Average price of gabapentin in the U.S. It was also reported that being sold as an "antibiotic" or "antibiotic with anabolic" properties (the actual difference was the fact that gabapentin had just been approved by the FDA and had not been approved for use as an "antibiotic"). The FDA subsequently added other ingredients to the package of a generic variation the drug, including a dose of the active ingredient. For a period of months (June 2005 to March 2006) there was a significant and continuing increase in sales of gabapentin the U.S., resulting in an average price of $10.84 per pill—nearly twice what it was in 2003. However, at the same time manufacturer of drug, Shire, announced that it was halting the promotion of gabapentin and that they were looking for new opportunities. The market opportunity was for it to be marketed as an adjunct "antibiotic" for cancer. In the U.S. general, prescriptions for gabapentin increased from a low of about 3,000 cases per year in 2004 to a high of over 25,000 prescriptions per year in 2006. At the time of FDA's actions, a small number of physicians had initiated a marketing push to physicians and others for the drug, "antibiotic" marketing that they were seeking seemed to be a way create market niche for the drug. According to Shire, the company began advertising drug as an antibiotic for cancer in late 2005, and this resulted in a reduction generic prices many areas of the U.S. and an increase in sales. Shire has indicated that they will discontinue the antibiotic marketing activities in 2007. The FDA's action A number of years ago, in its final rule approving gabapentin as an "antibiotic" (see below), the FDA noted that: It is important to note that the current labeling provides patient no indication of the therapeutic potential gabapentin and that the patient is not in fact receiving a therapeutic amount of the drug. Thus, drug itself has no approved benefits and risks for use in individuals with cancer, and the agency has concerns that this labeling is misleading because it likely to mislead patients into believing that the drug is effective when it not. [emphasis added] However, the FDA also stated that it would not make changes in the approved labeling or statements for gabapentin without specific approval from the agency. When agency refused to approve the label changes, Shire announced that it would voluntarily withdraw the "antibiotic" label for drug, and discontinue marketing activities in order to avoid further legal action. In 2007, the FDA released its final rule, which approved the following claims: Gabapentin may treat cancer of the digestive tract in patients who have not been treated by other therapies. The drug has not been evaluated in patients with cancer who are taking other medications. It has not been evaluated in patients with cancer who suffer from chemotherapy or severe infections with bacteria such as Clostridium difficile or methicillin-resistant Staphylococcus aureus. (emphasis added) (source) The agency noted that some physicians were making such claims as "a painless treatment for gastrointestinal cancer," and asked Shire to submit evidence show that the claims had reasonable certainty of being true: The Agency is concerned that labeling for [gabapentin] includes marketing claims which are intended to be made promote the drug for a condition or disease unrelated to its intended uses, and which are not supported by sufficient clinical evidence. The label's claims are likely to mislead a reasonable consumer, and the labeling is likely to be misleading a patient, because it is likely to misinform that individual. For example, the "antibiotic" claim relates to a condition or disease not caused by the use of drug and not responsive to the therapeutic use of drug. Thus, the claim is likely to mislead consumers because it is likely to mislead consumers. It is therefore necessary that the marketing claims be supported by adequate clinical evidence to justify their use. In order to support the claims in these cases, [the company] would have to show sufficient clinical evidence support the statement that [the drug] has the effect physician is] claiming for it, and such evidence is not presently available to the agency. According to Shire the company is in process of completing all FDA documentation, reviewing the FDA's proposed final determination, and preparing the appropriate documents to support claims. What can you do about it? While these products may seem like a good investment on the surface, it's important to remember the FDA's warning from 2004 final rule: you may be buying a canada prescription drug prices treatment that could be misused by a physician.
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