Valsartan ban causes medical chaos
By Kim Hyun-bin
The Ministry of Food and Drug Safety's decision to ban sales of an additional 59 locally manufactured high blood pressure pills containing a possible carcinogen has brought chaos to patients and pharmacies around the nation.
“My father has been taking high blood pressure pills for over a decade, and as soon as the news broke out I told him to go to a pharmacy,” said a Seoul resident identified only as Choi. “How can a pill induce cancer? This is absurd.”
The drug safety ministry posted a list of the banned medications online but most high blood pressure patients are elderly who choose to call their pharmacist to ask about their prescriptions.
“The government announces the ban and the pharmacists have to deal with the aftermath,” said Lee who runs a pharmacy in Dongjak-gu, southern Seoul.
A recent investigation conducted by the country's drug safety watchdogs concluded there were high levels of possible carcinogens in locally manufactured Valsartan, made with ingredients imported from China.
Valsartan lowers blood pressure by suppressing the secretion of hormones that constrict blood vessels.
The findings led the ministry to ban sales of the 59 medications manufactured by 22 Korean pharmaceutical firms.
The move marks the second time the government suspended sales and production of high blood pressure medications linked to Valsartan's ingredients.
Last month, 115 high blood pressure treatments supplied by China's Zhehiang Huahai were banned after high levels of cancer-inducing N-Nitrosodimethylamine (NDMA) were discovered. Health authorities around the world including the U.S and Europe have taken similar action against the drugs.
The latest investigation discovered some Valsartan produced by Korea's Daebong LS to contain more than the standard 0.3 parts per million (PPM) of NDMA, as high as 4.89 ppm. Valsartan manufactured by Zhejiang Huahai contained up to 112.1 ppm, and hypertension drugs locally made from the materials contained up to 18.72 ppm of NDMA.
The firm has been importing ingredients from China's Zhuhai Rundu Pharmaceutical, the ministry said.
Over the last three years, Daebong LS has accounted for around 3.5 percent of the country's raw material Valsartan market.
The 59 banned products account for 10.7 percent of Valsartan products available in Korea, with over 181,000 people taking the medications.
All the patients will need to go to a pharmacist to get new prescriptions for other high blood pressure drugs.
The drug safety ministry announced that when taking a 320mg government-certified pill that contains NDMA for three years, one out of every 11,000 is expected to be diagnosed with cancer.
“There is confusion in what drugs we can prescribe to high blood pressure patients, and we are really worried that the government doesn't have a responsible countermeasure plan,” the Korean Medical Association said. “The government will need to guide the public with relevant information and do its upmost to reduce public anxiety.”
The situation is more chaotic for pharmacies around the country and pharmacists are voicing discontent as the government tossed their responsibility to pharmacists to handle the issue.
“The high blood pressure patients have no choice but to ask a pharmacist and we have to take all the blame,” the Seoul Pharmaceutical Association said. “This is the second time in a month we have had to deal with the issue. The health authorities need to take responsibility and they need to create a compensation system for pharmacists.”