More than dozen blood pressure medications recalled since July

PITTSBURGH — Another day, another problem for blood pressure medications, and it's starting to frustrate Cindy Bryan who takes her pills daily.

"Even the doctors don't know about it, " Bryan said. "They can't keep up with all of this."

Channel 11 has reported more than a dozen blood pressure medication recalls since July of last year. Each recalled medication contains trace amounts of the chemical NDEA, which the FDA deems a "probable human carcinogen."

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Dr. Mark Schmidhofer, from UPMC Presbyterian, said the carcinogen is a waste byproduct created during a new manufacturing process that drug companies and the FDA didn't know could happen.

"You only find what you test for, and people didn't anticipate that this was there, so they didn't routinely test for it," Schmidhofer said,

Schmidhofer said taking the maximum dose of one of these medications over four years could lead to a one in 8,000 chance of developing liver cancer.

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Canonsburg-based pharmaceutical company Mylan produces Valsartan, one of the drugs recalled in recent months. In a statement, Mylan said it has "taken immediate action to eliminate NDEA from the Valsartan API manufacturing process."

But pharmacist Dan Asti, of Asti's Pharmacy in the South Hills, said drug companies need to do a better job of announcing recalls directly to doctors, pharmacists and patients.

He said there needs to be a direct line of communication.

"They're not getting that information to us quicker and in a more accurate fashion," Asti said. "We can call you instead of you calling us."

But, Schmidhofer said, despite the rise in recalls, patients shouldn't lose faith.

"Medicine is doing something right," he said. "Are there problems with it? You bet. And are there things we can do better? Tons."

15 blood pressure medications recalled by FDA since July

• Jan. 22, 2019 - Torrent Pharmaceuticals Limited / "losartan potassium tablets, USP; losartan potassium hydrochlorothiazide combination tablets, USP"
• Jan. 18, 2019 - Prinston Pharmaceutical Inc. dba Solco Healthcare LLC / Irbesartan and Irbesartan HCTZ Tablets
• Jan. 3, 2019 Aurobindo Pharma USA, Inc./ 80 lots of Amlodipine Valsartan Tablets, Valsartan HCTZ Tablets, and Valsartan Tablets (NDEA)
• Dec. 4, 2018 / Mylan Pharmaceuticals / Valsartan-containing products (NDEA)
• Nov. 27.2018 / Teva Pharmaceuticals /  Amlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination Tablets (NDEA)
• Nov. 20, 2018 / Mylan Pharmaceuticals / Amlodipine and Valsartan Tablets; Valsartan Tablets; Valsartan and Hydrochlorothiazide Tablets (NDEA)
• Nov. 8,2018 / Sandoz Inc / Losartan Potassium Hydrochlorothiazide (NDEA)
• Oct. 30, 2018 / ScieGen Pharmaceuticals, Inc / Irbesartan Tablets (NDEA)
• Oct. 26,2018 / Aurobindo Pharma Limited / Irbesartan Drug (NDEA)
• Oct. 23, 2018 / Torrent Pharmaceuticals Limited / Valsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tablets (NDMA)
• Oct. 17, 2018 / Torrent Pharmaceuticals / Valsartan/Amlodipine/HCTZ Tablets (NDMA)
• Aug. 8, 2018 / Camber Pharmaceuticals, Inc. / Valsartan Tablets (NDMA)
• July 17, 2018 / Teva Pharmaceuticals USA / Valsartan and Valsartan Hydrochlorothiazide Tablets (NDMA)
• July 17, 2018 / Prinston Pharmaceutical Inc. dba Solco Healthcare LLC  / Valsartan Tablets and Valsartan-Hydrochlorothiazide Tablets (NDMA)
• July 13, 2018 / Major Pharmaceuticals / Valsartan tablets (NDMA)

NDEA and NDMA are both possible cancer-causing carcinogens. NDEA is found in certain foods, drinking water, air pollution and industrial processes. Find more info about NDMA on the EPA website.

The FDA is trying to trace the source of the contaminants. Originally, they were linked to factories in China and India that help supply Valsartan to generic drug makers. A Chinese manufacturer was linked to a deadly batch of heparin that killed at least 81 people in 2007 and 2008. That factory had serious manufacturing deficiencies according to the FDA.

"Millions of Americans take medication daily to control their blood pressure. In June 2018, we found that some generic versions of the angiotensin II receptor blockers (ARB) class of medicine, which treats high blood pressure and heart failure, contain impurities – including certain valsartan, irbesartan and losartan-containing medications. These products have been recalled from the U.S. market and the agency continues to investigate and test all ARBs. The FDA is committed to taking swift action when it identifies these impurities above acceptable daily intake levels and to keeping the public informed of voluntary recalls of these products on our webpage. Patients taking any recalled ARB should continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication." – FDA

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Mylan is committed to ensuring a reliable supply of high quality medicines for patients and customers in the markets it serves. A trace amount of the impurity N-nitrosodiethylamine (NDEA) has been detected in the Valsartan active pharmaceutical ingredient (API) that the company uses and sells for the manufacturing of Valsartan finished dose products. Mylan previously confirmed that its Valsartan API and finished dosage products tested below the required thresholds for NDMA.

Mylan has taken immediate action to eliminate NDEA from the Valsartan API manufacturing process. As a precautionary measure, Mylan has suspended the distribution of Valsartan, Valsartan hydrochlorothiazide (HCTZ), and Amlodipine and Valsartan tablets containing the impacted API where the products are marketed. Mylan is working proactively with health authorities to determine if any market actions are required as the company continues to quickly, diligently and thoroughly assess the situation. 

On Nov. 20, Mylan initiated a recall in the U.S. On Dec. 4, Mylan expanded its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry.

As background, the presence of NDMA and NDEA in Valsartan tablets is an industry-wide issue and was first identified earlier this summer when the impurities were traced back to API manufactured by Chinese manufacturer Zhejiang Huahai Pharmaceuticals. Following this initial detection and a series of recalls over the summer, health authorities, like FDA, issued a methodology to manufacturers for detecting NDMA and NDEA. Mylan implemented the FDA-provided detection protocol and identified NDEA as a substance that formed through a specific sequence of manufacturing steps and chemical reactions.

Cox Media Group