Archive for the ‘FDA’ Category

US Food & Drug offers 4 Medication Safety Tips for Older Adults

Explore these topics for your health and that of your family and friends

  1. Take Medicine as Prescribed—with Input from Your Health Care Provider
  2. Keep a Medication List
  3. Be Aware of Potential Drug Interactions and Side Effects
  4. Review Medications with Your Health Care Provider

Whether you’re settling into your sixties or heading into your ninth decade, be careful when taking prescription and over-the-counter medicines, herbal preparations, and supplements. And if you’re caring for older loved ones, help them stay safe, too.

Why the special concern? The older you get, the more likely you are to use additional medicines, which can increase the chance of harmful drug effects, including interactions. And, as you age, physical changes can affect the way medicines are handled by your body, leading to potential complications. For instance, your liver and kidneys may not work as well, which affects how a drug breaks down and leaves your body.

“There is no question that physiology changes as we age. Many chronic medical conditions don’t even appear until our later years,” explains RADM (Ret.) Sandra L. Kweder, M.D., F.A.C.P., a medical officer at the U.S. Food and Drug Administration. “It’s not that people are falling to pieces; some changes are just part of the normal aging process.”

Deck the halls with vows of safety

CONSUMER FORUM

Posted Dec. 19, 2016, at 1:22 p.m.

The greatest gift that you could give this season might be yourself, safe and sound, arriving for a visit with a loved one or a friend.

Safety messages are everywhere this time of year. However, we all seem to be so busy that we may dismiss the cautions. Here are a few suggestions for consumers who want to keep themselves and those close to them safe:

—  Replace batteries and smoke/carbon monoxide detectors. Many of us replace batteries when we set clocks ahead in the spring and back in the fall. If you forgot, do it now. Smoke and CO detectors need good batteries to save lives. They also don’t last forever. If the date of manufacture on your smoke detector is more than 10 years old, it’s time to replace the unit. CO detectors are generally effective from five to seven years.

— Decorate safely. Spun glass known as “angel hair” can irritate eyes and skin. Wear gloves when you’re using it or use non-flammable cotton instead. Decorate with children in mind. Ornaments with metal hooks should go high on the tree. Use a good step ladder for hanging decorations.

— Clear your path. Keep wrapping paper, decorations and toys out of areas where you walk. The National Safety Council has tips about avoiding falls at nsc.org/learn/safety-knowledge/Pages/safety-at-home-falls.aspx.

— Keep pets safe. Holiday plants such as mistletoe and holly may attract household pets, and eating some plants can cause harm. Don’t feed table scraps to the dog or cat. Carmela Stamper, a veterinarian with the Food and Drug Administration, says rich, fatty foods can cause a potentially lethal condition called pancreatitis. And be careful of alcoholic beverages and chocolate around pets.

— Be aware of toy recalls. Check SaferProducts.gov for recall notices to avoid things such as lead paint, laceration risks or other hazards.

Officials in the insurance industry offer a number of tips, beginning with indoor tree safety. Avoiding open flame (candles) and frequent watering head the list.

Careful inspection of lights is another must. Allstate advises that holiday lights may contain PVC and may be tainted with lead. After you’ve decorated, wash up and keep children away from lights they might handle before sticking fingers in their mouths.

You can look for labels reading “RoHS” (Reduction of Hazardous Substances) meaning lead was not used in making the lights.

Outside your home, most safety precautions revolve around shopping. Make sure purchases are safe and out of sight when leaving them in your vehicle. Keep close watch on your wallet or purse, and be cautious of prying eyes when entering a PIN.

Back at home, be careful when cooking; the festive season can distract us and might increase the risk of a fire. Party responsibly. Celebrate safely, and make the season bright.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

Have regulators become deadly slow with tainted food alerts?

CONSUMER FORUM

By Russ Van Arsdale, executive director Northeast CONTACT
Posted June 20, 2016, at 7:44 a.m.

Consumers are “at risk of injury or death.” That’s the kind of headline you’d expect to see in tabloids and on the talking head interview shows.

However, the above quote came from investigators for the Inspector General at the U.S. Department of Health and Human Services. They were referring not just to the commercially produced foods that made people sick but also to the slow pace of recalling tainted foods.

Those recalls are supposed to be handled by the Food and Drug Administration, or FDA. But the investigators found that, even after foods had been determined to pose health hazards, in some cases the agency was slow to force recalls.

Auditors had looked at 30 voluntary recalls from October 2012 to May 2015. They issued what’s termed a “rare alert” about two mandated recalls, saying “consumers remained at risk of illness or death for several weeks after FDA knew of potentially hazardous food.”

