swallowing: oral (chewing, moistening and delivering food to the back of the mouth); pharyngeal (which includes the closure of the larynx by the epiglottis and vocal cords, and the temporary inhibition of breathing as the food passes); and esophageal (the rhythmic contractions of the esophagus to deliver food to the stomach, among other actions).

“We have an unconscious ability to know when food is moistened and masticated enough to be delivered to the back of the throat,” Cassivi says. For instance, no one chews yogurt—typically one just swallows it—but not being able to chew a hard substance like a pill can throw the mind-body connection in swallowing off, he says.

The oral phase is the voluntary phase and may be the key to helping many people overcome pill-swallowing difficulties.

http://www.foxnews.com/health/2013/09/27/why-is-it-hard-for-some-people-to-swallow-pills/

 

Americans throw out billions of pounds of food every year because they falsely believe “sell-by” and “best-before” dates on package labels indicate food safety, researchers have found.

A study published Wednesday by Harvard Law School and the Natural Resources Defense Council found that dates printed on packaged foods, which help retailers cycle through stocked products and allow manufacturers to indicate when a product is at its peak freshness, are inconsistent. They confuse consumers, leading many to throw out food before it actually goes bad.

“The labeling system is aimed at helping consumers understand freshness, but it fails – they think it’s about safety. And (consumers) are wasting money and wasting food because of this misunderstanding,” said co-author Emily Broad Lieb, who led the report from the Harvard Law School’s Food Law and Policy Clinic.

Broad Lieb and NRDC scientist Dana Gunders said that, while labels “appear to be a rational system,” they are essentially meaningless to consumers. Manufacturers often decide on their own how to calculate shelf life and what the dates mean.

As a result, huge amounts of food, not to mention considerable natural resources and labor, go to waste in landfill and taxes, and harm the environment.

A lack of binding federal standards on labeling means the dates are governed by a patchwork of state and local laws.

“It’s like the Wild West,” Gunders said.

The authors recommended that “sell-by” dates be invisible to consumers so they cannot be misinterpreted as safety labels; that a clear, uniform date label system be established; and that “smart labels” that rely on technology to provide food safety information be used more frequently.

David Fikes, a spokesman for the Food Marketing Institute, which represents food retailers and wholesalers, said the group agreed there had to be a clearer way for the consumer to read dates. However, it disagreed the code should be hidden from consumers, because that would make it difficult for store employees to stock shelves.

On Wednesday, Congresswoman Nita Lowey (D-NY) released a statement pressing for a consistent federal food dating system.

“Under the current patchwork of state and federal laws, consumers are left in the lurch, forced to decipher the differences between ‘sell-by’ and ‘best if used by,’ and too often food is either thrown out prematurely, or families wind up consuming dangerous or spoiled food,” she said.

Lack of understanding about the labels is not necessarily a health hazard. Researchers said they found no significant difference in incidents of food-borne illness between states such as Massachusetts, which has very strict labeling rules, and others such as New York, which is more lax.

In fact, University of Minnesota food safety scientist Dr. Theodore Labuza, who reviewed the study, said that in his more than 30 years of researching date labels, he was unaware of any outbreaks of illness related to food being kept in the refrigerator or on the shelf past an expiration date, as long as it was stored properly.

“People think the use-by date means either the product is going to die or you’re going to die if you eat it. And it’s just not true. You can’t tie shelf life to a date,” Labuza said.

“If the food looks rotten and smells bad, you should throw it away, but just because it’s past the date on the package, it doesn’t mean it’s unsafe.”

Source: Reuters.com