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1 14th November 03:55
sharon hope
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Default Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS


Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS

To my physician,

I believe that my symptoms may be due to the adverse effects a_ssociated
with cholesterol-lowering statin drugs. I need your help to understand the
cause of my symptoms, treatment options, and the prognosis for my recovery.

Please review the references below, published medical studies that show
similar problems a_ssociated with statin drugs. These are made available
via the National Institutes of Health (NIH,
http://www.ncbi.nlm.nih.gov/Entrez/) library of biomedical journal citations
and other major repositories of medical research.

Also, I am respectfully requesting that you file an adverse effects report
with the FDA (http://www.fda.gov/medwatch/how.htm), and that you please send
a copy of the report to the to the NIH-funded Statin Study, attention: Dr.
Beatrice Golomb, Principal Investigator.
Statin Study website: http://medicine.ucsd.edu/statin/
Statin Study contact info: http://medicine.ucsd.edu/statin/contactinfo.html
UCSD STATIN STUDY E-MAIL ADDRESS: statinstudy@ucsd.edu
MAILING ADDRESS: UCSD Statin Study 9500 Gilman Dr. La Jolla, CA 92093-0995
PHONE NUMBER: (858) 558-4950

Thank you

ERECTILE DYSFUNCTION (ED) AND STATINS

References (updated as of January 7, 2005):

Do lipid-lowering drugs cause erectile dysfunction? A systematic review.

Rizvi K, Hampson JP, Harvey JN.

University of Wales College of Medicine, Wrexham Academic Unit, Wrexham, UK.

Fam Pract. 2002 Feb;19(1):95-8. PMID: 11818357

BACKGROUND: Erectile dysfunction (ED) is common although under-reported by
patients. Along with the better known causes of ED, drug-induced impotence
needs to be considered as a cause of this symptom. Lipid-lowering drugs have
been prescribed increasingly. Their relationship to ED is controversial.
OBJECTIVES: Our aim was to clarify the relationship between lipid-lowering
therapy and ED. A secondary aim was to a_ssess the value of the systematic
review procedure in the area of adverse drug reactions. METHODS: A
systematic review was carried out using computerized biomedical databases
and Internet sources. Terms denoting ED were linked with terms referring to
lipid-lowering drugs. Information was also sought from regulatory agencies.
RESULTS: A significant literature was identified, much from obscure sources,
which included case reports, review articles, and information from clinical
trials and from regulatory agencies. Information from all of these sources
identified fibrates as a source of ED. A substantial number of cases of ED
a_ssociated with statin usage have been reported to regulatory agencies.
Case reports and clinical trial evidence supported the suggestion that
statins can also cause ED. Some information on possible mechanisms was
obtained, but the mechanism remains uncertain. CONCLUSIONS: The systematic
review procedure was applied successfully to collect evidence suggesting
that both statins and fibrates may cause ED. More numerous reports to
regulatory agencies complemented more detailed information from case reports
to provide a new perspective on a common area of prescribing.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11818357&dopt=AbstractERECTILE DYSFUNCTION AND STATIN THERAPY: INTERACTION WITH CARDIOVASCULARRISK FACTORS AND DRUG THERAPIESH. Solomon1, J. Man1, Y.P. Samarasinghe2, M.D. Feher2, A.S. Wierzbicki3, G.Jackson11Department of Cardiology, St. Thomas' Hospital, 2Beta Cell Diabetes Centre,Chelsea & Westminster Hospital, 3Department of Chemical Pathology, St.Thomas' Hospital, London UKErectile dysfunction has been a_ssociated with atherosclerotic risk factorsand drugs used in their treatment. This study investigated the relationshipof erectile function with cardiovascular risk factors and specific drugtherapies. International Index of Erectile Function (IIEF) scores measuredin 100 men attending cardiovascular risk clinics. Cardiovascular riskfactors and drug therapies were a_ssessed prior to initation and after 6months of statin therapy. Before statin therapy no correlation was observedbetween IIEF score and any individual cardiovascular risk factor thoughbetter scores were observed in patients on warfarin or angiotensin-IIreceptor blocker therapy (r=0.42; p <0.001). After 6 months of statintherapy, significant correlations were observed between lower IIEF scores(r=0.62; P<0.001) and age, smoking, diabetes and usage of warfarin orangiotensin-2 type 1 receptor blocker (ARB) therapy. Differences in dose,relative efficacy or relative lipophilicity of statin prescribed showed nocorrelation with change in IIEF score. This study suggests impotencefollowing statin therapy is likelier in patients with more severeendothelial dysfunction due to established cardiovascular risk factorsincluding age, and smoking and diabetes. This is complicated by adverseinteractions between statin therapy and concomitant treatment with warfarinor angiotensin-II type I receptor blockers.http://www.kenes.com/73eas/program/abstracts/126.docDrug Information Center: Information on Statin Drugs"On March 7, 2002, Colorado HealthSite interviewed Beatrice A. Golomb, MD,PhD, principal investigator of a study on Statin Drugs by the NationalInstitutes of Health. Dr. Golomb noted that the most common problemsreported about statin drugs pertain to muscle pain or weakness, fatigue,memory and cognitive problems, sleep problems, and neuropathy. Erectiledysfunction, problems with temperature regulation (feeling hot or cold, orhaving sweats) are among the other problems reported. "http://www.coloradohealthsite.org/pharmacology/statins.html"Question: What are the common complaints of patients who take statins?Dr. Golomb: The most common problems we hear reported pertain to muscle painor weakness, fatigue, memory and cognitive problems, sleep problems, andneuropathy. Erectile dysfunction, problems with temperature regulation(feeling hot or cold, or having sweats), are among the other problemsreported. "http://www.coloradohealthsite.org/topics/interviews/golomb.htmlBBC News: Wednesday, 15 March, 2000, 19:02 GMTHeart drug impotence warning"Statins prevent heart attacks by reducing the levels of dangerouscholesterol in the bloodstream. However, a small number of men prescribed the life-saving drug havecomplained that they are unable to achieve an erection.""Dr John Harvey, from the Wrexham Maelor Hospital in Wales, identified 220men who appeared to have lost their "virility" after starting to takestatins. "http://news.bbc.co.uk/1/hi/health/678811.stmBailey DG, Dresser GK. Interactions between g****fruit juice andcardiovascular drugs.Am J Cardiovasc Drugs. 2004;4(5):281-97. Review. PMID:15449971 [PubMed - indexed for MEDLINE] Blumentals WA, Brown RR,Gomez-Caminero A. Antihypertensive treatment and erectile dysfunction in acohort of type IIdiabetes patients.Int J Impot Res. 2003 Oct;15(5):314-7.PMID: 14562130 [PubMed - indexed for MEDLINE]
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2 14th November 03:55
wright
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Posts: 1
Default Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS


