The active ingredient in Darvocet is propoxyphene
(also found in Darvon and Wygesic), which is
dangerous and ineffective. Specifically,
propoxyphene can cause serious cardiac problems,
including issues with the heart pumping blood.
Propoxyphene also causes harmful effects on the
brain (sedation and confusion) that can lead to the
type of problems many people experience – difficulty
standing, loss of balance and difficulty thinking
clearly.
If that's not bad enough, once people are
started on these medicines, it can be hard to stop
because the medicines are addictive.
Drugs containing propoxyphene can be toxic even
at normal doses – over the past two decades, they
are estimated to have been responsible for at least
2,000 deaths in the United States. Their toxicity is
greater in the elderly, suggesting that the drug was
particularly inappropriate for Mrs. Cream, yet these
pills are prescribed for millions of older folks in
emergency rooms, nursing homes and in hospitals
after surgery.
Dangerous and ineffective are two qualities of a
drug that one would think might lead a concerned and
consumer-focused Food and Drug Administration to
take the drugs off the market. But the FDA is
neither.
Information about propoxyphene's dangers and
ineffectiveness of isn't new. These facts are at
least 20 years old. Public Citizen, the nonprofit
health advocacy group, publishes the useful "Worst
Pills, Best Pills" (Pocket, $19.95, 960 pages).
Based on sound research, the book has listed
medicines containing propoxyphene in the "do not
use" category for more than two decades. The sad
fact is that doctors – particularly older doctors –
seem unwilling to stop prescribing these drugs
despite the fact there are a number of safer and
more effective alternatives for pain relief.
Pills with propoxyphene remain among the top 25
most- prescribed generic drugs in America. Last year
alone, 22 million prescriptions were written for
these drugs. At this point, it is unclear who is
more addicted to the drug – doctors or their
patients.
Federal law requires the FDA to remove unsafe
products. I have no idea why drugs containing
propoxyphene remain on the market, particularly when
other countries removed them years ago based on the
documented dangers. But Americans may be a step
closer to having the drugs removed thanks to a
lawsuit filed last week by Public Citizen. The group
is suing the FDA for disregarding the known dangers
of the drug.
I called the FDA to ask whether it felt drugs
with propoxyphene were safe and effective. A
representative told me that she was unable to
comment on the drug's effectiveness or safety due to
the pending litigation. She did confirm that the FDA
has been working on "a response" to the complaint
for the past several years, but said these things
take time.
I asked how much time it could take to determine
if a drug was unsafe. She refused to comment. I
contacted her supervisor, who also was unwilling to
comment on whether the FDA was worried about the
drug's safety. I asked if the FDA felt the public
had any reason to worry. Again she would not
comment.
It appears that the FDA could have had one of two
responses. Either it could say the drug is safe and
effective and all the research showing its danger is
untrustworthy. Or it could say the safety of the
drugs is of concern and doctors should prescribe
other pain medication until the issue is fully
resolved.
"No comment" seems inexcusable as a response from
an agency whose mission is to protect the health of
the public.
Mrs. Cream is no longer taking Darvocet, and she
is pain free. But thousands of other patients are
being prescribed drugs containing propoxyphene.
It is unclear what direction the court will take,
but it is absolutely clear that until the drugs are
removed from the market, doctors should simply stop
prescribing them and choose alternatives that are
safe and effective.
As for you, if your doctor offers to prescribe
these medicines, don't take them. Ask for an
alternative pain reliever.
