A class of popular prescription sleeping pills may increase the user’s risk of death, according to a new study. WebMD reports that the pills in question, called hypnotics, include such popular drugs as Ambien, Lunesta and Resterol.
Using 2002-2007 data from a large Pennsylvania health system, researchers reviewed medical records for 10,529 people who were prescribed hypnotic sleeping pills and matched them with 23,676 patients who were never prescribed sleeping pills. They found that the top third of sleeping-pill users had over a five times higher dealth risk, as well as a 35% greater risk of cancer.
Hypnotic pills differ from other types of sleeping aids, in that they actually cause a person to fall asleep. By contrast, a supplement like melatonin promotes sleep through relaxation.
Sanofi-Aventis, the maker of Ambien, responded in a statement to WebMD: “Ambien has more than 17 years of real-world experience and is safe and effective when prescribed and taken according to its labeling.”
Also questioning the study’s validity is Nancy Collop, MD, president of the American Academy of Sleep Medicine. “You cannot assume, just because you find this kind of association, that hypnotics are killing people. People who go on sleeping pills are a sicker population. I know they tried to control for that, but these people simply are not as healthy,” she said to WebMD.
Makers of statins must revise their labels to warn about risks of elevated blood sugar levels – a cause of type 2 diabetes – and memory loss, HealthDay reports. The Food and Drug Administration made the announcement, but also stressed that the benefits of the cholesterol-lowering drugs far outweigh the potential dangers.
“We want health-care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” Dr. Mary Parks, director of the FDA’s Division of Metabolism and Endocrinology Products, said in a news release. The agency made the change following recent clinical trials and isolated reports of side effects.
The full list of statins include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe), the FDA said.
Statins are popularly precribed to patients who have high cholesterol or at risk for fatal and non-fatal cardiovascular events. Healthy individuals with one or more cardiovascular risk factors can also benefit from the drug.
Some patients fail to stick to the drug regimens prescribed by their doctors. Sometimes it’s due to cost considerations or sides effect, but it may also come down to simple forgetfulness.
Terrence Blaschke, MD, professor emeritus of medicine, has co-authored a review that documents the problems arising from the lack of proper adherence to medications. He spoke with Medical Xpress about how taking medications improperly can harm your health – and inadvertantly, the health of others as well.
Q: Can taking medication sporadically be just as bad for your health as not taking your medication at all?
Blaschke: Yes! In many infectious diseases (tuberculosis, malaria, HIV and even more common infections), partial adherence can promote the emergence of resistant organisms, which can be very difficult to treat. An important example is the contribution of partial adherence to the development of multi-drug resistant tuberculosis that may then be transmitted to other individuals. A similar concern has been well-documented for patients infected with HIV. There is also some suggestion that partial adherence with oral cancer drugs may also contribute to drug-resistant cancers.
You can read the rest of Blaschke’s Q&A at medicalxpress.com.
Despite the greater availabilty of inexpensive generic alternatives, prescription drugs are still an expensive proposition for many people. To help those of us for whom medication is a mainstay of the monthly budget, WebMD offers these “Dos” and “Don’ts” for cutting drug costs, which we summarize below:
Another useful “Do": Do check out RxEOB. This online service, available to many MedBen pharmacy plan members, allows patients learn about possible lower cost generic and therapeutic alternatives. Simply log in to the MedBen Access site and click on “My Rx”.
The overwhelming support for Qnexa came as something of a surprise, as concerns about potential risks of heart problems and birth defects had lead an earlier FDA advisory panel to reject it. But some of the same members who opposed it perviously said they were reassured this time that the drugmaker Vivus would take measures to minimize the risks, such as recommending that pregnant women not get the medication.
The committee was also swayed by the contention of Vivus and some obesity specialists that excessive weight carries its own set of risks.
The FDA is expected to decide whether to approve Qnexa by April 17. If approved, it would be the first new prescription drug to treat obesity in 13 years.
In order to head off critical cancer drug shortages, The Food and Drug Administration is loosening up its rules regarding the importation of unapproved foreign drugs, Bloomberg reports.
Detroit-based drugmaker Caraco will temporarily import the drug Lipodox from its Mumbai, India-based parent, Sun Pharmaceutical Industries. Lipodox contains the same active ingredient as Doxil, used for treating ovarian cancer and multiple myeloma.
In a statement announcing the action, the FDA said the supply of Lipodox “is expected to end the shortage and fully meet patient needs in the coming weeks.”
The agency has also given expedited approval to APP Pharmaceuticals for a generic form of methotreaxate, used for leukemia and tumors of the breast and lung. The product is expected to become available in March.
Methotreaxate and Doxil are among 220 types of drugs deemed to be in short supply in the U.S. by the American Society of Health-System Pharmacists.
Choosing generic drugs over costlier brand-name alternatives has benefited U.S. families in the wallet, The New York Times recently reported.