The Food Safety Modernization Act of 2011, or FSMA, gave the FDA the power to force companies to recall tainted products; it has used that power only twice, both times in 2013.

Recalls of salmonella-tainted pet food and adulterated dietary supplements came months after FDA learned of the problems.

Investigators also were troubled by two voluntary recalls. The first case occurred in 2014, when salmonella turned up in nut butter. The investigators say 165 days passed from the time the problem surfaced to the date the manufacturer issued a recall. There were 14 illnesses reported in 11 states.

Later that year, a listeria outbreak was traced to cheese products. The alert said it took 81 days to complete a series of recalls; at least nine people became ill.

George Nedder, who led the audit, was blunt. “I think the time that these recalls took were problematic, absolutely.”

The Center for Science in the Public Interest, or CSPI, has taken FDA to task over all voluntary recalls. Senior food safety attorney David Plunkett called on FDA to use the authority in FSMA to issue recalls, instead of letting manufacturers issue recalls voluntarily. Plunkett said,

“Unfortunately, based on the agency’s actions to date, the FDA hasn’t done much to implement those recall provisions and doesn’t appear to take informing consumers much more seriously [than some manufacturers] did,” he said.

The FDA fired off a news release following the rare alert. It stated that while lengthy delays happen in a minority of cases, such delays are still “unacceptable.” The release said the FDA is taking “concrete steps” to speed the pace of recalls.

“These steps include the establishment of a rapid-response team made up of agency leaders and the introduction of new technologies to make the process even swifter,” it stated.

The release did not indicate how those new technologies will operate.

In an agency blog, the FDA’s Dr. Stephen Ostroff and Howard Sklamberg wrote that deadlines are needed, but they won’t all necessarily be short. “The time needed to collect evidence can vary, but to request a recall without evidence risks recalling the wrong product and leaving consumers vulnerable to contaminated food that is still on the market,” they wrote.

Leaving contaminated food on store shelves is what concerned the auditors in the first place. We’re anxious to see FDA’s future recall record. See our blog for links to FDA recall information.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

Editor’s note: Consumer Forum will not be published the week of June 26. It will return the week of July 3.

New food-labeling rules aim to make Americans less fat

CONSUMER FORUM

Posted Aug. 30, 2015, at 3:12 p.m.
The expert in statistics in his field at the U.S. Centers for Disease Control and Prevention said we need to think of diabetes as an iceberg.

Roughly 29 million Americans have diabetes, mainly Type 2, which is closely linked to weight issues. However, the CDC’s Edward Gregg said about 28 percent of adults with diabetes don’t know they have it, while another one-third of all adults are considered at high risk for diabetes.

The undetected cases represent the part of the iceberg that’s under water.

Experts say three factors account for the country’s increasing obesity problem: larger portion sizes, greater sugar intake and less exercise. The U.S. Food and Drug Administration is taking aim at the first of those factors.

Click image for additional FDA resources

The FDA is proposing new rules for companies listing the contents of their packaged foods. The Nutrition Facts Label first appeared 20 years ago. Last March, the FDA began the long process of changing it. The agency hopes consumers’ knowledge will grow in three broad areas:

Understanding the science: New labels will contain information about “added sugars,” update values of sodium dietary fiber and vitamin D and list amounts of potassium and vitamin D, now declared “nutrients of public health significance.” You’ll still see “total fat,” “saturated fat” and “trans fat” on labels, but “calories from fat” will disappear. The FDA’s reasoning: “type of fat is more important than the amount.”

Serving size and per package labels: The ways many of us eat and drink today have changed since serving sizes first were set two decades ago. New labeling rules require that packaged foods normally eaten in one sitting be labeled as a “single serving” and nutrient information be listed for the whole package. Some packages that may be consumed either in one sitting or multiple sittings will need “dual column” labels; those will indicate “per serving” and “per package” calorie and nutrient information.

The FDA has little bit of wiggle room on the serving size issue. “By law, the label information on serving sizes must be based on what people actually eat, not on what they ‘should’ be eating,” its website states.

Updated design: Calorie counts and serving sizes will be more prominent, and the percent daily value of ingredients will move to the left, so it’s read first. The percent daily value, or %DV, tells consumers how much of certain ingredients they get from that food in the context of a daily diet.

Food manufacturers have not been idle. The Grocery Manufacturers Association and Food Marketing Institute have been actively promoting voluntary front-of-label nutrient listings. The industry’s Facts Up Front website, factsupfront.org, suggested at the time the program was announced that “manufacturers may also include information on one or two nutrients to encourage,” a less robust revealing of information than the FDA label rules would require.

