The new pills contain the highly addictive painkiller hydrocodone, packing up to 10 times the amount of the drug as existing medications such as Vicodin. Four companies have begun patient testing, and one of them — Zogenix of San Diego — plans to apply early next year to begin marketing its product, Zohydro.

If approved, it would mark the first time patients could legally buy pure hydrocodone. Existing products combine the drug with nonaddictive painkillers such as acetaminophen.

Critics say they are especially worried about Zohydro, a timed-release drug meant for managing moderate to severe pain, because abusers could crush it to release an intense, immediate high.

“I have a big concern that this could be the next OxyContin,” said April Rovero, president of the National Coalition Against Prescription Drug Abuse. “We just don’t need this on the market.”

OxyContin, introduced in 1995 by Purdue Pharma of Stamford, Conn., was designed to manage pain with a formula that dribbled one dose of oxycodone over many hours.

Abusers quickly discovered they could defeat the timed-release feature by crushing the pills. Purdue Pharma changed the formula to make OxyContin more tamper-resistant, but addicts have moved onto generic oxycodone and other drugs that do not have a timed-release feature.

Oxycodone is now the most-abused medicine in the United States, with hydrocodone second, according to the Drug Enforcement Administration’s annual count of drug seizures sent to police drug labs for analysis.

The latest drug tests come as more pharmaceutical companies are getting into the $10 billion-a-year legal market for powerful — and addictive — opiate narcotics.

“It’s like the wild west,” said Peter Jackson, co-founder of Advocates for the Reform of Prescription Opioids. “The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public.”

The pharmaceutical firms say the new hydrocodone drugs give doctors another tool to try on patients in legitimate pain, part of a constant search for better painkillers to treat the aging U.S. population.

“Sometimes you circulate a patient between various opioids, and some may have a better effect than others,” said Karsten Lindhardt, chief executive of Denmark-based Egalet, which is testing its own pure hydrocodone product.

The companies say a pure hydrocodone pill would avoid liver problems linked to high doses of acetaminophen, an ingredient in products like Vicodin. They also say patients will be more closely supervised because, by law, they will have to return to their doctors each time they need more pills. Prescriptions for the weaker, hydrocodone-acetaminophen products now on the market can be refilled up to five times.

Zogenix has completed three rounds of patient testing, and last week it announced it had held a final meeting with Food and Drug Administration officials to talk about its upcoming drug application. It plans to file the application in early 2012 and have Zohydro on the market by early 2013.

Purdue Pharma and Cephalon, a Frazer, Pa.-based unit of Israel-based Teva Pharmaceuticals, are conducting late-stage trials of their own hydrocodone drugs, according to documents filed with federal regulators. In May, Purdue Pharma received a patent applying extended-release technology to hydrocodone. Neither company would comment on its plans.

Meanwhile, Egalet has finished the most preliminary stages of testing aimed at determining the basic safety of a drug. The firm could have a product on the market as early as 2015 but wants to see how the other companies fare with the FDA before deciding whether to move forward, Lindhardt said.

Critics say they are troubled because of the dark side that has accompanied the boom in sales of narcotic painkillers: Murders, pharmacy robberies and millions of dollars lost by hospitals that must treat overdose victims.

Thousands of legitimate pain patients are becoming addicted to powerful prescription painkillers, they say, in addition to the thousands more who abuse the prescription drugs.

Prescription painkillers led to the deaths of almost 15,000 people in 2008, more than triple the 4,000 deaths in 1999, the Centers for Disease Control and Prevention reported last month.

Emergency room visits related to hydrocodone abuse have shot from 19,221 in 2000 to 86,258 in 2009, according to data compiled by the Drug Enforcement Administration. In Florida alone, hydrocodone caused 910 deaths and contributed to 1,803 others between 2003 and 2007.

Hydrocodone belongs to family of drugs known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, methadone and hydromorphone.

Opiates block pain but also unleash intense feelings of well-being and can create physical dependence. The withdrawal symptoms are also intense, with users complaining of cramps, diarrhea, muddled thinking, nausea and vomiting.

After a while, opiates stop working, forcing users to take stronger doses or to try slightly different chemicals.

“You’ve got a person on your product for life, and a doctor’s got a patient who’s never going to miss an appointment, because if they did and they didn’t get their prescription, they would feel very sick,” said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. “It’s a terrific business model, and that’s what these companies want to get in on.”

Under pressure from the government, Purdue Pharma last year debuted a new OxyContin pill formula that “squishes” instead of crumbling when someone tries to crush it.

