Ranitidine, the heartburn medication that is discontinued due to carcinogenic contamination
Ranitidine is a medicine for short-term treatment of heartburn. Available in supermarkets and pharmacies, a prescription is only required if a longer dose of the medicine is required over a longer period of time.
Ranitidine (sold under the brand names Zantac, Rani 2 and Ausran) is currently on the news as regulators have found that most formulations are contaminated with a chemical called NDMA, which is probably a carcinogen.
The drug was recalled by manufacturers in some countries. Two generic brands - Apotex Ranitidine and Sandoz Ranitidine - have been recalled in Australia so far, with further recalls likely.
Peptic ulcer disease was a significant health problem affecting millions of people around the world, and at the time of marketing ranitidine, approximately four million people in the United States had active peptic ulcer disease, resulting in 6,000 deaths per year.
Once, ranitidine, as it is marketed under the brand name Zantac, was the best-selling drug in the world.
However, the drug is no longer protected by patents (available in cheap generic formulations) and is listed as an anti-ulcer drug on the World Health Organization (WHO) list of essential medicines.
Ranitidine reduces the amount of acid produced in the stomach and is part of a larger family of medicines called H2 histamine receptor antagonists.
It is a type of antihistamine, but not the kind that is used to treat allergies. This is because the chemical histamine, although involved in allergic reactions, also stimulates the production of gastric acid. Blocking the action of histamine thus also reduces the production of gastric acid.
Ranitidine is commonly used to relieve the symptoms of heartburn and indigestion. In the past, however, it has also been used to treat more serious conditions such as gastric ulcers.
More recently, longer-lasting drugs called proton pump inhibitors, which more effectively reduce acid production, have largely replaced ranitidine in more serious diseases.
The most widely sold ranitidine formulations in pharmacies are oral tablets. For patients with dysphagia, the medicine is also available as an effervescent tablet (rapid dissolution in a glass of water) and as a prepared oral fluid.
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Similar warnings were issued by the Food and Drug Administration and Health Canada.
The contamination of ranitidine formulations is a problem as the World Health Organization lists NDMA as a likely carcinogen, meaning that it can cause cancer.
However, it is important to know that most people are exposed to NDMA as part of their normal life. NDMA can be found in cooked and smoked meat, which consists of smoking cigarettes, beer and even some toiletries and cosmetic products.
It is not clear how the ranitidine formulations were contaminated with NDMA. A similar chemical, dimethylamine, is used in the synthesis of ranitidine, and some NDMA may be produced during the manufacture of the drug. Alternatively, ranitidine can be degraded during storage to form NDMA.
It is important to determine the source of the contamination if new formulations are to be produced free of NDMA.
The answer in many countries was the recall of ranitidine formulations. In the US, Sandoz and Apotex have voluntarily withdrawn their brands from sale. In Canada, the government has asked companies to discontinue distribution of the drug.
On September 17, the Australian TGA announced it would call for a recall of ranitidine and work with international regulators and companies to investigate the issue. The TGA also announced that it will conduct batch testing of products to determine the extent of contamination in Australia.
Two products have been recalled since this announcement, Apotex Ranitidine and Sandoz Ranitidine, but further recalls and bottlenecks may occur.
If you decide to stop taking ranitidine, your pharmacist or family doctor may recommend other heartburn medications that may be effective for you.
Ranitidine (sold under the brand names Zantac, Rani 2 and Ausran) is currently on the news as regulators have found that most formulations are contaminated with a chemical called NDMA, which is probably a carcinogen.
The drug was recalled by manufacturers in some countries. Two generic brands - Apotex Ranitidine and Sandoz Ranitidine - have been recalled in Australia so far, with further recalls likely.
When was it developed?
Ranitidine was first described in the scientific literature in 1976 and was available in 1981.Peptic ulcer disease was a significant health problem affecting millions of people around the world, and at the time of marketing ranitidine, approximately four million people in the United States had active peptic ulcer disease, resulting in 6,000 deaths per year.
Once, ranitidine, as it is marketed under the brand name Zantac, was the best-selling drug in the world.
However, the drug is no longer protected by patents (available in cheap generic formulations) and is listed as an anti-ulcer drug on the World Health Organization (WHO) list of essential medicines.
How and why is it used?
Antacids work by either neutralizing acidity or reducing gastric acid production.Ranitidine reduces the amount of acid produced in the stomach and is part of a larger family of medicines called H2 histamine receptor antagonists.
It is a type of antihistamine, but not the kind that is used to treat allergies. This is because the chemical histamine, although involved in allergic reactions, also stimulates the production of gastric acid. Blocking the action of histamine thus also reduces the production of gastric acid.
Ranitidine is commonly used to relieve the symptoms of heartburn and indigestion. In the past, however, it has also been used to treat more serious conditions such as gastric ulcers.
More recently, longer-lasting drugs called proton pump inhibitors, which more effectively reduce acid production, have largely replaced ranitidine in more serious diseases.
The most widely sold ranitidine formulations in pharmacies are oral tablets. For patients with dysphagia, the medicine is also available as an effervescent tablet (rapid dissolution in a glass of water) and as a prepared oral fluid.
What is the connection with cancer?
Ranitidine is currently on the news after the Australian Therapeutic Goods Administration (TGA) issued a warning that many formulations of the drug were contaminated with a chemical called N-nitrosodimethylamine, abbreviated as NDMA. This should not be confused with the illegal party drug MDMA (Ecstasy), which is a completely different chemical.Similar warnings were issued by the Food and Drug Administration and Health Canada.
The contamination of ranitidine formulations is a problem as the World Health Organization lists NDMA as a likely carcinogen, meaning that it can cause cancer.
However, it is important to know that most people are exposed to NDMA as part of their normal life. NDMA can be found in cooked and smoked meat, which consists of smoking cigarettes, beer and even some toiletries and cosmetic products.
It is not clear how the ranitidine formulations were contaminated with NDMA. A similar chemical, dimethylamine, is used in the synthesis of ranitidine, and some NDMA may be produced during the manufacture of the drug. Alternatively, ranitidine can be degraded during storage to form NDMA.
It is important to determine the source of the contamination if new formulations are to be produced free of NDMA.
The answer in many countries was the recall of ranitidine formulations. In the US, Sandoz and Apotex have voluntarily withdrawn their brands from sale. In Canada, the government has asked companies to discontinue distribution of the drug.
On September 17, the Australian TGA announced it would call for a recall of ranitidine and work with international regulators and companies to investigate the issue. The TGA also announced that it will conduct batch testing of products to determine the extent of contamination in Australia.
Two products have been recalled since this announcement, Apotex Ranitidine and Sandoz Ranitidine, but further recalls and bottlenecks may occur.
What if you are currently taking ranitidine?
If the medicine works for you and you want to continue taking it, there is no immediate health risk. The only problem is long-term use and could potentially increase the risk of cancer later in life.If you decide to stop taking ranitidine, your pharmacist or family doctor may recommend other heartburn medications that may be effective for you.
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