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As I write this, I am in my sixth day of drug withdrawal. My head has pounded with crippling dizziness for the last few days. I feel nauseous. Drug withdrawal. Those very words make me feel like a junkie. The

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

sad irony is that I’m trying to come off doctor-prescribed SSRIs, antidepressants.

Depression hounded me through my teens and twenties. It was just the way it was. Not until I got married and my raging moods

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

Examples of combination products may in

began to take their toll on someone else and threaten our relationship did I decide to seek help.

I had always been resistant to chemical solutions for depression. At the age of six months, a well-meaning doc

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

tor prescribed Valium to treat my “hyperactivity.” To this day, I shudder to think what effects that had on my young, developing brain. In my teens, as I struggled with the usual pains of high schools – extrem

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

e shyness, the pressure of exams, bullying, etc, my doc prescribed tranquilizers (not telling me what they were). After two days of feeling worse than ever, I flushed them down the toilet.

Fast forward to a f

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

Combination pro

ew months before my thirtieth birthday. Everything was grey. I would go through days with no recollection of what I had done. I was disconnected from everything. My husband would take me to a movie to cheer me

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

up and I would break down in the parking lot, unable to cope with the decision of what to see.

The doc put me on Lexapro. I was so tired of feeling this bad that I gave in and tried drugs. I was reassured th

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

t Lexapro was a new kind of antidepressant with absolutely no side-effects. I felt better immediately. Despite being unable to sleep for the first week, I felt great. My mood swings improved at once. I was fin

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

ally on an even keel. This is how life was supposed to be.

So how did I get from there to where I am today?

As it happens there are quite a few things doctors don’t like to tell you about antidepressants. As

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

time passes, chances are that you will need to use a higher dose and with a higher dose, often comes an increased likelihood of side-effects. Over the course of four year, my doctor changed three times. Each

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

time one moved on and a new one took over, they would ask how I was doing and simply renew my prescription for another year. If I said I didn’t feel so good, my dose would be increased with little exploration

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

Following aspects would a

into other possibilities. At no point was I referred to a mental health professional or a therapist. Antidepressants are one of the few medications freely dispensed without a referral to a specialist. Side-eff

dd to the challenges in developing combination products:

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

ects were brushed aside. Despite being more active than ever, I was gaining weight rapidly. My doctor told me it couldn’t possibly be a result of the Lexapro. Instead I was told to exercise more.

Four and a h

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

alf years. Thirty five pounds. Slowly, the negatives outweighed the benefits. A few months ago, the fog began to return and my mood swings were worse than ever. I felt cold. Tired. Fat. Disconnected. Instead o

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

seeing my regular doc, I paid a visit to my endocrinologist, thinking perhaps these symptoms were related to my PCOS. His response was instant – stop the antidepressants. He told me how dozens of his patients

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

were often prescribed antidepressants by their family physician when the depression was being caused by other hormonal imbalances. Often, a short-term dose of antidepressants turns into several years.

When I

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

Professional from academic institutions, pharmaceutical industries, health care indust

did some online research, I was stunned by what I found: pages of peoples sharing their stories, describing the weight gain and other side-effects they experienced as a result of antidepressants, and how thei

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

r doctors responded by increasing doses and ordering more exercise.

I tapered my dose down slowly. Going cold-turkey when stopping SSRIs is NOT recommended. I have increased my intake of fish oils. A daily Dr

.

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

amamine helps to ease the temporary dizziness.

I am not against the use of antidepressants. They certainly helped me at a time when most other alternatives failed. However, they do have side-effects for a lar

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

Companies that provide selfless information through particip

ge number of people. Weight gain. Loss of libido. A massive slowing down of your metabolism. How ironic it is that they very remedy I used to treat my depression eventually became the thing that fed it further

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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