Gee, Sharon, do you really think your erectile dysfunction is due to
your use of statins? I bet your doctor would be fascinated.

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"If I have not seen as far as others, it is because giants
were standing on my shoulders." (Hal Abelson, MIT)
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3 14th November 03:55
sharon hope
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Posts: 1
Default Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS


Several months ago there was a request on the smc newsgroup, asking if
anyone had heard of statins causing ED. Since I was researching statin
adverse effects anyway, I decided to check into it, and found those study
results. On the assumption that if one person asks, others may have the
same question, I make the results available.

As for myself, I suffer from a different adverse effect - the damage to the
family. You have no idea how horrifying it is to watch your spouse of 30+
years experiencing constant excruciating neuromuscular pain, losing
short-term memory, and experiencing amnesia.

I am constantly researching statin adverse effects, in hopes of finding
something that will help my husband, disabled from 4 years of Lipitor at 10
mg per day, resulting in muscle pain, muscle wasting, peripheral neuropathy,
chronic excruciating pain, fatigue, exhaustion, extreme exercise
intolerance, short-term memory loss (measured at below the 1 percentile),
multiple witnessed episodes of transient global amnesia, aphasia, and CK
that continued elevating for 1 year off the drug. Three years later he is
still disabled, with most of the symptoms continuing, and hundreds of tests
and specialist consultations (52 the first year) serving to rule out all
other causes.

To date, my husband's Lipitor disability appears in a couple of studies, a
book, an article in Smart Money Magazine, and an article in the Los Angeles
Times Sunday Magazine. This public exposure of a very private sorrow is
permitted in hopes that no other family need go through what we have.

Thank you for asking.
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4 14th November 03:55
zee
External User
 
Posts: 1
Default Canadian adverse events reporting FORMS & WEBSITES


For Canadian healthcare consumers.

Canadian Adverse Events reporting:

Health Canada:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_adverse_report_e.html

PharmaWatch:
http://www.pharmawatch.net

PharmaWatch: Working for Consumer Rights and Safe Medicines

PharmaWatch is a non-profit advocacy group that believes
patients/consumers must play a central role in prescription drug safety
in Canada. All prescription drugs have side effects, and it is up to
patients, in consultation with their physician, to determine if the
benefits outweigh the risks. One of the main ways we are able to learn
about the risks is when patients tell us if and when they have had an
adverse drug reaction (ADR), especially (but not only) ADRs that are
serious or unexpected. Patients who know about a drug's side effects
can make more informed choices about what medicines they will use. But
if no one reports ADRs, it is impossible to know whether the benefits
continue to outweigh the risks.

