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Does Your Medicine Pose a Cancer Risk?

Establishing a drug-induced cancer risk may take 5 to 10 years or longer. The FDA rarely requires such long-term research. That leaves great uncertainty.
Does Your Medicine Pose a Cancer Risk?
Film chest X-ray PA upright : show pleural effusion at right lung due to lung cancer

Most people take prescription medications to relieve symptoms or prevent serious health problems. Some of the best sellers include blood pressure medicines, acid-suppressors, diabetes drugs and medications to ease pain and inflammation. People often take such medicines for years or decades. They do not imagine that a medicine that is supposed to improve their health might represent a cancer risk.

The Dreaded C Word:

People used to worry a lot about heart attacks. No surprises there. Cardiovascular disease has been the big killer of Americans for decades. But quick intervention with stents can save lives.

Just ask Bernie Sanders. He suffered a heart attack on October 1st. He was out of the hospital on October 4th. After a “few days” rest he is still scheduled to participate in the Democratic debate on October 15th. Like Bernie, many people who suffer heart attacks get on with their lives surprisingly fast.

The same cannot be said about cancer. A diagnosis of cancer impacts your life like a sledge hammer. Anxiety, anger, fear and depression are just a few of the emotions that can turn your world upside down. For many cancer patients, life is never the same.

FDA’s Response to the Zantac (Ranitidine) Cancer Risk:

That’s why we are so distressed with the FDA’s seemingly cavalier attitude about the cancer-causing potential of so many medications. The most recent scare involves the popular heartburn medicine ranitidine (Zantac). An independent laboratory found the probable carcinogen NDMA in various samples of this drug.

Many other countries have recalled this medication from pharmacy shelves. The FDA followed with an announcement that there is a:

“voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp. These medicines may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).”

The agency also announced a voluntary recall of prescription-strength ranitidine made by Sandoz.

On September 13, 2019 the FDA reassured the American public that:

“Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health. Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

The Food and Drug Administration went on to state:

“FDA is not recommending individuals stop taking all ranitidine medicines at this time.”

Valisure, the pharmacy that detected NDMA in ranitidine, asked the agency to:

“recall and suspend sale of all lots of all products containing ranitidine.”

It maintains that levels of the nitrosamine are far in excess of FDA’s established permissible daily intake limit for the probable human carcinogen. David Light, CEO of Valisure, has stated:

“There’s no acceptable cancer risk for a drug like this.”

On October 2, 2019 the FDA issued a modest reversal:

“To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine. The agency will provide more information as it becomes available.”

The ARB (Angiotensin Receptor Blocker) Mess:

The ranitidine controversy follows on the heels of the “sartan” scandal. For the last fifteen months the FDA has been announcing recalls of the blood pressure drugs irbesartan, losartan and valsartan because of nitrosamine contamination.

The agency downplayed the danger. It initially stated that the risk of cancer was very low: about one person out of 8,000 might be at risk for cancer after four years exposure. Now the FDA maintains that the risk is probably even lower.

Of course, there are no actual data to prove or disprove this number. It is unlikely the FDA or any other organization will pay for the long-term research to determine the true risk.

Other Medicines and a Cancer Risk:

Humira (Adalimumab):

There are dozens of other drugs that come with a cancer warning. The highly promoted drug Humira (adalimumab) is prescribed for rheumatoid arthritis, colitis and psoriasis. It comes with a black box warning:

“Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA…These cases have had a very aggressive disease course and have been fatal.”

Other immune modulators such as Enbrel (etanercept) and Remicade (infliximab) also come with malignancy warnings.

Actos (Pioglitazone) and Bladder Cancer?

Pioglitazone was once a top-selling diabetes drug. It is estimated that the manufacturer, Takeda Pharmaceutical, took in over $20 billion since the drug’s approval in 1999.

Then it paid out $2.4 billion to patients or their families because of lawsuits. The issue: bladder cancer. Although the drug was banned in France, Germany and India it is still on sale in the U.S. The FDA does require this warning, though:

“Bladder cancer: May increase the risk of bladder cancer. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer.”

