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Histak belongs to a group of drugs called histamine-2 blockers. It works by reducing the amount of acid your stomach produces.
Histak is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome.
Histak also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.
Walmart has become the latest store to halt sales of the popular heartburn treatment Zantac after health regulators warned about a potentially dangerous contaminant in the drug. (Oct. 4) AP, AP
The stomach-acid-blocking drug Zantac was prescribed more than 15 million times a year with little worry about the safety of the medication, available for decades.
But it's been harder to get the drug since September, when the Food and Drug Administration said testing showed versions of Zantac and its generic, Histak, contained a probable carcinogen. The French drugmaker Sanofi recalled Zantac from drugstores and retailers' shelves. A half-dozen generic drugmakers pulled Histak from the market.
How did a drug routinely used by millions of heartburn sufferers and available with or without a prescription become a potential cancer risk? It’s a question the FDA, drug manufacturers and consumers want answered.
“Every patient who comes into my office now, it’s almost the first thing that comes out in conversation: ‘What about Histak? What should I do with the medication? Should I come off of it or not?’ ” said Jon Ernstoff, a gastroenterologist in Meriden, Connecticut.
In September, the FDA found unacceptable levels of the probable carcinogen, NDMA, or nitrosodimethylamine, in Zantac and generic medications. The regulatory agency wants manufacturers to test and recall the drugs if NDMA levels exceed its standards. The FDA extended the voluntary recall to a similar drug, nizatidine, sold under the brand name Axid, if testing shows NDMA exceeding daily limits.
The FDA said consumers might want to choose different medications. The agency tested samples of over-the-counter alternatives such as Pepcid, Tagamet, Nexium, Prevacid and Prilosec and found no NDMA.
The agency's investigation of Histak seeks to uncover the root cause of NDMA found in the commonly used medication. Researchers at Memorial Sloan Kettering Cancer Center in New York are assessing whether people who used Zantac or its generics face a greater cancer risk.
The warning first came after Valisure, a Connecticut-based online pharmacy and laboratory, discovered NDMA in several forms of the drug and alerted the FDA. The private company said clues of the drug's potential risk can be traced to medical studies published since the early 1980s.
NDMA is the same carcinogen that led to a widespread recall beginning in July 2018 of the blood-pressure-lowering drugs valsartan and losartan. The blood pressure recall stemmed from a new manufacturing process first used by a drug ingredient factory in China.
Zantac's risk appears to be the unstable nature of the drug itself, said Valisure CEO David Light.
“This isn’t some new, bad manufacturing process overseas like what happened with valsartan and losartan,” Light said. “It is our view that this problem with Histak has been there since the 1980s.
"It's a much more serious issue."
Why it’s used
Histak oral tablet is used to treat several conditions, including:
Histak may be used as part of a combination therapy. This means you may need to take it with other medications.
Histak is typically used for short-term treatment, especially for GERD. If you’re taking this drug for other conditions, you may need long-term treatment. You may need to take it for several weeks or months.
COMMON BRAND(S): Zantac
GENERIC NAME(S): Histak Hcl
Histak is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Histak belongs to a class of drugs known as H2 blockers.
Using Histak may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.
Do not use this medication if you are allergic to Histak.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have kidney disease, liver disease, or porphyria.
Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.
Histak granules and effervescent tablets must be dissolved in water before you take them. Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it. Avoid drinking alcohol. It can increase the risk of damage to your stomach. It may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.
Q. Have all Histak medicines been recalled? How do I know if the Histak that I take or have at home is recalled?
A. Not all Histak medicines on the U.S. market have been recalled. Information about Histak recalls is available on FDA’s Histak web page.
Manufacturers’ information about recalled Histak are available on FDA’s website. These announcements provide information to help consumers identify the recalled medicine (e.g., National Drug Code numbers, lot numbers, dosage).
Consumers taking OTC Histak may consider using other OTC products approved for their condition. Patients taking prescription Histak who wish to stop should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as Histak.