A pain killer that has been on the market for over 50 years has just been pulled by the FDA. Why? Because a new study proves that it interferes with your heart and can result in death.
The decision comes five years after the U.K. banned this drug. And 30 years after a public health group first petitioned the FDA to ban it.
The same group – led by doctors and researchers – has made repeated petitions to the FDA since then. They’ve provided proof and studies that show that the drug costs lives.
In fact, evidence from eight state medical examiners shows that it’s directly responsible for ending at least 5,000 lives. The FDA had this data and took no action whatsoever.
So in 2008, that same group went ahead and sued the FDA for endangering public safety. The lawsuit finally prompted action from the FDA and led to the removal of the drug.
So why did it take so long for the FDA to pull it from the U.S market? And what’s the consequence of its remaining at large since 2005?
The drug in question is called propoxyphene. It was first approved in 1957. And it treats mild-to-moderate pain. The most common forms are Darvon and Darvocet.
Last year alone, U.S. doctors prescribed the drug to 17.5 million Americans.
But the drug has been controversial for over 30 years. Health advocacy groups have been trying to get it banned since 1978.
Public Citizen, Inc. first petitioned the FDA in 1978. The group is directed by Dr. Sidney Wolfe, M.D., who previously worked for the National Institutes of Health. He founded the Health Research Group and currently teaches at Case Western Reserve University School of Medicine.
The 1978 petition said the drug could cause heart-related deaths. A preliminary study conducted by the drug maker showed it could cause heart blockages in animals.
However, the FDA denied the petition. And the drug stayed on the market for the next 30 years.
In 2005, the U.K. removed propoxyphene from the British market. The U.K. Committee on Safety of Medicines (CSM) found the drug to be dangerous. And not very useful. That report can be found on the U.K.’s Department of Health Web site.
It concluded that it could not "identify any patient group in whom the risk-benefit [ratio] may be positive."
Professor Gordon Duff, the CSM Chairman, says "the risk of toxicity is unacceptable."
That withdrawal prompted the European Union to review the drug… And led to its ban across Europe.
Those decisions were based partly on data collected by the Florida Medical Examiners. The data showed that approximately 100 deaths each year were the direct result of the drug. The FDA also reviewed that data.
The drug was successfully withdrawn in the U.K. So in 2006, Public Citizen made its second formal petition to the FDA.
Their recorded petition provided studies showing the dangers of the drug.
Those studies showed that the drug caused:
- Severe cardiac effects, resulting in death
- Cardiac depression
- Slowed heartbeats
- Reduced cardiac contractions
They also showed evidence from state medical examiners and disease control centers, including 18 years’ worth of autopsy reports.
That data added up to 5,462 deaths caused by toxins in the drug.
Those reports only represented one-third of the U.S. population. Logically, the actual fatality rates may be much higher.
The 2006 petition also included studies revealing that the drug is highly addictive.
Public Citizen also provided clinical trials and studies showing that the drug was not very useful. In fact, those studies showed that Tylenol, Ibuprofen, and even aspirin offered better results while posing significantly less risk.
The FDA reviewed all the data… and took no action.
Court records from 2008 show that agency officials dismissed the petition. Why? Because they hadn’t been able to reach a decision. They simply noted that it was a difficult decision that "raise[d] complex issues requiring extensive review by Agency officials."
Battle Goes to the Courts
The FDA took no further action. Instead, U.S. pharmacies filled another 22 million prescriptions for the drug in the following year alone.
After the U.K. withdrew the drug from the British market, the E.U. followed suit. They reviewed studies and autopsy reports. They found that propoxyphene offered less benefit than safer pain killers while causing cardiac-related deaths.
So in 2008, Public Citizen filed a lawsuit against the FDA for knowingly putting patients at risk.
Dr. Wolfe says it was a desperate attempt to force the FDA into action.
"Top FDA officials [know] this drug has considerable human toxicity, addiction potential, and abuse liability," says Dr. Wolfe. He also says it offers "very limited" benefits.
"Given this extremely unfavorable ratio of risks to benefits, it’s inexcusable that the FDA didn’t take [it] off the market long ago."
The suit revealed more details about the drug.
It’s converted into a metabolite that is toxic to the heart
It’s an addictive drug, even when taken in smaller amounts than the recommended daily dose.
Dr. Wolfe also says, "Due to FDA negligence, at least 1,000 more people in the U.S. have died from using it since time the U.K. ban."
"Our 2006 petition, following the UK ban, didn’t even result in an FDA advisory committee hearing," says Dr. Wolfe. That didn’t happen until they "sued the agency to force them to respond."
In response to the lawsuit, the FDA set up an advisory panel. Its job was to investigate the safety and effectiveness of the drug.
In February 2009, the panel voted 14-12 that the drug posed a fatal risk. That risk far outweighed the benefit of the drug. The panel concluded that the drug should be banned.
Despite the panel decision, the FDA still denied the petition to ban the drug in July 2009.
That decision came just months after the E.U. banned the drug in the rest of Europe.
Instead, the FDA ordered the drug maker to conduct its own human study. They wanted to know if "the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities."
That decision bought the drug maker a further 18 months of sales and profits.
The study was finally released in November 2010. It confirmed that propoxyphene drugs are significantly less effective than aspirin. They also pose serious risk of heart-related death.
"The study results show that the standard dose of [the drug is] harmful to the heart," says Dr. Gerald Dal Pan, the director of the FDA’s office of surveillance. "The cardiac study was the final piece of the puzzle that told us what the complete picture was."
Last week, the FDA ordered the drug maker to cease marketing the drug.
Dr. Wolfe says the decision has come at least five years too late. He says there was no excuse to keep the drug on the market after the U.K. reviewed similar findings to the FDA and chose to ban it in 2005.
"I would have praised them if they had done this six years ago," says Dr. Wolfe. "But there have been 120 million more prescriptions filled since 2005. And conservatively 1,000 to 2,000 more deaths. It’s inexcusable."
Dr. Pan says patients should continue taking the medication until their doctor prescribes a replacement therapy.
And Dr. Wolfe advises patients to ask their doctors whether they can switch to Extra Strength Tylenol or aspirin.
But a better option may be to actually tackle the cause of pain, rather than mask it with pain killers.
Most doctors believe that inflammation is the root cause of pain… from back pain to arthritis. There are effective, drug-free ways to combat inflammation.
The easiest option is to simply change your diet to ensure you take in good fats – like omega 3 in a higher ratio to bad fats like omega 6. That’s because omega 3 fats help combat inflammation – and general joint pain – while omega 6 promotes it.
Great sources of omega 3 are cold-water wild-caught fish. But fish oil supplements can also really boost your levels. Omega 6 is found in unhealthy quantities in fried food… hydrogenated oils… and everyday foods like mayonnaise.
Ian Robinson is a member of the Natural Health Dossier independent research team. The Natural Health Dossier newsletter scours the world for the most crucial, cutting-edge discoveries made by the best doctors and researchers in natural and alternative medicine.
Natural Health Dossier was originally developed from a series of private research briefs prepared for a reclusive millionaire. The newsletter continues to challenge established beliefs and evaluates new ideas in order to dispel mainstream myths about diet, exercise, nutrition, health and healing, aging, pain relief, and more.
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