What is a patient to make of such a cancer risk?

You can read more about the Actos controversy at this link:

Actos Maker Settles Lawsuits Worth Billions but Keeps Selling Drug Linked to Cancer

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ACE Inhibitors and Lung Cancer?

It is estimated that as many as 30 million Americans take ACE inhibitors each year. ACE stands for angiotensin converting enzyme. These are drugs like benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), (ramipril (Altace) and quinapril (Accupril).

Such drugs are very effective for controlling blood pressure. With the contamination controversy swirling around sartans, some doctors have switched patients to ACE inhibitors.

In 2012 there was a large (1.2 million) population-based study that reported a “modest increase in the risk of lung cancer” associated with ACE inhibitors (PLoS One, online, Dec. 12, 2012).

Six years later another epidemiological study analyzed data from nearly one million patients (BMJ, Oct. 24, 2018).  The objective:

“To determine whether the use of angiotensin converting enzyme inhibitors (ACEis), compared with use of angiotensin receptor blockers [ARBs, aka “sartans”], is associated with an increased risk of lung cancer.”

The authors introduced their research this way:

“Angiotensin converting enzyme inhibitors (ACEIs) are effective drugs used in the treatment of hypertension.1Although these drugs have been shown to be relatively safe in the short term, concerns have been raised that their long term use may be associated with an increased risk of cancer. These concerns have been subject to debate, with observational studies producing mixed findings, including with respect to lung cancer.”

Their Conclusions About a Cancer Risk:

“In this population based cohort study, the use of ACEIs was associated with an increased risk of lung cancer. The association was particularly elevated among people using ACEIs for more than five years. Additional studies, with long term follow-up, are needed to investigate the effects of these drugs on incidence of lung cancer.”

The cancer risk was considered “modest.” There was a “14% increased risk of lung cancer.” In terms of absolute risk: It went from 1.2 people per 1000 person-years for people not taking an ACEi to 1.6 people per 1000 person-years for those on an ACEi. That may seem less than “modest,” but when you consider how many millions of people are taking such drugs the total number potentially impacted is not trivial.

No one should EVER stop taking any medication without medical consultation. ACE inhibitors are valuable drugs and the cancer risk, if it exists at all, needs to be confirmed. You can read more about this controversial topic at this link:

ACE Inhibitors and Lung Cancer | Should You Be Concerned?

Hydrochlorothiazide (HCTZ) and Skin Cancer?

Here’s one that we doubt your doctor has ever heard of. The diuretic hydrochlorothiazide (abbreviated HCT or HCTZ) is taken by at least 20 million people. It is often combined with other blood pressure medications to exert a more powerful effect. We have written an article about the association between HCTZ and skin cancer:

Hydrochlorothiazide Side Effects: Skin Cancer and More!

What Should We Do About Drugs and a Cancer Risk?

We have only scratched the surface of this controversial topic. There are scores of medications people take every day that have some association with a cancer risk. Of course that means that thousands of drugs do not have a cancer risk.

A cancer risk leaves both physicians and patients confused. Is there danger to patients or are these alerts meaningless? Without long-term research, we will probably never have a good answer. The growing ranitidine and sartan controversies leave millions of people in limbo.

Share Your Thoughts:

What do you think about concerns linking popular medications to a cancer risk? Is this a tempest in a teapot or something worrisome? Should the FDA require long-term studies to try to determine whether there is a meaningful risk? 

Who should pay for such research? The original pharmaceutical companies are unlikely to pony up since many of their drug patents have expired. What should we do as a society to identify a cancer risk? The FDA seems reluctant to take much action.

Please share your thoughts in the comment section below.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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  • Azoulay, L., et al, "Long-term use of angiotensin receptor blockers and the risk of cancer," PLoS One, online, Dec. 12, 2012, doi: 10.1371/journal.pone.0050893
  • Hicks, B.M., et al, "Angiotensin converting enzyme inhibitors and risk of lung cancer: population based cohort study," BMJ, Oct. 24, 2018, https://doi.org/10.1136/bmj.k4209
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