Princess Health and Changes coming for Nutrition Facts labels on food products: emphasis on calories, added sugar and serving size. Princessiccia

Princess Health and Changes coming for Nutrition Facts labels on food products: emphasis on calories, added sugar and serving size. Princessiccia

calories childhood obesity diet federal regulation food food and drug administration food industry food marketing nutrition obesity

Gusty 14:14 Add Comment

Associated Press

By Danielle Ray
Kentucky Health News

Nutrition labels on food products will undergo a facelift over the next two years.

The U.S. Food and Drug Administration finalized plans Friday to change labeling to emphasize calorie count and added sugars in an effort to simply nutrition labels and clarify serving sizes.

First lady Michelle Obama, a longtime crusader against childhood obesity, said parents will benefit from the upcoming changes.

"You will no longer need a microscope, a calculator, or a degree in nutrition to figure out whether the food you're buying is actually good for our kids," she told The Associated Press.

The overhaul puts less emphasis on fats and more on caloric value and added sugars. Calories on upcoming labels will be listed in larger font than other nutrient facts. Added sugar will get its own line, separate from naturally occurring sugar.  Currently, both added and naturally occurring sugars were lumped under one category, "Sugars."

New labels will also include a new "percent daily value" for added sugar, which will tell consumers how much of their recommended daily intake they will get from a given item. The FDA recommends consuming less than 10 percent of total daily calories (200 calories in a typical diet) from added sugar.

"The new labels should also spur food manufacturers to add less sugar to their products," Michael Jacobson, president of the advocacy group Center for Science in the Public Interest, told AP. He said that under current labeling, it's nearly impossible for consumers to know how much sugar fits into a reasonable diet.

The footnote will better explain what "percent daily value" means. It will read: �The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.�

Serving sizes will also be clearer. The biggest difference will be that serving sizes will be based on what consumers typically eat instead of what they should eat. About one-fifth of foods will undergo revised calculations. For example, a serving size of ice cream will be 2/3 of a cup; previously it was a 1/2 cup.

If you've ever been duped into consuming more calories than you intended, or tried to calculate exactly what fraction of a slice of pizza constitutes a serving size, you're in luck. Package size affects what people eat, the FDA noted. So, products that were previously between one and two servings, such as a 20-ounce soda, will be labeled as a single serving, since consumers generally eat or drink the entire contents in one sitting.

Larger containers, like pints of ice cream, will have dual column labels: one column with information for a single serving and the other with information for the entire container.

Labels will also include two additional nutrients: potassium and Vitamin D.

Industry reaction was predictable. A representative for the Sugar Association told AP that emphasis on added sugar could confuse consumers, but other industry leaders welcomed the changes.

"This update is timely as diets, eating patterns and consumer preferences have changed dramatically since the Nutrition Facts panel was first introduced," Leon Bruner, of the Grocery Manufacturers Association, told AP.

Most food manufacturers have until July 2018 to comply. Smaller manufacturers will have an additional year.

The FDA proposed the changes two years ago. They are the first major update to nutrition labels since labeling was introduced in 1994. So far, more than 800,000 foods have nutrition labels.

For more information on the changes, click here.

Princess Health and FDA to regulate e-cigs: ban sales to minors, require warning signs, require federal approval; did not address advertising issues. Princessiccia

Princess Health and FDA to regulate e-cigs: ban sales to minors, require warning signs, require federal approval; did not address advertising issues. Princessiccia

e-cigarettes federal regulation food and drug administration smoking ban teens tobacco tobacco prevention youth

Gusty 08:34 Add Comment

In a long-anticipated move, the U.S. Food and Drug Administration announced May 5 that it is assuming regulatory authority over all tobacco products, including electronic cigarettes, cigars, hookah, tobacco and pipe tobacco that include banning sales to anyone under 18.

�Today�s announcement is an important step in the fight for a tobacco-free generation � it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions," Health and Human Services Secretary Sylvia Burwell said in a news release.

FDA's new tobacco regulations will prohibit sales of e-cigarettes and all tobacco products to anyone under 18, both in person and online, and buyers must now show photo ID.

Health warnings will also be placed on packages and in advertisements, saying, �WARNING: This product contains nicotine. Nicotine is an addictive chemical.� It also bans free samples and the sale of covered products in vending machines not located in adult-only facilities.

