BOTOX® was FDA-approved more than a decade ago for treating eyelid twitching, crossed eyes, and severe neck and shoulder spasms. However, prior to FDA approval in 2002 for a cosmetic indication, doctors also used BOTOX® off-label (a common and legal practice) for cosmetic purposes, such as treating facial wrinkles.
Some say that PCDC for lipo-dissolve is considered off-label use. This is an inaccurate statement because neither phosphatidylcholine nor deoxycholate (compounded to make PC/DC) have been approved by the FDA as active ingredients for any use. In a statement issued by the FDA, the agency states, "We are not aware of any phosphatidylcholine injectable products or sodium deoxycholate injectable products that caould be used 'off-label' in 'lipodissolve' procedures." The following outlines the differences between BOTOX® and lipo-dissolve to illustrate how PCDC has not undergone any of the necessary testing for FDA-approval and therefore its potency, purity, safety, and efficacy cannot be confirmed.
| BOTOX®** | Lipo-dissolve | |
| Main component | Botulinium Toxin Type A | Phosphatidylcholine and deoxycholate (PC/DC) |
| FDA-Approved | Yes. | No. |
| Pre-Clinical Data (Animal Testing) | Yes. Toxicity testing in animals has been done to identify undesirable effects of the compound. This is done before any studies are conducted in humans. | None. |
| Pharmacologic Studies | Yes, studies explored the compound's mechanism of action, i.e. how it works in the body, as well as its effect on practically all body systems. | None. The drug's mechanism of action is a theory. There have been no well-controlled studies to confirm how the body clears the fat cells that are broken down. |
| Pharmacokinetic Studies | Yes, studies demonstrated how the body effects the drug, such as how the drug is absorbed, distributed, metabolized, and excreted from the body. | None. Proponents of lipo-dissolve believe the drug is eliminated through the urine but no studies or research has been done to confirm this. |
| Toxicology Data | Yes. Toxicology data to illustrate the effects of long-term use was collected for continued administration of 12 months or more. | None. Effects of long-term use are unknown. |
| Prospective placebo controlled studies | Yes. An Investigational New Drug Application (IND) was filed before drug studies could be conducted in humans. The IND process ensures that there is sufficient scientific and clinical data on the drug's safety and efficacy. | None. No prospective, well-controlled studies as required by the FDA for drug approval have been conducted. The only studies that advocates of lipo-dissolve rely upon are retrospective studies which offer limited data and are based solely on historical observations. |
| Dosing and technique | Dosing and technique determined by well-controlled studies under FDA oversight. Drug formula and method of administration is standardized. | Dosing and technique of injection is determined by individual investigators. Neither the drug formula nor method of administration is standardized, as is required for FDA-approved drugs. |
| Safety monitoring/reporting requirements | Yes, law requires ongoing monitoring. Any reports of adverse reactions to the drug are subject to very strict FDA reporting requirements. | No safety monitoring or mandatory reporting of adverse events. |
| FDA oversight in manufacturing | Yes. Current Good Manufacturing Practice (cGMP) regulations are enforced which require manufacturers of BOTOX® to take a quality approach in order to minimize instances of contamination, mix-ups, and error. This protects the consumer from purchasing an ineffective or adulterated product. Failure of manufacturers to comply with cGMP regulations results in serious consequences. | None. There are no current Good Manufacturing Practice (cGMP) regulations for PC/DC manufacturing. Therefore, the identity, strength, safety, and purity of the drug cannot be confirmed. |
| Sourcing | Yes. Source of raw materials is outlined through a certificate of analysis. Incoming raw materials are tested for quality control (purity, concentration, stability). Raw material vendors are subject to periodic audits as a part of cGMP. | No. Source and quality of raw materials is unknown and uncontrolled. Identity, country of origin, purity, concentration are not easily ascertainable and therefore safety cannot be established. |
| New Drug Application (NDA)-application to sell the drug in interstate commerce | Yes, the FDA determines if the collected and analyzed data is enough to establish the safety and efficacy of the new drug. The NDA for BOTOX® was first approved for two eye muscle disorders in 1989 and has since been approved for other medical and cosmetic uses. | None. No data from laboratory, animal, or human clinical studies has been brought forth to the FDA. PCDC is currently being sold without FDA-approval. |
| Off-label use | Yes, approved products are sometimes used by a licensed practitioner for uses other than those stated in the product label. BOTOX® Cosmetic is used by physicians to treat facial wrinkles other than those specified by the FDA. | No. Lipo-dissolve use CANNOT be considered off-label use because phosphatidylcholine and deoxycholate are not FDA-approved as active ingredients for any use |
**BOTOX® is a registered trademark of Allergan Corporation. For more information, visit www.allergan.com