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The article below first appeared
in the January, 1998 Communication Network newsletter.
We will add
new pharmaceutical information as it becomes available.
Information
in this section is made available to help individuals make informed
decisions in conjuction with their health care
professionals.
Please
note: If your Physician needs more information about L-carnitine
(Carnitor®), or the newly introduced sugar free oral solution of Carnitor®, dosages, or has other questions, please have him/her
contact Sigma-Tau Pharmaceuticals, Inc.,
and ask for the Medical Information Department or state that he/she
has a question about carnitine. This service is available around
the clock 7 days a week. The phone number is 1-800-447-0169.
Other links explaining carnitine supplementation include MayoClinic.com and Rxcarecanada.com.
New
Drug Information: A new L-carnitine (Generic Drug Form) has been approved for distribution by the FDA. Click on 'Levocarnitine.' Please note
that this generic drug form by Rising
Pharmaceuticals, Inc. (as well as the brand name Carnitor®)
needs a Prescription from the Dr.
Please also
note that the generic DRUG form of L-carnitine is NOT
the same as the over-the-counter carnitine supplements often bought
at healthfood stores ~ those products are NOT regulated or
approved by the FDA to be used for metabolic disorders (read the
article below for further information). The term 'generic form of
a drug' should NOT be used interchangeably with the term
'over-the-counter supplement.'
Over the
last several years I have spoken with several FOD families that
were originally advised by their physicians, pharmacists, or HMOs
to substitute the health food version, or nutritional supplement
of carnitine, for the FDA-approved prescription drug product,
Carnitor®,
sold by Sigma-Tau
Pharmaceuticals, Inc. When I speak with FOD families, I
try to impress upon them that there are MAJOR DIFFERENCES between
the regulatory requirements of these products, and that for the
most part, today's standard treatment for many of the FODs (along
with special dietary requirements and/or supplements) is the use
of the drug Carnitor®, and NOT the health food version of carnitine.
The prescription
drug Carnitor® has gone through rigorous pre-clinical (animal)
tests, as well as clinical trials which demonstrated that the product
was SAFE and EFFECTIVE for PARTICULAR DISEASE STATES or CONDITIONS.
Additionally, the manufacturer had to submit to the Food and
Drug Administration (FDA) a complete chemistry, manufacturing, and
controls section of the prescription drug product, as well as samples
of the product. The FDA granted marketing approval to Sigma-Tau
Pharmaceuticals, Inc., for the treatment of primary carnitine deficiency
in 1986 and for secondary carnitine deficiency of genetic origin
in 1992.
Even though
Carnitor® is commercially available, the manufacturer must
continue to comply with additional regulatory requirements. If
there is any change in the chemistry or manufacturing processes
of the drug, any change in the labeling of the product, or any adverse
experiences associated with the use of the drug, the FDA MUST be
notified. Finally, the manufacturer of Carnitor® is required
to comply with FDA's Current Good Manufacturing Practices (CGMP)
regulations which set forth minimum methods, facilities, and controls
used in the manufacturing, processing, and packing of Carnitor®.
On the other
hand, the manufacturers of the health food store or nutritional
supplement version of carnitine, DO NOT GO THROUGH SUCH RIGOROUS
PRE-CLINICAL AND CLINICAL TESTING, NOR ARE THEY REQUIRED TO CONTINUALLY
MEET SPECIFIC REGULATORY STANDARDS. Although the manufacturers
of the health food version of carnitine must comply with the FDA's
CGMP regulations for FOODS, those requirements are MUCH LESS stringent
than for the manufacturing and sale of prescription DRUGS like Carnitor®.
Thus, the manufacturers are PREVENTED BY LAW FROM MAKING THERAPEUTIC
CLAIMS for their product because the EFFICACY (EFFECTIVENESS) FOR
USE IN THE TREATMENT OF DISEASE HAS NOT BEEN ESTABLISHED.
Additionally,
despite the FDA's regulations for foods, if the health food carnitine
manufacturer's facility is located OUTSIDE the U.S. (i.e. Japan
& Switzerland), the FDA does not routinely inspect those facilities.
