The Danger of Imported Pharmaceuticals
In a recent bulletin from the U.S. Food and Drug Administration (FDA), the manufacturers of certain high blood pressure, heart failure and post heart attack medications were ordered to recall some of the medicines they were producing in China because of a contamination found in the manufacturing process that produces a known probable human carcinogen. Why did it take an FDA recall to force these manufacturers to take action? Shouldn’t the pharmaceutical companies, who were aware of the contamination, have already taken steps to protect the American public from a potentially dangerous toxin?
On July 13, 2018, the FDA disclosed that Valsartan, the active ingredient used in some heart medications that were produced in a Chinese factory, had been contaminated with nitrosodimethylamine, known as NDMA. NDMA has been declared a probable carcinogen by the FDA and is known to scar the liver and cause liver tumors in rats. Pharmaceutical companies, including Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceutical Industries and others, contracted with a Chinese company to manufacture their heart medicines. During the manufacturing process of Valsartan, it became contaminated with NDMA. Twenty-two other countries besides the United States have also issued recalls of tainted Valsartan-containing heart medications manufactured in Chinese factories.
Check Your Medicine
While it is important to note that not all heart medicines containing Valsartan are contaminated with NDMA, Americans needing these medicines should check with their physicians to see if the Valsartan in their prescription is affected. Look at the label on the bottle for one of the manufacturers listed in the FDA recall or talk to your pharmacist. There are safe alternatives, and patients should continue to take their medication and see their doctors as soon as possible to determine if they should be switched to a suitable substitute.
Meanwhile, if your heart medicine does contain tainted Valsartan, Dr. Erin Michos, associate director of preventive cardiology at Johns Hopkins Medicine, says your risk of getting cancer is directly related to how much of the medicine you’ve taken. NDMA is an organic chemical used in the manufacture of some liquid rocket fuels, softeners and lubricants. It can also be a byproduct of pesticide manufacturing, fish processing and in the making of rubber tires, according to an August 28 article published by CNN’s online health magazine. The more of the contaminant you’ve ingested, the greater your risk of complications.
Baron & Budd is committed to protecting the public from unscrupulous drug manufacturers who fail to properly test their products or warn patients and physicians about toxic contamination and other issues. If you took a drug containing tainted Valsartan, Baron & Budd may be able to help. contact us online or call 866-723-1890 to learn more.