Not everyone loves the timing of FDA’s proposed changes. Back in 2010, the Center for Science in the Public Interest called on the agency to require more prominent counting of calories and revealing the nutrient content of realistic serving sizes. In a letter to FDA last year, the center urged action to prevent “the possible unintended consequence that some consumers view serving sizes as portion recommendations.”

If FDA’s goal is to get Americans to eat less, four studies cited in the journal Appetite suggest the opposite. In one study, 78 percent of participants thought “serving size” meant the amount of food that can or should be consumed at a sitting. Taken together, the writers say the studies “suggest that the proposed nutrition facts label’s increased serving sizes may lead people who use this information as a reference to serve more food to themselves and others.”

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

 

Legal questions swirl about off-label use of medications

CONSUMER FORUM

Posted Aug. 23, 2015, at 1:38 p.m.

Maine is among the states that will share in a $71 million settlement of the lawsuit against drug manufacturer Amgen.

Click image to see other Off-Label decisions on the DOJ site

The states bringing the suit alleged Amgen promoted biologic medications Aranesp and Enbrel for off-label uses. Their complaint said the company promoted the use of Aranesp for longer periods than the U.S. Food and Drug Administration approved.

The complaint also charged that Amgen claimed Aranesp could fight anemia caused by cancer without having either FDA approval or scientific research to support that claim.

The complaint said the company also promoted Enbrel as effective in treating mild plaque psoriasis; the FDA has approved use of the drug only to treat chronic-moderate to severe plaque psoriasis. The complaint also charged that Amgen overstated the length of time Embrel was effective in treating psoriasis.

The settlement was announced last week by several state attorneys general. In a statement, Amgen said the settlement resolves some of the same matters as in a 2012 settlement with the federal government. Under the settlement with the states, Amgen did not admit any wrongdoing or liability.

Maine also was a party to the December 2012 settlement. A U.S. Department of Justice news release at that time said the company paid $612 million to resolve lawsuits under the False Claims Act and $150 million in criminal penalties and forfeiture.

In its statement sent to Northeast CONTACT, Amgen said, “separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters.”

The company added it has a “strong compliance program, and our management is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law.”

The company also says all Aranesp-related conduct that riled regulators took place during the years 2002 and 2007; it says all Enbrel-related conduct happened between 2004 and 2011.

Over the years, pharmaceutical companies have handed over billions of dollars to settle claims of misbehavior. Federal regulators don’t want drug company reps talking to doctors about off-label uses of drugs; manufacturers have maintained they should be able to have such conversations, as long as they are truthful.

In May, Amarin Pharma filed suit against the FDA, saying it had a constitutional right to share information with doctors. Lawyers for the company say they believe it is the first time the FDA has been sued pre-emptively over the free speech issue.

Floyd Abrams, attorney for Amarin, put it this way in an interview with Business Day: “If you tell the truth — if you’re not misleading — then the First Amendment protects you when you provide this sort of information.”

Dr. Michael Carome of the advocacy group Public Citizen holds the opposite view.

“If this lawsuit were to succeed, it would be devastating for drug safety and undermine the drug approval process,” Carome said.

If it goes that far, a court might rule either broadly or narrowly, making an outcome tough to predict. Consumers can best protect themselves by carefully reading the data sheets that come with their prescription meds. If what your doctor tells you doesn’t match the intended uses in the instructions, start asking questions.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

Phony medication call centers target military families

CONSUMER FORUM

By Russ Van Arsdale, executive director Northeast CONTACT
Posted May 10, 2015, at 4:35 p.m.

Click image to read TRICARE’s April 10th article

The Defense Health Agency has been warning military families and veterans covered by TRICARE about scams involving “call centers.” Callers ask clients to reveal personal and medical information over the phone, with promises to help them get medications.

TRICARE is a civilian health care program run by the U.S. Department of Defense Military Health System. It offers benefits for active duty service people, retirees and their families. The program was formerly known as the Civilian Health and Medical Program of the Uniformed Services, or CHAMPUS.

A call from a “call center” generally begins with the caller claiming to be from a sound-alike agency, “calling to tell you about a prescription pain cream you qualify for that TRICARE will cover.” The caller chats up the client — sometimes using personal information gleaned from Google or other sources — and asks for the name of the client’s doctor and other TRICARE information.

“TRICARE will never call beneficiaries and ask for personal information,” Defense Health Agency spokesman Kevin Dwyer said.

But others will, including a host of less-than-reputable companies that deal in compounded prescriptions.

A recent article on the Military Times website notes a huge increase in compounded medications, from $5 million in 2004 to over $700 million in the first three months of this year.

