Serc, Betaserc, Vasomotal, Vertiserc, Vertin,
Urutal, and Agiserc are brand names of Solvay, S.A., for the drug
betahistine hydrochloride (sometimes called betahistine
dihydrochloride or betahistine dyhydrochloride; commonly called simply
"betahistine"). Serc is a histamine analog.
The purpose of Serc in treating
Meniere's Disease is as a vasodilator: to dilate blood vessels to
increase the flow of blood to the vestibular structures of the inner
ear.
One
study, abstracted at PubMed, concludes that betahistine induces
increases in vestibular blood flow, and that the findings support the
potential use of betahistine for treatment of vestibular disorders
which may be caused by compromised circulation -- but that's just one
study.
How
effective is Serc?
Serc in the treatment of Meniere's
Disease has been and is controversial; it has its supporters, who find
relief from the symptoms of Meniere's disease, and its detractors, who
find that it is unhelpful.
Famous Meniere's doctor
Timothy Hain has
authored a comprehensive
review that answers many of the commonly asked questions about
Serc (betahistine).
This
review is a must read for all Meniere's Disease patients.
Does any authoritative U.S. doctor
prescribe it? (Yes -- Dr. Hain does.)
As Serc is a histamine agonist, would
it make sense to be treated simultaneously with Serc and an
antihistamine (anti-histamine) such as meclizine hydrochloride (Antivert)?
("Perhaps.")
Has Serc been proven effective -- or is
it a placebo? ("[T]he jury is still out.")
The
Official Policy on Serc from the FDA (.pdf, 377 KB). (Download free Adobe Acrobat Reader software for .pdf files
here.) Serc and other brands of "betahistine"
are widely prescribed for Meniere's Disease in Europe, Canada, Mexico,
Australia, and elsewhere around the world, but no brand of
betahistine, including Serc, is approved for sale within the U.S.
There has been much speculation in the patient community about the
whys and wherefors of this situation. Reader Ed Lopez contacted
his Representative in the U.S. Congress and asked about Serc.
His Representative contacted the U.S. Food and Drug Administration
(FDA) and obtained a response dated August 20, 1998. Ed's
Representative in turn wrote to Ed and provided a copy of the FDA response, which Ed provided to the
MDIC. Many thanks to Ed! You may email your own thanks
to Ed at EdLopez12@aol.com.
In generic, compounded, form, Serc
(betahistine hydrochloride) is available by prescription from
compounding pharmacists in the U.S.
Compounding pharmacist John
Yakim has provided the following
information to the MDIC
While the manufactured drug brand
Serc is not available in the U.S., it is lawful for doctors to
prescribe the compounded form of "betahistine." It is lawful for
compounding pharmacists to fill such prescriptions. A compounding
pharmacist is one who actually mixes chemical compounds to create the
drug prescribed. Most pharmacists in the U.S. today merely dispense
drugs that are already manufactured.
For example, a U.S. doctor could
prescribe "compounded betahistine," (strength in number of
milligrams), (quantity), (directions for use), and a compounding
pharmacist could fill the prescription. U.S. insurance companies
may -- or may not -- cover compounded betahistine.
A prescription may be filled by mail
order in the U.S., so long as a physician licensed in the U.S. writes
the prescription, according to John. John is willing to discuss this
issue with both patients and physicians.
John can be reached by email at jyakim@aol.com or by
telephone in Pittsburgh at 412-372-3700 or (toll-free)
1-800-368-3112. The pharmacy is located at 412 Broadway,
Pitcairn, Pa. 15140
We don't know whether it is legal for U.S.
residents with prescriptions to order Serc by mail from Canadian
pharmacies. Interested patients might be able to obtain further
information by calling the Canadian pharmacies and, of course, the
FDA.
FDA activity in recent years.
We haven't seen anything from the FDA more
recent than November 14, 2002. However, you can click
here to search up-to-date.
November 14, 2002 -- The FDA issued a
notice that Pharmacy Compounding Advisory Committee is terminated,
which was published in the Federal Register November 14, 2002.
The termination was a consequence of a court decision that invalidated
the legal authority for establishing the committee.
February 21, 2001.
Reader Ed Lopez
reports that the FDA reports no news on the Serc
front. Email response from the FDA to an inquiry from Ed:
"02/21/2001 -- Thank you for your message to the
Division of Drug Information in the Center for Drug Evaluation and
Research (CDER), one of the five centers within the Food and Drug
Administration (FDA). The Proposed Rule for List of Bulk Drug
Substance That May Be Used in Pharmacy Compounding is not yet
finalized, and the information on betahistine remains the same:
http://www.fda.gov/cder/fdama/pclist.txt."
May 7, 1999.
The Pharmacy Compounding Advisory Committee of the
U.S. FDA
recommended that betahistine be placed on the FDA's bulk
compounding list. Supporters hope that will make U.S.
physicians less reticent to prescribe it. Thanks to
contributor Ed Lopez for
this information.
March 23, 1999. The advocacy group Public Citizen submitted
comments to the FDA in opposition to the addition of a number of drugs
to the bulk compounding list, including betahistine. Here are
the
comments (betahistine is #21).
January 7, 1999. Continued compounding of betahistine in the U.S.
will be subject to a decision of the FDA on whether to include it on a
"bulk compounding list" currently under development. If the FDA
includes betahistine on the list, it will continue to be available in
the U.S. by prescription. If the FDA does not include
betahistine on the list, it will no longer be lawful to compound it.
Until a decision is made one way or the other, betahistine may
continue to be compounded by prescription. See the FDA's proposed rule.
Israeli Company Seeks FDA Approval for
Betahistine as Anti-Obesity Drug.
According to
this December 1, 2005, report on the Israeli business news
site Globes Online, an Israeli company is seeking FDA approval to
market "Betahistine" for treatment of obesity as early as 2007.
We take "Betahistine" to mean a branded form of the generic drug
betahistine hydrochloride (or betahistine dihydrochloride or
betahistine dyhydrochloride), commonly known by the brand name Serc,
the drug frequently prescribed in Canada, Australia, European and
other countries to treat Meniere's Disease. The brand name drug
Serc was once available in the U.S., but FDA approval was later
withdrawn. The generic drug betahistine hydrochloride is
currently available in the U.S., but only as compounded by a
"compounding pharmacy," which has the effect of making the drug less
widely known and prescribed that it would be as an FDA-approved
branded drug. See our extensive coverage below.
When FDA approval is given to use a drug for one purpose, the drug may
lawfully be prescribed "off-label" for another purpose.
Therefore,
this report gives rise to speculation that "Serc" by another
brand name may again become widely prescribed in the U.S. The
effectiveness of Serc as a treatment for Meniere's Disease is
controversial.
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