But Zogenix, whose drug is time-released but crushable, says there is not enough evidence to show that such tamper-resistant reformulations thwart abuse.

“Provided sufficient effort, all formulations currently available can be overcome,” Zogenix said in a written response to questions by The Associated Press.

At a conference for investors New York on Nov. 29, Zogenix chief executive Roger Hawley said the FDA was not pressuring Zogenix to put an abuse deterrent in Zohydro.

“We would certainly consider later launching an abuse-deterrent form, but right now we believe the priority of safer hydrocodone — that is, without acetaminophen — is a key priority for the FDA,” Hawley said.

FDA spokeswoman Erica Jefferson said the agency would not comment on its discussions with drug companies, citing the need to protect trade secrets.

Drug control advocates say they’re worried the U.S. government is too lax about controlling addictive pain medications. The United States consumes 99 percent of the world’s hydrocodone and 83 percent of its oxycodone, according to a 2008 study by the International Narcotics Control Board.

One 41-year-old loophole in particular has fed the current problem with hydrocodone abuse, critics say. The federal Controlled Substances Act, passed in 1970, puts fewer controls on combination pills containing hydrocodone and another painkiller than it does on the equivalent oxycodone products.

A Vicodin prescription can be refilled five times, for example, while a Percocet prescription can only be filled once.

The Drug Enforcement Administration and Food and Drug Administration have been studying whether to close this loophole since 1999 but have made no decision. Congress is now considering a bill that would force the agencies to tighten the controls.

“This is a problem that is fundamentally an oversupply problem,” said Jackson, the drug-control advocate. “The FDA has kind of opened the floodgates, and they refuse to recognize the mistakes made in the past.”

Pure hydrocodone falls into the stricter drug-control category than hydrocodone-acetaminophen medications, meaning patients would have to go to their doctors for a new prescription each time they needed more pills. But Jackson said that’s no guarantee against abuse, noting that dozens of unscrupulous doctors have been caught churning out prescriptions in so-called “pill mills.”

The Drug Enforcement Administration, which enforces controls on prescription medicines along with the FDA, said it could not comment on drugs that have not yet been approved for sale.

However, Zogenix has acknowledged the abuse issue could become a liability.

“Illicit use and abuse of hydrocodone is well documented,” it said in a filing with the Securities and Exchange Commission in September. “Thus, the regulatory approval process and the marketing of Zohydro may generate public controversy that may adversely affect regulatory approval and market acceptance of Zohydro.”

Technorati Tags: hydrocodone, Oxycontin, Zogenix, Zohydro

According to HAAD, it has received numerous reports involving the abuse of the drug. “HAAD has received reports of theft (of Pregabalin) from pharmacies as well as pharmacists being threatened to provide Pregabalin. We advise all pharmacies to report promptly to police as well as notify HAAD Narcotics Officer (call 02-4193375) of any such incidents,” a recent circular issued by the authority to healthcare centres and pharmacies warned.

According to the authority, the drug is used for the treatment of neuropathic and generalised anxiety disorder. Evidence shows that it produces some pharmacological effects characterised by anxiolytics, and has been abused for its positive psychic effects (euphoria). “We remind you of the Prescriptions Only Medicines (MOP) status of Pregabalin, which must only be dispensed against a valid prescription,” the authority warned pharmacists. HAAD further reminded the prescription supply of the drug was limited to 30 days of treatment only and for all dispensed, pharmacies must retain the original prescriptions.

According to pharmacies in the capital, they received the circular on June 15. “Here we have the circular displayed. We never sell drugs without a valid prescription. We have to abide by the health authority rules and regulations,” said a pharmacist at Alya Pharmacy.

A pharmacist at another pharmacy said they never had an incident where people came for the drug without a valid prescription, and nor were threatened for not selling the drug without a prescription.

He said: “We are very strict about selling drugs without a prescription. And so far, we have had no problem where people come and force us to sell them medicine without a prescription. Most of our customers are blue-collared Asian workers who cannot afford to invite a problem.”

Technorati Tags: generalised anxiety disorder, pain relief drug, Pregabalin

Remoxy is an investigational abuse-resistant, long acting, oral painkiller containing narcotic oxycodone intended for moderate-to-severe chronic pain. It is an encapsulated, water insoluble, twice-daily oral formulation.

Commenting on the rejection, Pfizer said it is working to evaluate the issues and plans to have further discussions with FDA around them.

Olivier Brandicourt, Pfizer President and General Manager, Primary Care said, “Pfizer is working to understand and address the issues in the FDA Complete Response Letter. Pain is an important strategic disease area for Pfizer. We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue.”

