Is Your Medication FDA-Approved for Safety?

Chances are you are taking a prescription drug that is not approved by the Food and  Drug Administration (FDA) for either safety or efficiency. This means that you may be taking medication that is not safe or may not work. Drugs that are not FDA-approved are called off-label drugs. Prescribing “off-label” drugs for patients is legal and there is no requirement that patients be advised their medication is off-label.

When a drug is approved by the FDA, the medication can only be prescribed for the approved purpose so the patient population for the drug is small resulting in limited sales and profits. However with off-label drugs, the profit margin greatly increases as the constraints of safety and efficiency are removed and the drug can be prescribed to treat any number of medical conditions.

So how does a prescription drug become off-label?

Once a drug is approved by the Federal Drug Administration (FDA) for a specific purpose it can be prescribed for a completely different purpose that is not tested or approved by the FDA for either safety or efficiency.  Prescribing a drug for medical conditions not approved by the FDA is one way a drug becomes off-label. Drugs can also become off-label when they are prescribed:

·        in unapproved combinations

·        at an unapproved dosages

·        in unapproved formats

·        outside the approved age group

·        longer than the approved length of time

·        for unapproved dosing schedules


Is off-label prescribing legal?

Yes, physicians can legally prescribe off-label drugs.  Drug companies, however, cannot market drugs for off-label use. However in their drive to increase sales and profits, drug companies often offer healthcare providers subtle encouragement to use their drugs for off-label use.

An example of subtle off-label  marketing occurred with the Pfizer drug Neurontin. This drug was originally approved for the treatment of epilepsy and seizures, a small patient market with limited profits. Taking advantage of the off-label  loophole, Pfizer encouraged the use of Neurontin for a wide-variety of neuralgic disorders including migraine headaches. Naturally profits soared with Neurontin’s off-label use accounting for almost 90% of Pfizer’s sales. Unfortunately the off-label use of this drug resulted in serious injuries and death.

Similarly, Merck promoted the off-label use of the drug Vioxx. This drug was originally approved for the treatment of osteoarthritis and dysmenorrhea (acute premenstrual pain).  Recognizing the profit constraints of small patient populations, Merck encouraged the use of Vioxx as an off-label prescription drug for general pain relief creating worldwide sales with profits over 2.5 billion dollars. Consumers suffered serious side effects from the off-label use of Vioxx including heart attacks, strokes and death.

 Why should I care about off-label medications?

Off-label prescribing is a growing practice that poses tremendous risks for both physicians and patients. Since off-label drugs are taken without the benefit of safety studies or studies to determine if the drugs work, patients are taking uninformed risks with their health. Physicians open themselves to lawsuits when they engage in off-label prescribing unless they can fully inform patients about the off-label status of their medication and the risks associated with the off-label drug. 


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