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Off label use of medications
In the United States , the Food and Drug Administration (FDA) requires drug companies to conduct clinical trials to prove safety and efficacy so the drug can be approved and taken to market as an approved drug. The drug’s manufacturer and FDA agree on specific drug package insert.( can be found inside the box containing the medications) The dose of the medication, the route and the indications for usage are included on the drug’s label. There is more information in the drug’s package insert. Once the FDA approves a drug for prescription use, they do not attempt to regulate the practice of medicine. The physicians are allowed to make decision based on their best judgment how to use the medication. There is no requirement to adhere only to the published indication for the specific drug. It is legal in the United States and countries over the world to use drugs off-label, namely use the medications for other medical indication that are not listed in the documents of the FDA , when the drug is approved. Some drugs are used more frequently off-label than for their original, FDA-approved indication.
In a study by the U.S. General Accounting Office it was found that about one-third of all drug administrations to cancer patients was off-label. More than a half of cancer patients received at least one drug for an off label indication. It is quite common to find that the standard of care for a particular cancer type and stage involves the off-label use of drugs that were not approved by the FDA specifically for the indication the drug is used. The best example is the usage of LHRH Antagonists (Lupron, Zoladex and others) in all stages of disease, while the label of use inn the FDA documents indicate that these drugs should be used only for Advanced Prostate Cancer Disease only. Yet these drugs are prescribed in an off-label manner to all stages of disese.
In the United States, FDA regulations permit physicians to prescribe approved medications for other than their intended indications. Pharmaceutical companies , on the other hand are not allowed to promote a drug for any other purpose without formal FDA approval. When a drug is approved for sale for one purpose, physicians are free to prescribe it for any other purpose that in their professional judgment is both save and effective and not limited to the official approved indications. This practice of using off label-use drugs is most commonly occurs with older , generic medication that found new uses but have not had the formal (and costly) applications and studies requited by the FDA to formally approve the drug for the new discovered indications. It is not unusual to find medical literature to support the off-label use.
The Noscapine as a substance listed as over the counter list of the FDA. The drug was approved world wide as a drug many years ago. It was approved for use as a medication given to control cough. There is information about the safety of the Noscapine after many years of using it for the specific indication for cough. Once It was found by different researchers that it has anti-cancer activity in the lab animal models, the interest in Noscapine peaked up the interest of physicians and patients alike. It did not go unnoticed that the drug is quite safe in larger doses as seen in a current clinical study. Patients with Prostate Cancer like to take oral medications. When Noscapine is found in the lab to have anti cancer activity with similar mode of action as the most popular chemotherapy agents, it creates excitement in the heart and minds of many patients. The mechanism of action for the most common Chemotherapy agent given to prostate cancer patient is the Taxotere is shared with the Noscapine. This is the Anti-Tubulin effect that disrupts division of cancer cells
Here is where the Prostate Cancer Research and Education finds itself with the Noscapine.. After a presentation By the Medical Director of the Prostate Cancer Research and Education Foundation, a lot of interest was generated by patients who became very eager to know more about it and even desiring to take Noscapine on their own. The poster which was presented in Vail, Colorado in the 17th International Prostate Cancer Update on Feb 15, 2007 showed that Noscapine has anti prostate cancer tumor activity and anti metastatic properties.
The Goal of the Foundation is to further basic research and facilitate clinical studies with Noscapine. With that goal in mind, Dr Barken contacted leaders of thought in the Oncology community to come up with plans to write clinical studies and evaluate the cost of these studies with intention to get funds to launch the clinical research. Knowing that patients might get hold of Noscapine on their own Dr Barken calls for caution and restratint. Dr Barken encourages all users of Noscapine regardless of how they obtain the substance , to register on a Medical History Graph to record their clinical experience. It would be of utmost importance to centralize the national and international information on Prostate Cancer and Noscapine, so we can learn about the activity of noscapine whether it is coming from participants in studies or being use as off label drug. The registration on the web based data based is user friendly and gives the user of the program a one page print out of all the medical history , tests results , imaging tests, all on one colorful page. Dr Barken encourages each individual not to take the over the counter medication without involving their treating physicians and be extremely cautious with the dose and form of Noscapine they take.
To that means, the Prostate Cancer Research and Education created the www.noscapine.org a web site to function as clearing house of information, sharing clinical date and report experiences. The Foundation hopes to study the data bases that will be available to get answers regarding the efficacy and safety of Noscapine.
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