Zantac is the latest drug outed by Valisure. This online pharmaceutical company analyzes each batch of medications. Distinguishing them from other pharmacies, Valisure’s testing procedures ensure their customers receive drugs free from any known contamination. Examination of Zantac’s over-the-counter medication raised red flags. Valisure alerted the FDA to the findings.
Overseas Drug Manufacturers
According to a press release from Diana Degette of Colorado, 40% of all prescription drugs are manufactured overseas. In February of 2020, Politico reported 60% of all factories producing drugs for America were found outside the country. 40% are in China and India. About 80% of active pharmaceutical ingredients (API) in our medicines are imported. With China’s relaxed environmental concerns and lower labor costs, manufacturing some of the ingredients simply is easier to do in China than in America.
In 2012, senators passed the Food and Drug Administration Safety and Innovation Act (FDASIA). This act expanded the FDA’s inspection responsibilities to include foreign inspections. Prior to 2012, the US inspected domestic facilities every two years but had no similar line for foreign facilities. Starting in 2015, the FDA inspected more foreign facilities than US facilities. This peaked in 2016 at 1,041 international facilities inspected. 2019 ended with 966 facilities inspected.
When conducting a non-domestic surveillance inspection, the FDA announces the inspection prior to showing up at the facility. This announcement allows the manufacturer time to inspect the facility before the FDA shows up. With a for-cause check, one triggered due to a concern, the FDA does not need to announce they are arriving.
How does the FDA decide whom to inspect
Due to the passage of FDASIA, the FDA stopped the domestic 2-year schedule of inspections. The act allowed the FDA to request records instead of a physical examination. Any facility denying an inspection resulted in every drug produced at that facility labeled adulterated.
In 2005, prior to the passage of the FDASIA, the FDA created a Site Selection Model. This program uses a risk-based mathematical equation to produce a list of the highest risk facilities to inspect. It looks to see what facilities could hurt the public the most should they not comply with the FDA.
The 2012 Generic Drug User Fee Amendments (GDUFA) gave the FDA funds necessary to rev up inspections to foreign drug and API manufacturers. The FDA cut its international non-inspected facilities from 965 to 470. Facilities deemed high-risk are inspected, per median, every 2.1 years. In every place but India, 90% of manufacturers were recorded as “No Action Indicated” or “Voluntary Action Indicated.” India trailed at 83%.
With FDA inspections, how can medicine be compromised?
With increased inspections, our medicines should be safe, right? The FDA inspects facilities every two years, mostly if it turns up on the Site Selection Model, and announces ahead of time it is coming. Companies have the ability to clean up their act before the FDA shows up. In June of 2019, Senator Chuck Grassley wrote the Human Health Services regarding this very issue. He claimed a former inspector found falsified records and intentional fraud in 67 of the 86 drug manufacturing facilities he examined.
Certain manufacturers of drugs and APIs are able to ship to the United States without ever needing an inspection. When this happens, the drugs are sent to America and in distribution before the FDA runs an inspection. Even with warning letters sent to companies, it becomes difficult for the FDA to reign in the issue after it has been set into motion.
If the FDA feels a warning letter needs to be sent, there is a delay. Following the end of the inspections, it takes an average 6-month delay for the FDA to send foreign manufacturers their letter. This decreased from the over 12-month delay in 2016. Training a new investigator takes about two years. Expecting a quicker return on investigations is not likely to happen soon.
The FDA stated it is not feasible to test every single pill. While they perform thousands of tests and only about 1% fail, they do not have the capacity to test the 180 trillion-plus pills on the market. This leaves an opening for compromised APIs or medicines to enter American medicine cabinets. Where the FDA left off, Valisure picked up.
Valisure and Zantac testing
When doctors prescribed Adam Clark-Joseph’s infant daughter Zantac, he instructed his company to run the medication. This wasn’t the first time the company tested medicines through its labs to ensure quality and consistency. It is precisely the reason Valisure came to existence.
During graduate school, Clark-Joseph noticed an identical medicine did not work. The solution was to try a new pharmacy. Doctors told him his current pharmacy may have a bad batch. Clark-Joseph called his friend David Light, a biotech worker. After research, they decided this was a real problem and one the American people should not have to worry about.
The two personally funded most of Valisure. With a group of scientists, they test medicines to ensure consistency, chemical makeup, and safety before selling to their customers. In fact, 10% of the batches the company tests are rejected due to contaminants, inability to dissolve correctly, or the wrong dose. This is quite different from the FDA’s percentage.