A study by the RAND Corporation revealed that the number of Americans living in a family that spent more than 10% of its out-of-pocket income on prescription drugs decreased from 2003 to 2008. This represents a reversal of the preceding five-year period (1999-2003), when drug costs rose annually.
The study also noted that the declines were due, in large part, to financial incentives from employers and health plans to encourage the use of generic drugs over brands. Through the use of Rx formularies – tiered lists that offer lower patient copayments for less expensive medications – prescription plan members can realize greater savings while still getting the same health benefits as with pricier pills.
At MedBen, we offers a standard (more open) formulary, as well as a high-performance formulary designed to drive drug use to lower cost drugs in class while still providing a wide range of prescribed drug therapies. And that’s in addition to superior Rx discount rates for plan members.
Employers also see significant savings through MedBen pharmacy plans. All network discounts and rebates received for both retail and mail order prescription drug claims are passed through to the group.
For additional information about MedBen pharmacy plans, please call Vice President of Sales and Marketing Brian Fargus at (888) 627-8683.
On Wednesday, a weight-loss drug gets a second chance to impress the Food and Drug Administration. The New York Times reports that a committee of outside advisers to the agency will weight the benefits of the drug, called Qnexa, against concerns that it may cause birth defects and heart problems.
Qnexa is a combination of two existing drugs: the stimulant phentermine and the epilepsy and migraine drug topiramate, also known by the brand name Topamax. Some doctors already prescribe (legally) the pair to obese patients.
The FDA rejected Qnexa in 2010 following reports that the drug increases the risk of a heart attack, and that use of topiramate during pregnancy may be linked to oral clefts, such as cleft lip, in newborns. Drugmaker Vivus had then proposed that Qnexa be allowed on the market with a warning against its use by women of childbearing potential – a suggestion rejected by the FDA as overly broad.
Clinical trials of Qnexa have shown that in addition to losing weight, users had improvements in blood sugar, blood pressure and cholesterol compared to those given placebos. Even so, the advisory committee may request the Vivus conduct an additional trial to further assess the risk of heart attack – a process that could delay approval by years.
Here’s a eye-opener for anyone who has thought about bypassing their doctor and buying medications online without a prescription: Most websites that sell Lipitor and other cholesterol pills fail to provide vital information about contraindications (factors which may increase the drug’s risk), key warnings and side effects.
The Pharmalot blog reports that a recent British study found that the 92% of the websites were lacking general contraindications, while information about contraindicated medicines was absent on 47.3%. Warnings were missing about symptoms associated with myopathy (37% absent), liver disease (48%), hypersensitivity (9%) and pancreatitis (96%). Only 7% listed side effects compatible with current prescribing infomation.
“This has potentially serious implications for the safety of purchasers who may not be aware of the problems associated with ordering medicines online or the actual medication, which they receive. Direct to consumer advertising websites need tighter controls,” wrote the authors in the latest issue of Pharmacoepidemiology & Drug Safety.
The study also noted that 95% of the websites didn’t bother to mention that the drugs were precription-only, and 92% didn’t state that they should only be taken by adults. And just 46% of the sites noted that the buyer should speak with a physician if they’re aleady using other medicines.
The birth control compromise offered by the Obama administration quelled – momentarily, at least – a growing political headache. But, as the New York Times notes, it ignored one conspicuous point.
To appease religiously-affiliated employers that oppose contraceptive usage, the administration announced last week that insurers, rather than the organizations, would be required to cover women’s birth control costs in full. Trouble is, many of these organizations self-fund their employee health care benefits – which means that they serve as their own insurers, and therefore, are still responsible for covering the costs.
So far, the administration has only said that the details will be worked out with religious leaders in the coming weeks. But some aren’t confident that a suitable solution can be reached.
“Putting the obligation on the insurer and not the employer doesn’t help much if they are the same person,” said Richard M. Doerflinger of the United States Conference of Catholic Bishops. Ironically, several Catholic organizations went the self-insurance route in order to avoid similar birth control mandates already present in certain states.
As we noted here last week, President Obama has proposed a compromise regarding the mandate that religiously-affliated businesses cover contraceptive services. But even if the Catholic Church accepts the work-around, questions and controversy remain.
From Insureblog, third party administrator Nate Ogden points out that “free” contraceptives are anything but:
“When employers pay claims under a self funded plan, the majority of the time that is coming right out of the employer’s general account. So while it may seem like it’s ‘free’ to the employees (just like it seems like it’s ‘free’ to folks on fully insured plans), it’s really coming out of their raises, bonuses, even salary.
“Which brings up the first big question, one that hasn’t seen much (if any) press: What birth control is provided for free? Can we cover the generic 100%, or if their doctor prescribes something new at $500 per month are we stuck covering that 100% as well? Remember, it’s not the insurance company getting stuck with the bill here.”