The boom in sales has attracted aggressive marketers, who cold call TRICARE clients, ask if they have certain medical needs and if so, whether they are interested in compound medications. The meds can cost a few hundred dollars to more than $9,000 for a prescription.

The Military Times article cites an ad on Craigslist searching for both customers and sales representatives. The ad claimed meds are “handcrafted for every individual” and formulated to help deal with everything from post-traumatic stress disorder to chronic pain and scars.

Supporters of the compounding industry say the majority of its members are small companies that try to help patients and want a fair price in return. But the entry of hustlers during a time of changing regulation has put the industry under a microscope.

Starting May 1, Express Scripts, which administers the TRICARE pharmacy program, is under orders to screen every ingredient in compounded meds to make sure substances meet Food and Drug Administration regulations. TRICARE will cover those with allowable ingredients; others will have to be reformulated or will need prior approval to be covered.

[questions and answers about TRICARE’s new compound drug policy]

It’s unclear how many recent prescriptions may not be reimbursable.

In any case, those cold calls are likely to keep coming.

TRICARE officials say beneficiaries should never reveal personal or financial information over the phone. If they receive such a call, they’re urged to call Express Scripts at 866-759-6139 or 866-216-7096 or email fraudtip@express-scripts.com.

Betty Balderston, statewide coordinator for Maine Senior Medicare Patrol, alerted Northeast CONTACT to the cold calling. She urges all seniors who receive similar calls to avoid revealing personal and financial information.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visithttps://necontact.wordpress.com or email contacexdir@live.com.

 

A quick means to looking older — not in a good way

CONSUMER FORUM

By Russ Van Arsdale, executive director Northeast CONTACT
Posted April 26, 2015, at 11:22 a.m.

After several days of cloudy weather, most of us may not be worrying about getting too much sun. With prom and beach seasons approaching, many people are looking for ways to get a suntan going.

However, many medical professionals are concerned about overexposure to sunshine, specifically to ultraviolet rays, or UVR. Some who treat skin disorders are especially concerned about the use of tanning beds by young people.

WebMD reports UVR exposure damages fibers in our skin called elastin. That breakdown causes the skin to sag and stretch and to lose its ability to go back into shape after stretching.

The bottom line: UVR exposure can make us look older, sooner.

In February, researchers at Yale University released results of a study on UVR exposure. They found evidence of a chemical chain reaction that can damage DNA more than three hours after exposure. They said it’s not clear how many skin cancers may result from this previously unknown reaction.

Click image to view “Are teens heeding the warnings on tanning beds?”

Tanning beds have been the focus of attention of many health experts, because their UVR is more concentrated than the sun’s. The U.S. Food and Drug Administration requires sunlamps and tanning beds to carry a warning that people younger than 18 should not use these products.

An FDA website on tanning, found at fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/Tanning/default.htm, declares repeated UV exposure from sunlamp products “poses a risk of skin cancer for all users.”

Jeffrey Shuren, the doctor in charge of FDA’s Center for Devices and Radiological Health, says, “the highest risk for skin cancer is in young persons under the age of 18 and people with a family history of skin cancer.”

Last July, the U.S. Surgeon General issued a “Call to Action to Prevent Skin Cancer.” The document notes that, while genetic factors — being fair-skinned, having a family history of skin cancer — may heighten a person’s risk, the most common types of skin cancer are strongly associated with UV radiation and that exposure to UV is the most preventable cause of skin cancer.

At least 42 states regulate the use of tanning beds. Eleven states ban their use by children younger than 18.

In Maine, anyone under age 14 may not use commercial tanning beds; 14- and 15-year-olds must have a parent’s permission.

A bill to raise the age to 18 passed two years ago but was vetoed by Gov. Paul LePage. A similar bill was introduced this year but did not pass.

Critics of regulation say links between UVR exposure and development of tumors are based on “circumstantial data and inference, rather than clinical trials and sound scientific data.”

Some also charge public cautions are aimed at younger women, while statistics show men are twice as likely as women to die of melanoma.

Tanning isn’t just about perceived good looks. It’s a $5 billion industry that thrives based on what many consumers are told constitutes a “healthy look.”

The FDA disagrees, stating on its website, “UV radiation, whether from natural or artificial sources, damages the skin.” Visit the FDA website, FDA.gov, and search “tanning risks” to learn more about tanning beds in particular and the health risks of UVR exposure in general.

Consumer Forum is a collaboration of the Bangor Daily News and Northeast CONTACT, Maine’s all-volunteer, nonprofit consumer organization. For assistance with consumer-related issues, including consumer fraud and identity theft, or for information, write Consumer Forum, P.O. Box 486, Brewer, ME 04412, visit https://necontact.wordpress.com or email contacexdir@live.com.

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