PharmInfoBYTES            Vol. 2 #10                        25 May 1998
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Parallels Between Redux and Viagra

It's looking a little like deja vu all over again for the pharmaceutical
industry!

Some bad news about Viagra is emerging: it may be dangerous to use Viagra
with certain other {*filter*}; we've even heard reports of deaths associated
with Viagra being investigated by the FDA. Will Viagra suffer the same
fate as Redux and be forced off the market?

You no doubt recall that FDA took Redux off the market after reports that
long-term use caused heart valve problems (see, for example, FDA ANNOUNCES
WITHDRAWAL OF FENFLURAMINE AND DEXFENFLURAMINE -
http://www.***.com/ ). Now there are concerns that
Viagra, when used with recreational nitrates (including amyl
nitrate/nitrite or "poppers" and others) may cause "a precipitous drop in
{*filter*} pressure [that] could range from no symptoms or mild symptoms of
hypotension such as dizziness or light-headedness, to syncope (most likely
postural), to a significant lowering of coronary perfusion and conversion
of an area of myocardial ischemia to infarction, with all of its potential
consequences." (See Dear Doctor: Concomitant Administration of Viagra and
Organic Nitrates).

Why haven't these problems been seen before? As with any new drug, the
fact is that not all combinations of {*filter*} have been tested with Viagra.
Also, problems that were not seen in relatively small-scale clinical
trials may surface only when millions of people begin taking {*filter*} under
uncontrolled situations.

That is why it is extremely important that new {*filter*} be used with caution
and only under a doctor's supervision. Viagra could be a very significant
help to patients that really require it for the approved indication
(erectile dysfunction) and when used with the proper caution.

We believe that Pfizer is acting prudently to prevent the misuse and to
stop inappropriate prescribing situations -- such as prescribing Viagra to
patients over the phone without knowing their full medical history.

Take a lesson from Redux. It now appears that short-term use of Redux --
the way it was intended to be used -- may not lead to heart valve problems
afterall (see Short-term Dexfenfluramine Therapy Not Associated with
Heart-valve Damage - http://www.***.com/ ).
Nevertheless, Redux will never be re-introduced to the market. Viagra
could suffer the same fate if it is continued to be prescribed and used
inappropriately.

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Date of update: 5/25/98

Concomitant Administration of Viagra and Organic Nitrates
     (Medwatch) In this Dear Doctor letter, Pfizer Inc. notifies health
     professionals -- especially emergency physicians -- of concomitant
     administration of Viagra and organic nitrates.
      http://www.***.com/

FDA DETERMINES CHOLESTIN TO BE AN UNAPPROVED DRUG
     (Medwatch) FDA decided that Cholestin, a product promoted as a dietary
     supplement intended to affect cholesterol levels, is not a dietary
     supplement, but is instead an unapproved drug under the terms of the
     Federal Food, Drug, and Cosmetics Act.
      http://www.***.com/

Sildenafil for Erectile Dysfunction
     (MSB) Sildenafil (Viagra) recently has been approved for the treatment
     of erectile dysfunction in men. This article explains how it works,
     provides clinical tips, and points out the dangers of concomitant use
     with certain other {*filter*}.
      http://www.***.com/

Risedronate for Paget's Disease of the Bone
     (MSB) Risedronate (Actonel) recently has been approved by the FDA for
     use in Paget's disease of the bone. This article explains how it works
     and provides clinical tips.
      http://www.***.com/

Tolterodine for the Management of Overactive Bladders
     (MSB) Tolterodine (Detrol) is indicated for treatment of patients with
     an overactive bladder with symptoms of urinary frequency, urgency, or
     urge incontinence. This article explains how it works and provides
     clinical tips.
      http://www.***.com/

Can Chondroitin Sulfate Solution Reduce Snoring?
     (MSB) This article reports the results of a study to determine if
     chondroitin sulfate -- a long-acting tissue-coating agent -- could
     effectively reduce snoring.
      http://www.***.com/

Viagra Meets 'Ultimate Goal' For Erectile Dysfunction Treatment
     (DrugPR) Pfizer Inc's Viagra (sildenafil citrate) is the only approved
     therapy that meets American Urological Association treatment standards
     for erectile dysfunction, according to the results of two major
     clinical trials summarized in this press release.
      http://www.***.com/

Viagra (Sildenafil) Appropriate Use Guidelines Reiterated
     (DrugPR) In this press release Pfizer Inc reiterated guidelines for the
     appropriate use of Viagra (sildenafil citrate), its {*filter*}medication for
     the treatment of erectile dysfunction (ED) now available in the United
     States by prescription.
      http://www.***.com/

Xeloda (Capecitabine) Approved For Metastatic {*filter*} Cancer
     (DrugPR) In this press release Hoffmann-La Roche Inc. announced that it
     has received accelerated approval from the U.S. cooking.net">food and Drug
     Administration for Xeloda (capecitabine), an {*filter*}anticancer drug for
     patients with metastatic {*filter*} cancer whose tumors are resistant to
     standard chemotherapy with paclitaxel and an anthracycline-containing
     regimen.
      http://www.***.com/

Evista (Raloxifene) Osteoporosis Trials Show Reductions in {*filter*} Cancer
Incidence
     (DrugPR) Evista is a new drug for the prevention of osteoporosis in
     postmenopausal women, reduced by more than 50 percent the incidence of
     {*filter*} cancer among women enrolled in ongoing osteoporosis studies,
     according to data being presented at the annual meeting of the American
     Society of Clinical Oncology.
      http://www.***.com/

Statement Regarding Raloxifene Data Presented at American Society of
Clinical Oncology Meeting
     (DrugPR) Data presented at the American Society of Clinical Oncology
     (ASCO) meeting in Los Angeles suggest raloxifene may someday join
     tamoxifen in a new class of {*filter*} with the potential to prevent {*filter*}
     cancer.
      http://www.***.com/

Herceptin, First Monoclonal Antibody to Slow Metastatic {*filter*} Cancer
     (DrugPR) The use of a monoclonal antibody has slowed the progression of
     cancer and increased tumor shrinkage in women with metastatic {*filter*}
     cancer, according to Rush researchers who presented their finding at
     the annual meeting of the American Society of Clinical Oncology.
      http://www.***.com/

NEW TAXOL REGIMEN SIGNIFICANTLY INCREASES A WOMAN'S CHANCES FOR {*filter*}
CANCER CURE
     (DrugPR) According to this press release, which summarizes data
     presented at the annual meeting of the American Society of Clinical
     Oncology, the addition of the anti-cancer drug TAXOL (paclitaxel) to
     standard chemotherapy dramatically increases the chances of a cure for
     women with {*filter*} cancer.
      http://www.***.com/

--
John Mack

webmaster, PharmInfoNet ( http://www.***.com/ )