Off-label use of anti-cancer drugs in India: To be or not to be!

Gota, Vikram; Patial, Pankaj

doi:10.4103/0973-1482.80455

Cited by 12 publications

(16 citation statements)

References 6 publications

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“…[17] This has led to off-label promotion based primarily on covert marketing techniques ultimately leading to many controversies. For example, in the USA before 1997, marketing of off-label uses by pharmaceutical companies was illegal.…”

Section: Perspective Of Regulatory Agenciesmentioning

confidence: 99%

“…The EMEA too is sympathetic to off-label practice by actively endorsing clinical trials of off-patent drugs for off-label uses, notably in the pediatric population. [17] Recently, France came up with regulations for prescriptions of medicines for non-regulatory approved indications as well. [3]…”

Section: Perspective Of Regulatory Agenciesmentioning

confidence: 99%

“…[25] Despite the IMA's positive opinion about off-label prescribing, any rule about the off-label prescribing is yet to come in India. [17] Many are of the opinion that authorizing off-label prescribing will set a bad example because of ignorance of patients and domination of pharmaceutical companies on prescribing patterns in India. [25]…”

Section: Perspective Of Regulatory Agenciesmentioning

confidence: 99%

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Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities

Gupta¹,

Nayak²

2014

Journal of Pharmacology and Pharmacotherapeutics

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Off-label prescribing of medicines is prevalent worldwide because it gives freedom to physicians to apply new therapeutic options based on the latest evidence. Although physicians may lawfully prescribe approved drugs for any use consistent with available scientific data and proper medical practice, but unfortunately, usually this is done without adequate scientific data. Often, when the best available therapeutic option fails, patients demand new approach or new treatment which ultimately leads to off-label uses. Major concerns about efficacy and safety have been raised by inappropriate use of off-label drugs because it leads to drug being used without risk-benefit analysis by the regulatory agency. Although the regulatory approval process requires ample proof of efficacy and safety for granting approval for specific indications of prescription drugs but unfortunately, more clarity is required about regulations governing off-label use of medicine. Above all because of the financial aspects involved it is highly impractical to expect that pharmaceutical companies will restrict or stop off-label promotion. Off-label use might be compared to double-edged sword which might be very useful for some patients while it can also expose them to unrestricted experimentation, unknown health risks, or ineffective medicine. Hence, there is an urgent need for guidance to encourage proper off-label use of medicine by the distribution of scientifically valid and authentic information from the pharmaceutical companies. In fact, few countries such as the USA and France have taken an initiative and have come up with the regulations about off-label use of medicine.

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Section: Perspective Of Regulatory Agenciesmentioning

confidence: 99%

Section: Perspective Of Regulatory Agenciesmentioning

confidence: 99%

Section: Perspective Of Regulatory Agenciesmentioning

confidence: 99%

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Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities

Gupta¹,

Nayak²

2014

Journal of Pharmacology and Pharmacotherapeutics

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“…nın 10963 kanser hastası üzerinde yaptıkları çalışmada post-kemoterapi iskemik inme insidansının %0.137, iskemik inme ile komplike olan kemoterapi siklusu sıklı-ğının ise %0.035 olduğu gösterilmiştir. [6] Bu konuda en çok suçlanan ajan olan sisplatin [7] günümüzde metastatik testiküler ve over kanseri, mesane kanseri, baş ve boyun kanserleri, ösofagus, mide ve anal kanal kanserleri, lenfoma, akciğer kanseri gibi birçok malignensinin tedavisinde yaygın olarak kullanılmaktadır. [8] Sisplatin tedavisi uygulanan ürotelyal karsinomalı 271 hasta ile yapılan bir çalışmada 35'inde vasküler olayların görül-düğü, ancak bunların sadece üçünde iskemik inme tespit edildiği rapor edilmiştir.…”

Section: Discussionunclassified

Acute Ischemic Stroke Developing in the Course of Cisplatin Treatment of Small Cell Lung Cancer: A Case Report

Yılmaz¹,

Güngör²,

Sahlepçi³

2014

J Kartal TR

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“…On the other hand, there is a need for protecting patients by ensuring safety and efficacy of the drugs which are in the market and preventing their misuse, which is only possible by imposing rules and regulations [12].…”

Section: Off-label Use and Clinical Experimentationmentioning

confidence: 99%

Ethical and Legal Aspects of Conducting Clinical Trials in Alcohol Withdrawal Syndrome

Reddy

2014

JCDR

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Off-label use of anti-cancer drugs in India: To be or not to be!

Abstract: Very limited off-label prescribing was found in oncology practice in India. Since off-label use offers several advantages, judicious use of this practice should be encouraged among the oncologists.

Cited by 12 publications

References 6 publications

Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities

Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities

Acute Ischemic Stroke Developing in the Course of Cisplatin Treatment of Small Cell Lung Cancer: A Case Report

Ethical and Legal Aspects of Conducting Clinical Trials in Alcohol Withdrawal Syndrome

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