We have previously discussed the role the federal Food and Drug Administration plays in helping regulate the pharmaceutical industry and ensuring a flow of safe, effective medications to patients throughout the United States. Readers may remember that one method FDA uses to help meet this goal is by issuing warnings that are printed on labels that come with drugs that are meant to inform both medical professionals and patients about the potential harm a certain medication may cause. This allows doctors and patients to weigh the benefits and risks of any given course of pharmaceutical treatment and come to a conclusion with which both are comfortable.
Last month, the FDA released a statement regarding the use of general anesthetics and drugs used for sedation of patients during surgery. The statement warns that long-term or frequent use of such drugs on very young children (three-years-old and under) and pregnant women in their last trimester may have an effect on the development of a child’s or fetus’ brain. Basically, studies in animals and humans have resulted in evidence that repeated or long-term exposure to these drugs may cause loss of nerve cells in the brains of children and fetuses.
Because of this, the FDA is requiring that drug manufacturers add warnings to this effect on the labels of their general anesthetic and sedative medications. Doctors and other health care professionals should be discussing these potential consequences with patients who are in the affected categories.
Of course, in many cases a surgery may be necessary to save the life of the patient, or otherwise have benefits that outweigh the risks involved in being put under a general anesthetic. However, individuals who are not warned about these possible complications and who suffer injury to themselves or to a loved one, such as a child, may have legal recourse for compensation through either a medical malpractice or pharmaceutical liability law suit.