Pharmacy News
Published May 11, 2020
On April 1, 2020, the U.S. Food and Drug Administration (FDA) requested manufacturers to withdraw all prescription and over the counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). For detailed information, read the FDA public alert.
| What’s happening? |
On April 1, 2020, the FDA requested manufacturers to withdraw all prescription and over the counter (OTC) ranitidine drugs from the market immediately. |
| What should members taking prescription ranitidine do? |
Members are asked to continue to take their prescription medication as directed and contact their provider for alternative treatments as soon as they can.
Because this medication is being withdrawn from the U.S. market, members won’t be able to fill prescriptions for it. As stated above, members should speak with their prescriber about alternative treatment options and have them submit a new prescription for an alternative treatment to your pharmacy. |
| What should members taking OTC ranitidine products do? |
Members should stop taking OTC ranitidine products immediately (the most common brand name is Zantac) and find alternative treatments. |
| What should members do with excess ranitidine products? |
Considering the COVID-19 pandemic, the FDA recommends that you don’t take your withdrawn medication to a drug take-back location, but instead safely dispose of the unused medication at home by doing the following:
- Mix the pills/liquid with an unappealing substance such as dirt, cat litter, or used coffee grounds; don’t crush them.
- Place the mixture in a container such as a sealed plastic bag.
- Throw away the container in your trash at home.
- Remove or delete all personal information on the prescription labels of empty medication bottles or packaging, then throw them away or recycle them.
|
| What’s NDMA? |
N-Nitrosodimethylamine (NDMA) is a known probable human carcinogen (a substance that could cause cancer) based on lab test results. It’s also a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. |
| Why is NDMA a problem for people taking ranitidine products? |
In some ranitidine drug products, NDMA levels increase over time and when stored at higher than room temperatures. These situations may result in exposure to unacceptable levels of the impurity determined by the FDA. |
| How are we communicating to members? |
ESI is notifying impacted mail order customers with a letter mailed from Express Scripts (ESI) on April 17, 2020 and Premera is notifying with a letter mailed on April 24, 2020. |