Canadians rely on safe medicines to help them manage chronic conditions
like asthma or diabetes or to overcome a temporary or long-term
illness. The job of Health Canada is to make sure these drugs are safe
and effective when they make it on to the market. It also is Health
Canada's job to ensure that patient experiences with approved
prescription drugs are monitored. This is called "post-market
surveillance" and it is the early warning system that allows us to know
what the potentially dangerous side effects of prescription drugs might
be.

People who experience adverse reactions to prescription medicine are
often left alone to search for information about the drug they may be
having problems with, as well as the problems themselves. They often
lack the support they need to connect with others who may have similar
experiences. As patients, people are often isolated and made to feel at
fault for adverse reactions.

PharmaWatch believes that consumers and patients have unique
perspectives and experiences. They can provide information and insight
that contributes to the effective and safe use of medicines. Reporting
by patients and consumers can provide an early warning signal to
regulators, manufacturers, physicians, health professionals and other
consumers.

The goal of PharmaWatch is to highlight and validate consumer
experiences and heighten consumer involvement in adverse drug reaction
reporting. In addition to do***enting these experiences, we aim to
facilitate networking among individual patients/consumers and advocacy
groups who share our concerns about the lack of adequate post-market
monitoring by the pharmaceutical industry and Health Canada.

PharmaWatch aims to raise public awareness about the role of
consumers/patients in reporting their own adverse drug reactions - or
those experienced by their children, a spouse, a brother or sister, or
a parent. The group plans to teach people how to report an ADR, how to
encourage others to report, and what role ADR reporting has played or
can play to help ensure the medicine we take is right for us.

~~~~~~~~~~~~~~~


http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11818357&dopt=AbstractERECTILE
DYSFUNCTION AND STATIN THERAPY: INTERACTION WITH CARDIOVASCULARRISK
FACTORS AND DRUG THERAPIESH. Solomon1, J. Man1, Y.P. Samarasinghe2,
M.D. Feher2, A.S. Wierzbicki3, G.Jackson11Department of Cardiology, St.
Thomas' Hospital, 2Beta Cell Diabetes Centre,Chelsea & Westminster
Hospital, 3Department of Chemical Pathology, St.Thomas' Hospital,
London UKErectile dysfunction has been a_ssociated with atherosclerotic
risk factorsand drugs used in their treatment. This study investigated
the relationshipof erectile function with cardiovascular risk factors
and specific drugtherapies. International Index of Erectile Function
(IIEF) scores measuredin 100 men attending cardiovascular risk clinics.
Cardiovascular riskfactors and drug therapies were a_ssessed prior to
initation and after 6months of statin therapy. Before statin therapy no
correlation was observedbetween IIEF score and any individual
cardiovascular risk factor thoughbetter scores were observed in
patients on warfarin or angiotensin-IIreceptor blocker therapy (r=0.42;
p <0.001). After 6 months of statintherapy, significant correlations
were observed between lower IIEF scores(r=0.62; P<0.001) and age,
smoking, diabetes and usage of warfarin orangiotensin-2 type 1 receptor
blocker (ARB) therapy. Differences in dose,relative efficacy or
relative lipophilicity of statin prescribed showed nocorrelation with
change in IIEF score. This study suggests impotencefollowing statin
therapy is likelier in patients with more severeendothelial dysfunction
due to established cardiovascular risk factorsincluding age, and
smoking and diabetes. This is complicated by adverseinteractions
between statin therapy and concomitant treatment with warfarinor
angiotensin-II type I receptor
blockers.http://www.kenes.com/73eas/program/abstracts/126.docDrug
Information Center: Information on Statin Drugs"On March 7, 2002,
Colorado HealthSite interviewed Beatrice A. Golomb, MD,PhD, principal
investigator of a study on Statin Drugs by the NationalInstitutes of
Health. Dr. Golomb noted that the most common problemsreported about
statin drugs pertain to muscle pain or weakness, fatigue,memory and
cognitive problems, sleep problems, and neuropathy.
Erectiledysfunction, problems with temperature regulation (feeling hot
or cold, orhaving sweats) are among the other problems reported.
"http://www.coloradohealthsite.org/pharmacology/statins.html"Question:
What are the common complaints of patients who take statins?Dr. Golomb:
The most common problems we hear reported pertain to muscle painor
weakness, fatigue, memory and cognitive problems, sleep problems,
