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."
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."
- 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.
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