Big Pharma “Off-Label use” of Drugs

When we get sick we are often prescribed medications to treat our ills. Most prescribed drugs are safe, effective and expensive. Unfortunately Big Pharma ( Big Pharma is the nickname given to the pharmaceutical industry) typically push new and untried uses for their products often referred to as “off label use.” (Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration). The practice is entirely legal and very common.

When medications are approved by the FDA, they are approved for a particular purpose and for particular users. The approval process relies on testing that shows that the drug is safe and effective for the approved purpose. However, this restricted approval doesn’t stop Big Pharma  from making an attempt to extend the marketplace for a drug by claiming that it can be used to treat alternative issues.

Does anyone remember Fen-Phen for weight loss?  The off label use /combination proved to me very damaging to patients taking the drugs for weight loss.

Another example, is one drug company promoted Depakote, an anti seizure drug, off label to treat those with dementia praecox and Alzheimer’s. The problem is that the drug had not been shown to be effective for either use, and it often caused serious side effects.

Another drug company touted Risperdal, a tranquillizer, as a drug that would be safe and effective as a way to chemically restrain individuals in nursing homes, despite the facts that such a usage was not approved by the FDA and was never found to be safe and effective. The drug increased the risk of death in patients with dementia. Even botulinum toxin A has been marketed to treat maladies such as headaches, pain, and brain disorders but has not bee approved to treat these conditions.

Unfortunately, patients are not in a position to evaluate medications on their own. And patients rely and believe doctors will safeguard them from improper use of drugs.  The reality is that doctors do not research medications on their own and often times will rely on Big Pharma’s  promoting reps, whose job it is to sell the company’s drugs. The explosion of medicines offered places doctors in a position that they cannot possibly keep up with the proliferation of drugs.

As a result, doctors typically and perhaps inadvertently prescribe medications for off-label use based upon a reps touting.  So why does Big Pharma promote off-label use? the answer is simple: cash. Drugs are high-ticket items and translate into profits. Off-label use will increase the use of a particular drug, the motivation is simple.

Keep in mind though that Off-label prescribing isn’t necessarily bad. It can be beneficial, especially when patients have exhausted all other approved options, as may be the case with rare diseases or cancer.

The next time your physician gives a you prescription, you should know that it is possible that the drug may not be approved for your specific condition or age group. In fact it is estimated that about 20%  one in five prescriptions written in the United States are for off-label uses.

Drugs do save lives and can improve ones health. Just be aware that all medications carry risks. Don’t be afraid to ask your doctor questions, he or she wants to help you but you also must be an active participant in your own care. I truly believe that good food, exercise and sleep goes along way to keeping us healthy.

If you believe you have got been injured by a medication “off-label” or otherwise you should seek the assistance of a personal injury attorney or medical malpractice attorney.

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