Conway, other AGs ask FDA to require generic prescription pain pills to be abuse-resistant, tamper-resistant

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.

Deadly, recalled pills still circulating in Pennyrile Region

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)

FDA could require tamper-resistant painkillers; without such action, prescription-drug abuse problem would worsen

UPDATE, Jan. 14 : Laura Ungar of The Courier-Journal reports, "Addicts by the scores used to get a quick and easy high from snorting or shooting up the powerful narcotic OxyContin — until manufacturer Purdue Pharma developed a new version that’s harder to abuse. But with the company’s patent on its original drug set to expire in April, activists, lawmakers and doctors are worried that cheaper, easily crushable generic versions will flood Kentucky and worsen the state’s already-devastating prescription drug abuse problem."

The Food and Drug Administration will force generic manufacturers of powerful pain pills to switch to a tamper-resistant composition if it finds evidence the composition curbs prescription drug abuse and addiction, Alan Rappeport of The Financial Times reports. Public-health advocates worry that if generic versions of opiate pills are not made tamper-resistant, the prescription drug abuse epidemic may worsen.

If the agency finds tamper-resistance significantly deter abuse, it has legal authority to require generic drug makers to switch their opiate formulas. Just as manufacturers of some pain pills began switching formulas to make the pills harder to crush, easily crushable, generic forms of OxyContin and Opana were released. Purdue Pharma and Endo Pharmaceuticals, which make Opana, have hoped to extend patent life of their drugs by pushing the FDA to prevent generic makers from using old versions of their drugs. Generic makers argue this will keep patients from buying cheaper drugs.

The FDA said it will take a "flexible" approach to determining the effectiveness of tamper-resistant drugs because abusers are constantly finding new ways to avoid deterrents. (Read more)

UK study: Old, perhaps obsolete heart drug increases deaths in patients with atrial fibrillation

A drug widely used against heart disease can increase the possibility of death when used by patients with atrial fibrillation, a common heart rhythm problem, according to a study by University of Kentucky researchers. Digoxin, a derivative of the foxglove plant, is an old yet controversial heart drug. Though considered obsolete by some, it is still widely used.

The study, published in European Heart Journal, analyzed data from 4,060 atrial-fibrillation patients. It was led by Dr. Samy Claude Elayi, associate professor of medicine at UK HealthCare's Gill Heart Institute. The results of the study indicate that further review by the Food and Drug Administration is warranted to determine if stronger warnings about its use should be required. (Read more)

Graphic warning labels help smokers remember tobacco health risks, study finds

Study participants looked at these two images while
researchers assessed how effectively they were viewed.
Graphic by Penn Medicine.

Graphic warning labels on cigarette packages can help smokers remember the message and the health risks associated with smoking, a study has found.

Researchers asked 200 smokers to look at either a text-only label advertisement — which is similar to warnings that have been on cigarette packages since 1985 — or a graphic warning label showing a hospitalized patient on a ventilator along with a written warning — which has been proposed by the U.S. Food and Drug Administration.

Researchers used eye-tracking technology to measure how the advertisement was looked at and for how long, reports research-reporting service Newswise. Then participants were asked to rewrite the message they'd seen to show how well they remembered it.

Results showed 50 percent of participants who saw the text-only ad remembered the warning label, while 83 percent of those who saw the graphic image warning remembered what they'd seen.

"In addition to showing the value of adding a graphic warning label, this research also provides insight into how the warning labels may be effective, which may serve to create more effective warning labels in the future," said Andrew A. Strasser, associate professor at the University of Pennsylvania, where the study was conducted. "We're hopeful that once the graphic warning labels are implemented, we will be able to make great strides in helping people to be better informed about their risks, and to convince them to quit smoking."

The 2009 Family Smoking Prevention and Tobacco Control Act mandated the FDA to require graphic warning labels on cigarettes packaging starting in September 2012. The mandate has since been held up in court. (Read more)

Trans fat levels in white adults have fallen by more than half since FDA started requiring labeling of the unhealthy food ingredient

After the Food and Drug Administration required food manufacturers to label how much trans fat is in their products, levels of the unhealthy ingredient in the bloodstream dropped by 58 percent. (Associated Press photo by Ed Andrieski)

The numbers come from a study assessing blood levels between 2000 and 2008. FDA required trans-fat labeling in 2003. Researchers at the Centers for Disease Control and Prevention noted the decline after analyzing blood drawn for the annual National Health and Nutrition Examination Survey, a nationally representative sample of about 5,000 people. The drop was seen in white adults; more research is being conducted to see if it also dropped in other ethnic and racial groups.

"The decline, unusually big and abrupt, strongly suggests government regulation was effective in altering a risk factor for heart disease for a broad swatch of the population," reports David Brown for The Washington Post.

Trans fat is typically used for deep-frying and as an ingredient in baked goods. One study determined "if a person increases total calorie intake 2 percent all in the form of trans fat, risk of heart attack rises by about 20 percent," Brown reports.

"Our findings provide information about the effectively of these interventions," said Hubert W. Vester, a CDC chemist who led the analysis. "This reduction is substantial progress that should lower the risk of cardiovascular disease in people." (Read more)

Judge continues to block graphic images on cigarette packs

Getting graphic labels on cigarette packages continues to be an uphill battle for the Obama administration, as a skeptical judge sided with cigarette makers who say "they can't be forced to spread the government's anti-smoking advocacy with 'massive shocking, gruesome warnings' on products they legally sell," reports The Associated Press.

U.S. District Judge Richard Leon of Washington, D.C., has already decided that the cigarette makers will probably succeed in their lawsuit, because he has ordered the government to not enforce the requirement that the labels appear on cigarette packages next year.

The labels, approved by the Food and Drug Administration, "included color images of a man exhaling cigarette smoke through a tracheotomy hole in his throat; a plume of cigarette smoke enveloping an infant receiving a mother's kiss; a pair of diseased lungs next to a pair of healthy lungs; a diseased mouth afflicted with what appears to be cancerous lesions; a man breathing into an oxygen mask," among others, AP reports.

Leon has indicated he thinks the labels go overboard in their efforts to convey the dangers of cigarettes. He has ruled they are too large; they were intended to cover the top half of packs. "It sounds like they are headed to a place," he said Wednesday, "where you have to watch a 10-minute video before you can even buy a pack of cigarettes." (Read more)

Morning-after pill should not be available to young girls over the counter, HHS secretary says, reversing FDA

Contrary to the recommendation of the U.S. Food and Drug Administration, girls younger than 17 won't be able to get the "morning-after pill" without a prescription. The FDA was overruled by Health and Human Services Secretary Kathleen Sebelius on Wednesday.

"Right now, girls age 17 and older can get the emergency contraceptive without a prescription, but a prescription is required for girls age 16 and younger," reports Darla Carter of The Courier-Journal.

Teva Women's Health requested that the drug, known officially as Plan B One-Step, be available to all girls of child-bearing age. FDA Commissioner Margaret Hamburg was in favor of the request, saying she felt there was "adequate, reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective."

But Sebelius disagreed and directed the FDA to write a letter denying Teva's request. "She cited insufficient data to support the company's application, plus cognitive differences between older adolescents and younger girls, such as 11-year-olds," Carter reports. (Read more)