Staff reviewers for the U.S. Food and Drug Administration said that a potential increased risk of cancer with drugs containing calcitonin salmon appears plausible.
In briefing documents released on Friday, the reviewers said the risk raises concerns about the overall risk versus benefit of calcitonin products to treat osteoporosis in postmenopausal women.
Calcitonin products include Novartis AG's Miacalcin injection and nasal spray and Unigene Laboratories Inc's nasal spray. Privately held Upsher Smith Laboratories Inc. distributes Unigene's product in the United States. Generic calcitonin products are also available.
Calcitonin salmon is a man-made version of the hormone calcitonin that is found in salmon.
The reviewers said significant questions remain about calcitonin salmon's effectiveness in reducing fractures in the treatment of postmenopausal osteoporosis.
An advisory panel to the FDA is scheduled to discuss the products on March 5 and will make a recommendation to the agency on whether to allow the continued marketing of these products for that use.
Last July European regulators recommended that long-term use of calcitonin be curtailed after a review found evidence of a small increased risk of cancer with long-term use of the drugs.
They recommended that they should only be authorized for short-term use in Paget's disease, a bone disorder; for acute bone loss due to sudden immobilization; and for excess calcium in the blood caused by cancer. They ruled that the benefits of calcitonin-containing medicines did not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition.
Unigene officials declined to comment on the FDA staff review as they do not distribute a calcitonin product in the United States. Upsher Smith officials were not immediately available for comment. Novartis said in a statement that it "places the highest priority on patient safety and the appropriate use of its medicines and is looking forward to the opportunity to engage in the discussion at the upcoming meeting."
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More Americans know about and smoke electronic cigarettes in the U.S., the Centers for Disease Control and Prevention reported on Thursday -- something that highlights the need for government regulation and evaluation, the head of CDC's office on smoking and health said.
The CDC found the number of smokers who have tried them doubled in just a year amid heavy marketing -- from 10 percent in 2010 to about 21 percent in 2011. The numbers grew from 2.5 percent to 7.4 percent for former smokers, the report, published in the journal Nicotine & Tobacco Research, finds.
Nearly six in 10 adults in the U.S. are aware of the battery-powered devices that heat a liquid nicotine solution and create vapor that users inhale, according the first study to assess the change in awareness and use of electronic cigarettes on a national level.
"These finding sort of tantalizingly underscore the need for more rigorous study of patterns of use of e-cigarettes and impacts," the CDC's Dr. Tim McAfee said in an interview with The Associated Press. "Until there's regulatory authority and oversight, it's going to be more difficult to be certainly reassuring around things like toxic effects."
Some of the nation's largest tobacco companies have gotten into the e-cig market as part of the industrywide push to diversify beyond the traditional cigarette business. Reynolds American Inc., the second-biggest U.S. cigarette maker, has begun limited distribution of its first electronic cigarette under the Vuse brand. Lorillard Inc., the nation's third-biggest tobacco company, acquired e-cigarette maker Blu Ecigs in April. Some e-cigarettes are made to look like a cigarette with a tiny light on the tip that glows like the real thing.
The Food and Drug Administration says e-cigarettes have not been fully studied. The federal agency is expected to assert regulatory authority over e-cigarettes later this year to treat them the same as traditional cigarettes and other tobacco products.
The FDA has said its tests found that the liquid in some electronic cigarettes contained toxins besides nicotine as well as cancer-causing substances that occur naturally in tobacco. But some public health experts say the level of carcinogens was comparable to those found in nicotine replacement therapy, because the nicotine in all of the products is extracted from tobacco.
According to the results of a series of online surveys, the CDC reported, awareness of electronic cigarettes increased from 40 percent in 2010 to nearly 60 percent in 2011, and use among adults doubled to 6 percent during that time.
McAfee said the motivations behind e-cigarette use remain unclear. For example, a former smoker could be experimenting with them as a new nicotine delivery system, or could have used an electronic cigarette to quit smoking regular cigarettes. Current smokers might be using e-cigs in places where tobacco smoking isn't allowed.
More than 45 million Americans smoke cigarettes, and about half of smokers try to quit each year.
First marketed overseas in 2002, e-cigarettes didn't become easily available in the U.S. until late 2006. Now, the industry has grown from the thousands of users in 2006 to several million worldwide. Analysts estimate sales could double to $1 billion in 2013. Some companies have even started running TV commercials.
