The rheumatoid arthritis drug Arava (leflunomide) will now carry a black box warning, the Food and Drug Administration’s most serious warning, to alert patients to the danger of fatal liver damage associated with taking the drug. The FDA received 49 adverse effect reports, including 14 deaths, between 2002 and 2009. This warning comes after the nonprofit consumer advocacy group Public Citizen asked the FDA to remove leflunomide from the market because it was too dangerous. As a dangerous drug attorney, I hope that in the future, patients will have enough information about the risks of this medication to make informed decisions about whether to take it.
Leflunomide has carried a boldface warning since 2003, explaining the risk of severe liver injury and warning women who are pregnant or may become pregnant not to use the drug. This year’s review of more recent adverse effects prompted the FDA to issue a stronger warning. Besides the 14 deaths associated with taking leflunomide, adverse effects reported to the FDA included jaundice, bleeding and clotting disorders, and encephalopathy, or injury to the brain. Thirty-six of the patients reporting adverse events were hospitalized. For most of those who were harmed, the injuries occurred within the first six to 12 months of treatment, although in some cases the injuries happened after six years. Itching, yellow eyes or skin, dark urine, loss of appetite and light-colored stool are warning signs that should prompt a patient taking leflunomide to contact a health care professional.
The new black box warning states that patients with preexisting liver disease or elevated liver enzymes should not take leflunomide, and that health care professionals should use caution when prescribing it to patients who are taking other drugs that can injure the liver, such as Tylenol, Motrin, Advil, and Aleve. These categories of patients are at the greatest risk of injury from the drug. Patients who do take lefunomide should have their liver enzyme levels monitored at least once a month for three months at first, and then at least quarterly after that.
Most people suffering from rheumatoid arthritis must take medications for the illness for the rest of their lives, so the potential for injury by this medication may be great. Rheumatoid arthritis is an autoimmune disorder in which the body’s immune system mistakenly attacks the body’s own tissues, causing joint problems, fever, and fatigue. It affected 1.3 million people in the United States in 2005. Leflunomide was approved by the FDA in 1998 for treatment of rheumatoid arthritis under the brand name Arava, and went generic in 2005, most likely broadening its appeal because patients could get it for a lower price. That means hundreds of thousands of patients could be taking this risky medication.
From my perspective as a defective drug lawyer, it’s good that the FDA is adding a more serious warning to this drug, and I hope that no more patients will be harmed by it. I’ve worked with many patients who have been hurt by medications that they thought would help them, and what they have to go through is heartbreaking. They incur sometimes vast medical costs as doctors try to figure out why they’re sick and how to help them get better. Sometimes their injuries are permanent and cause intense pain. They miss work because they don’t feel well and have to attend so many medical appointments, and their quality of life and their relationships with family and friends suffer. All of those are injuries directly caused by the harmful prescription drugs they took, and patients have the right to hold the drugs’ manufacturers legally liable for causing them, if the manufacturers failed to warn about a risk they knew or should have known about. That means patients can recover compensation for all of those costs directly from the drug manufacturer.
At Carey, Danis & Lowe, our dangerous medication lawyers specialize in helping individuals and families hurt by defective drugs. We offer free, confidential consultations, at which we can explain your legal rights and help you choose the best course of action to set things right. Because of our years of experience in this field, we know what to expect in dangerous drug cases and how to obtain the best outcomes for our clients. It’s important to speak with an attorney early on in a defective medication case to ensure that all relevant medical records are preserved and to forestall any attempts by the drug company to persuade you to settle for a smaller amount of money than you deserve. If you have been hurt by a defective medication, please call Carey, Danis & Lowe today, toll-free, at 1-877-678-3400 or contact us through our website.