Pharmaceutical

images PharmaceuticalsInformation 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 prescription information about the brand name liquid or tablet Levocarnitine - 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. The phone number is 1-800-447-0169.

Other links about carnitine info and supplementation include MayoClinic and eMedicine.
Because of a variety of reasons (ie., child will not take the medicine), some families have contacted Compounding Pharmacies for assistance.

If you're having trouble with coverage of your medications check out these 2 sites -  Patient Assistance Programs and Needymeds.org.

The liquid and tablet generic drug brand for Levocarnitine was approved for distribution by the FDA several  years ago. Please note that the generic drug form, as well as the brand name Carnitor®, needs a Prescription from the Dr.  Additionally, the generic authorized by Sigma-Tau is available from Hi-Tech Pharmacal  - as an oral solution and tablet .

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.'

BE ON ALERT: MAJOR DIFFERENCES BETWEEN THE DRUG CARNITOR® AND THE HEALTH FOOD VERSION OF CARNITINE

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. (and more recently also the generic drug levocarnitine by Hi-Tech Pharmacal/Akorn). 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 multidimensional treatment for many of the FODs (along with special dietary requirements and/or supplements) is the use of the drug Carnitor® or Levocarnitine, and NOT the health food version of carnitine.

The Prescription drugs (i.e., Carnitor®) went 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® (as well as the generic drug, Levocarnitine) 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. 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, as well as the generic drug brand) 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/adults with FODs? We know Carnitor® and the Generic Drug Brand are SAFE and EFFECTIVE DRUG products doing what they are designed to do ~ help our FOD children and adults!

Deb Lee Gould, MEd, Director, FOD Family Support Group

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.