* FDA says evidence confirms heart danger
* Damage to heart not permanent
* Public Citizen says too little, too late
(Adds sales for Darvon, number of patients, background)
By Maggie Fox, Health and Science Editor
WASHINGTON, Nov 19 The company that makes the
highly popular narcotic painkiller Darvon has pulled the drug
from the market because it can cause fatal heart rhythms, the
U.S. Food and Drug Administration said on Friday.
The FDA said it asked Kentucky-based Xanodyne
Pharmaceuticals Inc (XANO.O) to stop selling Darvon and
Darvocet after new data confirmed fears that the active
ingredient, propoxyphene, could cause serious or even fatal
heart rhythm abnormalities.
The decision means patients will have even fewer safe
options to manage pain, the FDA said. The agency says 10
million patients took Darvon or a generic version in 2009 and
18 million prescriptions were dispensed.
"These new heart data significantly alter propoxyphene's
risk-benefit profile. The drug's effectiveness in reducing pain
is no longer enough to outweigh the drug's serious potential
heart risks," Dr. John Jenkins of the FDA's Center for Drug
Evaluation and Research said in a statement.
Dr. Sidney Wolfe of the Public Citizen's Health Research
Group said it was too little, too late, noting that Britain
banned the drug six years ago.
"Due to FDA negligence, at least 1,000 to 2,000 or more
people in the United States have died from using propoxyphene
since the time the U.K. ban was announced," Wolfe said in a
An FDA advisory committee split on whether to ban the drug
in 2009. The European Medicines Agency pulled it from the
market in June 2009.
"The FDA's pitiful excuse that it needed to order a human
study to find that 'the drug puts patients at risk of
potentially serious or even fatal heart rhythm abnormalities'
before deciding whether to ban propoxyphene only emphasizes how
out-of-step the agency is with the rest of the world," Wolfe
But the FDA noted that many people take the drug and that
there are few choices equivalent to the mild opioid. These
include over-the-counter pain relievers such as aspirin,
ibuprofen and acetaminophen, codeine, oxycodone or
Aspirin and ibuprofen can cause fatal bleeding and codeine
can cause severe constipation.
The FDA said it was difficult to show that deaths
associated with Darvon use were not, in fact, overdoses. But a
comparison with similar drugs showed propoxyphene was more
"Over a five-year period, the number of drug-related deaths
was approximately 16 deaths per 100,000 prescriptions for
propoxyphene, 10 deaths per 100,000 prescriptions for tramadol
and 8 deaths per 100,000 prescriptions for hydrocodone," the
FDA said in a statement.
The FDA said it was advising healthcare professionals to
stop prescribing propoxyphene and said patients taking it
should speak to a doctor about switching to another drug as
soon as possible.
"Since 1978, the FDA has received two requests to remove
propoxyphene from the market. Until now, the FDA had concluded
that the benefits of propoxyphene for pain relief at
recommended doses outweighed the safety risks," the FDA said.
The FDA's Dr. Gerald Dal Pan said Darvon does not cause
permanent damage to the heart. "Once patients stop taking
propoxyphene, the risk will go away," he said.
(Editing by Xavier Briand)