James Brown, president and CEO of Durect noted that Pfizer has an experienced team of scientists dedicated to resolving the remaining issues.

Pain Therapeutics had submitted the initial new drug application for Remoxy in June 2008, however, it was rejected by FDA in December that year, requesting for more data. Later, Tennessee based King Pharma assumed the control of the drug and filed a resubmission in December 2010, further to an abuse liability study. When Pfizer acquired King Pharma, in February 2011, it received the rights to Remoxy.

In April end, Pain Therapeutics announced that an abuse liability study of Remoxy met all primary endpoints. The study recorded that patients on Remoxy showed lower liking for the drug compared with standard care oxycodone and placebo.

DRRX shares are trading down 30.42 percent at $2.16 on a volume of 1.29 million shares, while PTIE is down 39.50 percent at $5.5701 on a volume of 6.77 million shares.

PFE shares are currently trading at $20.28, down 1.84 percent on a volume of 12.44 million shares.

Technorati Tags: FDA, Pain Killer, Pfizer, Remoxy

Only 31 percent of people in the study knew that Tylenol contains acetaminophen, while 75 percent of people knew that Bayer contained aspirin and 47 percent of people knew that Motrin contains ibuprofen, the study said.

Nineteen percent of people in the study knew that Aleve contains naproxen sodium, and 19 percent of people knew Advil contains ibuprofen, according to researchers from the Feinberg School of Medicine at Northwestern University.

Acetaminophen overdose is the leading cause of liver failure among adolescents and young adults — some accidental, some intentional, said Dr. Lee M. Sanders, an associate professor of pediatrics at University of Miami Miller School of Medicine, who was not involved with the study. The big concern is that people are taking multiple medications that contain acetaminophen without realizing that they all contain the ingredient, he said

The study was published today (May 3) in the American Journal of Preventive Medicine.

Participants’ knowledge

Researchers conducted focus groups with 45 English-speaking adults in two cities to test their knowledge and use of over-the-counter painkillers. Forty-four percent of the people in the groups read at or below a sixth-grade level.

However, the population represents low-income and low-educated people who are at the greatest risk for medication safety issues, Sanders said.

Researchers found that only 41 percent of people in the study read the ingredients on the drug labels. They also learned that some of the ingredients are confusing to people, since, for example, acetaminophen is also called “APAP” on some drug labels.

Labeling suggestions

While the study’s findings are alarming, they are not surprising, Sanders said. Previous research by Sanders shows that there is similar confusion among the parents of young children who use liquid over-the-counter medication for their children.

It’s not consumers’ fault that the labels are so confusing, Sanders said.

“I think the marketing and labeling of these products is very confusing,” Sanders told MyHealthNewsDaily. “I often get called by medical colleagues (M.D.s and Ph.D.s) with questions about this.”

The study researchers propose having a symbol printed on the drug label that indicates the active ingredient, so that people can easily see what they are taking. They also suggest having clearer warnings on drug packaging for liver damage.

Pass it on: Many people do not know what’s in their over-the-counter pain relievers.

Follow MyHealthNewsDaily staff writer Amanda Chan on Twitter @AmandaLChan.

This story was provided by MyHealthNewsDaily, a sister site to LiveScience.

Technorati Tags: Naproxen, over-the-counter medication, pain relievers, painkillers

University at Buffalo researchers interviewed 75 patients hospitalized for opioid detoxification and found that 31 of them said they first became addicted to legitimately prescribed painkillers.

Another 24 patients said their addiction began when they used a friend’s left-over prescription pills or stole drugs from a parent’s medicine cabinet, while the remaining 20 patients said they got hooked on street drugs.

But the study found that 92 percent of the patients said they eventually bought illegal drugs (usually heroin) because street drugs are less expensive and more effective than prescription drugs. Their reasons for continuing to use drugs included to feel “normal,” to feel “like a better person” or to ease emotional pain and stress.

“We are seeing an increase in the number of patients addicted to prescription drugs, so we wanted to better understand how they first got hooked,” study senior author Dr. Richard Blondell, a professor of family medicine, said in a University at Buffalo news release.

“This information suggests that there is a progressive nature to opioid use, and that prescription opioids can be the gateway to illicit drug addiction. It also tells us that people who use prescriptions illegally may be at greater risk for subsequent heroin use than those who use prescriptions legally.”

The study was published recently in the Journal of Addiction Medicine.

