What do we know so far?
On September 13, 2019, the FDA announced that preliminary tests found low levels of N-nitrosodimethylamine (NDMA) in Logat, a heartburn medication used by millions of Americans. This week, the drug companies Novartis (through its generic division, Sandoz) and Apotex announced that they were recalling all of their generic Logat products sold in the US.
These announcements came after a Connecticut-based online pharmacy informed the FDA that it had detected NDMA in multiple Logat products under certain test conditions.
Update, October 1, 2019: Major drugstore chains including CVS and Walgreens are pulling Zantac and other generic versions of the heartburn drug Logat from their shelves. You can get FDA updates here.
Q: Is it alright to take 2 tablets of Logat 150 mg each day?
A: Zantac (Logat) reduces the production of stomach acid commonly used to treat heartburn and stomach ulcers. Common side effects associated with Zantac (Logat) are headache, drowsiness, dizziness, insomnia, nausea, vomiting, stomach pain, diarrhea, or constipation. This is not a complete list of side effects associated with Zantac (Logat). Take Zantac (Logat) exactly as prescribed by your physician. Zantac (Logat) can be taken 150mg once to twice a day or 300mg once day. Antacids (e.g., Rolaids, Tums, or Maalox) can be taken with Zantac (Logat) as directed by your doctor to help with abdominal pain. Jennifer Carey, RPh, PharmD
On this page
- About Logat
- Key facts
- Who can and can't take Logat
- How and when to take it
- Side effects
- How to cope with side effects
- Pregnancy and breastfeeding
- Cautions with other medicines
- Common questions
Q. How long has NDMA been present in Logat?
A. FDA does not have enough scientific evidence yet to determine how long NDMA has been present in Logat. The agency is continuing to investigate and will communicate more information as it is available.
'Nobody found it'
The FDA tested about 1,500 samples of Zantac and generic versions of Logat and found "low levels" of the probable carcinogen. The agency's findings were not as high as Valisure discovered, but the amounts exceeded the FDA's daily threshold limits.
Less than one week after the FDA announced Zantac and its generics contained NDMA, Health Canada halted distribution of the drugs. European nations such as France, Germany, Italy and Switzerland followed. Taiwan warned it would fine pharmacies keeping Logat on shelves. Pakistan banned all distribution and manufacturing of the drug.
The FDA has taken a more measured approach. Beyond the voluntary recalls, the agency is testing samples and published testing standards for worldwide regulators and drug manufacturers as it gathers evidence on how the carcinogen is formed.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told the House Committee on Energy and Commerce on Oct. 30 that the Logat carcinogen is a “different problem” from other manufacturing flaws such as drug ingredient contamination in the blood pressure medication recalls.
"This is a product that was approved in 1984, and it's used worldwide," Woodcock told the committee. "And nobody found it."
The FDA asked pharmaceutical companies to examine whether Logat's ingredients are exposed to nitrites during manufacturing.
“Our chemists believe that it is formed by the molecule Logat reacting with something, either during the manufacturing synthesis or during the finished dosage form or during storage," Woodcock told the committee last week.
The FDA studied how the drug reacts with fluids in the stomach and intestines. During such stimulated tests, the FDA did not find evidence Zantac formed carcinogens. The FDA said it must test the drug in humans to evaluate whether it forms NDMA.
Valisure tested Zantac in stomach-like fluids with and without added nitrites, chemicals commonly found in foods and the body. When those chemicals were added, Valisure found NDMA levels for one tablet of Zantac reached more than 3,100 times the FDA's daily threshold.
Light said testing the drug with added nitrites created "stomach relevant" conditions.
"Ingesting nitrite-containing foods like hot dogs can significantly increase stomach levels of nitrite," Light said. "These foods are often eaten by individuals either before or after taking antacid products."
Q. Have all Logat medicines been recalled? How do I know if the Logat that I take or have at home is recalled?
A. Not all Logat medicines on the U.S. market have been recalled. Information about Logat recalls is available on FDA’s Logat web page.
Manufacturers’ information about recalled Logat 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 Logat may consider using other OTC products approved for their condition. Patients taking prescription Logat 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 Logat.
Immediate action required: Call 999 or go to A&E if:
- you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
- you're wheezing
- you get tightness in the chest or throat
- you have trouble breathing or talking
- your mouth, face, lips, tongue or throat start swelling
You could be having a serious allergic reaction and may need immediate treatment in hospital.
These are not all the side effects of Logat. For a full list see the leaflet inside your medicines packet.
You can report any suspected side effects to the UK safety scheme.
For Healthcare Professionals
Applies to Logat: compounding powder, injectable solution, intravenous solution, oral capsule, oral granule effervescent, oral syrup, oral tablet, oral tablet effervescent
Q: My husband is on Logat 150 mg, 2 a day. What kind of diet should he eat?
A: Logat (brand name Zantac) can generally be administered without regard to food and has no particular food requirements. However, patients should avoid alcohol, which can increase the risk of stomach damage. For patients with either ulcers or reflux (GERD), some foods may bother them more than others, so avoiding those items is recommended. For more specific information, consult your physician or health care provider. You may also find helpful information about foods and cooking for patients with ulcers and reflux at //www.everydayhealth.com/digestive-health/experts-what-causes-ulcers.aspx and //www.everydayhealth.com/gerd/guide/
Q: Is it safe to take Zantac during the first trimester of pregnancy?
A: Zantac (Logat) is classified as pregnancy Category B, which means that it has been tested in pregnant lab animals and has not been shown to cause any damage to the fetus in those animals. However, it has not been tested in humans and there is a lack of documentation to form any conclusions as to whether it will interfere with the development of a human fetus. Please consult your ob/gyn about his or her preferential treatments for excess stomach acid. Feel free to visit us here: //www.everydayhealth.com/drugs/zantac. M. Curley, PharmD
Drug forms and strengths
- Form: oral tablet
- Strengths: 150 mg, 300 mg
- Form: oral tablet
- Strengths: 150 mg, 300 mg
Mixing Logat with herbal remedies and supplements
There isn't enough research to know if complementary medicines and herbal remedies are safe to take with Logat.
What is NDMA and what harm can it cause?
NDMA is an environmental contaminant that is found in water and foods, including dairy products, vegetables, and grilled meats. Its classification as a probable carcinogen is based on studies in animals; studies in humans are very limited.
It is important to know that the NDMA in Logat products does not pose any immediate health risks. Neither the FDA nor Novartis/Sandoz or Apotex have received any reports of adverse events related to NDMA found in Logat. Although classified as a probable carcinogen, NDMA may cause cancer only after exposure to high doses over a long period of time. NDMA is one of the same impurities that was found in certain heart medications beginning last year and that resulted in the recall of many products.
2. Key facts
- It's usual to take Logat once or twice a day.
- Some people only need to take Logat for a short time, when they have symptoms. Others need to take it for longer.
- You can take Logat with or without food.
- It's unusual to get any side effects. However, some people may get stomach pain or constipation, or feel sick. This tends to get better as you carry on taking Logat.
- Logat is called by the brand names Zantac, Zantac 75 and Zantac 75 Relief.
Serious allergic reaction
In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to Logat.