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Birth Injuries: The Dangers in Off-Label Prescription Drug Use
In personal injury law, one area of interest and great concern is off-label prescription drug use. Off-label prescription drug use is defined as medications prescribed by a physician for use in a manner that is not consistent with the tested and approved use of the product.
All prescription drugs, approved by the FDA, must go through clinical testing for the intended use. The clinical testing helps identify any adverse side effects or dangers of the drug under a particular set of circumstances. Off-label drug use can be dangerous as there may be little if any clinical testing to understand the adverse side effects or dangers when a specific drug is used in a manner inconsistent with its intended use. To complicate the issue, many patients are never told they have been prescribed a medication that is not intended for their particular medical condition or set of circumstances. Even worse, the patients frequently are not thoroughly informed of the dangers or adverse risks associated with the off-label use.
Under the current FDA rules, it is legal for a physician to prescribe a drug for an off-label use. However, it is illegal for the manufacturer of the drug to advertise or promote the drug for off-label use. In the past, pharmaceutical companies encouraged physicians to prescribe drugs of off-label use.
In some cases, the physicians received monetary compensation in the form of contracts or substantial consulting fees that were linked to the use or promotion of prescription drugs in an off-label manner. Recently, the FDA announced efforts to increase the criminal penalties for drug company executives who promote or advertise their drugs for off-label use.
While the FDA has levied several fines of $1 billion or more against major pharmaceutical companies, the practice of off-label drug use continues on a daily basis. One of the more common drugs used in an off-label manner is Terbutaline.
Terbutaline is an asthma medication that has been used to treat pre-term labor for more than twenty years. When used in this manner, Terbutaline has been linked to cardiomyopathy or other serious cardiac problems for the mother and unborn infant, autism in the children of mothers that are treated with Terbutaline and even death to the mother or infant.
In 1997, the FDA sent their initial warning about using Terbutaline for treating pre-term labor. It was not until February of 2011 that the FDA required the pharmaceutical companies to apply a black box warning on the product labels for Terbutaline.
The above is only one example of the thousands of prescription drugs currently on the U.S. market that have been used “off-label”. Others, such as Bextra, Zyprexa, and most recently NovoSeven have been linked to off-label uses that have resulted in serious injuries or death of the patient.
As a consumer and patient, you are entitled to know what you are being prescribed, the intended use of the drug, the known side effects, and any known risk associated with the drug. If you are prescribed a drug that does not appear to be intended for your particular condition, it is your right to question the physician and even obtain a second opinion before agreeing to the course of treatment. It is your body and you have every right to know what is being put in it.
If you are seeking legal counsel for an off-label prescription drug use claim, a personal injury attorney from Lutz, Bobo & Telfair, P.A., can assist you. To learn more about filing a off-label drug use case, contact our law offices today to schedule a free consultation.