A Texas physician sees a patient and realizes that the risks outweigh the benefits of the medication that he or she would normally prescribe to treat that condition. However, the drug manufacturer has provided information about another medication that could be helpful, even though it was actually developed and tested for treatment of another health issue.
According to the FDA, the doctor can legally prescribe that medication, even though the intended use in this case is not listed on the drug label provided by the manufacturer. All drug companies must submit evidence to the FDA of the drug’s safety and its effectiveness when used according to the label, but how it is prescribed is actually up to the discretion of the physician.
WebMD notes that some patients may feel uncomfortable knowing that physicians do not have to tell them that they are prescribing a drug for an off-label use. This may be a legitimate concern; in the past, off-label drug use has led to serious side effects that cost patients their lives.
On the other hand, just because the FDA has not approved a drug for a specific use does not mean no one is looking out for the patients. Medicare and health insurance companies often examine such uses carefully before providing coverage for the costs of the medication.
Still, unless or until there are laws requiring disclosure of off-label use, patients should be aware that any medication their doctors recommend could be an off-label prescription. With this in mind, they may want to ask whether it is an on- or off-label use, and if so, request that the doctor provide evidence of the effectiveness and safety of the drug for that condition.