Devotees tout e-cigs as a way to break addiction to real cigarettes. They say the devices address both the nicotine addiction and the behavioral aspects of smoking — the holding of the cigarette, the puffing and exhaling something that looks like smoke — without the more than 4,000 chemicals found in cigarettes.
"The bottom line is ... the impact of e-cigarettes on public health remains uncertain," McAfee said.
Codeine can kill some children when it is used to help with pain after tonsil and adenoid surgery, and it shouldn’t be used any more, the Food and Drug Administration cautioned on Wednesday.
The FDA said it was adding a strong warning, called a boxed warning, to the label of the drug, and also will warn that it is not to be used in certain patients – especially children after tonsil or adenoid surgery.
“Health care professionals should prescribe an alternate analgesic for post-operative pain control in children who are undergoing tonsillectomy and/or adenoidectomy. Codeine should not be used for pain in children following these procedures,” the FDA says in a statement.
Last year, the FDA said it was investigating the deaths of three children. They died after getting their tonsils or adenoids removed, and had been given codeine to ease the pain. Codeine is turned into morphine in the liver, and morphine can suppress breathing.
“Many of the cases of serious adverse events or death occurred in children with obstructive sleep apnea who received codeine after a tonsillectomy and/or adenoidectomy,” the FDA said.
The children appeared to have metabolisms that natually converted codeine to morphine at an unusually high rate – meaning they got a higher-than-expected dose of the drug once the body processed it.
“Since these children already had underlying breathing problems, they may have been particularly sensitive to the breathing difficulties that can result when codeine is converted in the body to high levels of morphine. However, this contraindication applies to all children undergoing tonsillectomy and/or adenoidectomy because it is not easy to determine which children might be ultra-rapid metabolizers of codeine," the FDA says.
The FDA says between one and seven percent of people are “ultra-rapid metabolizers,” but people of North African, Ethiopian, Greek and African-American descent are especially likely to be.
The FDA says parents should call 911 if their children have been given codeine and show any of these signs:
The Food and Drug Administration says U.S. marshals have seized illegal dietary supplements from a Florida company because some may contain a dangerous pharmaceutical ingredient.
Several of the supplements from Globe All Wellness LLC contain the active ingredient in Meridia, a weight loss drug that was withdrawn from the market in 2010. The drug was pulled after studies showed it could increase the risk of heart attack and stroke.
Among other problems, the Hollywood, Florida-based company made unsubstantiated claims about the benefits of its products and did not comply with manufacturing standards.
Dietary supplements are subject to lighter regulation than prescription drugs. They cannot contain prescription drug ingredients or claim to treat disease.
Government agents seized various lots of products including: SlimXtreme, SlimPlus, SlimLee, GelSlim, SlimDrops and Colonew.
The Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year.
The FDA said in an online post Tuesday that at least one batch of the drug distributed by a New York company does not contain the active ingredient in real Avastin, which is used to treat cancers of the colon, lung, kidney and brain. The drug was distributed by Medical Device King, which also does business as Pharmalogical. The vials are packaged as Altuzan, the Turkish version of Avastin that is not approved for use in the U.S.
The agency warned doctors in April about a similar case of fake Turkish Avastin distributed by a U.K. distributor. Prior to that, the FDA announced in February an investigation into a different batch of fake Avastin distributed to doctors in several states. Both of those cases appeared to involve different networks of distributors than the latest incident.
The FDA said it's currently unclear whether any U.S. patients have received the drug. Specifically, Altuzan labeled with the lot numbers B6022B01 and B6024B01 may be counterfeit. Importing even authentic Altuzan into the U.S. is illegal, since the FDA has only reviewed Avastin as safe and effective.
The agency is asking doctors to stop using any products from Medical Device King, Pharmalogical or Taranis Medical, another affiliated business.
A telephone number listed on Medical Device King's website was not in service. Company representatives did not immediately respond to emails sent Wednesday.
Roche's Genentech unit sells Avastin in 120 countries and manufactures and packages the drug at eight sites worldwide. The drug had sales of $5.8 billion in 2012 and was Roche's second-best selling drug overall. The injectable drug usually sells for about $2,500 per vial.
The FDA warned doctors to be wary of drug prices that seem "too good to be true."
"Deep discounts may be offered because the product is stolen, counterfeit, substandard, or unapproved," the agency states.
