What is Prilosec?
Prilosec is a medication that is used to treat gastroesophageal reflux disease (GERD), peptic ulcer disease, and heartburn. It is also used to prevent stomach ulcers caused by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).
What are the active ingredients in Prilosec?
The active ingredient in Prilosec is omeprazole, which belongs to a class of medications called proton pump inhibitors.
Why was Prilosec taken off the market in 2019?
Prilosec was not taken off the market in 2019. However, in March 2020, the U.S. Food and Drug Administration (FDA) issued a voluntary recall of some forms of prescription and over-the-counter (OTC) Prilosec due to concerns of low levels of a cancer-causing impurity called N-nitrosodimethylamine (NDMA).
Why was NDMA found in some forms of Prilosec?
NDMA is a byproduct of the manufacturing process of some drugs, including Prilosec. Low levels of NDMA may be found in some batches of Prilosec and other medications as a result of this process. NDMA is classified as a probable human carcinogen and has been linked to cancer in animal studies.
What forms of Prilosec were affected by the recall?
The recall affected some forms of prescription and OTC Prilosec capsules, including 10mg, 20mg, and 40mg doses. The affected products were manufactured by various companies, including Aurobindo Pharma USA, Inc., Dr. Reddy’s Laboratories Ltd, and Teva Pharmaceuticals USA.
What should I do if I have been taking Prilosec?
If you have been taking Prilosec, it is recommended that you speak with your healthcare provider to determine if you are using an affected product. If you are using an affected product, your healthcare provider can advise you on alternative medications or treatments.
Is Prilosec still available for sale?
Yes, Prilosec is still available for sale. However, some forms of Prilosec were affected by the 2020 recall due to concerns of low levels of NDMA.
Has the issue with NDMA in Prilosec been resolved?
The 2020 recall of some forms of Prilosec was initiated to address concerns of low levels of NDMA. The manufacturing companies involved in the recall have implemented corrective actions to prevent contamination with NDMA and other impurities. As of August 2021, there have been no additional recalls of Prilosec due to NDMA concerns.
What are the side effects of Prilosec?
The most common side effects of Prilosec include headache, stomach pain, diarrhea, and nausea. Less common side effects may include fatigue, dizziness, and constipation. In rare cases, Prilosec may cause allergic reactions and severe skin reactions.
Can Prilosec cause long-term side effects?
There is some concern that long-term use of Prilosec and other proton pump inhibitors may increase the risk of bone fractures, kidney damage, and infections such as pneumonia and Clostridioides difficile (C. diff) infections. However, the risk of these complications is generally low and varies depending on the individual.
What are the alternatives to Prilosec?
There are several alternative medications and treatments for GERD, peptic ulcer disease, and heartburn. These may include other proton pump inhibitors such as Nexium and Prevacid, H2 blockers such as Zantac and Pepcid, and lifestyle modifications such as weight loss and avoiding trigger foods.
What should I do if I want to switch from Prilosec to another medication?
If you are considering switching from Prilosec to another medication, it is recommended that you speak with your healthcare provider. Your healthcare provider can recommend an alternative medication based on your individual needs and medical history.
Prilosec is a commonly used medication for the treatment of GERD, peptic ulcer disease, and heartburn. While Prilosec was not taken off the market in 2019, some forms of the medication were affected by a 2020 recall due to concerns of low levels of NDMA. If you are taking Prilosec or have concerns about its safety and effectiveness, it is recommended that you speak with your healthcare provider.
- U.S. Food and Drug Administration. (2020). FDA alerts patients and health care professionals to NDMA found in samples of ranitidine. https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-ndma-found-samples-ranitidine.
- U.S. Food and Drug Administration. (2020). FDA updates and press announcements on NDMA in metformin. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.
- U.S. National Library of Medicine. (2021). Omeprazole. https://medlineplus.gov/druginfo/meds/a693050.html.
- Was Prilosec taken off the market in 2019?
- No, Prilosec was not taken off the market in 2019.
- Why was Prilosec recalled in 2020?
- Some forms of prescription and OTC Prilosec were recalled in 2020 due to concerns of low levels of NDMA, a cancer-causing impurity.
- Is Prilosec still available for sale?
- Yes, Prilosec is still available for sale, but some forms of the medication were affected by the 2020 recall.
- What are the side effects of Prilosec?
- The most common side effects of Prilosec include headache, stomach pain, diarrhea, and nausea.
- What are the alternatives to Prilosec?
- There are several alternative medications and treatments for GERD, peptic ulcer disease, and heartburn, including other proton pump inhibitors and H2 blockers, as well as lifestyle modifications.