Off-Label Use

Off-label drug use occurs when a drug is used in some way that is not approved by the FDA. This can mean that the drug is prescribed in unapproved dosages, used for an unapproved condition, or given to an unapproved demographic of people. This practice is perfectly legal in the United States and much more common than most people realize.  An estimated 1 in 5 prescriptions are written for off-label use.

The idea behind off-label prescriptions is that doctors, through their training and practice, are able to gauge when a certain therapy would be safe and effective and they should not be limited by the FDA when trying to achieve the best outcomes for their patients. Most off label uses are relatively safe and frequently effective, but sometimes these uses have dangerous consequences.

One possible example of this is the drug Zofran. The drug, which is approved for use in preventing nausea and vomiting, is often used off-label to treat morning sickness in pregnant women. Some studies have shown a correlation between Zofran use during pregnancy and birth defects. Women affected by Zofran and other off-label prescriptions may never have known that the drug they were taking was not FDA approved for that use. Doctors are not required to inform patients that they are prescribing a drug off-label.

When patients are unjustly harmed by a drug, no matter how it was prescribed, they may be entitled to compensation. If you or a loved one has been injured by a drug that was prescribed off-label, we can help. Give us a call.


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