NLM® released DailyMed® Mobile on January 31, 2011. DailyMed provides access to over 20,000 structured product labels (SPL) from the Food and Drug Administration. DailyMed mobile features a simplified design enabling easy search, retrieval and display of SPLs from any Web-enabled mobile device (see Figure 1). Users can also e-mail SPLs to themselves or colleagues for later viewing on other platforms.
Editor Flahiff’s note: You also cannot go wrong with these nonmobile(at least for now!) resources (via a Consumer Health Library Guide
Information about ingredients in more than three thousand selected brands of dietary supplements. It enables users to determine what ingredients are in specific brands and to compare ingredients in different brands. Information is also provided on the health benefits claimed by manufacturers. These claims by manufacturers have not been evaluated by the Food and Drug Administration. Check out the Help section for tips on how to browse and search this site.
This noncommercial consumer health and drug information site provides information about drugs and treatment options to be discussed with your primary health care provider or a pharmacist. Information about over 1,500 drugsas well as common herbs and supplements. The check interactions tab (potential interactions between drugs) and conditions/treatments area provide easy-to-read overviews. Information provided by Drawing pharmacy experts, licensed doctors of pharmacy, and physicians. From ExpressScripts.
Drugs and Supplements (sponsored by the Mayo Clinic)
Somewhat lengthy drug and over-the-counter medicationinformation with these sections: description, before using, proper use, precautions and side effects. From Micromedex, a trusted source of healthcare information for health professionals.
Herb and supplement information includes information on uses based on scientific evidence as well as safety and potential interactions with drugs, herbs, and supplements. From Natural Standard, an independent group of researchers and clinicians.
A good central source of drug information by the US government (the National Institutes of Health). It links you to information on over 12,000 drugs from trusted consumer drug information sources, the US Food and Drug Information, and LactMed*** (summary of effects on breastfeeding i), It also gives any summaries from medical and toxicological articles (however, some whole articles may not be for free on the Internet).
Aids in the identification of unknown solid dosage pharmaceuticals using images to identify pills (color, shape, etc) as well as a separate advanced search (imprint, drug manufacture, ingredients, etc)
Beware of Fraudulent Weight Loss “Dietary Supplements”
The Food and Drug Administration warns that false claims and tainted products can cause serious harm to consumers.
Consumer Update: Dietary Supplements
The Food and Drug Administration has found nearly 300 fraudulent products—promoted mainly for weight loss, sexual enhancement, and bodybuilding—that contain hidden or deceptively labeled ingredients.
- Drug Information Product DailyMed Mobile Version Launched (jflahiff.wordpress.com)
- PubMed Health Provides Disease and Treatment Information for Consumers (jflahiff.wordpress.com)
has added complementary and alternative medicine (CAM) products. CAM
products generally consist of dietary supplements derived from botanicals
(herbals), “nutraceuticals” (natural and synthetic nonherbals, such as
coenzyme Q10), and related products.
STANFORD, Calif. — Many prescriptions for the top-selling class of drugs, known as atypical antipsychotic medications, lack strong evidence that the drugs will actually help, a study by researchers at the Stanford University School of Medicine and University of Chicago has found. Yet, drugs in this class may cause such serious effects as weight gain, diabetes and heart disease, and cost Americans billions of dollars.
“Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits,” said Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, who is senior author of the study to be published online Jan. 7 in Pharmacoepidemiology and Drug Safety.*** “These are commonly used and very expensive drugs.”
Prescriptions for these drugs have risen steadily since they first came on the U.S. market in 1989, largely replacing the first generation of antipsychotics, which were mainly used to treat schizophrenia. The U.S. government’s original stamp of approval for the new drugs was for treating schizophrenia, but they’re used more today for other conditions, including other psychoses, autism, bipolar disorder, delirium, dementia, depression and personality disorders. And while some of these uses have recently been approved by the U.S. Food and Drug Administration, many have not….
…These new drugs accounted for more than $10 billion in retail pharmacy U.S. prescription drug costs in 2008, representing the largest expenditure for any single drug class — nearly 5 percent of all drug spending, surpassing even blockbusters like statin cholesterol medications. According to a 2004 study, a quarter of all residents of U.S. nursing homes had taken them. Among the drugs are quetiapine, aripoprazole (brand name, Abilify), olanzapine (Zyprexa) and risperidone (Risperdal), each with annual U.S. sales exceeding $1 billion.
Stafford’s new study adds to concerns about the drugs, which have been the focus of thousands of lawsuits, and as a class make up the single largest target of litigation filed under the federal False Claims Act. All major companies selling new-generation antipsychotics have either recently settled cases for hundreds of millions of dollars or are currently under investigation for skewing results or using questionable marketing tactics.
