The Food and Drug Administration has taken an odd position on medication cancer risks. On the one hand, the agency asserts that it only approves medications that have been proven “…safe and effective for the intended use…” And yet the FDA routinely allows drugs on the market even if there are medication cancer risks.
George Orwell published his book, 1984, over 75 years ago. It provided examples of something he called “doublethink.” The concept was that citizens in this dystopian country were supposed to believe two contradictory ideas simultaneously.
They included phrases such as “War is Peace,” “Ignorance is Strength” or “Freedom is Slavery.” Is a drug that can cause cancer “safe”? We routinely see pharmaceutical commercials on television that state “death” is a possible adverse drug reaction of the medicine in question.
Apparently the FDA would like us to believe that a drug that can cause blood clots, heart attacks, strokes, cancer or death is safe! Apparently it works, because pharmaceutical manufacturers keep spending millions of dollars on these commercials. Maybe people just don’t seem to care about serious adverse drug reactions, including cancer…until they are affected personally
The $2.2 Billion Zantac Settlement:
One of the most expensive drug scandals in recent memory involves the heartburn medicine ranitidine. It used to be sold as Zantac. (The “new” Zantac has a different ingredient called famotidine.)
During its heyday in the 1980s, this acid suppressing compound was the number one most prescribed drug in the country. Zantac later became available over the counter.
In early October of 2024, the company that originally developed Zantac, GSK (GlaxoSmithKline), settled over 80,000 lawsuits from patients. The plaintiffs claimed that this heartburn and ulcer medicine caused their cancers. The company did not agree that ranitidine caused all those malignancies, but it decided to settle on the grounds that spending $2.2 billion to end the litigation was in the “best long-term interest of the company.”
Medication Cancer Risks and the FDA:
The FDA approved Zantac in 1983. It wasn’t until 2019 that an independent testing laboratory, Valisure, found that Zantac as well as generic forms of the drug contained a “probable human carcinogen” called NDMA. The FDA requested a recall of all ranitidine products early in 2020.
The independent laboratory that raised the red flag on this drug had already found carcinogenic chemicals in numerous other medicines and body care products. Valisure found NDMA in a wide variety of medications including blood pressure pills like irbesartan, losartan and valsartan. Some forms of the diabetes drug metformin were also contaminated.
The laboratory has also uncovered cancer-causing chemicals in a variety of body care products such as sunscreens, spray antiperspirants, hand sanitizers, dry shampoos and, more recently, popular acne products. It found benzene, a potent carcinogen, in 34 percent of the lotions, gels, creams and acne washes it tested. All contain benzoyl peroxide (Journal of Investigative Dermatology, Oct. 2024).
Downplaying Medication Cancer Risks:
The FDA doesn’t seem to know what to do about these disconcerting discoveries. The agency rarely conducts testing that would uncover such problems. When they do show up, the regulator seems uncertain how to address the problem in a timely manner.
The agency has pointed out its legitimate need to go slow:
“The FDA has ongoing assessment, surveillance, compliance and pharmaceutical quality efforts, which includes evaluating the root cause of benzene contamination. The agency acts on information provided from a variety of sources, such as that provided by Valisure’s citizens petition, but such data must be verified as accurate and reproducible before it can be utilized to make regulatory decisions such as recommending product sale suspensions and recalls.
“The FDA has been working with companies marketing drugs under approved applications and of other drugs, including over-the-counter monograph drug products, to address benzene issues in drugs prior to March 2021.”
We acknowledge that possible questions should be addressed carefully, and that takes time. However, problems with benzoyl peroxide (BPO) had become apparent well before 2021. Long before benzene became an issue, there was research from the 1980s identifying BPO as a tumor promoter (Science, Aug. 28, 1981; Human Toxicology, Jan. 1985).
A review of the safety of benzoyl peroxide published in 1999 in an IARC (International Agency for Research on Cancer) monograph concluded:
“There is inadequate evidence in humans for the carcinogenicity of benzoyl peroxide. There is limited evidence in experimental animals for the carcinogenicity of benzoyl peroxide.”
The FDA decided that BPO was not a problem. Now the agency is struggling with the benzene issue.
Other Medication Cancer Risks:
Much of the controversy about medications and cancer has resulted from contamination. That is to say, a carcinogen is created during or after the manufacturing process. The reason the FDA requested the withdrawal of Zantac (ranitidine) from the market was the formation of the nitrosamine NDMA when the drug was exposed to heat or extended storage.
In addition, analysts have found benzene contaminating some antiperspirant and deodorant body sprays. That was presumably because propellants like butane or propane were the source of this carcinogen.
I recently reported that the FDA recalled millions of capsules of generic Cymbalta (duloxetine). That was because of nitrosamine contamination with N-nitroso-duloxetine.
Medication Cancer Risks from the Drug Itself:
Hydrochlorothiazide:
What about medications that are not contaminated with a carcinogen but may increase the risk for cancer? The tongue twister hydrochlorothiazide is a diuretic. It was first granted FDA approval in 1959. Brand names have included Esidrix, HydroDiuril, Oretic and Microzide. The generic name is often abbreviated HCTZ or HCT.