The regulation also requires manufacturers of all newly-regulated products introduced to the market after Feb. 15, 2007, a date that is set by the Tobacco Control Act of 2009, to require federal approval. An amendment to the legislation has been submitted to change the date so more e-cigarettes would be grandfathered in, Jayne O'Donnell and Laura Ungar report for USA Today.

The e-cigarette industry is pushing back on these regulations.

"Industry experts say treating e-cigarettes, which don't contain tobacco, the same as cigarettes could lead to such onerous and costly approval that all but the largest tobacco companies would be forced out of the market � and possibly those companies, too," USA Today writes. Jeff Stier, an e-cigarette advocate with the National Center for Public Policy Research and industry officials, told USA Today that it could cost $1 million or more per application.

Vapers also argue that e-cigs help people quit, but studies on that conflict.

Ellen Hahn, a professor at the University of Kentucky College of Nursing and co-chair of the UK Tobacco-free Task Force, told USA Today that the new rule is a good first step toward controlling e-cigarettes, noting "vaping" can get youth addicted to nicotine and threatens to prolong "the tobacco epidemic."

"From a health perspective, to reduce the social acceptance of them is good because frankly, it's the wild, wild West out there," she told the newspaper. "Vape stores are everywhere."

The Robert Wood Johnson Foundation commended the FDA for these regulations, noting the use among high school students has "rocketed from 1.5 percent in 2011 to 16 percent in 2015, an increase of more than 900 percent." But it also said the regulation did not go far enough.

"Studies have proven that tobacco advertising directly influences youth, and that such sweet e-cigarette flavors as gummy bear and cotton candy play a role in children trying these products," Dr. Risa Lavizzo-Mourey, CEO of the RWJF, said in the statement "Today's final rule did not address these issues, and we strongly urge the FDA to take aggressive regulatory and enforcement actions to prevent and reduce youth tobacco use, in any form it takes."

The regulation goes into effect Aug. 8, and gives affected industries two years to comply. The original proposal was introduced in 2014.

Princess Health and Levels of suspected 'hormone disruptors' in teen girls dropped after they switched to products that didn't contain them . Princessiccia

Princess Health and Levels of suspected 'hormone disruptors' in teen girls dropped after they switched to products that didn't contain them . Princessiccia

endocrine system federal regulation food and drug administration teenagers teens

Gusty 06:56 Add Comment

A recent study found that after three days of not using personal-care products that contain "problematic substances," the levels of chemicals that potentially disrupt hormones in the bodies of teenage girls dropped, Environmental Working Group Vice Preisdent Alex Formuzis writes for its Enviroblog.

The study, led by Kim Harley of the Center for Environmental Research and Children�s Health at the University of California-Berkeley, asked 100 Latina girls between 14 and 18 years old to not use personal-care products such as cosmetics, shampoos and soaps, for three days and instead to only use products free of the suspected hormone disruptors: phthalates, parabens and triclosan. The girls, all volunteers, were given products that did not contain these chemicals.

After three days, the teens' urine tests showed a 44 percent decrease in the levels of methyl and propyl parapen, preservatives widely used in cosmetics, shampoos and skin lotions; a 35 percent decrease in triclosan, a commonly used antibacterial chemical that has been linked to the disruption of thyroid and reproductive hormones; and a 27 percent decrease in mono-ethyl phthalates, a common industrial plasticizer found in some nail polishes and fragrances.

�Techniques available to consumers, such as choosing personal care products that are labeled to be free of phthalates, parabens, triclosan, and oxybenzone, can reduce personal exposure to endocrine-disrupting chemicals,� the study authors wrote. �Our study did not test for the presence of these chemicals, but simply used techniques available to the average consumer: reading labels and investigating product safety through web-based databases.�

The study, published in Environmental Health Perspectives, notes that the study shows that "consumers may be able to reduce exposures to these chemicals by seeking out commercially available products with lower levels of these chemicals."

However, Formuzis pointed out that the federal Food and Drug Administration has "virtually no authority" over this industry and notes that this study helps to, "underscores the need to regulate the personal care products industry."

Legislation by U.S. Sens. Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine), proposes to do just that.

"The Feinstein-Collins Personal Care Products Safety Act would give the FDA tools for ensuring the safety of personal care products as strong as those that regulate food and drugs," Formuzis writes. The bill would require the FDA to investigate the safety of five cosmetics ingredients and contaminants yearly; cosmetic makers would have to register their manufacturing facilities,disclose their ingredients, report health incidents related to their products, and label their products with disclosures and warnings as needed; and it would allow the FDA the authority to recall dangerous products.

