Research shows the anti-lupus drug belimumab—sold under the brand name Benlysta—causes suicidal ideations and behaviors in users.
What Is Benlysta? When Is It Prescribed?
Benlysta is the brand name for the drug belimumab. Made by Human Genome Sciences, Inc. and sold in cooperation with GlaxoSmithKline plc, this prescription medication is the first systemic lupus erythematosus (lupus) treatment a pharmaceutical company has developed in more than 50 years. The U.S. Food and Drug Administration (FDA) approved Benlysta in May 2011, but it discourages use of the drug by those with severe active lupus nephritis or severe active central nervous system cyclophosphamide and those using other biologics or intravenous cyclophosphamide. Benlysta comes in the form of 10 mg/kg doses taken at three two-week intervals and then at four-week intervals after that.
An antibody is an immune agent that attacks foreign substances in the body, such as viruses, bacteria, protists, fungi, and other pathogens. In systemic autoimmune diseases such as lupus, the antibodies of a person’s immune system instead attacks his or her own heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous system. Benlysta is a monoclonal antibody, meaning researchers created it by duplicating immune cells from a single parent cell and then collected the antibodies they created. The monoclonal antibody inhibits the activities of a substance known as “B-lymphocyte stimulator” (BLyS), which causes the B-cells of the immune system to attack the body’s friendly organs. By inhibiting the BLyS, Benlysta reduces the symptoms and damage caused by lupus.
Despite the alleged promise the drug holds, a group of Human Genome Science’s shareholders are suing the company and its board of directors for making false and misleading statements regarding Benlysta’s potential for causing suicidal ideations and behaviors that purchasers of Human Genome Science’s common stock between July 20, 2009 and November 11, 2010, relied on when choosing to invest in the company. The shareholders allege that they learned of the drug’s possible harmful effects at the FDA’s November 16, 2010, Arthritis Drugs Advisory Committee Meeting.
Benlysta Suicidal Behavior and Ideation Side Effects
The “Warnings and Precautions” section of the FDA label for Benlysta contains an entry for “Depression.” In clinical trials, 16 percent of Benlysta users reported adverse psychiatric events, as opposed to 12 percent taking a placebo. Serious depression occurred at a rate of 0.4 percent of Benlysta takers compared to 0.1 percent of placebo users, and two patients (0.1 percent) committed suicide during the clinical trials.
Benlysta Might Cause Other Serious Side Effects
- Mortality. The FDA label also notes that more Benlysta users died during clinical trials than placebo users, the mortality rate was 14 deaths out of 2,133 patients in three trials.
- Serious Infection. 71 percent of Benlysta-takers versus 67 percent of placebo-takers reportedly suffered infections, mainly occurring in the upper respiratory tract and the urinary tract. Infections caused four deaths.
- Hypersensitivity reactions and infusion reactions. Hypersensitivity reactions occurred in 13 percent to 11 percent of Benlysta versus placebo users. Anaphylaxis occurred in nine patients as well. Adverse infusion reactions in general occurred in 17 percent of Benlysta users, as opposed to 15 percent on the placebo.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Benlysta lawsuit on your behalf if necessary.
If you have taken Benlysta and believe it harmed you, contact RLG today.