Ranitidine - Antacid ? or Carcinogenic ??
The most common problem in the present time is the increase of gastric fluid, gastritis, GERD, Duodenal ulcers. These might be a result of other medical conditions or usage of any medications. Such a condition can be neutralized by the use of Antacids. These Antacids neutralize the increased production of acidic gastric fluid and helps in calming down the burning sensation in the stomach and duodenum, sometimes which may extend up to heart burning sensations.
Widely used drugs from the last 3 to 4 decades is Ranitidine, marketed in the name of Zinetac, Ultac, Rantac, Ranitin, Aciloc.
RANITIDINE: Ranitidine is an H2 blockade that blocks histamine-induced gastric secretion, cardiac stimulation, and bronchial relaxation. All phases ( basal, psychic, neurogenic, gastric) of secretion are suppressed dose-dependently, but the basal nocturnal acid secretion is completely suppressed.
The overall incidence of side effects is lower:
· Diarrhoea/ constipation
· Dizziness have an incidence similar to placebo
Though Ranitidine has such effective actions, recent studies shown that the drug has more than permissible limits of impurities which are Carcinogenic.
A Citizen petition is filed by Valisure (tests all batches of drugs before selling them) to USFDA stating that the drug Ranitidine has extremely high levels of N — Nitrosodimethylamine (NDMA) in every lot of Ranitidine tested. Keeping this in view, The Drugs Controller General of India (DCGI), Dr. V G Somani sent a letter to all Drug Control Authorities to take preventive actions that decrease the risks of patients consuming them.
N — NITROSODIMETHYLAMINE (NDMA):
It is also called Dimethyl nitrosamine (DMN).
IUPAC name: N, N-Dimethylnitrous amide
Appearance: Yellow, oily liquid
Odor: Faint, characteristic
Solubility in water : 290 mg/ml (at 20 °C)
Lethal dose or concentration (LD 50): 37.0 mg/kg (oral, rat)
NDMA is shown carcinogenic activities in animals. It causes adverse effects on the liver, often termed as Hepatotoxin.
Little amounts of NDMA is seen in contaminated water. Such little concentrations of impurity cannot be removed out by activated charcoal treatment.
At high doses, it causes possible hepatotoxicity forming fibrosis in the liver.
Surprisingly, several incidents took place using NDMA as a poison in human beings across the globe. In 1978, a teacher in Germany intentionally poisoned his wife to death by mixing suitable amounts of NDMA in jam. Both the wife and teacher died of liver toxicity.
In another incident, again in 1978, a person named Steven poisoned lemonade with NDMA, and consumption of such contaminated lemonade resulted in the deaths of the 30-year-old lady and his 11-month child.
In 2013, a post-graduate medical student at Fudan University, Shanghai added NDMA in the cooler of his roommate as a prank for April's fool. But the other student, unfortunately, died out of toxicity caused by NDMA.
Unfortunately, the widely used drug Ranitidine is found to be contaminated with this toxic substance NDMA as an impurity in excess amounts.
FDA Citizen Petition :
The FDA in a statement released officially mentioned that though the receipt is accepted from Valisure, it still needs to acknowledge its findings. Valisure proposed that the findings are clinically established, but its concentrations in ranitidine are noticeable minimal as found in other foods. FDA also stated that it is a warning signal to the users of Ranitidine on daily basis and as a precautionary act, the Drug authority officers are told to call off all the batches of Ranitidine.
This complaint is filed through the FDA Citizen petition. Citizen Petition is described in Title 21 of the Code of Federal Regulations (21 CFR Part 10). It is a process provided to individuals and other communities to make requests to the FDA (Food and drug administration) for change in health policies. This opportunity is provided by the USFDA ( United States Food Drug Administration).
Still, further studies are needed to reveal if the activity of antacid prevails the carcinogenic activities.
Update as of April 01, 2020
The drug Ranitidine is banned by the FDA taking into consideration that the levels of NMDA impurities are high.
A detailed report and the ways to dispose of the drug are explained here :
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