andneuropathy. Erectile dysfunction, problems with temperature
regulation(feeling hot or cold, or having sweats), are among the other
problemsreported.
"http://www.coloradohealthsite.org/topics/interviews/golomb.htmlBBC
News: Wednesday, 15 March, 2000, 19:02 GMTHeart drug impotence
warning"Statins prevent heart attacks by reducing the levels of
dangerouscholesterol in the bloodstream. However, a small number of men
prescribed the life-saving drug havecomplained that they are unable to
achieve an erection.""Dr John Harvey, from the Wrexham Maelor Hospital
in Wales, identified 220men who appeared to have lost their "virility"
after starting to takestatins.
"http://news.bbc.co.uk/1/hi/health/678811.stmBailey DG, Dresser GK.
Interactions between g****fruit juice andcardiovascular drugs.Am J
Cardiovasc Drugs. 2004;4(5):281-97. Review. PMID:15449971 [PubMed -
indexed for MEDLINE] Blumentals WA, Brown RR,Gomez-Caminero A.
Antihypertensive treatment and erectile dysfunction in acohort of type
IIdiabetes patients.Int J Impot Res. 2003 Oct;15(5):314-7.PMID:
14562130 [PubMed - indexed for MEDLINE]
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5 17th November 23:58
chuck forsberg
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Posts: 1
Default Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS


Are there any double blind controlled studies addressing this issue?
Statin use and ED may be a correlation, not causal.

If the ED resolved after discontinuance of statins, that would be
more interesting.
--
Chuck Forsberg caf@omen.com http://www.omen.com 503-614-0430
Developer of Industrial ZMODEM(Tm) for Embedded Applications
Omen Technology Inc "The High Reliability Software"
10255 NW Old Cornelius Pass Portland OR 97231 FAX 629-0665
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6 17th November 23:58
sharon hope
External User
 
Posts: 1
Default Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS


I have posted the studies that I could find.

Our internist did say once a few years ago that she was seeing a problem
with younger men on statins. She said that the testosterone needs a
cholesterol/lipid base to do its normal job. She had asked about it at a
medical convention, and the popular wisdom was to just prescribe viagra.
Her response: Testosterone controls much more in a male - up to and
including drive to succeed in business. These guys were losing ground in
their jobs, something viagra wouldn't fix.

No citation - just a quick conversation in the hallway, leaving an
appointment. I haven't seen that in any studies, and it would have caught
my eye because of that conversation. And I'm not sure how you would devise
the study to pick up the drive for success and masculinity factors in a
measurable way.

There are, however, lots of studies on low cholesterol and violence.

Again, if there hadn't been a few questions posted over the last few years,
to the degree that it seemed to be something people were concerned about, I
wouldn't have added it to the FAQ.

Then again, I had left out the "obvious" - muscle damage and
rhabdomyolysis - because there had been so much publicity that it was the
one area of statin adverse effects where doctors seemed to be informed. But
lately there have been several questions posted (not necessarily on this ng)
from people asking if their muscle pain could possibly be related to
statins, that I decided to go ahead and add those, too.

But that made the original all-inclusive statin adverse effects FAQ go more
than 77 pages. Thus, the breakout. And it seems to be more effective that
way - certainly the individual FAQs have generated far more comments than
the big 77 pager with the same info.
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7 17th November 23:59
zee
External User
 
Posts: 1
Default Personal experiences of statin induced erectile dysfunction


Chuck here are some anecdotal comments I pulled off the rxlist Lipitor
board. The second anecdote talks about testosterone. Zee

One of the lesser known side effects of statins. All from:

http://www.rxlist.com/rxboard/lipitor.pl

"Took lipitor 8/97 thru 10/03...noticed decline in lower leg muscle
stamina, increasing pain, etc...but had other problem I never
connected until recently...Please listen with care....Over the past few
years, I have noticed a decline in one area of ***ual performance...No
problem with
ED, no discomfort during ***, but the climaxes have become less and
less...it seems that the muscles that should produce ejaculation
just...don't....evrything else is normal, but instead of a regular
ejaculation, almost nothing comes out...no pulsing or spurting at
all...then shortly later, fluid gradually leaks out...I feel this lack
of muscular contractions may be the result of 6 yrs of lipitor...any
similar
experiences? any thoughts? I'm 55 and otherwise very youthful..."