Technorati Tags: prescribed painkillers, prescription drugs, prescription medicines, Prescription Painkillers, prescription pills

In the study, which involved a 2008 survey of more than 5,300 Utah adults, almost 2 percent of respondents said they had taken an opioid pain medicine not prescribed to them over the past year.

Ninety-seven percent of the time, the drug came from a friend or relative, and in most cases the drug was handed over willingly.

The study is published in the Feb. 19 issue of the U.S. Center for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Many Utah residents do have at least one prescription for opioid painkillers, according to the Utah Department of Health researchers.

“We found that one in five patients are prescribed opioids and the majority of those have leftover medication,” said report co-author Erin Johnson, project coodinator for the department’s Pain Medication Management & Education Program.

The majority of patients (71 percent) keep their leftover medication, she added.

Johnson and her team warned that holding on to unused prescription opioid painkillers can result in fatal overdoses, especially among people who were not prescribed the drugs.

According to the report, 85.2 percent of people who used an opioid drug without a prescription said the drug was given to them by someone who did have a prescription, and 9.8 percent said they took the medication without the knowledge or permission of the owner. Only 4.1 percent said they had bought the drug.

“With all these excess pills, there is a great likelihood of misuse and abuse that could result from that,” Johnson said. “So dispose of your leftover pain medication immediately,” she added.

From 1999 to 2007, deaths in Utah from poisoning by prescription pain drugs increased almost 600 percent, from 39 in 1999 to 261 in 2007, according to the report.

Johnson pointed out that any misuse of a prescription in Utah is a felony. That even includes taking your prescribed medication for an illness or pain episode other than what it was prescribed for.

The best thing to do with leftover opioids: throw them out, Johnson said. “The recommended way is to mix the pills with something undesirable in a separate bag and take the bottle and cross out any identifying information and throw that away separately,” she said.

Although the U.S. Food and Drug Administration recommends flushing unused prescription drugs, in Utah experts would prefer that people do not dispose of medicines this way, to avoid contaminating the environment, Johnson said.

In Utah, police stations also have drop boxes to collect unused medications, she added.

Johnson noted that most people are reluctant to get rid of their unused drugs. The main reason: They paid for these drugs and may need them again, she said.

Although enforcing drug disposal is hard, Johnson hopes that public awareness of the dangers of keeping unused opioids around will encourage people to dispose of these drugs.

In addition, Utah is trying to get doctors to prescribe only the number of pills they think a patient will need to deal with their pain, Johnson said.

“It not a big deal for someone to call in and say they are running low,” she said. “The doctors are understanding and they will write more.”

Dr. James Garbutt, a professor of psychiatry at the University of North Carolina at Chapel Hill, said that, “increased use and misuse of opioid medication is a significant health problem.”

Overdose deaths from opioids have risen significantly over the past 10 years, and “this a particular problem in young people who are not aware of the risks of these medications,” he noted.

“The net effect is that more opioid medications are available, and perhaps one consequence of this is that more individuals are getting into trouble with opioid medications,” he said.

The Utah report encourages physicians to only use opioids when clearly indicated, not to prescribe excessive quantities, to avoid long-acting opioids such as Oxycontin unless needed, and to encourage patients to discard leftover medication, Garbutt said.

“The report is more evidence of the increasing problem of opioid misuse in the United States. This problem is costing lives, including the lives of young healthy people,” he said. “Education of both physicians and the public is needed.”

Technorati Tags: opioid medication, opioid painkillers, Oxycontin, pain medicine, prescription opioid painkillers, prescription pain drugs

The Food and Drug Administration in February had asked manufacturers including Johnson & Johnson and King Pharmaceuticals to come up with a joint plan to deal with the public health problem, particularly involving slow release and long acting versions of the drugs. This is the first time the agency has sought to develop risk evaluation and mitigation strategy for an entire class of drugs.

At a Friday meeting, industry representatives told FDA they intended to develop a phased-in approach to deal with the problem. This could include a voluntary training program for doctors to better educate them about proper use of pain killers and government certification for prescribing of controlled substances.

Currently, a physician must be certified by the U.S. Drug Enforcement Agency to prescribe this class of drugs. Congress would have to approve any requirement for physician training to receive DEA certification.

The director of the FDA’s Office of New Drugs, John Jenkins, said the goal was to find a balance between reducing abuse of the drugs and maintaining access for patients who need the pain killers.

There was concern that doctors might opt out of prescribing the pain killers if the requirements are too burdensome.

FDA will hold more meetings with the industry group, doctors and the public next year.