And at Slate, Matthew Yglesias offers the counterpoint:
“While birth control costs more than nothing, it costs less than an abortion and much less than having a baby. From a social point of view, unless we’re not going to subsidize consumption of health care services at all (which would be a really drastic change from the status quo) then it makes a ton of sense to heavily subsidize contraceptives… The unfortunate thing is that under the American setup the subsidies tend to be passed through the employer, which has set the stage for this controversy.”
Overall drug costs in the U.S. will go up from 3% to 5% in 2012, according to the annual report from The American Journal of Health-System Pharmacy.
Entitled “Projecting Future Drug Expenditures,” the report analyzes trends for total drug expenditures as well as hospital an clinic sectors. Expenditures on clinic-administered drugs will increase by 5-7%, while hospital drug expenses are expected to rise no more than 2%.
The report notes that widely used drugs have experienced only moderate cost growth over the past several years, due in large part “to the ongoing introduction and wide use of generic versions of high-cost, frequently used medications.” Generic drugs currently account for over 3 out of 4 of all retail prescriptions dispensed.
Conversely, expenditures for specialized medicines have greatly increased as of late, especially for clinic-administered drugs.
Among the factors that will shape costs this year are drugs in development, distribution of new drugs, ongoing drug shortages, increased use of generics, and uncertainty about biosimilars (drugs that are copies of biological agents).
(Thanks to Drug Topics for the link.)
Still on the fence about whether to switch from Lipitor to a new generic alternative? Here’s some thoughts from Anthony Komaroff, M.D., the Editor in Chief of Harvard Health Publications – a doctor who puts his medication money where his mouth is:
“[T]he generic version of Lipitor, called atorvastatin, is highly likely to be just as safe and effective as Lipitor, but also cheaper. And under most health insurance plans, that means cheaper for you, because of lower co-pays, not just for the insurance company.
“A generic drug contains the same chemical as the corresponding brand-name drug. The FDA is legally required to determine that generics are ‘bioequivalent’ to brand-name drugs, which means they produce similar blood concentrations of the same chemical…“So I can’t give you an absolute guarantee that generic atorvastatin will be equal to brand-name Lipitor. But I can tell you this: I take Lipitor, and I’ll be switching to generic atorvastatin, so I will be following my own advice (something my wife has suggested that I should do more often).”
A reminder to MedBen plan members who get pharmacy benefits management services through Pharmacy Data Management (PDMI): You can get information about generic alternatives and compare prices through MedBen Access. By clicking on your name under “My Rx Claims” in the sidebar menu, you will be taken directly to the RxEOB service.
To access MedBen Access, simply go to MedBen.com, select “Online Client Services", and click on “MedBen Access".
Since the Food and Drug Adminstration approved direct-to-consumer pharmaceutical advertising in 1997, drug manufacturers have worked overtime to promote name recognition to potential customers. One proven strategy used in this pursuit: the checklist.
The New York Times recently examined the phenomenon of “disease mongering", in which a marketing team devises a list of symptoms that a specific medication can treat – symptoms defined broadly enough to make consumers think they may suffer from the condition. The checklists are then placed on websites, on downloadable apps and in pamphlets in doctors’ offices. And patients who diagnose their ailments in this manner associate the drug as an effective cure.
From the Well Blog:
“The makers of Yaz, a birth control pill, for example, used a checklist to help promote the use of their drug as a treatment for premenstrual dysphoric disorder, a controversial diagnosis said to affect up to 10 percent of women. Alongside links to articles on fashion, makeup, hair and celebrity news, Yaz’s Web site offered a ‘Body Diary’ checklist to help patients determine whether they suffer from the disorder.
“Taking its cues from the Diagnostic and Statistical Manual of Mental Disorders, or D.S.M., which mental health professionals use to diagnose disease, the checklist offered watered-down and potentially more inclusive descriptions. A symptom described in the D.S.M. as “persistent and marked anger or irritability or increased interpersonal conflicts” appeared in the Yaz questionnaire as “Felt angry, or irritable.” … The printable results that patients could then take to their doctors (the site has since been taken down) were on a form emblazoned with the birth control brand.”
The third time’s the charm for the diabetes drug Bydureon. MedPage Today reports that the Food and Drug Administation has approved the once-weekly injection for type 2 diabetes – the first such treatment to get the green light.
Drugmakers Amylin and Alkermes submitted Bydureon (exenatide extended-release) for FDA review in 2009, but approval was twice delayed due to questons about the manufacturing process and a possible cardiovascular side effect. The agency did make approval contingent upon the drugmakers putting together a strategy to address concerns over acute pancreatitis and potential risk of thyroid cancer.