The company created a formula mimicking stomach acid. They dissolve tablets into the formula and study the reaction. One tablet took 24-48 hours to dissolve, despite marketed to only take 12 hours. The company uncovered carcinogens in particular blood pressure medications earlier in 2018. At that time, Valisure had reported 50 issues to various drug companies.
They don’t just use the stomach-acid solution, but also lasers. They recently added an instrument to detect carcinogens. Valisure re-evaluated ranitidine because of its role in Zantac. Dr. Kaury Kucera, the chief scientific officer of Valisure, observed a spike after testing ranitidine. This signified a concerning amount of NDMA was present.
What exactly did Valisure find in ranitidine?
Valisure alerted the FDA of NDMA in ranitidine in June of 2019. By September, the company filed a citizen petition. The petition reviewed the acceptable level of the probable carcinogen NDMA is 96 nanograms (ng). When Valisure tested the tablet, the value of NDMA was over 3,000,000 ng. Their reasoning was because ranitidine has a nitrate (“N”) and dimethylamine (DMA) and is an unstable molecule. When it breaks apart, it forms NDMA.
Using an FDA recommended protocol, Valisure tested the ranitidine in temperature of 130 degrees Celsius. Because conditions of the oven may cause high levels of NDMA, they conducted tests mimicking human body conditions. They further analyzed Stanford’s trials on individuals using ranitidine. Stanford gave ten individuals Zantac and then tested their urine. The levels of NDMA in the urine 47,000 ng. All tests still showed unacceptable levels of NDMA.
When Valisure examined ranitidine with added nitrites, the NDMA levels were 3,100 times the acceptable levels. The issue is nitrites are found in processed meats frequently consumed in America. Anyone who has eaten too many hot dogs or salami knows it’s not beyond measure to have a sour stomach. What does someone reach for? Zantac.
The company looked at safety studies on ranitidine. They suggested the studies were inadequate in providing enough information to show valid safety of the medication and expressed concern for the study’s methods. Valisure concluded the method yielded results showing safety where they otherwise would have not.
How the FDA responded to NDMA in Zantac
On September 13th, 2019, the FDA released a statement reporting low levels of N-nitrosodimethylamine (NDMA) in ranitidine medicines. Per the FDA’s drug recalls page and as of February 2020, Zantac 150, Zantac 150 Cool Mint, and Zantac 75 are among 18 various medications recalled due to the inclusion or potential inclusion of NDMA in their medicine.
NDMA is classified as a probable human carcinogen. Due to the process of cleaning drinking water, NDMA is already a bi-product consumed by humans. The molecule is also in some foods such as meats smoked or blackened. Before medication is ever taken, some NDMA is already ingested.
The FDA recommended safe levels of NDMA for human consumption. The acceptable daily intake for NDMA is .0096 micrograms. This level is based on lifetime exposure and is the level used for the FDA’s recommended recall. The tested lots of Sanofi Pharmaceuticals OTC’s 150mg ranged from .01 to .36 micrograms. The 75mg ranged from .01 to .04 micrograms per dose. Those taking Zantac regularly have constant exposure to the probable carcinogen above the recommended daily safe level.
I took Zantac or ranitidine. What should I be looking out for?
At this point in time, the CEO of Valisure, David Light, suggests anyone using Zantac speak with their doctor about switching to another medication. His company is an online pharmacy priding itself in testing medications before using them.
Per Light, “There’s no acceptable cancer risk for a medication like this. It’s given to pregnant mothers; it’s given to infants. There are plenty of alternatives out there.”
Certain types of cancers may have a link to taking Zantac, although Valisure is still working to pinpoint the precise cancers. The EPA found prolonged use caused tumors in the lungs and liver in animal studies. Studies with pregnant mice and NDMA showed mothers given NDMA during pregnancy resulted in the baby mice born dead or dying shortly after. Understandably, Zantac prescriptions for pregnant women raises concerns. At this point, no conclusive results have shown the correlation for humans.
Lawsuits are happening nationwide against companies due to NDMA in their medications. If you have been diagnosed with any of the below types of cancers, used Zantac, Zantac OTC or a generic ranitidine, and have taken the medication for at least three months, you may have a case.
- Colon or rectal
- Esophageal, throat or nose
- Prostate or testicular
- Small Intestine
- Other digestive tract cancers
How the FDA responded to NDMA in Zantac
If you or a loved one have been diagnosed with cancer as a result of taking Zantac (ranitidine), you may be entitled to monetary compensation. Contact The Hayes Firm today to review your case and match you up with an experienced lawyer for your claim. No one fights cancer alone. We are here to help you recover damages.