Note: This story was updated on March 18, 2019 with the recall of 43 lots of Losartan.
Dozens of medications used to treat high blood pressure have been recalled over the past several months as federal investigators discover potentially cancer-causing impurities in them. When American Health Packaging recalled one lot of valsartan pills on March 7, the Public Interest Research Group said it was the 75th recall of blood pressure medications since the problem first appeared.
The problems have become so widespread that on March 12 the FDA prioritized approval of a new generic of valsartan to help relieve shortages of the drug.
“We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines,” said FDA Commissioner Scott Gottlieb, MD. Gottlieb said the agency will continue to work with drug manufacturers so that more medicines like valsartan can be approved.
The FDA is also working to determine what exactly has caused the impurities and what changes need to be made in the manufacturing process to prevent it. The Public Interest Research Group said in March that the FDA needs to step up the pace.
"After 75 recalls it is clear more aggressive action is needed," PIRG consumer watchdog Adam Garber said in a release. "Americans expect their blood pressure medicadtion to treat their conditions, not cause cancer. The FDA needs to finish its investigation and develop a plan to prevent further contamination."
Almost 60 million prescriptions were written for losartan drugs in 2016 and 14 million for valsartan or a drug that includes it. An additional 3.6 million prescriptions were written for irbesartan that year. Here’s what you need to know.
What blood pressure drugs have been recalled?
Valsartan. There have been so many types of valsartan recalled this year that the FDA has created a website listing just for them. The latest is American Health Packaging's 160 mg valsartan tablets, lot number 179791 that expire on March 31, 2020. The pills come in 100-count blister packs with NDC number 60687-139-01.
The agency has also created a page that lists the drugs that have not been recalled.
Losartan. In December, the FDA announced a voluntary recall of losartan potassium tablets USP. An addition eight lots of Torrent Pharmaceuticals' losartan tablets were added to a previous recall in January. See which products were affected by the recall.
In November, the FDA announced a voluntary recall of losartan potassium/hydrochlorothiazide, 100 mg/25 mg tablets in 1,000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912, Exp. Date 06/2020.
Torrent's recall was expanded on Jan. 22 to include 10 additional lots of losartan potassium tablets, and six lots of losartan potassium and hydrochlorothiazide tablets. See the full list here.
Macleods Pharmaceuticals Limited on Feb. 25 recalled one lot of losartan potassium/hydrochlorothiazide combination tablets 100mg/25mg, with a July 2019 expiration date.
Camber Pharmaceuticals on Feb. 28 recalled 87 lots of losartan tablets USP 25mg, 50 mg and 100 mg. See the affected products and what the label looks like.
Irbesartan. In July, the FDA announced a voluntary recall of irbesartan tablets. See which products were affected by the recall. In January 2019, Prinston Pharmaceutical Inc., doing business as Solco Healthcare LLC, voluntarily recalled eight llots of irbersartan-based drugs. These are not yet listed on the FDA's website of all recalled ibersartan products. The recall involves irbersartan and irbersartan HCTZ tabletes manufactured in China.
Why are the drugs being recalled?
In each case, a recalled drug was contaminated with N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) or N-Nitroso N-Methyl 4-amino butyric acid (NMBA).
NDEA is used to make rocket fuel and can also be found in some food and drinking water, but at low levels. It can also be a created through certain chemical reactions and as a byproduct of industrial processes.
What is the risk of getting cancer from one of these drugs?
The FDA says it is very small. The amount of NDMA found in the recalled valsartan drugs exceeds acceptable levels. Records from drug manufacturers show the impurity may have been in the valsartan products for up to 4 years. The FDA estimates that if 8,000 people took the highest valsartan dose, which is 320 milligrams, from recalled batches every day for 4 years, there would likely only be one additional case of cancer over the life of those 8,000 people.
For context, 1 in 3 people in the United States will be diagnosed with cancer in their lifetime.
What’s driving the spike in recalls?
A common thread among all of these recalls is that the drugs, or ingredients in the drugs, were all made in China or India.
American drug companies since the 1990s have increasingly used factories in other countries to manufacture their products. About 40% of finished medications are made overseas, the Government Accountability Office says. Nearly 8 out of 10 active pharmaceutical ingredients, which are made into pills at other plants, are, too.
This globalization of the nation’s drug supply helps keep prices down, as it is cheaper to have them made in other countries. But with lower costs sometimes comes lower quality control.
What’s being done about products made in other countries?
An FDA spokesman says the agency is still investigating how these drugs became contaminated. Inspectors believe contaminated compounds were unintentionally created through a chemical reaction.
What should people who rely on these medicines do?
Experts say anyone taking a recalled drug should continue to do so, but contact your doctor or pharmacist immediately. The threat from the contamination may be less than the threat of not taking the drug.
Your doctor or pharmacist can help you find an alternative. But at least one expert says the recalls are making it more difficult to find valsartan drugs that have not been recalled. And, he says, some blood pressure drugs not on the recall list have seen price increases as demand spikes.