Formuzis reports that "some of the corporations backing the Feinstein-Collins bill include Revlon, Johnson & Johnson, Proctor & Gamble, Unilever, L�Oreal, California Baby and the industry trade organization, the Personal Care Products Council."

Princess Health and Full House has Senate bill to regulate how druggists dispense 'biosimilar' medication that hasn't even been approved by FDA . Princessiccia

Princess Health and Full House has Senate bill to regulate how druggists dispense 'biosimilar' medication that hasn't even been approved by FDA . Princessiccia

food and drug administration generic drugs legislation lobbying lobbyists pharmacists

Gusty 11:39 Add Comment

Update: SB 134 passed the state House 96-0 March 23 with a floor amendment that allows communication by fax, telephone, electronic transmissions or other prevailing means by the pharmacist to the provider to suffice as notice. The bill now awaits concurrence.  

Brand-name drugs called "biologics," because they are made from living tissues, have no competition from "interchangeable biosimilar" products in the U.S. because no interchangeable products have been approved by the U.S. Food and Drug Administration. But that hasn't stopped the drug industry and Kentucky lawmakers from moving a bill to regulate how pharmacists could dispense these drugs if and when they are approved.

"This bill allows Kentucky pharmacists the ability to dispense safe and less expensive biological medications by allowing substitution of interchangeable biosimilars," Sen. Ralph Alvarado, R-Winchester, told the House Health and Welfare committee, which approved it March 17.

Current law does not allow these substitutions without advanced approval from the prescriber, Alvarado said. "This bill removes that hurdle."

The most contentious part of Senate Bill 134 has been its requirement that pharmacists must notify prescribers when they make this substitution, which advocates say is necessary because there are slight variations between the drugs.

Alvarado, also a physician, said the notification comes down to a "safety mandate," noting that if the patient had a "bad outcome" while on one of these medications, it is important for the provider to know exactly what medication the patient is taking.

Democratic Rep. David Watkins, a retired physician from Henderson, voted for the bill and supported the provider notification requirement.

"We're not talking about generics where you have exactly ideal medications, you are talking about biosimilars . . . which would be in some instances different molecules and have some different aspects," Watkins said. " I think that not notifying my office would be a gross disservice to my patients."

But the pharmacists disagree, and want substitution of interchangeable biosimilars to be handled the same way as generic medications, with the prescriber able to place a note on the prescription that says "do not substitute," said Bob Oakley, chairman of the Kentucky Pharmacists Association.

Oakley told the committee that while pharmacists support automatic substitution of an interchangable biosimilar for the name-brand biologic, they do not support notification. "Therefore, we are here to ask that we just keep it simple and keep it seamless," he said.

Rep. Addia Wuchner, R-Florence, said the bill had accommodations to make notification manageable for pharmacists, and asked Oakley what their real problem was. He replied, "It just adds more work to . . . their busy day."

But the pharmacists' lobby has cited other reasons. KPhA Executive Director Bob McFalls told James McNair of the Kentucky Center for Investigative Reporting, "Prescriber notification requirements have shown to increase costs for the health-care system overall" since they cause more brand-name drugs to be dispensed.

SB 134 passed the Senate 36-1 March 2, with Republican Sen. Jimmy Higdon, the majority whip from Lebanon, the only one voting against it. Higdon had submitted several floor amendments to modify the notification requirements, but withdrew them before the final vote.

Higdon told McNair that he didn't understand the urgency to pass this bill, noting that its passage would have no immediate effect.

�It�s the kind of bill that should be discussed,� Higdon said. �This whole thing is very complicated and futuristic, and a lot of people are talking to us about passing this. I just want to err on the side of caution. It doesn�t need to be fast-tracked. We need to do it right.�

Higdon was referring to the many lobbyists hired by pharmaceutical manufacturers that have descended on Kentucky in support of this bill.

"At least nine drug companies and groups have stated an interest in the Senate bill, according to the Kentucky Legislative Ethics Commission, McNair reports. "The number of registered lobbyists hired by pharmaceuticals employers has nearly doubled, from 46 in 2011 to 83 today. Their annual spending has more than doubled, to $824,196 in 2015."

