You may remember back in the summer of 2018, several pharmaceutical companies began recalling their heart and blood pressure medications. After the Food and Drug Administration (FDA) tests found trace amounts of impurities and carcinogens in valsartan, losartan, and irbesartan, drug companies began recalling certain lots of the drug and recalls have continued well into 2019.
Currently, the FDA is investigating the cause or causes as to how and why these toxic substances ended up in the medication. Although their investigation is not yet complete, past inspections at drug manufacturing companies in India and China reveal a consistent pattern of issues with the manufacturing process – before this current batch of dangerous drugs even hit the market.
We know many of our clients have concerns and questions about these medications, the recalls, what drugs are affected, and what the FDA is doing to fix it.
What drugs are affected by these FDA and company recalls? The prescription medications valsartan, losartan, and irbesartan are the targets of the recalls. These drugs work by blocking the effect of a hormone that narrows blood vessels, and doctors typically prescribe these medications to regulate blood pressure and heart conditions.
Why were the drugs recalled? The FDA discovered impurities and contaminants in factories in China and India that make and supply valsartan ingredients to drug companies all over the world. This past summer, they found these factories contained N-nitrosodimethylamine (NDMA), a possible carcinogen. Later on in September, the FDA’s testing revealed another contaminant, NDEA, in some varieties of valsartan drugs.
Am I going to get hurt if I take these drugs? Not necessarily. Although there were many lots of medication recalled – whether used alone or as a component of other drugs – there were many other lots that weren’t. Find the most updated and comprehensive list of recalled drugs on the FDA website.
What factories made these tainted drugs? The majority of the tainted drugs and recalls came from the Zhejiang Huahai Pharmaceutical factory in Linhai, China. During previous inspections, FDA found equipment in disrepair and factory workers failing to investigate testing anomalies. Even with these issue, manufacturing operations continued, until June 2018 when testing revealed unacceptable levels of NDMA in the factory, prompting the FDA to announce the recall in July.
In Jadcherla, India, workers at Hetero Labs were discovered shredding documents before a 2016 inspection. The FDA also warned their workers about failing to investigate testing anomalies, as well as failing to regularly clean equipment.
The FDA eventually issued an import warning against the Zhejiang factory to prevent its drugs from making their way to the United States. However, it hasn’t issued one against Hetero as of this writing.
What is the FDA doing to make my medicine safer? All international drug manufacturers are subject to FDA inspection. These manufacturers are also required to notify federal regulators if they change or deviate the way they make their drug ingredients.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, says the FDA is focusing on the supply and manufacturing chain. “While the total exposure to these impurities for most patients was small, we are deeply concerned that patients were exposed to this impurity in the first place and that the presence of nitrosamines went undetected for a period of time. The potential for the development of genotoxic impurities during manufacturing processes is an area of intense focus.”
She adds that patients should not stop taking their medication without the guidance of their doctors. “We remind patients taking these medications or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option.”
If you were harmed by valsartan or any other dangerous drug, talk to the lawyers at Eichen Crutchlow Zaslow, LLP. Our attorneys are skilled, experienced, and ready to stand up to drug companies on your behalf. We have offices in Edison, Red Bank, or Toms River, New Jersey. Call us today for a consultation at 732-777-0100 or fill out our contact form.