Common side effects of Bydureon include nausea, diarrhea, upper respiratory tract infection, and injection site nodules. But earlier trials showed that the drug promotes weight loss rather than gain, and shows better glycemic control than with the once-daily version of exenatide (Byetta).
The Food and Drug Administration needs to enact more stringent safeguards to protect the users of dietary supplements, according to a physician writing in the New England Journal of Medicine.
Pieter A. Cohen, MD, of Harvard Medical School writes that the more than 100 million Americans who annually buy vitamins, minerals, herbal ingredients, amino acids and other natural products presume that they are “both safe and effective". But weak FDA oversight of supplements provides no such reassurances.
In an article about Cohen’s essay, MedPage Today notes that ingredients used and sold in supplements prior to 1994 can be legally marketed without proof of safety or efficacy. A law called the Dietary Supplement Health and Education Act (DSHEA) requires manufacturers of any ingredient introduced after 1994 to provide the FDA with evidence supporting “a reasonable expectation of safety.” But Cohen says that part of the law “has thus far not been enforced.”
There are currently over 55,000 supplements on the market, 51,000 of which were introduced after DSHEA became law. But since 1994, the FDA has received notification for just 170 new supplement ingredients – “undoubtedly a small fraction of the ingredients for which safety data should have been submitted,” Cohen writes.
Last year, the FDA did issue draft guidance regarding information supplement manufacturers must submit to the agency. Cohen says the guidance “provides a thoughtful framework” and is a step in the right direction, but further measures are needed to protect consumers.
Some medications tolerate food with no problem. Others… well, let’s say if they don’t get along, there’s a good chance you’ll know in no uncertain terms.
Not that the combination of food and certain drugs will necessarily result in a physical reaction. The effectiveness of some medications can get diluted when taken immediately before or after a meal.
The American Academy of Family Physicians offers these tips to avoid negative drug-food interactions (via HealthDay News):
New federal government initiatives could speed the process of getting generic drugs to consumers, Business Insider reports. Last week, the Food and Drug Administration submitted recommendations to Congress, including a Generic Drug User Fee Agreement.
Under the proposed agreement, the FDA could levy fees on drug manufacturers to help fund generic drug development and review. In exchange, the agency promises to complete inspections of foreign and U.S.-based drugmakers by 2017, which it says will help cut back on review times.
The generic program is similar to the Prescription Drug User Fee Agreement, which collects funds from brand name drugmakers in return for an expedited review process and increased drug and research development.
Allan Coukell of the non-profit Pew Health Group supported the FDA’s recommendations. “Under PDUFA, the FDA has reduced the time it takes to approve new drugs. Now thanks to the first ever agreement with the generic drug makers, industry has made an investment in greater oversight of U.S. medicines made overseas,” Coukell said.
Expect to see significant price increases on brand name drugs in 2012, according to Sector & Sovereign Research. The Pharmalot blog reports that the Wall Street firm believes that after a 11% jump in 2010, we’ll see an even more substantial spike this year, as drugmakers need the higher prices to “generate needed revenue growth.”
SSR’s analysis goes against conventional wisdom. Usually in an election year, the pharmaceutical industry is reluctant to raise prices dramatically – even more so when the preceding year saw a double-digit increase. But the firm predicts that brand-name drugmakers will weigh the need for higher prices to offset declining volume against the risk of getting pilloried on the campaign trail, and ultimately vote for the bottom line.
However large or small pharmaceutical industry increases are in 2012, MedBen has the tools in place to buffer their impact on your group’s health care expenses. Through a combination of superior drug discount rebates, useful reports and formularies, and ongoing plan consultations, we keep your costs well below the average national trend. And we always pass through 100% of negotiated discounts and deliver 100% of paid rebates back to the client.
To learn more about MedBen pharmacy plans, please contact Vice President of Sales and Marketing Brian Fargus at (888) 627-8683.
Sometimes, it seems that not a week goes by that common wisdom doesn’t get turned on its head. Repeatedly, we’ve been told that taking aspirin regularly can help healthy people to prevent heart disease. But a new report says such advice is not only groundless, but harmful as well.
Reuters (via Yahoo! Health) reports that researchers reviewed nine previous trials of aspirin use in people who had never shown signs of heart problems. Based on the data, they could find no evidence that aspirin prevented fatal heart attacks. It did apparently cause a small reduction in non-fatal heart attacks, though no more than taking a placebo.
Such minor benefits, however, are more than offset by an increased risk of serious bleeding from stomach ulcers and other conditions – as much as 30%, said Dr. Kausik Ray, who studies heart disease prevention at St. George’s University of London and led the study. “It is actually not net benefit, it is a net harm.”
“What we need to focus on is lifestyle, smoking cessation, and statin and blood pressure medications,” Ray added. “I don’t recommend aspirin.” The article notes, however, that among other teams of scientists who have recently analyzed the same data Ray looked at, one team did interpret the results in favor of aspirin.