Advice Pool - Health and Fitness

Persons with addictive disease continue to use their substances in the face of a long history of adverse consequences in significant areas of their lives, including medic

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

al problems, legal problems, relational problems, and employment problems. The drive to use often is stronger than one's love for a significant other or a child; stronger

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

than loyalty to an employer or a friend; and stronger than one's values or even spiritual tenets. Persons with addictive disease continue to use long after any rational

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

individual would choose to do so. This article provides a brief summary of one factor, among many, involved in the power of addictive disease: the role of fear of withdra

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

wal.

Fear of withdrawal is one of the fundamental forces at play in the power of addictive disease, be it alcoholism or drug addiction. Withdrawal in this context is def

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ined to include the physical signs and symptoms of withdrawal usually associated with abrupt cessation of use of a substance, after chronic use to the point of developmen

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

t of tolerance and tissue dependence. For example, here are some of the signs and symptoms associated with withdrawal after physical dependence on alcohol: cravings for a

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

lcohol, tremors, sleeplessness, diarrhea, anxiety, sweating, loss of appetite, up to hallucinations and seizures in severe cases.

The withdrawal referred to here also em

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

braces the symptoms of a more subjective nature associated with psychological dependence upon a substance, with obsessive thoughts and preoccupation with the substance. A

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

lso included within the withdrawal definition is the apprehension felt by the recovering person that he/she will now have to face all of the pain and vicissitudes of life

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

without the drug used as a primary coping mechanism for years. The individual will be acutely aware of the fact that recovery will require facing the pain and consequenc

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

es of active addiction (e.g., harm caused to loved ones), again without his/her drug. Often the pain, guilt, remorse, and self-hatred emotionally overwhelm the individual

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

, triggering the coping response of the addict or alcoholic, namely, use of his/her drug of choice.

Withdrawal from physical dependence on opiate drugs such as Vicodin (

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

hydrocodone) or OxyContin (oxycodone)is usually NOT a life threatening experience (absent medical complications), with symptoms similar to a bad case of the flu. Withdraw

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

al from physical dependence on stimulants such as cocaine or methamphetamine, or Ritalin or Adderall, can be serious especially in the presence of medical complications,

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

and the depression that can accompany cessation of use can be severe; a person with thoughts of self harm should seek immediate help from a mental health professional. Wi

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

thdrawal from dependence on alcohol or sedatives such as the benzodiazepines (for example, Xanax, Ativan, Valium) can be life threatening and the person should seek help

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

from qualified medical professionals.

Fear of withdrawal as defined here is an imposing obstacle to the development of willingness on the part of an addict or alcoholic

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

to choose abstinence and recovery. The cumulative effect of chronic pain and consequences, if properly presented to the addicted individual by a skilled mental health pro

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

fessional with expertise in addictions, with a healthy dose of hope for a way out of the morass of addiction, can help the individual to face these fears though treatment

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Advice Pool - Role of Fear of Withdrawal in the Power of Addictive Disease

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