In the October, 2011 issue of The American Journal of Medicine, one of the grand old men in hypertension research, Dr. Franz Messerli, and his colleague wrote:
“Hydrochlorothiazide (HCTZ) has become by far the most commonly prescribed antihypertensive drug in the US. In 2008, 47.8 million prescriptions were written for HCTZ alone and 87.1 million prescriptions for HCTZ combinations. However, there is no evidence that HCTZ in its usual dose of 12.5-25 mg daily reduces myocardial infarction, stroke, or death.”
HCTZ remains a very popular blood pressure medication by itself and in combination with other drugs such as lisinopril and losartan. It is considered very safe by most health professionals, though it can cause low potassium levels, low sodium levels, low magnesium levels, low zinc levels, elevated blood sugar levels, high uric acid levels and sensitivity to sunlight.
It is the sensitivity to sunlight that worries us.
In the 2017 October issue of the Journal of Internal Medicine Danish researchers titled an article on HCTZ:
“Hydrochlorothiazide use is strongly associated with risk of lip cancer”
In 2022 a systematic review and meta-analysis published in the European Journal of Clinical Pharmacology (June, 2022) concluded:
“Our results confirm the association between the use of hydrochlorothiazide and the cutaneous and lip squamous cell carcinoma development.”
Canadian researchers, writing in the Journal of the American Academy of Dermatology (JAAD, Aug. 2023), added this:
“Increased risks of keratinocyte carcinoma and melanoma were observed with longer durations of use and higher cumulative doses of HCTZ.”
On August 20, 2020 the FDA approved this change to the official prescribing information for hydrochlorothiazide:
“Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.”
Do health care professionals warn patients taking HCTZ to protect themselves from the sun and get regular whole-body exams? Possibly. But when a drug has been on the market as long as hydrochlorothiazide, prescribers may take it for granted. A new discovery about cancer might be ignored.
Omeprazole:
Another example of medication cancer risks that no one talks about has to do with powerful acid-suppressing drugs like omeprazole (Prilosec). This drug was first approved by the FDA in 1989. It became available over the counter to treat heartburn in 2003.
Many gastroenterologists prescribe proton pump inhibitors to prevent esophageal cancer in patients with a condition called Barrett’s esophagus (BE). Canadian researchers created some confusion, however, when they reported an increased risk of stomach cancer associated with proton pump inhibitors (Gut, Jan. 2022).
Here are their conclusions:
“In summary, the results of this large real-world study suggest that patients newly treated with PPIs may be at an increased risk of gastric cancer compared with patients newly treated with H2RAs [histamine antagonists like famotidine], although the absolute risk remains low. While PPIs have established clinical benefits when used according to evidence-based guidelines, this study highlights the need for physicians to regularly reassess the necessity of ongoing treatment. This is especially important in patients who are prescribed PPIs in the long term and for patients without an evidence-based indication for use.”
Investigators published a review of proton pump inhibitors and cancer risk in the Journal of Clinical Medicine, March, 2024:
“Multiple comprehensive studies have consistently suggested a noteworthy link between prolonged PPI usage and an increased risk of developing gastric, esophageal, colorectal, and pancreatic cancers, yet the precise underlying mechanism remains elusive.
“Our review indicates that prolonged use of proton pump inhibitors (PPIs) for more than three months is linked to a higher risk of cancer, whereas shorter-term usage (less than three months) appears to carry a comparatively lower risk.”
“Although PPIs have been effective in controlling gastrointestinal conditions, the very extended usage of the drugs may increase cancer risk.
Medication Cancer Risks That No One Talks About:
The few examples provided above are just the tip of the iceberg. We have written that the:
“FDA Stance on Drugs & Cancer is Confusing”
Remember that we started this article with the FDA’s claim that it only approves medications that have been proven “…safe and effective for the intended use…” Apparently cancer is not considered something to worry about.
The hottest drugs in the pharmacy these days are GLP-1 agonists. You know them as brands such as Ozempic and Wegovy (semaglutide).
They come with this boxed warning:
“In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined .
“WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of WEGOVY and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). “
Even if you have watched TV commercials for drugs like Humira to treat psoriatic arthritis, you may have missed the warning about “cancers including lymphoma.” Many of the powerful “biological” meds frequently advertised on television for conditions like psoriasis, eczema and Crohn’s disease come with a quick warning about lymphoma and other cancers.
Final Words:
Drug companies and the FDA do not seem to worry too much about medication cancer risks. And yet I suspect that if you ask people which diseases they fear the most, cancer would be right at the top of the list.
You might think that the $2.2 billion dollar payment announced by GSK to settle over 80,000 lawsuits might deter some drug companies. Apparently, though, if they warn people that their medicine might cause cancer, they do not fear litigation. It is only when they do not mention a cancer risk that they can get into trouble. That’s especially true if they keep such a risk to themselves.
I wish the FDA were a little more concerned about medication cancer risks. It seems to me that the agency is often slow to respond and often downplays the problem.
What do you think? I would love to read your thoughts in the comment section below. And if you think this article is worth sharing, please send it to family and friends. Putting the cancer cat back into the bag is always a challenging process.
