Valsartan recall can teach us an important lesson about the safety of generic drugs

The U.S. Food and Drug Administration does a good job trying to keep our medications and food as safe as possible. So far this year, the FDA has issued recalls of more than 60 medications and warnings on hundreds of food-related products that have been contaminated.

Food recalls often make the news. Remember the E. coli bacteria that contaminated our romaine lettuce supply earlier this year? Many food recalls are voluntary, done by the company that manufactures the contaminated product. My kids were upset to hear the news last month that Pepperidge Farm Goldfish crackers might be contaminated with the bacteria Salmonella. This was a voluntary recall and, luckily, no one became sick.

Most medication and supplement recalls receive a lot less publicity.

One supplement called Poseidon, used for "male sexual enhancement," was recently found to contain traces of Viagra and Cialis, which probably made it work better than other natural supplements. The FDA removed it from the market because it was being sold as an over-the-counter supplement, despite containing a prescription drug.

Blood pressure medications may not be as interesting to talk about as Viagra or Goldfish crackers, but were the subject of a recent important recall.

Valsartan is one of the most commonly used generic medications to treat hypertension, and has been available for several years. Much of the national supply was recently recalled by the FDA because it contains an impurity called NDMA (N-nitrosodimethylamine), which has been found to cause cancer. This was initially discovered in July in a generic made in China, and now has been found in the product made by several other companies, including one in India, and may have been in the drug for the last four years.

The recall has been handled primarily by pharmacies calling patients and letting them know that their medication may be dangerous. According to the FDA, the risk is small, but real.

I saw one patient the other week who stopped taking valsartan after getting a call from his local CVS. When I saw him a week after stopping, his blood pressure was dangerously elevated. Stopping it suddenly was vastly more harmful than the small risk of cancer. The takeaway message: Call your doctor before stopping valsartan, and check with your pharmacy if you take the drug to see whether there is a problem.

There are other generic medications that are available that are similar to valsartan (angiotensin receptor blockers) that are just as good, as is the brand name Diovan. But some generics have become very expensive. One of my patients found this out the hard way. His insurance plan told him that his new generic (irbesartan) would be $160 a month when his valsartan was only $10 a month.

If generic medications are getting more expensive, why not go back to the brand-name drugs, especially if they are safer?

In the United States, generics already make up 84 percent of the total pharmaceutical market. In an article last October that was eerily prescient, researchers looked specifically at valsartan to find out the chance of developing a side effect when switching from the brand name Diovan to the generic valsartan. The authors found that the similar medications losartan, valsartan and candesartan were associated with a 7.5 percent, 17.1 percent, and 16.6 percent higher chance of having an adverse effect when switching to a generic, respectively.

The researchers suggested that there may be a medical reason why generics result in more problems: They may be as much as 20 percent different in terms of potency yet still be considered equivalent. This difference may result in side effects. Aggressive campaigning in favor of brand-name drugs by pharmaceutical representatives and companies may create suspicion in consumers' (and doctors') minds about the use of generics, making the perception of ill effects more likely. An important finding of the study was that most people quickly got used to taking the generic, and most side effects were minor and went away after a few months.

Trying to prevent the use of generics versus brand-name medications is a fight that big pharma lost long ago. Not that they haven't tried. Pfizer's brand name Lipitor (atorvastatin) was the best-selling drug of all time until a generic version became available in the U.S. in November 2011. Pfizer cut deals with insurers to keep the generic as expensive as Lipitor, and paid a generic manufacturer to keep its brand off the market for an extra year to help maintain market share. The strategy worked for a while.

Even though the availability of generic atorvastatin led to a 28 percent reduction in cost from 2012 to 2014, directed prescriptions to Lipitor during those two years led to an estimated $2.1 billion in profit for Pfizer, because so many people stayed on the brand-name drug. Now, four years later, almost everyone takes the generic, so the windfall was short-lived.

When a drug comes off patent, and a generic version becomes available, it is cheaper, and this decreases costs. We are not going back to the more expensive brand-name drugs once they come off patent, nor should we. But, as we use generics, they need to be affordable and not restricted by insurance company formularies.

The valsartan scare suggests that continued monitoring by the FDA, especially of overseas makers of generic medication, will be crucial to maintain a safe supply of medications that Americans rely on for their health. Less expensive should not mean less safe, and the valsartan recall should be a wake-up call for all of us about potential dangers of generics, and the importance of careful oversight.

David Becker, M.D., is a frequent Inquirer contributor and a board-certified cardiologist with Chestnut Hill Temple Cardiology in Flourtown. He has been in practice for 25 years.