It's no secret that direct-to-consumer drug advertising made drugs like Viagra, Lipitor, Prozac or Nexium into rock stars. What is less apparent is how many new drugs betrayed serious risks after millions took them.
Big Pharma has friends in high places by Martha Rosenberg
Here are some blockbusters in the drug graveyard that Big
Pharma hopes we forget about.
1. Darvon and Darvocet
Is an opioid-linked medication that relieves pain worth the overdoses, death, addiction and abuse that are often in its wake? It is a question we hear today with drugs like OxyContin--but dates all the way back to 1957 when Eli Lilly began marketing Darvon.
Darvon and Darvocet (Darvon with acetaminophen, approved in 1972) were synthetic weak opioids that found themselves under safety clouds almost from the beginning. In 1978, Public Citizen called for their ban or severe restriction due to heart toxicity and deaths. Instead of banning or restricting Darvon, the government allowed Lilly to run an "educational program" about the risks. How did it work out? Lilly "converted its education program into a marketing initiative," said the Department of Health Education and Welfare. No kidding! In 2004, Darvon was still the 12th highest-selling generic in the U.S. with 23 million prescriptions filled.
In 2006, Public Citizen again called for a ban saying that Darvon had been linked to 10,000 confirmed U.S. deaths since its introduction and that coroners "note its presence in more deaths each year than most other prescription drugs." Why is Darvon so lethal? A dose and overdose are very close in strength, it is extremely toxic when mixed with alcohol, it eliminates slowly from the body and it appears to be impervious to naloxone, the drug carried by beat cops and paramedics to treat/reverse heroin overdoses.
Finally, in 2010 the FDA heeded the decades of warnings and banned Darvon and all products containing Darvon. The ban came five years after the United Kingdom began withdrawal of the drug. Was Darvon less dangerous in the U.K. cynics asked?
Pills that promise weight loss are never hard to sell and Abbott's Meridia offered the added benefit of a "high"--since it was closely related to amphetamines or "speed." Debuted in 1997, as direct-to-consumer advertising was beginning, Meridian ads showed overweight women crediting the drug with giving them more will power while the ads simultaneously warned of heart and other health risks and "dependence" in those who abused the controlled drug.
When it came to safety, there was a cloud over Meridia even before it was approved. In 1996, an FDA advisory committee voted 5 to 4 that the drug's benefits did not outweigh its risks. In 2002 Public Citizen petitioned the FDA to ban the drug for its heart and cardiovascular risks revealed in several studies. In 2009 there were 84 reports of Meridia deaths from cardiovascular reasons in the FDA Adverse Event Reactions database.
Still, three years after its approval, Meridia had been used by 2 million people in the U.S. and was widely marketed in other parts of the world as Reductil, Siredia and Sibutrex. It was not until 2010, after Meridia was sold for 13 years, that Abbott withdrew it from the U.S. market under FDA pressure.
Some of Meridia's quick rise stemmed from it being approved just as Fen-Phen was withdrawn. Pondimin or "fen" (fenfluramine) was not popular until marketers combined it with phentermine. Fen-Phen certainly took pounds off but in combination, "fen" was linked to at least 41 cases of pulmonary hypertension a rare lung disorder in which arteries narrow and can cause high blood pressure, valve problems and possible right heart failure. American Home Products (which became Wyeth, then Pfizer) quickly developed Redux, a similar drug to fen it hoped would be safer. But in 1997 the FDA withdrew both drugs for heart valve problems.