Incidents of counterfeiting reported by drugmakers have increased steadily over the past decade, though only about 5 percent of cases are typically reported in the U.S. The rise in counterfeiting comes as pharmaceutical supply chains increasingly stretch across continents. More than 80 percent of the active ingredients used in U.S. pharmaceuticals are now manufactured overseas, according to a recent congressional report.
The popular Botox wrinkle treatment made by Allergan Inc has been approved to treat adults with overactive bladder who cannot tolerate or failed to be helped by other drugs for the condition, the U.S. Food and Drug Administration said on Friday.
Botox injected into the bladder muscle causes the bladder to relax, increasing its storage capacity and reducing episodes of urinary incontinence, or leakage.
"Clinical studies have demonstrated Botox's ability to significantly reduce the frequency of urinary incontinence," Hylton Joffe, director of the FDA's Division of Reproductive and Urologic Products, said in a statement. "Today's approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States."
Botox had previously been approved for other non-cosmetic uses, such as migraine headaches, severe underarm sweating and loss of bladder control due to nerve damage.
Allergan, which has yet to report full year financial results, said it expects 2012 Botox sales of $1.76 billion to $1.8 billion. Analysts have said that approval for overactive bladder could add more than $200 million a year to Botox sales.
The treatment can be repeated when the effect wears off, but with a gap of at least 12 weeks between treatments, the FDA said.
About 3.2 million Americans suffering from overactive bladder take oral medications from a class of drugs called anticholinergics, such as Pfizer Inc's Detrol. The Botox approval is for those who are not helped by, or cannot take, those drugs, the FDA said.
Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine, feeling a sudden and urgent need to urinate, and frequent urination.
Common side effects for Botox injected into the bladder reported during clinical trials included urinary tract infections, painful urination, and incomplete emptying of the bladder, or urinary retention.
People being treated for overactive bladder with Botox should not have a urinary tract infection and should take antibiotics before, during, and for a few days after Botox treatment to lower the chance of developing an infection from the procedure, the FDA said.
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Phamacist Prakash Deshpande injects Judith Echevarria with influenza vaccine at a Manhattan pharmacy. Americans are clamoring for influenza vaccine thanks an an unusually early flu season this year.
Drugs stores running out of vaccine. One company’s supply nearly sold out. An unusually early flu season has Americans clamoring for vaccines and all of a sudden they are scarce.
Yet back in September, public health officials were begging people to get vaccinated. Why the disconnect?
There are four main reasons:
It may be 2013, but the United States still uses technology developed in the 1940s to make flu vaccines. In fact, the process for making next year’s flu vaccine is just starting to gear up right now, even though this year’s flu season is nowhere near to being over.
Experts have to first predict which strains of flu virus will be circulating next year. Influenza mutates all the time and there are different strains, so this is tricky. It’s also the reason people have to get a new flu vaccine every year.
The virus must be isolated from patients’ blood, purified, and injected into chicken eggs to grow. These aren’t just any chicken eggs, either – they have to be fertilized, have a chicken embryo inside and they need to be a certain size. The process is fraught with danger and often breaks down if eggs don’t develop right or if there’s contamination.
Then the virus is purified and made into vaccine. New technology is in the works and Novartis now makes flu vaccine at a factory in Holly Springs, North Carolina, using dog cells instead of eggs—a process that’s slightly faster, easier to control and that can be scaled up more quickly.
The hope is for a universal flu vaccine – one that would work against all strains of flu and protect people for years at a time, but progress is slow.
“A vaccine that would provide protection against all of the known strains of influenza has been a goal since flu vaccine was discovered,” says Dr. John Treanor, a vaccine researcher at the University of Rochester in New York. “It’s not going to be a straightforward, easy shot.”
In the meantime, companies predict how much demand there will be months before flu season even starts, and there’s no way to ramp up production when a season like this one hits and there’s suddenly a surge in demand.
This leads to the next problem: Americans don’t like getting flu shots. It’s the main reason demand is hard to predict. About 128 million people, or about 42 percent of the U.S. population, got immunized against influenza last year. That’s even though the Centers for Disease Control and Prevention says everyone over the age of six months should get a vaccine – every year. More than 30 million doses of flu vaccine never got used and were almost certainly thrown away, according to CDC.
“If people followed the recommendations every year, there would be no shortages,” says Dr. Walter Orenstein of Emory University’s Emory Vaccine Center and a former head of the CDC’s immunization program.
“The first issue is that Americans are pretty deeply divided on whether they think flu vaccination is a good idea,” says Katherine Harris, a RAND Corporation economist who studies flu vaccine issues.