The bill now resides in the House. Speaker Pro Tem Jody Richards, D-Bowling Green, has filed a floor amendment to remove the notification requirements.

About biologics and biosimilars

While conventional medications are made from pure chemical substances and can be easily replicated, biologics are made from living tissues and each batch varies slightly from the last, according to the FDA. That's why these products can't be called generics, which are chemcially identical.

The most common biologics are Humira and Remicade for arthritis and Enbrel for psoriasis. They are very expensive and can cost thousands of dollars each month.

"Express Scripts, the pharmacy benefits manager, estimates that while biologics accounted for only 1 percent of all prescriptions in 2014, they accounted for 32 percent of all prescription-drug spending," McNair reports.

Biosimilars are medications that are "highly similar" to already FDA-approved biological products. To date, only one of these, Zarxio, used for certain cancer patients, has been approved by the FDA, but it was not designated as interchangeable. According to the Regulatory Affairs Professional Society, six biosimilars have applied for FDA approval.

Interchangeable biosimilars are expected to produce the same clinical results in any given patient as it's "highly similar" biologic. To date, no interchangeable biosimilar medications have been approved by the FDA. When appoved, Alvarado suggested that they will cost up to 40 percent less than the biologics.

Kentucky is home to the North American distribution hubs for Amgen, Genentech and Johnson and Johnson and is the primary distribution point for many of the biologics (and soon to be biosimilars) in the U.S., according to an e-mail from RunSwitch PR.

Princess Health and Biotech firm buys UK professor's anti-overdose nasal spray.Princessiccia

Princess Health and Biotech firm buys UK professor's anti-overdose nasal spray.Princessiccia

drugs food and drug administration heroin University of Kentucky

Gusty 12:27 Add Comment

Pharmacy Professor Daniel Wermeling at the University of Kentucky invented a nasal spray to fight heroin overdoses, and a biotech firm has bought the product, which may be on the market within six months, pending approval by the U.S. Food and Drug Administration. The device "contains a single dose of a mist form of naloxone and delivers the drug in a way similar to how Flonase is used to treat allergies," Mary Meehan reports for the Lexington Herald-Leader.

The product is on a fast track for approval because of the rising rates of heroin overdoses across the country, said UK Provost Tim Tracy, former dean of UK's pharmacy school. Wermeling doesn't know exactly when his product will be on the market, but he said the FDA approved another fast-track, anti-overdose therapy after only 14 weeks. The fast-track program speeds development of drugs to treat serious or life-threatening conditions. "Last year, 233 people [in Kentucky] died with heroin in their systems, according to the state medical examiner's office," Meehan notes.

Wermeling has been developing the project at UK since 2009 with the help of more than $5 million in federal and state tax dollars. Tracy said Indivior PLC, the spinoff pharmaceutical company that bought the nasal spray, will be able to manufacture, market and distribute the product. Right now, emergency responders and hospitals must draw naloxone, branded as Narcan, in a syringe to provide the correct dose.

Princess Health and Partial knee replacement using a robotic arm used in Ky. for first time; offers hope of longer lasting knees that feel more natural.Princessiccia

Princess Health and Partial knee replacement using a robotic arm used in Ky. for first time; offers hope of longer lasting knees that feel more natural.Princessiccia

arthritis food and drug administration orthopedics surgery

Gusty 07:45 Add Comment

A partial knee replacement surgery that utilizes a robotic arm was performed for the first time in Kentucky in May, Mark Hansel reports for the Northern Kentucky Tribune.

RIO, Robotic Arm System
(Photo from NKYTribune)

Dr. Matthew Hummel of Commonwealth Orthopaedic Physicians, which serves the greater Cincinnati area, performed the Stryker MAKOplasty partial knee resurfacing procedure at St. Elizabeth Edgewood May 19.

Hummel said "benefits of the minimally invasive procedure are expected to include a more natural feeling post-surgery and improved recovery time," Hansel writes.

�Stryker MAKOplasty allows us to treat patients with knee osteoarthritis at earlier stages and with greater precision,� Hummel said. �Because it is less invasive and preserves more of the patient�s natural knee, the goal is for patients to have relief from their pain, gain back their knee motion, and return to their daily activities.�

Osteoarthritis is the most common form of arthritis and a leading cause of disability worldwide, according to the American Academy of Orthopaedic Surgeons.

Hummel said the procedure has been "around for several years," and that he has been tracking its progress, including recent results and upgrades in technology, before using it on his patients.

