Valsartan Recall History
Though dangerous generic valsartan side effects are a relatively recent development that’s been known for only a few months, the high blood pressure medication has a long history. Originally, valsartan was developed by Novartis, a giant pharmaceutical company with headquarters in Switzerland and offices throughout the world. Indeed, Novartis sells drugs in at least 155 nations.
In January of 1997, the U.S. Food and Drug Administration, or FDA, approved valsartan in capsule form for use in treating hypertension, also known as high blood pressure and the most widespread health problem in the United States. Later the FDA also approved the drug for treating heart failure.
Generic Valsartan Sales Rise After Patent Expiration
Novartis originally sold valsartan under the brand name Diovan. After Novartis lost patent protection for valsartan in 2012, several other pharmaceutical companies began making and selling generic versions of the drug. These generic valsartan drugs -- not Diovan -- are the ones which may have been contaminated during the manufacturing process after some companies selling generic valsartan outsourced the work to China and India. There, it’s known that the poisonous contaminant NDMA was introduced to some valsartan compound products.
Valsartan Contaminants Found
Such products were on the market for around four years after the contaminants were introduced to the drug. In fact, it was only in late July of 2018 that the contamination was discovered by China’s Zhejiang Huahai Pharmaceuticals, a leading manufacturer of generic valsartan and the biggest wholesale producer of valsartan compound. During routine quality control tests, Zhejiang Huahai officials learned that some batches of the valsartan compound it was making were contaminated with NMDA, or N-nitrosodimethylamine, a poisonous element. This apparently happened due to its production lab’s new method of synthesizing valsartan, which the company had begun a few years earlier.
This meant that contaminated valsartan products had been sold in the U.S., Europe and elsewhere for several years -- and sold in large numbers. In the U.S. alone, Zhejiang Huahai had distributed valsartan wholesale to U.S. affiliates Solco, Prinston and Huahi. Those companies then used the drug to manufacture, package, market and sell their own generic versions of valsartan.
FDA Valsartan Recall Issued
Zhejiang Huahai alerted these and other pharmaceutical companies, as well as safety officials, immediately after discovering the contaminant in July of 2018. That led to a U.S. Food and Drug Administration valsartan recall of potentially contaminated valsartan, as well as a valsartan recall by European health officials.
Pharmaceutical wholesalers Zhejiang Tianyu Pharmaceuticals of China and Hetero Labs Ltd. of India also found NDMA in the valsartan they produced, though in lower levels than in Zhejiang Huahai’s products. Not all generic valsartan products sold in America have been contaminated by NDMA or recalled by FDA. Persons who have taken generic valsartan can learn which version they’ve taken and whether it’s among the recalled drugs by contacting their prescribing physician.
So far, the FDA’s valsartan recall in the U.S. includes only valsartan sold by Solco Healthcare, Major Pharmaceuticals Teva Pharmaceutical. However, that list may expand as more discoveries are made. In the meantime, the Chinese company at fault has ceased distributing its valsartan compound products, and the FDA is collaborating with the pertinent companies to reduce or remove it from the drug marketplace.
Valsartan Lawsuits Have Been Filed
Following the news that valsartan recalls had been made -- news which showed a link between defective generic versions of the drug and harmful side effects such as cancer -- valsartan lawsuits began being filed in U.S. courts. Such valsartan lawsuits can claim payments for victims’ losses as a result of medical and hospital expenses, lost present and future wages and pain and suffering.
Millions of people worldwide who have high blood pressure have taken generic valsartan products, which has had billions of dollars in sales. Many of these people have been exposed to the cancer-causing contaminant known as NDMA. Victims may need a valsartan cancer lawsuit of BP cancer lawsuit to protect their legal rights.
If the valsartan history we’ve provided here has indicated to you that you may be among valsartan cancer victims, contact The Willis Law Firm today for a free legal review of your case. You’ll be at no obligation, and it’s completely confidential. Contact us today, and let us help you explore your valsartan lawsuit options.