“There are the people that get it and the people that don’t, and the people that don’t get it have pretty bad attitudes about it.”
And people aren’t afraid of the flu, even though it kills as many as 36,000 people in a bad year, including 100 children every year. Flu puts as many as 200,000 people into the hospital every year. But in some years it may be a mild season and kill 4,000 people. This variation lulls people into thinking flu isn’t a problem. “Many people who don’t get flu vaccine don’t get it because they don’t feel they, personally, are at risk,” Treanor says.
The flu vaccine isn’t perfect, either, leading many to think it’s a waste of time to get one. This year’s is only 62 percent effective. On top of that. lots and lots of viruses act like flu – causing coughing, headache, muscle aches and so on – so many people believe they have flu even if they don’t. But Orenstein says if 80 percent of Americans got vaccinated with this vaccine, it would provide “herd immunity” against flu.
“I have had in the last three weeks two respiratory illnesses,” Orenstein says. “And I was vaccinated. But even if one was the flu, the other one was not. Maybe neither of them was flu.” But such uncertainty can make people doubtful about the value of vaccination.
The belief that flu vaccine causes flu is still rampant, although doctors all agree it’s not true. Many people also fear side-effects from the vaccine. Vaccine regulators and public health experts still remember the 1976 swine flu debacle, when the U.S. government rushed out a mass immunization against a swine flu virus that never spread off one military base.
Several hundred cases of a rare neurological disease called Guillain-Barre syndrome were reported afterward and the incident made many people mistrustful of immunizations. More recent fears center on a mercury-based preservative called thimerosal, which was taken out of most vaccines after activists claimed it could cause autism. The link is discredited by many scientific studies but suspicion persists among some parents and activists.
Harris says people do trust their personal physicians, but doctors are not usually paid by health insurance companies to talk people into getting flu vaccines, and they aren’t paid much to administer them. Doctors have to compete with pharmacies, big companies that buy up vaccine to give to their employees, and large stores like Wal-Mart and Target to even get vaccine to stock, and they have to eat the cost if they don’t sell all the vaccines they buy to patients.
“It is a cost that comes right off their books,” Harris says. So many don’t even bother.
“We don’t really have a way for compensating health care providers for encouraging us to take preventive steps,” she said. The 2010 Affordable Care Act does have provisions for rewarding preventive medicine, however, which take effect in 2014.
Harris believes that if doctors’ offices worked harder to remind people to get a flu shot, more people would get it, vaccine makers would provide more supply, and flu shot shortages would ease up.
The Trust for America's Health agrees. It recommends that insurers be required to cover flu vaccines under public and private insurance without cost-sharing. "For instance, currently, 12 states and Washington, D.C. do not require Medicaid to cover flu shots with no co-payment requirements for beneficiaries under the age of 65," the group said in a statement released Tuesday.
The federal government is trying to help in other ways, too. Ten years ago, just four companies made flu vaccines. This year, the U.S. government has licensed vaccines made by seven manufacturers. They include a nasal spray that’s been shown to work especially well in children and a special formulation for older people, whose immune sytems don’t respond as well to vaccines.
The idea is to spread the risk as well as to increase availability. Sanofi Pasteur, which provides about half of the flu vaccine in the U.S., says it has sold out of four of its six formulations of its Fluzone seasonal flu vaccine because of late-season demand.
Companies are wary of making too much vaccine, however, because they can’t re-sell it next year. The flu strains will likely have changed enough to make this year’s vaccine out of date for next year. “It’s not like you can carry it over if you don’t use it,” says Orenstein.
In 2008-2009 the U.S. government shipped 162 million doses of vaccine, but only 90 million were used. And last year 30 million doses or more went unused – most at a loss to the drug makers.
As a result, this year the seven companies made 135 million doses of flu vaccine. So far 128 million have been distributed to pharmacies, doctors’ offices and other providers.
“We have received reports that some consumers have found spot shortages of the vaccine,” Food and Drug Administration commissioner Dr. Margaret Hamburg says in her blog. “We are monitoring this situation and will update you at our Website and at www.flu.gov.” There’s a flu vaccine finder on those websites.
“The flu season usually peaks in January or February, but can extend as late as May,” Hamburg adds – meaning it’s not too late to get a vaccine if you can find one.
“All of us should be encouraging our friends, our neighbors – everyone – to get vaccinated,” Orenstein said.