In 2005, the FDA issued its strongest type of caution, the “black box” warning, for use of new-generation antipsychotics, because of increased risk of death for dementia patients.
“Most people think, ‘If my doctor prescribed this, the FDA must have evaluated whether this drug was safe and effective for this use.’ That’s not true,” said Stafford. When doctors prescribe drugs for purposes other than those approved by the FDA, it’s called “off-label” use. Though it’s riskier for patients, there’s nothing illegal about it, and can make sense medically in some instances, Stafford said, especially if there are no approved treatments or if a patient has not responded to approved drugs.
Previous studies had shown that antipsychotic drug use is ballooning. Stafford’s new study not only corroborated and updated these findings but also identified the fraction of off-label use that is based on uncertain evidence.
The researchers’ first step was to analyze the results of a physicians’ survey conducted by health-care information company IMS Health. The IMS Health National Disease and Therapeutic Index survey gives a snapshot of the conditions doctors treated and drugs they prescribed. About 1,800 physicians participate each calendar quarter and each is randomly assigned two days per quarter to provide data.
After identifying which antipsychotics were being used, and for what, the researchers assessed the strength of the evidence supporting those that lacked FDA approval, using efficacy ratings from the widely used drug compendium, Drugdex.
Lead author Caleb Alexander, MD, assistant professor of medicine at the University of Chicago, and colleagues conducted the analysis. Stafford supervised the project and with Alexander interpreted the data. Stanford clinical assistant professor of psychiatry Anthony Mascola, MD, provided expertise on the treatment of psychiatric conditions.
Among their findings:
Antipsychotic treatment prescribed during the surveyed doctors’ visits nearly tripled from 6.2 million in 1995 to 16.7 million in 2008, the most recent year for which they had data. During this period, prescriptions for first-generation antipsychotics decreased from 5.2 million to 1 million.
Antipsychotic use for indications that lacked FDA approval by the end of 2008 increased from 4.4 million prescriptions during surveyed doctors’ visits in 1995 to 9 million in 2008.
In 2008, more than half — 54 percent — of the surveyed prescriptions for the new-generation antipsychotics had uncertain evidence.
An estimated $6 billion was spent in 2008 on off-label use of antipsychotic medication nationwide, of which $5.4 billion was for uses with uncertain evidence.
Prescriptions for antipsychotics began dropping slightly in 2006, shortly after the FDA issued a warning about their safety.
Stafford suggests the upswing in prescriptions for antipsychotics despite the absence of good evidence for their value in many instances is the result of marketing — whether legal or illegal — and ingrained cultural tendencies. “Physicians want to prescribe and use the latest therapies — and even when those latest therapies doesn’t necessarily offer a big advantage, there’s still a tendency to think that the newest drugs must be better,” he said.
Physicians could benefit from more feedback on what percentage of their prescriptions is for off-label uses, said Stafford. “In many cases, physicians don’t realize they’re prescribing off-label,” he said.
In fact, in a previous survey of physicians, Alexander found that the average respondent accurately identified the FDA-approval status of drugs for a given condition just over half the time.
Related news article
It includes information on how to read the labels and also provides guidance in other nutrition areas as calories, daily values of nutrients, and importance of select nutrients as fat, fiber, cholesterol, and calcium.
The FDA Website has a Web page devoted to food safety, regulations, and other FDA related topics. It includes links to recall information, information on dietary supplements, food ingredients, and more.
Related Web Sites of Note
One may Ask-An-Expert, and receive a reply within a few days. There is a link to previously answered questions.
Food and Nutrition (FamilyDoctor.org) has links to general nutrition Web pages, nutrition for weight loss, kids & nutrition, and special diets (as the Mediterranean diet)
Herbs at a glance: a quick guide to herbal supplements is a 100 page indexed PDF document which gives the basics on the most common herbs in dietary supplements – historical uses, what they are used for now, scientific evidence on effectiveness, and potential side effects.
It is published by the US National Center for Complementary and Alternative Medicine (NCAAM).
The NCAAM Web site includes links to information under titles as
- Health Topics A-Z with Evidence-based information on treatments and conditions
- Information for Consumers with numerous fact sheets to help you decide if complementary/alternative medicine is right for you. (Don’t forget to consult with your health care providers! These fact sheets can be great discussion starters)
- A good introductory page on What is Complementary and Alternative Medicine?
- News and Events
- Ways to get updates bv email, newsfeed (RSS), Twitter, Facebook, and Youtube
A few related Web sites
- Complementary and Alternative Medicine (MedlinePlus)has links to overviews, specific conditions, tutorials, videos, research, and more
- Herbal Medicine (MedlinePlus) has links to overviews, specific conditions, research, and more
- Complementary Medicine (NetWellness) has links to general information,treatment, and Ask-An-Expert answered questions. One can ask a question at this site, and receive a reply within a few days.
