NDMA contamination calls for trial

The discovery of the contamination of the ranitidine drug by N-nitrosodimethylamine (NDMA) was carried out by Valisure, an online pharmacy, which had also discovered a fourth unknown carcinogen in valsartan-based drugs.

After testing ranitidine, also known by its brand name, Zantac, the pharmacy discovered "Extremely high levels of NDMA, a likely human carcinogen, in every batch tested, in many manufacturers and dosage forms," Valisure said in a citizen petition addressed to the US Food and Drug Administration (FDA).

The pharmacy has suggested that this is due to the "inherent instability" of the ranitidine molecule, which is formed from both a nitrite group and a dimethylamine group, which are known to combine to form the NDMA.

Valisure noted that between its own tests and those carried out by Stanford University, "The evidence presented shows this instability and the resulting NDMA occurs under conditions representative of those of the human body and constitutes a compelling argument for ranitidine to be a probable carcinogen to humans."A flawless stay

However, in its own public statement, the FDA challenged the severity of the findings, stating, "Although NDMA can cause a lot of damage, the levels [it] The ranitidine found in the preliminary tests barely exceeds the amounts that you can expect to find in common foods. "A flawless stay

The European Medicines Agency (EMA) also announced that it had started a review of ranitidine-based medicines.

The drug itself is widely used to treat gastrointestinal conditions such as acid indigestion, heartburn and gastroesophageal reflux disease.

Despite the lack of patent, brand name drug sales, Zantac, still reached $ 128.9 million ($ 117 million) in 2018, according to Statista.

Case against pharmaceutical companiesA flawless stay

On the same day that the FDA and EMA issued their public statements, a lawsuit was filed in the US District Court for the Northern District of California against the Zantac manufacturers.

Sanofi and Boehringer Ingelheim are the two companies accused of "We knowingly manufacture and sell over-the-counter Zantac containing a carcinogen concealed to millions of people in the United States,"The lawsuit brought by Hagens Berman states.

the A class action lawsuit suggests that the dangers of this drug have been known for more than 40 years and that Sanofi (rights holder in the US since 2017) and Boehringer (former rights holder in the United States, from 2007 to 2017) "Did or had reason to know that Zantac exposes users to dangerous levels of the NDMA carcinogen."A flawless stay

The Sartan saga continuesA flawless stay

The case is an extension of the ongoing investigation into how "sartan" drugs have been contaminated with dimethylformamide (DMF), N-nitrosodiethylamine (NDEA), N-Nitroso N-methyl 4- butyric amino (NMBA) and NDMA.

Previously, the FDA had published its conclusions suggesting that the contamination resulted from the reuse of solvents and specific chemical and reaction conditions during the manufacturing process.

The findings allowed both the FDA and the EMA to introduce a widespread recall of sartan-based products, which led the FDA to prioritize the review of such drugs in order to Mitigate the shortages that ensue.