Technorati Tags: methadone, morphine, opioid drugs, oxycodone, pain killers, prescription pain medications

Manufacturers must strengthen the labels of propoxyphene-containing products by adding boxed warnings that emphasize the potential for overdose and developing medication guides to be given to each person filling or refilling a prescription.

The manufacturers must also conduct a new safety study to assess unanswered questions, such as how propoxyphene affects the heart when taken at higher-than-recommended doses, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, said during a news conference.

The FDA is also working with several health-care organizations to collect additional safety data on these products, Woodcock said, adding that “the data we accumulate could result in additional regulatory action.”

Woodcock also announced that the FDA has denied a petition from the consumer advocacy group Public Citizen asking for a phased withdrawal of products containing propoxyphene.

“The reason for the denial is that FDA has determined that propoxyphene is an acceptable option for relief of mild-to-moderate pain when taken as directed,” she said. “Moreover, FDA recognizes that other options clinicians might have for pain management come with their own safety concerns.”

Propoxyphene-containing products have been linked to fatal overdoses, FDA officials said. Between 1959 and 2005, 91 deaths attributed to an overdose of these products have been recorded in the adverse-events database, said Dr. Gerald Dal Pan, head of the FDA’s office of surveillance and epidemiology.

But that database would not necessarily register information on deliberate overdosing, Woodcock said.

Last month, European regulators called for the withdrawal of dextropropoxyphene from the market because people taking the 50-year-old drug have been dying from overdoses.

Dextropropoxyphene, which is called propoxyphene in the United States, is an opioid widely used to treat mild to moderate pain. It was first introduced in the United States in 1957 under the brand name Darvon and is marketed today by a wide number of generic drug makers.

Last week, an FDA advisory panel recommended that the popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, be banned.

Darvocet contains acetaminophen.

Technorati Tags: acetaminophen, Darvocet, pain medications, Pain pills, propoxyphene

Q: What’s the reason?

A: It’s easy to get too much acetaminophen because the drug is in many medicines and a few extra doses a day can cause liver problems.

Q: I’ve taken Tylenol at recommended doses for years. Could I be damaging my liver and should I get tested?

A: Doctors say recommended doses are safe and they aren’t recommending routine tests; possible liver damage can be detected with blood tests.

Q: Would I know if I have liver damage?

A: Liver damage from excess acetaminophen tends to cause sudden symptoms, within a few days of taking too much. These may include nausea, vomiting and jaundice — yellowing of the skin or whites of the eyes.

Q: What should I do if I’ve taken extra doses and develop these symptoms?

A: Seek immediate medical care. Quick treatment with antidote medicine can prevent permanent liver damage; waiting too long can be fatal.

Q: How can I avoid getting too much acetaminophen?

A: Carefully read drug labels; don’t exceed recommended doses and don’t take more than one medicine containing acetaminophen. Also, avoid drinking alcohol while using acetaminophen-containing drugs.

Q: Are the proposed limits likely to be adopted?

A: The full FDA has not taken any action but will likely consider the recommendations separately. Its decisions are months away.

Technorati Tags: acetaminophen, pain medicine dangers, prescription drugs, tylenol

Buy Celebrex medication from US pharmacy

Things to consider before taking drug Celebrex

Taking an NSAID such as Celebrex can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

You should not use this medication if you are allergic to celecoxib, or if you have a history of allergic reaction to aspirin, sulfa drugs, or other NSAIDs.

Before taking Celebrex tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart attack, stroke, or blood clot;
• heart disease, congestive heart failure, high blood pressure;
• a history of stomach ulcers or bleeding;
• liver or kidney disease,
• a seizure disorder such as epilepsy;
• asthma;
• polyps in your nose; or
• a bleeding or blood clotting disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Celebrex.

Celebrex belongs to FDA pregnancy category C. Celebrex medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Celebrex during the last 3 months of pregnancy may harm the unborn baby. Do not take Celebrex during pregnancy unless your doctor has told you to. Celecoxib passes into breast milk and may affect a nursing baby. Do not take Celebrex without first talking to your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

Celebrex side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Celebrex and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• swelling or rapid weight gain;
• urinating less than usual or not at all;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious Celebrex side effects may include:

• upset stomach, mild heartburn, diarrhea, constipation;
• bloating, gas;
• dizziness, nervousness, headache;
• skin rash, itching;
• blurred vision; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Technorati Tags: Celebrex ingredients, Celebrex medication, Celebrex medicine, Celebrex pain, Celebrex side effects, Celebrex tablets, drug Celebrex