A new study reveals that many patients taking drugs for off-label uses aren't aware that the Food and Drug Administration may not approve. Off-label drug use describes when a doctor prescribes a medication, dosage or form of dosage that may not be approved by the FDA and a 2006 report showed that at least 1 in 5 prescriptions are for an off-label use. This is shocking, as prescription drugs used for an unintended purpose can have devastating consequences.
The study authors reported that Morphine, asthma inhalers, anticovulsants, and proton pump inhibitors were some of the most commonly prescribed drugs for off-label uses. Specifically, other research has found that 79% of children discharged from the hospital were on at least one of these drugs, which are not approved by the FDA for use in children. Unfortunately, doctors are not required to discuss off-label use of drugs with their patients, and they are not held liable for off-label drug use.
Furthermore, while drug makers are not allowed to advertise their products for off-label use, they can respond to questions from doctors about potential off-label use and distribute medical publications about off-label drug use. Recent news report highlight scary off-label uses of drugs such as antipsychotic medications, which are approved to treat major mental illnesses such as schizophrenia and bipolar disorder, in children with ADHD. Another recent report highlighted the use of synthetic steroids in pregnant women to prevent their female fetuses from developing a propensity towards lesbianism, bisexuality or tomboyism, as well as intersexuality. These are more severe cases of off-label use of prescription drugs, but they are nevertheless indicative of how extreme the consequences can be if drug companies and some doctors are left to their own devices without the knowledge of patients and the approval of the FDA.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.