Hansel explains that the procedure is performed using RIO, a highly advanced, surgeon-controlled robotic arm system. The system correlates a pre-surgical plan that was created by using a CT scan of the patient's knee taken before the surgery with a three-dimensional, virtual view of the patient's bone surface during the procedure.

Hummel told Hansel that some patients are "apprehensive about having a robot perform the procedure," but assures them that "I am actually operating and doing all the work, but it is helping me apply the best laser lines and guiding techniques."

In addition to a more rapid recovery, the procedure is expected to result in reduced pain, a smaller scar, minimal hospitalization, less implant wear and loosening, and better motion that feels more natural, Hansel reports.

�If my implants completely match my plan CT scan, I�m hopeful that with today�s technology, we can have knees that last 25 and 30 years,� Hummel said

Hummel has since performed the procedure on at least one other patients at St. Elizabeth Edgewood. It is anticipated that this procedure will be expanded to total hip and total knee replacements, but these procedures have not yet gained the U.S. Food and Drug Administration's approval.

Princess Health and Princess Health andHighly addictive, crushable pain killer to be released this month; political leaders beg FDA to reconsider its decision .Princessiccia

Princess Health and Princess Health andHighly addictive, crushable pain killer to be released this month; political leaders beg FDA to reconsider its decision .Princessiccia

addiction food and drug administration prescription drug abuse prescription drugs

Gusty 09:00 Add Comment

A new narcotic pain pill is set to be released to the market this month, and critics are begging the Food and Drug Administration to reverse its decision, fearing its addictive qualities and overdose potential, Laura Ungar reports for The Courier-Journal.

Zohydro ER is an extended-release hydrocodone medication made by Zogenix. It is a highly addictive drug only meant for patients with pain severe enough to require daily, round-the-clock, long-term treatment, for whom other treatments are inadequate.

"It�s a capsule of pure hydrocodone so powerful that one accidental dose can kill," Ungar writes. Doctors, lawmakers, drug-control officials and others are voicing their concerns that Zohydro ER will bring a new wave of prescription drug abuse to Kentucky just as Kentucky has been making "great strides" against this already existing problem.

Zohydro ER, unlike recent formulations of the popular painkillers OxyContin and Opana, is not crush-resistant, making it easier for abuse by crushing and then snorting or injecting it, Ungar reports.

Kentucky ranks third in the nation for overdose deaths, with more than 1,000 Kentuckians dying each year from prescription drug overdoses. The number has leveled off following passage of laws that target pill-pushing clinics and doctors, and put stricter regulations on painkillers.

�We could see the OxyContin days come back, just in a new form,� Dan Smoot, president and chief executive officer of the Eastern Kentucky anti-drug organization Operation UNITE, told Ungar.He was referring to the drug that first sparked Appalachia�s prescription abuse problem in the late 1990s.

The FDA approved Zohydro ER last fall, even though its own scientific advisory panel cited concerns about misuse and abuse and voted 11-2 against approving it. It�s set to hit the market early this month, Ungar reports. Last week a coalition of more than 40 health, consumer and other organizations urged the FDA to revoke its approval.

Attorney General Jack Conway was among 28 attorneys general who sent the FDA a letter asking it to reconsider, noting that it is reportedly "five to 10 times more potent than traditional hydrocodone products, and has no abuse-deterrent properties."

�We do not want to see the great strides we have made in Kentucky combating prescription drug abuse reversed,� Conway said in a statement after signing the letter. �For decades, we have fought the disastrous effects of the illegal marketing of the drug OxyContin. Zohydro ER has the potential to exacerbate the prescription-pill epidemic. ... The FDA�s decision to approve the drug doesn't make sense.�

U.S. Rep. Hal Rogers, R-5th District, and Senate Republican Leader Mitch McConnell, as well as two other senators, have expressed their disapproval, but the FDA says the drug meets its safety requirements and the benefits outweigh the risks for patients who qualify for the drug, Ungar reports.

Zogenix officials told Ungar they are committed to going �above and beyond FDA requirements� to make sure the drug is used appropriately, will monitor for misuse, and will allow an outside group to monitor and analyze their data. They said they are also working on an abuse-resistant pill.

They also pointed out that Zohydro ER will be regulated as a Schedule II controlled substance, which means it can only be dispensed through a physician�s written prescription, with no refills.

