Drugs Q & A

Why Was Nexium Taken Off The Market?

Nexium is a brand of Esomeprazole magnesium, an FDA-approved medication used as part of combination therapy to treat conditions caused by too much acid production in your stomach. These conditions include the following:

•          Heartburn caused by gastroesophageal reflux disease (GERD) and erosive esophagitis. Erosive esophagitis is caused by acid-related damage to the esophagus.

•          Zollinger-Ellison syndrome. This rare condition is characterized by the formation of tumors in the digestive tract.

•          H. pylori infections when used in combination with other treatments, such as antibiotics. This infection causes ulcers in part of your intestine.

This drug is also used to prevent stomach ulcers due to the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Nexium belongs to a class of drugs called proton pump inhibitors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Nexium decreases the amount of acid your stomach produces. It works by blocking the proton pump in the stomach’s cells. When the proton pump is blocked, your stomach makes less acid.

The US Food and Drug Administration also approved Nexium for short-term use in children ages 1–11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved the drug in 2 forms, a delayed-release capsule, and a liquid form. Nexium is approved in dosages of 10 or 20 mg daily for children 1–11 years old compared with 20 or 40 mg recommended for pediatric patients 12–17 years of age.

Why Was Nexium Taken Off The Market?

Nexium was taken off the market because the US Food and Drug Administration was informed by AstraZeneca that one lot of Nexium 20 mg capsules contained a different medication, Seroquel XR 150mg tablets. The affected product involves a total of 34,524 bottles of lot #FC0064, with an expiration date of May 2017. The concern is the potential for accidental exposure to Seroquel XR, an atypical antipsychotic medication, which could lead to unwanted side effects.

A manufacturer can voluntarily recall their medication or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer voluntarily recalled one lot of Nexium 20 mg capsules. An affected lot of Nexium 20 mg capsules was recalled by the manufacturer on June 12, 2015.

Medications like Seroquel can increase the risk of suicide and suicidal thoughts, especially at the start of treatment. Report any sudden changes in mood to your healthcare provider, including depression, anxiety, restlessness, panic, irritability, impulsivity, or aggression.

What are the side effects of Nexium?

Nexium capsule doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The adult side effects for esomeprazole magnesium are slightly different from the side effects for children.

Adult side effects can include:

•          headache

•          diarrhea

•          nausea

•          flatulence (passing gas)

•          stomach pain

•          constipation

•          dry mouth

Children’s side effects can include the above, plus:

•          regurgitation (burping up food) in babies

•          increased breathing rate in babies

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

•          Severe diarrhea. Symptoms can include:

o          watery stool

o          stomach pain

o          fever that doesn’t go away

•          Bone breaks. Using this drug every day for a long time can increase the risk of osteoporosis-related fractures of your hip, wrist, or spine.

•          Atrophic gastritis (inflammation of the stomach lining). Using this drug every day for a long time can cause this condition. You may or may not have symptoms. If you do, they can include:

o          stomach pain

o          nausea

o          vomiting

o          weight loss

•          Low blood levels of magnesium. Using this drug every day for a long time can cause this side effect. Symptoms can include:

o          seizures

o          dizziness

o          abnormal or fast heart rate

o          jitteriness

o          tremors (jerking movements or shaking)

o          muscle weakness

o          spasms in your hands and feet

o          cramps or muscle aches

o          spasm of your voice box

•          Vitamin B-12 deficiency. Using this drug every day for a long time can make it harder for your body to absorb vitamin B-12. Symptoms can include:

o          nervousness

o          neuritis (inflammation of a nerve). symptoms can include:

         nerve pain

         tingling

o          numbness and tingling in your hands and feet

o          poor muscular coordination

o          menstrual bleeding that’s heavier than normal

•          Allergic reaction. Symptoms can include:

o          trouble breathing or swallowing

o          shortness of breath

o          angioedema (swelling of your face, throat, or tongue)

o          itching

o          symptoms of kidney damage, such as:

         decreased urination

         flank pain (pain in your side and back)

o          chest tightness

o          paleness or reddening of your face and body

o          panic attack or feeling of impending doom

•          Inflammation in your kidneys. This can happen at any time during treatment with this drug. It may be part of an allergic reaction. If this happens, your doctor will have you stop taking this drug. Symptoms can include:

o          nausea and vomiting

o          diarrhea

o          low blood pressure, which can cause dizziness and fainting

o          decreased urination

o          flank pain (pain in your side and back)

•          Cutaneous lupus erythematosus (CLE). Symptoms can include:

o          rash on the skin and nose

o          raised, red, scaly, red, or purple rash on your body

•          Systemic lupus erythematosus (SLE). Symptoms can include:

o          fever

o          tiredness

o          weight loss

o          blood clots

o          heartburn

•          Fundic gland polyps (These don’t usually cause symptoms.)

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