- Alternative Medicine (NIH) contains links to information at US government sites
- Drug Information Portal (NIH) provides a wealth of information for consumers and professionals.
- US Office of Dietary Supplements contains fact sheets, news items, decision making guidance, consumer protection information, nutrient recommendations, and more
and a related news item…
From the December 16, 2010 Health Day news item U.S. Spending Millions to See if Herbs Truly Work
THURSDAY, Dec. 16 (HealthDay News) — People have been using herbal supplements for centuries to cure all manner of ills and improve their health. But for all the folk wisdom promoting the use of such plants as St. John’s wort and black cohosh, much about their effect on human health remains unknown.
But the federal government is spending millions of dollars to support research dedicated to separating the wheat from the chaff when it comes to herbal supplements.
“A lot of these products are widely used by the consumer, and we don’t have evidence one way or the other whether they are safe and effective,” said Marguerite Klein, director of the Botanical Research Centers Program at the U.S. National Institutes of Health. “We have a long way to go. It’s a big job.”
In August, the U.S. National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements awarded about $37 million in grants to five interdisciplinary and collaborative dietary supplement centers across the nation. The grants were part of a decade-long initiative that so far has awarded more than $250 million toward research to look into the safety and efficacy of health products made from the stems, seeds, leaves, bark and flowers of plants.
Reliance on botanical supplements faded in the mid-20th century as doctors began to rely more and more on scientifically tested pharmaceutical drugs to treat their patients, said William Obermeyer, vice president of research for ConsumerLab.com, which tests supplement brands for quality.
But today, herbal remedies and supplements are coming back in a big way. People in the United States spent more than $5 billion on herbal and botanical dietary supplements in 2009, up 22 percent from a decade before, according to the American Botanical Council, a nonprofit research and education organization.
The increase has prompted some concern from doctors and health researchers. There are worries regarding the purity and consistency of supplements, which are not regulated as strictly as pharmaceutical drugs.
“One out of four of the dietary supplements we’ve quality-tested over the last 11 years failed,” Obermeyer said. The failure rate increases to 55 percent, he said, when considering botanical products alone.
Some products contain less than the promoted amount of the supplement in question — such as a 400-milligram capsule of echinacea containing just 250 milligrams of the herb. Other products are tainted by pesticides or heavy metals.
The U.S. Food and Drug Administration warned supplement makers on Dec. 15 that any company marketing tainted products could face criminal prosecution. The agency was specifically targeting products to promote weight loss, enhance sexual prowess or aid in body building, which it said were “masquerading as dietary supplements” and in some cases were laced with the same active ingredients as approved drugs or were close copies of those drugs or contained synthetic synthetic steroids that don’t qualify as dietary ingredients.
But even when someone takes a valid herbal supplement, it may not be as effective when taken as a pill or capsule rather than used in the manner of a folk remedy. For example, an herb normally ground into paste as part of a ceremony might lose its effectiveness if prepared using modern manufacturing methods, Obermeyer said.
“You move away from the traditional use out of convenience, and you may not have the same effect,” he said.
Researchers also are concerned that there just isn’t a lot of evidence to support the health benefits said to be gained from herbal supplements. People may be misusing them, which can lead to poor health and potential interactions with prescription drugs.
“Consumers often are taking them without telling their doctor, or taking them in lieu of going to the doctor,” Klein said……
Each year, the Food and Drug Administration (FDA) approves many generic drugs that treat a wide variety of conditions and help consumers save money.
Significant FDA approvals of generic medications are listed below.
Be aware that the notes included with the description of each drug listed below do not include all warnings, side effects, or use instructions associated with these products. You should read the medication guide, when available, and speak with a health care professional regarding any medication you are taking, have been prescribed, or are considering taking
- Anastrozole Tablets
- Venlafaxine Hydrochloride extended-release capsules
- Aztreonam (for Injection)
- Enoxaparin Sodium Injection
- Losartan Potassium Tablets
- Generic Drugs: Vital Facts
- Generic drugs are identical to their brand-name equivalents in dosage, safety, strength, quality, performance characteristics, intended use, and the way they’re administered to patients.
- On average, the cost of a generic drug is 80 to 85 percent lower than the brand-name product.
- New drugs are patented to protect the investments of the manufacturers that develop them. As patents or other periods of exclusivity on new drugs expire, manufacturers—including firms that did not develop the drugs—can seek FDA approval to sell generic versions.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-
For More Information
- News and Events (updates, press releases, meetings,etc)
- Guidance, Compliance & Regulatory Information with links on legal, regulatory, and policy issues related to tobacco products.