~~~~~~~~~~`

My husband was on 20mg. of Lipitor for 3 years. It nearly wrecked our
marriage! Go and have your testosterone level checked. Lipitor destroys
your
ability to make that wonderful male hormone. My husband had to be
given NATURAL testosterone by injection for about 2 months as well as
using the NATURAL testosterone cream for his level to rise where he
felt normal. After quiting the Lipitor he started taking Zocor...
after only 2 weeks on this statin drug the testosterone level dropped
once again to that of an 11 year old boy. He still has to use the
cream daily. I would advise all men on statin drugs to get their
testosterone serum checked!

~~~~~~~~~~~~~~

Don't stay on this drug - if you ever want to return to a normal life
- get off it now. There are alternatives - such as diet, exercise,
niacin. The side effects are awful and this is not the only one that is
unacceptable. Believe me, my poor husband totally lost his
"abilities" over a year ago - and he was only 52 at the time.
Because of all the other negative side effects he has experienced,
this one is on the bottom of the list. He's lost the ability to use his
left arm, his right eye is suffering from occular hemorrhaging, his
right
leg is swollen with edema from foot to hip - which sometimes spreads to
the genitals, he's lost a lot of his hair, he has had rashes on his
body
that suddenly just start bleeding, and the pain - constant pain that
never
ever stops, muscle loss - to the point of not being able to move, dress
himself, get up from a chair, get into or out of a bathtub, up or down
stairs, drive a car. he has a swollen liver and digestive disorders
too long to list. You name it - it's been there and still is there.
This
drug kills... ."

~~~~~~~~~~~~~~~~

I took myself off Lipitor a little over a week ago. Before that, I
took the drug for a little over a month. During that time I
experienced severe cramping in my calves, and stiffness, soreness, and
cramping in my shoulders. Worst of all, I began experiencing erectile
dysfunction--semi-flacid erections, a lack of sensation, and sometimes
outright impotence--something I had never experienced in my life.
Since the only thing that had changed in my lifestyle was taking
Lipitor, and since the problem had never occurred before I took it, I
thought maybe the drug was the problem. While the erectile dysfunction
is somewhat improved after a week off Lipitor, it is still severe
enough that my wife and I are as yet unable to have ***ual relations.
The leg cramps have subsided, but the stiffness, soreness, and
cramping in my shoulders is still a problem. My doctor insists that
Lipitor has no ***ual side effects. However, I never had this problem
when I took Pravachol, although I did have leg cramps.

Can anyone give me some idea of how long one has to be off Lipitor
before erectile dysfunction/impotence symptoms go away? As you may be
able to tell, I'm really pretty spooked by all this. At age 43, I'm
not at all ready to give up my ***ual relationship with my wife."

~~~~~~~~~~~~~~~~~~~~~~
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8 17th November 23:59
listener
External User
 
Posts: 1
Default Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS


So the answer to the question "Are there any double blind controlled
studies addressing this issue? Statin use and ED may be a correlation,
not causal." is no? Or we could say, other than a brief, anectdotal
conversation with an internist you have not found any controlled studies
to support your contention. Would *that* be correct?

L.
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9 18th November 00:00
sharon hope
External User
 
Posts: 1
Default Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS


The answer is: I spend my research time on things that might help my
Lipitor-disabled husband, and the rest of my time earning our income. This
Statin Adverse Effects FAQ: ERECTILE DYSFUNCTION (ED) AND STATINS faq was a
bit of a diversion for my purposes, but I collected the articles on ED and
statin adverse effects because people suffering statin adverse effects asked
for information, and it was somewhat congruent. You have drifted well past
my area of interest, purpose or curiosity, so....

Go for it! You, too, can do RESEARCH! Find the answer for all of us!

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi
"PubMed, a service of the National Library of Medicine, includes over 15
million citations for biomedical articles back to the 1950's. These
citations are from MEDLINE and additional life science journals. PubMed
includes links to many sites providing full text articles and other related
resources. "

Just put in your search terms and you may be able to find out. Varying the
search terms with synonyms in different combinations helps.

Some search terms & equivalents:
Lipitor = atorvastatin
Coenzyme Q10 = CoQ10 = Ubiquinone = UbidecarenoneS
tatins = hydroxymethylglutaryl coenzyme A reductase inhibitors =
HMG-CoAReductase Inhibitors
Lipitor, Mevacor, Pravachol, Zocor, Lescol, and Baycol =
atorvastatin,cerivastatin, fluvastatin, lovastatin, pravastatin, and
simvastatin

plus all the ED synonyms you can come up with.

When you find what you are looking for, remember the search terms with the
right 'hits' and repeat them monthly to keep up with new publications.

Good luck, and don't forget to share what you learned with the rest of the
newsgroup.

Another interesting data point would be to keep track of the time you spend
in searching, reviewing, selecting, do***enting, quoting, summarizing, etc.,
plus posting and responding to ng questions, and then maintaining the info
to keep it current.
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