Following the results of a recent safety trial, the Food and Drug Administration (FDA) has issued a warning that the weight loss drug lorcaserin (Belviq) may increase the risk of cancer. Therefore, the agency is issuing a Belviq recall.
According to the CDC, around 40% of Americans are obese. Many seek supplements or weight loss pills to lose weight. These pills can have significant adverse effects. For example, in 1997, the FDA removed the diet pill “Phen-Phen” from the market due to damage to heart valves. Now, there is a Belviq recall due to cancer concerns. The FDA approved the drug in 2012 without any significant risk trials. Like Phen-Phen, Belviq decreases appetite. However, the agency demanded a larger trial to test cardiac safety.
When the initial trial ended in 2018, 12,000 patients had zero cardiac side effects. However, a follow-up study showed something shocking.
Long-Term Carcinogenicity Rat Study
The FDA required biweekly updates to Arena’s initial study for approval. Early results in 2007 showed that Belviq caused rate and aggressive tumors including lethal, malignant mammary and brain tumors. Other malignant tumor formations included the liver, thyroid, and squamous carcinomas of subcutis, schwannomas. Then, the week 96 results showed that 55-96 of the rates of female rats with cancerous tumors increased while the cancer metastasized. However, by the time week 104 occurred, the malignant tumors declined. Yet, the manufacturer could not provide the FDA with supporting data to the cause of the mysterious shift.
First FDA Submission in December 2009
The first submission for FDA approval showed significant errors in pathology reports. However, Arena insists that the tumor finds were irrelevant to humans. There was also a 2 year mouse study results. However, the results are inconclusive with possible data manipulation. The researchers decreased the dose level to stop the tumors. Yet, the levels to not have tumors was so low that the drug was ineffective. The FDA says that if it is carcinogenic to rodents that it will be harmful to humans as well. They reject it 9-4. Arena persists with their hired experts for a second look at the drug. The FDA suggests an independent pathologist panel look at the lung slides from the study. The group concludes that there isn’t a risk to humans in 2011. The FDA reconvenes and approves the drug 18-4.
CAMELLIA-TIMA 61 Trial
After approval of Belviq, the FDA wanted a long-term trial evaluating cardiovascular effects. This was a randomized, double-blind, placebo controlled clinical trial studying 12,000 men and women over 5 years. Researchers conducted it at over 400 sites in 8 countries including the US. It was the largest heart trial conducted to date for a weight loss medication. The study showed that there wasn’t a higher rate of major cardiovascular events than with the placebo. However, the researchers found 7.7% patients developed cancers including lung, colorectal, and pancreatic.
Recall Belviq Study
At the five-year study follow-up, the Data Safety Monitoring Board showed a higher rate of cancer than those who received the placebo. Due to this, the FDA asked for an immediate market withdrawal. These cancers ranged from pancreatic, lung cancer and colorectal cancer. Users developed cancer within one year of use and risk increases the longer duration of drug use.
Because of the cancer concern, in January 2020, the FDA announced publically a review of clinical trial data. Then, a public alert notified the public of a possible risk of cancer associated with lorcaserin based on preliminary analysis of the data. The report showed a range of cancers including pancreatic, colorectal, and lung.
Therefore, in February 2020, the FDA requested the manufacturer, Eisai Inc. to initiate a Belviq recall.
Speak to an Attorney Today
If you or a loved one has been harmed by Belviq, you need an attorney with experience helping people who have been harmed by pharmaceutical drugs. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against drug manufacturers to get clients what they need.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a drug company in manufacturing and selling drugs is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed cancer after taking Belviq for at least two years, please speak to us to learn more about your rights.
Case evaluations are free of cost and without obligation. Call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.