A new drug is FDA approved and released on the market which is made to solve one medical issue, but also ends up helping in other ways. That’s generally a very good thing. That is, until the marketers get wind of it. One of the most common of these stories is Viagra. Pfizer was working on a drug to help with blood pressure and ended up with the little blue pill that solved men’s bedroom issues. Often these types of incidents end up for the better. However, there are potentially large risks involved when using a drug for something other than its intended use – even when it’s doctor prescribed.
One recent example of off-label drug use is the Low Testosterone therapy (Low T) craze. Low T therapy was first FDA approved as a way to treat men with hypogonadism, which affects the hormones developed in male genitalia. It didn’t take long for the pharmaceutical industry to figure out how to market “Low T” to every man over 40 who was grouchy or had lost a step to their 25 year old self. The resulting boom in the Low T industry (nearly $2B a year!) is now thought by many to be responsible for an increase of men experiencing heart attacks, strokes, and other circulatory problems as their slightly-worn ‘engines’ try to cope with an increased red blood cell count and thicker viscosity blood (known as polycythemia).
Off-label drug use is increasing, leading to more and more complications with prescription drug users. Off-label drug use means a medication is being used for something other than its originally intended purpose, as specified by the FDA. The sole purpose of the Food and Drug Administration is to regulate drug approval and make sure every drug is safe for people to use. However, the FDA has little say over how doctors actually prescribe the drugs.
More often than not, off-label drug use does not result in any negative side effects. However, as with many cases like the one with Low T, the results can be negative. Another FDA off-label example is the Da Vinci Surgical Robot. This device was originally FDA approved to improve a narrow range of laparoscopic surgical procedures. The Da Vinci surgical robot promised less pain, downtime, and discomfort for patient. Hospitals purchasing the device would often market it as futuristic, but to pay for the expensive systems, hospitals started using them for an ever-increasing number of procedures – which led to unintended consequences as more patients allegedly suffered various injuries at the “hands” of the da Vinci surgical robot. Another clear example of how a manufacturer’s marketing goals helped to re-interpret an FDA approval – and how consumers were made to suffer the consequences.
When it comes to any type of off-label medical use, most doctors should let their patients know the possible risks and rewards with each device or drug. Do yourself a favor and take the extra step of researching a drug or medical device’s original FDA approval.