E-DRUG: Lawsuit against FDA on banning Darvon (propoxyphene)
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For Immediate Release: June 19, 2008
Public Citizen Sues FDA for Failure to Act on Dangerous Drug Propoxyphene
Has Hazardous Side Effects And Is No More Effective Than Similar Drugs
WASHINGTON, D.C. - Public Citizen sued the U.S. Food and Drug
Administration (FDA) today for failing to act on its petition to withdraw
Darvon, Darvocet and all drugs containing propoxyphene gradually from the
market as has now been required in the United Kingdom (U.K.). Public
Citizen's complaint, filed in the U.S. District Court for the District of
Columbia, argues that the FDA is violating the law by not acting on Public
Citizen's Feb. 28, 2006, petition. By not acting, the FDA is allowing drugs
containing propoxyphene to remain on the market, putting patients at risk.
Propoxyphene is physically and psychologically addictive, is no more
effective than safer alternatives and has been associated with more than
2,000 accidental deaths in America since 1981, Public Citizen told the FDA
in its 2006 petition. Despite the drug's health risks, however, it was one
of the 25 most prescribed generic drugs last year, with 22 million pres-
criptions filled in pharmacies in 2007. According to Dr. Sidney Wolfe,
director of the Health Research Group at Public Citizen, "Top FDA drug
officials, including Center for Drug Evaluation and Research Director Dr
Janet Woodcock and Dr Robert Temple, are well aware that this drug has
considerable human toxicity, addiction potential and abuse liability, but
very limited therapeutic usefulness. Given this extremely unfavorable ratio
of risks to benefits, it is inexcusable that the FDA did not take
propoxyphene off the market long ago. It is our hope that this lawsuit will force the agency to finally begin this
desperately needed regula- tory process." The U.K. began a phased
withdrawal of Darvocet from the British market in 2005, following the
recommendation of the U.K. Committee on Safety of Medicines (CSM). In
its report, the CSM stated that it could not "identify any patient group in
whom the risk-benefit [ratio] may be positive." The withdrawal was
completed at the end of 2007. However, three years after the British
government began its action to withdraw the drug, and two years after
Public Citizen petitioned for its phasing out, the FDA still has not done
anything to protect Americans from propoxyphene's dangerous side effects.
A large proportion of the deaths from propoxyphene occurred because
most of the drug is converted into a metabolite that is highly toxic to the
heart, lasts longer in the body than the original compound and results in
cardiac depression. Adverse cardiac events associated with propoxyphene
include an interruption of heart transmission of electrical impulses, slowed
heartbeats and a decreased ability of the heart to contract properly.
Propoxyphene-acetaminophen, or Darvocet, is more dangerous than
acetaminophen (the ingredient in Tylenol) alone, yet a study has indicated
that Darvocet is no more effective in treating post-operative pain than
acetaminophen. Reports on propoxyphene dosage suggest addiction can
occur at less than the maximum recommended daily dose and
unequivocally confirm addiction at just twice the recommended daily dose.
In addition, propoxyphene has been deemed inappropriate for the elderly
because of its adverse effects on the central nervous system - such as
sedation and confusion - that have been found to increase the likelihood of
falls and fall-related fractures. Studies have shown that propoxyphene use
is widespread in emergency rooms, institutionalized populations and
retirement communities. Public Citizen is asking the court to find that the
FDA's delay in ruling on the 2006 petition is unlawful and to order the FDA
to issue a decision on the petition. Public Citizen publishes Worst Pills,
Best Pills, a monthly newsletter available in print and electronic formats
through Public Citizen's Web site, www.WorstPills.org. This site has other
searchable information about the uses, risks and adverse effects
associated with prescription medications, including all the information
contained in Public Citizen's best-selling book, "Worst Pills, Best Pills,"
which has listed propoxyphene as a DO NOT USE drug since its first
edition in 1988. Public Citizen has a strong track record of identifying
dangerous drugs well before federal regulators take action to ban or put
warnings on these drugs. For example, Public Citizen warned consumers
about the dangers of Vioxx, ephedra, Bextra, Rezulin, Baycol, Propulsid
and many other drugs years before the drugs were pulled from the market.
To read the suit, go to www.citizen.org/documents/FDAComplaint1.pdf
Sidney M.Wolfe M.D.
Director, Health Research Group of Public Citizen
1600 20th St. NW, Washington, DC. 20009
202 588-7735 fax 588-7796
e-mail swolfe@citizen.org
Web sites: www.citizen.org/hrg
www.worstpills.org