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Tuesday 30 July 2013

Darvon, Darvocet, Co-Proxamol: history of a banned painkiller

Pharmaceutical drugs come and go. They come initially heralded as wonder drugs, magic bullets. They go as unsafe, dangerous, or even lethal. It is a pattern that has been repeated decade after decade for the last 100 years. (See 'Banned, withdrawn, dangerous Big Pharma drugs').

Darvon, or Darvocet, or Co-Proxamol (Big Pharma drugs are called different names in different countries) is such a drug. The main ingredient of the drug is propoxyphene, and the drug may be masquerading under other names - it is the way the drugs industry obfuscates and misleads us so we never quite know what we are taking! The drug was introduced in the 1950's, and had a long history of safety fears. But obviously, it is in Big Pharma's best interests to keep drugs on the market for as long as possible, and this is what they have done.

The problem is that the drug caused heart problems. The public interest group, 'Public Citizen' called for the drug to be banned in 1978. It again called for a ban in 2006. It was eventually banned in the UK in 2006. But as dangerous as the drug might have been here, it continued to be sold elsewhere, throughout the world. The European Drugs Agency banned the drug in Europe in 2009. But it was still sold in the USA, and other parts of the world.

Eventually it was banned by the FDA in the USA on 19 November 2010. But even then, there was prevarication. Drugs are not banned without a fight! Following the Public Citizen petitioning to ban the drug in 2006, it took three years for an 'expert advisory committee' to vote, narrowly, to ban the drug. But that was not the end of the matter. The FDA overruled the committee's decision, and asked the drug company to investigate the affect of the drug on the heart. Only when this report was received was the drug banned!

When banning the drug the FDA said that it puts patients at risk of abnormal, and even fatal heart rhythm abnormalities. Yet the drug has been marketed as a painkiller for over 50 years before ANY action was taken, even though the evidence of its dangers had been known for most of that time. So, for over 50 years, patients were given a drug that could have given them serious heart disease.

It has been estimated that 10 million people in the US took the drug. But the advice from FDA had a further sting in the tale. Patients must not stop taking the drug - because there was a danger of 'serious withdrawal symptoms'. So they had to continue taking the drug, which caused heart disease; or they had to suffer severe withdrawal symptoms.

As usual, patients did not receive a good deal from the Big Pharma drugs industry!

And little timely, or effective protection from the statutory drug regulatory bodies!

Indeed, Public Citizen castigated the FDA for waiting for so long to protect the public. They said the because of FDA negligence at least 1,000 to 2,000 people in the USA died from using these drugs - just during the period between the ban in the UK and the ban in the USA.

Yet, in another sense, all this is routine stuff. The drugs industry introduces a drug, after testing and regulatory controls are undertaken. It is given to patients. Reports of 'side-effects' or 'adverse reactions' are received, and ignored by the regulators. Patients suffer by contracting new, usually more serious diseases. Many patients die. And only then, when faced with an untenable situation, do the drug regulators act.

There is no fail safe mechanism in the world of pharmaceutical drugs. Drugs are considered safe until such time that they prove, overwhelmingly, that they are not. It has been the same with drugs-past, drugs-now, and drugs-future. These drugs have little to do with health, and plenty to do with the drugs business, and making money.