On Wednesday 1st April 2020, the United States Food and Drug Administration announced through a press release posted on their official website that they were officially requesting pharmacies and drug manufacturers to withdraw all over-the-counter and prescription ranitidine drugs from the market with immediate effect. The FDA stated that this was their most recent effort in an ongoing investigation into a potentially toxic substance called N-Nitrosodimethylamine (NDMA) that is commonly found in ranitidine drugs such as ZANTAC. The FDA claims to have found that the level of NDMA in ranitidine medications such as Zantac increases over time especially when the drugs are exposed to conditions such as extreme heat during storage. Consumers can, therefore, be exposed to higher than normal levels of this potentially toxic substance.
For this reason, the FDA made the decision to request all relevant stakeholders to remove ranitidine medications such as Zantac from the market. This is seen as a move to safeguard the health and well-being of US consumers. The FDA further stated that it is committed to ensuring that no American falls ill because of using unsafe or ineffective medications.
The Science Behind The Decision
The move by the FDA to request the removal of Zantac and other ranitidine drugs from the market was not completely unexpected. The FDA had in September 2019 warned of the potential risks of using Zantac for various health conditions. They also went ahead to say that they would undertake thorough investigations into the potential health risks of ranitidine drugs. The FDA says that they consulted various professionals in the medical field to determine which quantities of NDMA are acceptable. The FDA notes that they collected numerous samples of the subject drugs from the market and tested them for NDMA. Despite most of the samples of Zantac that they tested having acceptable levels of NDMA, the FDA still decided to recommend its removal from the market due to the numerous issues that arise from how the drug is stored.
The FDA had already established that storage of Zantac and other ranitidine drugs had an effect on NDMA levels. This means that patients and consumers could still be exposed to potentially dangerous levels of this substance if the agency did not take appropriate steps. Jane Woodcock, the MD of the FDA’s Drug Evaluation and Research Center assured consumers that the agency will continue to undertake further investigation on all and any substances found in OTC and prescription drugs that may pose a health risk to consumers.
NDMA Is A Possible Carcinogen
NDMA, the potentially toxic substance found in Zantac, is listed as a possible human carcinogen. This simply means that it can cause or aid the development of numerous cancers in the body. The FDA first became aware that NDMA was present in Zantac and other ranitidine drugs in the summer of 2019. Although the initial levels that were discovered were low, the possibility that these levels could increase over time had to be investigated. Low levels of NDMA are not harmful to humans. However, higher levels can cause cancer and other severe health complications. The FDA has now gathered sufficient scientific evidence to prove that Zantac and other ranitidine drugs may indeed have unacceptable levels of NDMA if they are not stored properly.
Testing and 3rd Party Confirmation
In the press release mentioned above, the FDA states that they partnered with third-party research labs to establish how NDMA levels in ranitidine medications increased over time. Under normal storage conditions, ranitidine drugs maintained acceptable levels of NDMA. However, When stored at higher temperatures, the NDMA levels in the drugs increased significantly. Further tests also revealed that the longer a drug like Zantac stayed on the shelves, the higher its NDMA levels were.
Implications of The Announcement
The announcement by the FDA has far-reaching implications as far as consumers and the medical fraternity is concerned. Because these drugs had already been widely circulated in the market, many consumers may have been exposed to their negative side effects. If this is the case, there may be consumers who are suffering from various health complications because of using Zantac or other ranitidine medications. Patients who are currently on ranitidine medication are advised to immediately stop taking the drugs and consult their doctors as soon as possible.
Dalimonte Rueb specializes in helping patients and consumers who have been adversely affected by toxic products like Zantac. No one should have to suffer in any way due to the negligence, recklessness or carelessness of an individual or company. Although the FDA does its best to safeguard Americans from potentially dangerous products, there is always the possibility that some dangerous products may find their way into the market. Fortunately, there are laws that protect consumers from manufacturers that bring in such products into the market without undertaking comprehensive and thorough research, and testing.
So, if you have experienced any health complications from using Zantac or any other ranitidine medication, do not hesitate our mass tort attorneys. We will help you get the legal redress you deserve.