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Off-Label Drugs Endanger Patients

By August 26, 2014March 14th, 2022Dangerous Drugs

Off-label medications can be dangerous to patients because they can result in a patient suffering an adverse reaction or unexpected side effect.  A defective drug lawyer in the St. Louis, Missouri area should be consulted if you or a loved one is prescribed a medication and become sick as a result of the drug.  Carey, Danis & Lowe can represent you in a claim against the drug manufacturer so you can recover compensation for damages. 

The Dangers of Off-Label Drugs

Before a drug is approved and sold, it must be tested by the manufacturer and it must obtain clearance from the Food and Drug Administration (FDA). Drugs are tested for a specific purpose. For example, a medication may be intended to treat diabetes and will be tested to determine if it has a positive impact on the health of diabetes patients.

Once a drug is approved, doctors may prescribe the medication for any purpose that they believe will be beneficial to the patient. If the doctor thinks that a drug approved for one medical condition could help a patient with a different medical problem, the doctor can prescribe that drug to the patient. This is called off-label prescribing. According to WebMD, as many as one out of every five prescriptions written by doctors on an outpatient basis my be for off-label drugs.

While doctors are allowed to prescribe off-label drugs, drug companies are not allowed to market their medications for a purpose other than what the drug has been approved for.  Unfortunately, pharmaceutical companies sometimes break these rules. For example, a powerful narcotic painkiller called Subsys was approved by the FDA in 2012 but it was intended to be used by patients who were already taking painkillers virtually all the time, like cancer patients who were in serious pain.

According to a New York Times  article, the drug has now become a $100 million business.  Unfortunately, oncologists are also prescribing the medication in about one percent of cases and less than half of the prescriptions for the drug are written by pain management specialists. The remainder of the prescriptions are being written by general practice doctors and others who are not specialists in pain management including podiatrists and dentists. This means a powerful narcotic is frequently being prescribed to patients who may not need such a strong drug, even at a time when there are growing concerns about prescription pain killer abuse.

The New York Times indicates that several former sales-reps for the company have asserted that they were encouraged to market the medication for off-label use and that they were rewarded with higher commissions if they sold higher doses.

While there are no known reports of harm from these actions yet, it is clear that off-label drugs can have serious consequences.  As The Star recently reported, off-label prescribing of an anti-nausea drug to pregnant patients has resulted in babies being born with severe birth defects impacting the kidneys and the heart. At least two infants have been killed.

Getting Legal Help for Off-Label Drugs

If a drug manufacturer encourages off-label drugs to be prescribed, the pharmaceutical company could be liable for the consequences.  A defective drug lawyer at Carey, Danis & Lowe can help victims harmed by defective drugs and off-label drugs to pursue a claim for compensation. Call today or contact us online to schedule your free consultation.