Belviq (lorcaserin) is a new diet and weight-loss pill that was first approved in 2012. Although it has only been on the market for a short time, there is already concern about side effects — psychiatric disorders, heart valve damage, cancer (especially brain and breast tumors found in rodent studies), and much more. Our Belviq lawyers are concerned that these risks could outweigh the benefits of weight-loss, but patients are not being warned about the danger.
What is Belviq?
When the U.S. Food and Drug Administration (FDA) approved Belviq (lorcaserin) in June 2012, it was the first weight-loss medication approved in the United States in 13 years. Its manufacturer (Arena Pharmaceuticals) and marketer (Eisai Co., Ltd.) did not start selling Belviq until June 2013.
Belviq works by influencing serotonin, a neurotransmitter in the brain that makes a person feel full and satisfied after eating a meal. Belviq makes a person feel full sooner, which can help them eat less food and lose weight, in conjunction with healthy eating and exercise. In clinical studies, patients who took Belviq for one year lost between 3% and 3.7% of their body weight.
What’s the problem with Belviq?
Belviq influences serotonin, a chemical that does much more than regulate feelings of fullness. Serotonin also plays important roles in the heart, nervous system, gastrointestinal tract, and more. Medications that adversely influence the serotonin system can have a wide variety of side effects.
Unfortunately, the long-term risks of Belviq are unknown. Some side effects, like cancer or heart disease, may not appear in clinical studies because they take years to develop and even longer to research.
FDA Approval Despite Concerns of Belviq and Cancer
The FDA rejected approval of Belviq in October 2010 due to concerns about Belviq and cancer. In clinical studies, rodents who were given 7-times the normal human dosage of Belviq developed breast and brain tumors. Arena Pharmaceuticals responded by assuring the FDA that these were rodent-specific tumors and the disease was not relevant to humans. In June 2012, the FDA voted 18-4 to recommend approval of Belviq.
Belviq and Heart Valve Damage
In clinical studies, 2.4% of Belviq patients developed heart valve damage, compared to 2% of patients who took a placebo. The study also found that patients on Belviq had a slower heart rhythm than placebo patients, decreased by 1-2 beats per minute.
The cardiovascular studies of Belviq are concerning because the last two diet drugs (Fen Phen and Redux) were recalled in 1997 after tens of thousands of people developed life-threatening pulmonary hypertension and heart valve damage. Belviq works in much the same was as fenfluramine, an ingredient in Fen Phen — it targets serotonin 2C receptors and the hormones that control appetite.
The manufacturer of Belviq claims it is safer than Fen Phen because it is more selective in targeting serotonin, which is why they do not recommend patients undergo evaluations for heart problems before starting Belviq or while taking Belviq.
The Prescribing Information for Belviq simply warns:
“Some people taking medicines like Belviq have had problems with the valves in their heart. … Before taking Belviq, tell your doctor if you have or have had any heart problems.”
Belviq Side Effects
Most common Belviq side effects:
- Additional side effects in diabetics: Cough, back pain, low blood sugar
Most serious Belviq side effects:
- Heart problems
- Heart valve damage
- High blood pressure in lungs (pulmonary hypertension)
- Decreased heart rate
- Cancer (studies of rodents found signs of breast and brain tumors)
- Psychiatric disorders (euphoria, dissociation, etc.)
- Cognitive impairment
- Memory loss
- Decreased attention
- Serotonin Syndrome
- Neuroleptic Malignant Syndrome (NMS)
- Increased prolactin (hormone that can cause gynecomastia or galactorrhea)
- Growth of male breast tissue (gynecomastia)
- Breast-milk production in females (galactorrhea)
- Low white blood-cell count
- And more