- Protecting Kids from Tobacco with information on related regulations
- Resources for you with links to information on how to quit, tobacco prevention in youth, and information for health care providers
The Tools and Alerts section on the home page includes options for email alerts and Twitter. Contact information by phone and fax is also provided.
For Immediate Release: Nov. 17, 2010
Media Inquiries: Michael Herndon, 301-796-4673, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA Warning Letters issued to four makers of caffeinated alcoholic beverages
These beverages present a public health concern
The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law.
The companies receiving Warning Letters and their products are:
• Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
• New Century Brewing Co., LLC: Moonshot
• Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
• United Brands Company Inc.: Joose and Max
FDA’s action follows a scientific review by the Agency. FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers. FDA also performed its own independent laboratory analysis of these products.
“FDA does not find support for the claim that the addition of caffeine to these alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner. “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”
Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication. The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.
The agency said the products named in the Warning Letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA). Each Warning Letter requests that the recipient inform the FDA in writing within 15 days of the specific steps that will be taken to remedy the violation and prevent its recurrence. If a company does not believe its products are in violation of the FFDCA, it may present its reasoning and any supporting information as well.
If the FDA believes that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.
FDA’s action today follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.
FDA is aware that on November 16, Phusion Projects, LLC, the maker of Four Loko, announced its intention to remove caffeine and other stimulants from its drinks. FDA views this announcement as a positive step. FDA has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product. FDA intends to work with Phusion Projects, LLC and the other manufacturers to assure their products meet safety standards.
For More Information:
- Caffeinated Alcoholic Beverages — FDA Web Page
- Caffeinated Alcoholic Beverages — Consumer Update
- Caffeinated Alcoholic Beverages – Warning Letters:
- Qs & As on Caffeine in Alcoholic Beverages
- Caffeinated Alcoholic Beverages — FDA Page on Flickr
- Caffeinated Alcoholic Beverages — CDC Fact Sheet
- FTC Sends Warning Letters to Marketers of Caffeinated Alcohol Drinks
For Immediate Release: November 4, 2010Media Inquiries: Dick Thompson, 301-796-7566, firstname.lastname@example.orgConsumer Inquiries: 888-INFO-FDAFDA reclassifies certain digital mammography devicesDevices capturing digital image of breasts to be Class II
The U.S. Food and Drug Administration today announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast.These systems, known as Full Field Digital Mammography Systems, are an alternative to mammography systems that produce X-ray film.When first approved by FDA in 2000, digital mammography systems were categorized as a high risk or Class III device, because they were then considered novel systems for screening and diagnosing breast cancer.Since then, digital mammography has been well-validated in scientific studies involving tens of thousands of patients. The benefits and risks of digital versus film mammography have also been well -described to physicians. As a result, the FDA has decided to reclassify digital mammography from Class III devices to Class II or medium risk devices…….…For more information:#
Excerpts from a US Food and Drug Adminstration (FDA) Oct 6 press announcement
The U.S. Food and Drug Administration today unveiled a report outlining the agency’s plans to advance regulatory science through its Regulatory Science Initiative.
Regulatory science is the science of developing new tools, standards and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products.
The report provides examples of current FDA activities in regulatory science and also considers how advancements in the field can help deliver better, safer, more innovative products to Americans in seven different public health areas.
Copies of the report will be released at the National Press Club in Washington, D.C., when FDA Commissioner Margaret A. Hamburg M.D. speaks to a club luncheon.
Her address will begin at 1 p.m. and will be broadcast live by C-SPAN.
For more information:
At home genetic testing kits have been available online for some time. However geneticists have long warned about the dangers of consumers self testing without clinical guidance in self testing and self diagnosing.
The Food and Drug Administration has sent warning letters to at least 20 companies planning on selling these kits as over the counter items. The letters state direct-to-c0nsumer genetic testing may require FDA approval. At least one company has since postponed selling the kits in their stores.
When population screening for medical conditions is independent of any defined individual risk, the screening program should adhere to established principles in order to avoid undue harm and expense: there must be a suitable and acceptable test addressing an important health problem that has a recognizable latent or early symptomatic state, a well-understood natural history, and an accepted and available treatment or intervention.4,5 Most genetic screening currently cannot meet such expectations. More important, DTC genetic screening may place a substantial burden on the health care system without providing demonstrable benefit.
The potential harms of DTC genetic testing include the loss of protections for patients offered by established health care delivery systems (e.g., doctor–patient confidentiality and beneficence), invalid analytic or clinical results from medical devices, and population screening without consensus on interpretation and follow-up. These risks must be balanced against the potential benefits of innovation. The government’s role in this arena should include both regulation and the funding of collaborative research that enables the optimal use of genetic information.