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Jonathan Rosenfeld

July 24, 2015

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pharmaceutical complicationOff-label drugs are medications that doctors prescribe for purposes other than what they were initially intended or received approval for.

The practice of off label use of drugs is far more widespread and common than most people believe.

As an increasing number of people are experiencing adverse effects of medications that were rushed to market, the question of who has the responsibility and oversight of regulating these forms of prescriptions becomes more prevalent.

You may be alarmed or even angry once you understand the answer to this question and how big pharmaceutical companies get away with marketing harmful or deadly medications while making enormous profits off of the infirm without a care in the world about the repercussions.

How is Off-Label Use of Drugs Prescribed?

The nagging question that most people have concerning medications prescribed for reasons other than they were designed or intended is how or why doctors are allowed to place patients on the meds in the first place.

In truth, the process of gaining approval by the Food and Drug Administration and subsequent oversight over the prescribing and administration of medications is so full of loopholes that it may require a complete overhaul for the sake of the average person’s well-being.

Once a pharmaceutical company has created a new drug, it must conduct its own research and trials— the results of which are submitted to the FDA.

It is the information that is provided by the drug companies that influences the FDA’s decision to approve or deny the marketing of the medication, and the FDA does not conduct any research of its own or demand independent research to confirm the conclusions that are presented by the pharma company peddling the new medication.

It makes it far too easy for drug manufacturers to omit, fabricate or misrepresent data when submitting trials.

Once a medication has been approved, doctors can prescribe it for any purpose that they feel will benefit their patients.

Things often go awry because pharmaceutical companies will then make erroneous claims about how the medications may be used or the associated risks. In some cases, doctors will even be enticed with kickbacks or other incentives for prescribing certain medications.

How Common Are Off Label Use of Drugs Prescribed?

The FDA does not govern the practice of medicine and is only responsible for preventing hazardous drugs and substances from reaching the market and removing those already on the market.

Off-Label Drug Use Regulations

Almost twenty percent of prescriptions written in the United States are for off-label medications, and no oversight or regulations disallow doctors to continue this practice.

Is Off-Label Use Legal?

Your doctor has complete discretion to place you on the medication that he or she feels will best address your symptoms or condition.

The majority of the information influencing his or her decisions in this regard is provided by pharmaceutical companies, which have a growing track record of concealing, omitting, or denying risks associated with their medications.

What is more alarming is that children are exposed to far more off-label prescriptions than adults and are treated as test subjects in the process.

One study showed that 38% of patients under the age of sixteen were prescribed medications for off-label purposes, and in as many as 84% of cases, the medications were prescribed with very little or no scientific support for their use.

Off Label Use of Drugs for Pregnancy

The FDA has designated a specific category system for rating medications prescribed for pregnant or nursing women.

There are five categories with varying degrees of risk and providing different forms of advice to doctors considering prescribing a medication to pregnant women.

These classifications range from being considered completely safe to warning of specific risks and severe harm that may be caused to the unborn child.

The key flaw in the category system, however, is that the FDA relies on data submitted by the pharmaceutical companies rather than independent researchers— this is how Zofran was prescribed off-label for decades despite its manufacturer knowing of the potential risks, for example.

Who is At Fault When Off Label Use of Drugs Cause Adverse Effects?

It can be argued that doctors are immensely burdened to ensure their patients’ safety and should know better than to prescribe harmful or deadly medications.

However, doctors must rely on the information they provide and often weigh every medication’s benefits and risks before writing prescriptions.

In many cases, they cannot be blamed for making decisions based on inaccurate or erroneous information. Still, in some cases, they should know better than to place patients on medications that lack specific data to support their benefits and safety.

Pharmaceutical companies carry far more blame for consistently circumventing the process of acquiring FDA approval for using medications to treat specific conditions and constantly finding loopholes that allow them to profit from harming others.

Aside from pushing to amend the laws and requiring more oversight, the only way to obtain justice for this gross lack of concern for our safety when creating and marketing medications is to take the matters before a civil court.

A Chicago prescription drug recall attorney from Rosenfeld Injury Lawyers, LLC is a leading group of pharmaceutical complication attorneys dedicated to holding these mega-corporations to account for their sins. If you have been harmed by using a medication issued in such a manner, we’d love to have the opportunity to defend your interests.

Contact us today to arrange a free consultation where you can speak with an attorney about any pending litigation involving cases similar to your own and how it may impact the value and outcome of your case as well as to learn about your rights and legal options and to launch an investigation into your matter to determine your best course of action.

Our dangerous drug lawyers are dedicated to serving your interests above all else, and we only receive compensation when our clients do. Our services are free if we cannot assist you or fail to collect compensation on your behalf.


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