�Opioids are important pain-relieving medications that can provide significant benefits for patients when used properly for their approved indications,� Zogenix wrote Ungar.

Another benefit cited by Zogenix officials is that unlike many other hydrocodone painkillers, Zohydro ER does not contain acetaminophen, which can cause liver failure when used over a long period. They said more than half of liver transplants are caused by acetaminophen overdoses from overusing these sorts of combination drugs.

Princess Health and Conway, other AGs ask FDA to require generic prescription pain pills to be abuse-resistant, tamper-resistant.Princessiccia

Princess Health and Conway, other AGs ask FDA to require generic prescription pain pills to be abuse-resistant, tamper-resistant.Princessiccia

attorney general drug abuse drug companies food and drug administration generic drugs prescription drug abuse prescription drugs

Gusty 14:47 Add Comment

Generic versions of popular pain relievers must be made harder to abuse, in order to curb prescription drug abuse that is epidemic in many states, Attorney General Jack Conway and 47 other attorneys general said in a letter sent to federal officials Monday.

The National Association of Attorneys General letter encourages the Food and Drug Administration to adopt standards requiring manufacturers and marketers of generic prescription painkillers to develop tamper- and abuse-resistant versions of their products, because the attorneys general are concerned that non-medical users are shifting to non-tamper-resistant formulations of generic opioids.

�Prescription drug abuse is an epidemic that kills more than 1,000 Kentuckians each year,� Conway, who co-chairs NAAG�s Substance Committee, said in a news release. �The development of tamper-resistant and abuse-deterrent opioid drug products is a valuable aid to the law enforcement, legislative and public awareness initiatives many of us have implemented in our states to combat prescription drug abuse.�

Prescription drugs can be deadly when abused, and fatal drug overdoses are now the leading cause of death due to unintentional injury in the United States and Kentucky, exceeding even motor vehicle deaths, according to the Centers for Disease Control and Prevention. Federal data show that U.S. drug overdose deaths totaled 38,329 in 2010, rising for the 11th straight year, and accidental deaths involving addictive prescription drugs overshadow deaths from illicit narcotics.

In Kentucky, the number of drug-overdose deaths in Kentucky rose a staggering 296 percent from 2000 to 2010, according to the Kentucky Injury Prevention and Research Center. Kentucky is one of the most medicated states in the country, and has the sixth highest overdose rate. Last year, 220 million doses of the highly addictive painkiller hydrocodone were dispensed in the state -- that�s 51 doses for every man, woman and child in the state, says the AG release.

The news release from Conway's office said he led the effort to reach out to the FDA, along with Attorneys General Luther Strange of Alabama, Pam Bondi of Florida and Roy Cooper of North Carolina. Click here to read the letter; for a news release, click here.

Princess Health and Deadly, recalled pills still circulating in Pennyrile Region.Princessiccia

Princess Health and Deadly, recalled pills still circulating in Pennyrile Region.Princessiccia

drug companies drugs food and drug administration pain pain management

Gusty 18:52 Add Comment

A pain reliever that has been recalled and declared dangerous by the Federal Drug Administration is still circulating around southern Kentucky.

The drug marketed under the name Reumofan Plus is being distributed in Elkton and the broader Pennyrile Region, despite being recalled, and a local doctor's office says patients on the drug have had dangerous side effects, reports Nick Tabor of the Kentucky New Era.

Dr. Keith Toms of Generations Primary Care told Tabor three of his patients have taken the drug and had bad side effects. One patient had dangerous elevations of liver enzymes, and two diabetic patients had dangerous spikes in blood sugar.

The Food and Drug Administration has received reports of deaths, strokes, severe internal bleeding, dizziness, insomnia, high blood sugar and other problems associated with the drug since June. The manufacturer, operating under the names Reumofan Plus USA, LLC and Reumofan USA, LLC, announced a voluntary product recall last month, reports Tabor.

According to the FDA, undeclared ingredients in the drug, which is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions, could result in serious illness. Tabor reports a FDA laboratory analysis of Reumofan Plus found that it contains diclofenac sodium, a non-steroidal anti-inflammatory drug, and methocarbamol, a muscle relaxant.

Tabor reports the FDA has issued an alert telling consumers to stop taking the drug immediately and consult a health-care professional. The agency also said it may follow up on the Reumofan recall with warning letters, seizure, injunction requests or criminal charges. (Read more)