The Risks of Ignoring Package Inserts for Medications
December 11, 2018
All prescription medications come with a package insert, which provides detailed information about the medication, the conditions it treats, and potential side effects, as well as possible drug interactions. Some prescribers believe that the prescribing information is more of a legal document written to protect the drug manufacturers. As a result, they may not take the document seriously enough to review it before prescribing a medication to a patient. However, if a physician prescribed a medication without consulting the prescribing information, and the patient experienced an adverse reaction, it could result in a medical malpractice lawsuit.
A professor at the University of Kansas School of Medicine, and an expert witness in many malpractice lawsuits, stated that package inserts should be taken seriously by physicians and any healthcare provider who prescribes medications to patients. If a prescriber fails to review the package insert and misses important information about dosing, drug interactions, or other important information, it can have serious health risks to the patient. In extreme cases, the interaction or dosing error can be fatal.
Malpractice Cases Involving Package Inserts
- A six-year-old boy was diagnosed with attention-deficit/hyperactivity disorder (ADHD) and was prescribed an amphetamine and methylphenidate at 50 mg/day. His dose was gradually increased to 200 mg after he did not adequately respond to the lower dose. The boy collapsed at school and was rushed to the hospital, where he went into cardiac arrest and died. According to the package insert, it warned against exceeding a dose of 2.5 mg/kg in children. It also recommended performing an electrocardiogram before starting the drug, and before any dose increase. When the boy collapsed in school, he was taking 8 mg/kg, which is three times higher than the recommended dose.
- An 18-year-old boy had suffered episodes of depression and anxiety at the prospect of losing his grandmother. He had also become dehydrated. He was given a prescription for quetiapine XR, which his health insurer switched to quetiapine IR. After taking the medication for 11 days, he came home from school and fell asleep on a reclining chair. The next morning, his mother was unable to wake him up and he is now in a vegetative state. According to the package insert, patients who are dehydrated should not take the medication. In fact, this was mentioned five times in the package insert.
Every time a healthcare provider prescribes a medication, he or she should review the package insert and document the reasoning behind their prescribing decision. When physicians and other prescribers do not take the time to do this, patients can suffer tragic consequences like the ones mentioned above. A skilled medical malpractice lawyer can protect victims of prescribing errors and other medical mistakes.
Baltimore Medical Malpractice Lawyers at LeViness, Tolzman & Hamilton Represent Victims of Prescribing Errors
If your health or safety has been compromised because your healthcare provider failed to consult the package insert before prescribing a medication, you are urged to contact the Baltimore medical malpractice lawyers at LeViness, Tolzman & Hamilton as soon as possible. When a physician does not take the time to review the information contained in the package insert, there is an increased risk for dangerous dosing errors and drug interactions. We will determine who is responsible for the error and seek the maximum financial compensation you deserve. To schedule a free, confidential consultation, call us today at 800-547-4LAW (4529) or contact us online.
Our offices are located in Baltimore, Columbia, Glen Burnie, and Towson, allowing us to represent medical malpractice victims in Maryland, including those in Anne Arundel County, Baltimore County, Carroll County, Harford County, Howard County, Montgomery County, Maryland’s Western Counties, Prince George’s County, Queen Anne’s County, Southern Maryland, and the Eastern Shore, as well as the communities of Catonsville, Essex, Halethorpe, Middle River, Rosedale, Gwynn Oak, Brooklandville, Dundalk, Pikesville, Nottingham, Windsor Mill, Lutherville, Timonium, Sparrows Point, Ridgewood, and Elkridge.
