Off-Label Use of Medicine
A recent case has resulted in an ophthalmologist being held liable for injury to a patient who lost their vision from off-label use of a medication, known as Avastin. “Off-label” use is the unapproved use of a medication that has been approved for other uses. For example, if the FDA approves a drug to treat migraines, but it is frequently prescribed by psychiatric doctors to treat depression, this would be an “off-label” use of that drug.
In the Avastin case, an older woman was suffering from a health condition related to her eyesight. The doctor injected Avastin into her eyes, which at first, improved her vision tremendously. Several years later, she had a second treatment, but her vision deteriorated shortly thereafter. She received several more “treatments” with Avastin injections, and eventually lost her eyesight completely.
The court, located in Greece, found that the woman’s ophthalmologist had fully informed her that the drug Avastin had not been used to treat her condition. Rather, they told her it was used to treat several types of metastatic cancers. He also informed her that it was widely used by doctors to treat they type of visual condition she suffers from. When the physician administered the drug, there was no existing treatment for her rare condition, other than one medication known as Macugen, which was far less effective. Many patients around the world continue to be treated with Avastin.
At the time the woman was treated with Avastin, clinical trials had already been conducted comparing Avastin with another drug, Lucentis. There were no statistically significant differences in efficiency or side effects between the two drugs.
The court also found that the physician may have contaminated the packaging because it had to be manipulated to use it in the off-label manner.
The physician was found to be liable for loss of the plaintiff’s eyesight because there were safer drugs on the market that did not require the risky repackaging involved with Avastin.
Medications are most often prescribed for uses in which they have not been approved because there is no known effective drug to treat the patient’s condition or traditional drugs have not been effective in treating the patient at issue. Shockingly, studies in recent years have found that more than half of all pediatric office visits resulted in the prescribing of drugs for off-label purposes.
At times, doctors prescribe drugs for off-label uses because they are much cheaper than drugs intended to treat a patient’s condition, the similar case with Avastin. This is never an acceptable reason for a physician to prescribe off label drugs if there are effective, safe drugs intended to treat a condition.
New Jersey Medical Malpractice Lawyers at Eichen Crutchlow Zaslow, LLP Litigate Off-Label Prescription Cases and Other Types of Medical Negligence
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