Therefore, safety issues for the bulk form of carnitine are in question
for these facilities. Our government checks the bulk carnitine
for health food use at the U.S. border and has issued an IMPORT
ALERT WARNING on some mixtures of carnitine as UNSAFE.
ONLY
the L-carnitine form (Carnitor® contains ONLY L-carnitine) is
naturally occurring and SAFE. It should also be noted that the
DL-carnitine, sold in health food stores as Vitamin B, competitvely
inhibits L-carnitine and can cause a deficiency, as well as possible
toxicity and myasthenia gravis-type symptoms.
In a study
comparing the pharmaceutical product of L-carnitine with 12 health
food products claiming to contain L-carnitine, it was found
that the disintegration rates of tablets and capsules were
UNACCEPTABLY LONG for 7 of the 12 health food brands tested.
Individuals using most of these products would receive LESS than
60% of the advertised amount of L-carnitine.
The pharmaceutical
product, on the other hand, MET ACCEPTABLE STANDARDS FOR BOTH DISINTEGRATION
AND CONTENT. The researchers stated that the inconsistent
behavior of the non-prescription products in the disintegration
test indicates a LACK OF QUALIITY CONTROL in the manufacturing
process.
FOD families
and professionals need to be aware of these MAJOR DIFFERENCES
because the health food store and nutritional supplement version
of carnitine is INAPPROPRIATELY BEING USED FOR THE TREATMENT OF
METABOLIC DISEASES. Thus, FOD individuals may be at high
risk for possible complications if a metabolic crisis should
occur.
WHY RISK
THE SAFETY and THE LIVES OF OUR CHILDREN? WE KNOW CARNITOR®
IS A SAFE and EFFECTIVE DRUG PRODUCT ALREADY OUT THERE DOING WHAT
IT'S DESIGNED TO DO ~ HELP OUR CHILDREN!
Deb Lee
Gould, Director, FOD Family Support Group
January 1998 Communication Network
References
Coley, C.
& Legino, R.L. (1997). Carnitine Deficiency: Levocarnitine Focus.
Reprinted with permission from The Kansas DUR Bulletin in the Exceptional
Parent, June 1997, p. 45.
Food & Drug
Administration, Dept. of Health and Human Services. Letter from
Allen B. Duncan, Acting Associate Commissioner for Health Affairs,
on the regulatory status of Carnitor®.
Millington,
D. S. & Dubay, G. (1993). Dietary supplement L-carnitine: Analysis
of different brands to determine bioavailability and content. Clinical
Research & Regulatory Affairs, 10(2), 71-80.
Additional
Reference Articles:
Campos, Y. et al. (I 993). Plasma carnitine insufficiency and effectiveness
of L-carnitine in patients with miitochondrial myopathy. Muscle
& Nerve 16, 150-153.
Gladwell,
M. (Sept 5, 1990). 13 Amino acids on sale without FDA approval.
The Washington Post, p. A 16.
Pons, R.
and DeVivo, D.C. (Nov 1995). Primary and secondary carnitine deficiency
syndromes. Journal of Child Neurology, 10 (Supplement 2), 2S8-2S24.
Roe, C.R.
(1997--in process of publication). Clinical experience with camitine
deficiency. Contact Dr. Roe for article information.
Roe, C.R.
et al. (1991). Therapeutic applications of L-camitine in metabolic
disorders. In Treatment of Genetic Disorders, Edited by Desnick,
R.J., Churchill-Livingstone, New York, p. 69.
Van Hove,
JLK et al. (I 994). Intravenous L-carnitine and acetyl-L-carnitine
in Medium Chain acyl-Coenzyme A Dehydrogenase Deficiency and Isovaleric
Acidemia. Pediatric Research, 35, 96-101.
On behalf of all of our FOD
Families, I would like to thank Sigma-Tau for their ongoing
financial support of our Group. It is through their generosity (as
well as from our FOD Family donations) that we are able to provide
our printed and online newsletters and FOD Family Packets for our
new families. Thank you from all of us! We are truly 'All in This
Together!'
Deb Lee
Gould, Director, FOD Family Support Group
Visit
Sigma-Tau's Website:
Email: Sigma-Tau
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