You trust your doctor to prescribe an FDA-approved medication when you ask them for help with a treatable health problem. However, what you may not know is that one in five prescriptions treat something that the drug was not labeled or approved to treat. This is called off-label usage, and the companies producing said drugs—in order to create more prospects for their products—often perpetuate this dangerous practice. With the competitiveness of the pharmaceutical drug market, off-label drug uses are on the rise and putting patients at risk more than ever.
Off-Label Drug Uses
Off-label prescriptions are nothing new. It is a legal practice that enables doctors to prescribe medication in a way that is not approved by the FDA. Often, drugs are prescribed for uses other than what is on the label even though the drugs have not gone through the rigorous testing required by the FDA for labeling. This is not necessarily a bad thing, because in some circumstances a particular drug warrants off-label drug uses.
For example, consider the benefits of Viagra. While it is FDA-approved to treat erectile dysfunction, which could be the effect of another health condition, many men are prescribed it without having a strict medical need. If this works for those who have a related concern, then the off-label drug use was a success. Others, however, may experience vision changes, continuing erectile dysfunction, heart palpitations, and other possible side effects of Viagra.
Problems with Off-Label Use
The chief problem with off-label drug use is that you are using a drug in a way that is not intended to be used. In nearly 75% of cases involving off-label drug uses, there is no evidence of testing that these drugs are beneficial when used in the manner prescribed. At this point, patients are relying on their doctor’s good judgment and knowledge of a particular drug. In some cases, using a particular drug for off-label uses can be exceedingly risky.
Patients prescribed drugs for off-label uses may suffer from severe side effects and interactions. When reports of these side effects come out in the public, those suffering can and will file lawsuits against the drug’s manufacturers. This has resulted in million- and billion-dollar lawsuit settlements, increasingly so in the last decade.
Illegal Off-Label Drug Marketing
Pharmaceutical manufacturing is a business, and looking for new ways to make a profit comes with the territory. Therefore, it should come as no surprise that it benefits pharmaceutical companies when doctors prescribe their products for off-label uses. The illegality of this practice comes into play when these companies actively market off-label uses of their drugs. When these practices come to light in the media, the repercussions for drug consumers and manufacturers can be staggering. The following examples represent just four cases of illegal off-label drug marketing.
The FDA approved the mood disorder drug Risperdal to treat schizophrenia and bipolar disorder in adults in 1993. However, the manufacturer (Johnson & Johnson’s Janssen Pharmaceuticals) began marketing using this drug for use in children before this was approved. Additionally, they also marketed Risperdal as a treatment for ADHD, anxiety, and depression. This off-label drug use has caused breast development, or gynecomastia, in boys in addition to movement disorders, diabetes, and cardiovascular problems. One lawsuit against Johnson & Johnson was recently settled for $1.75 million and several others are still pending.
Depakote—which is approved to treat bipolar disorder, epilepsy, and migraine headaches—was illegally marketed by Abbott Laboratories for depression, schizophrenia, and anxiety. Depakote has many serious side effects including liver failure, birth defects, and pancreatitis. This off-label use of Depakote subjects patients to these possible side effects, and even death, when there is no FDA-approved labeling for those conditions or consumers. One lawsuit involved a mother who had taken Depakote while pregnant and gave birth to a child with spina bifida. The verdict in this Depakote lawsuit awarded the plaintiff $23 billion.
Topamax is a drug approved for use as an anticonvulsant. It has also been approved for use in treating migraine headaches. In this case, off-label drug uses for Topamax have included treating posttraumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, borderline personality disorder, alcohol addiction, methamphetamine addiction, and cocaine addiction.
Off-label use of Topamax causes serious side effects such as increased body temperature, reduction in sweating, metabolic acidosis, glaucoma, suicidal thoughts, and birth defects. In 2010, Janssen Pharmaceuticals (formerly Ortho-McNeil Pharmaceuticals), entered a plea agreement with the FDA for illegally marketing and misbranding the drug, resulting in a $6.14 million fine. Hundreds of civil lawsuits are currently pending against Janssen.
Perhaps the most obvious case of off-label drug marketing, “Low T” was invented and marketed by several testosterone product manufacturers. In fact, low testosterone levels are an indication of a serious medical condition known as hypogonadism, which causes decreased testosterone production, impotence, and other side effects. However, testosterone replacement therapy has been marketed towards men with sexual dysfunctions, low sex drive, or decreased muscle mass, which are usually natural side effects of aging.
By marketing their products as treatments for a non-existent condition labeled as Low T, manufacturers have placed their consumers at risk of developing blood clots or experiencing strokes and heart attacks. The FDA released a safety warning for the off-label uses of testosterone products, which has prompted thousands of lawsuit claims. The first lawsuits against the manufacturers of AndroGel will be going to court in 2016.
If you have suffered serious side effects from any of these off-label drug uses, submit your case for a free legal review or call 866-242-0452 if you have questions. We will evaluate your claim and offer legal recommendations to help you get the justice others are also seeking against illegal off-label drug marketing.