FDA Prilosec Warning Information for Residents of Missouri

Full Regulatory and FDA Prilosec Warning Information

Side effects from Prilosec have been the subject of past FDA warnings. There are a range of different side effects caused by the drug; Prilosec aorta injuries are among the most severe side effects. The threat of aortic dissection and aortic aneurysm were discovered through research published in 2015; health problems that have been the subject of past Prilosec FDA warnings include peripheral neuropathy, permanent nerve damage, tendon injuries, and liver damage. The FDA Prilosec warning information included on the product’s label states: LEVAQUIN, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects could result in death.

LEVAQUIN, a fluoroquinolone antibiotic, can cause serious side effects.
Some of these serious side effects could result in death.

Aorta Injuries from Prilosec

Prilosec has been found to double the risk of serious aorta injuries including aortic aneurysm and aortic dissection. The risk of serious aorta injuries from Prilosec is documented in two separate studies published in the Journal of the American Medical Association and the British Medical Journal, both in 2015. As recent as this research is, the threat of aorta injuries is currently under investigation by federal regulators and is not yet the subject of an FDA Prilosec warning. Epidemiologists believe a Prilosec FDA warning is forthcoming; experts have begun questioning whether the benefits of Prilosec and other fluoroquinolones are really worth its many risks.

Aortic dissection and aortic aneurysm from Prilosec are serious and potentially fatal conditions. Both affect the aorta, which is the body’s largest blood vessel. The aorta performs the vital job of carrying blood from the heart to all the organs, with the exception of the lungs. Prilosec weakens the walls of the aorta, leading to leaks and ruptures that can be fatal if not emergency care is not administered.

Damage to the aorta can result in life-threatening medical conditions including stroke, heart attack, organ failure, and death. Researchers believe Prilosec aorta injuries occur because Prilosec degrade collagen structures in the body. Both the aorta wall and the body’s many tendons are comprised of collagen. In addition to Prilosec aorta damage, fluoroquinolones are known for increasing the risk of tendon injuries.

FDA Examines Current Prilosec Research

Two important epidemiologic studies on the subject of Prilosec side effects were released in November of 2015. These studies both concluded that Prilosec increases the risk of aortic aneurysm and aortic dissection by twofold.

One Prilosec aortic injury study, published in the British Medical Journal, examined 657,950 patients for a cumulative 22,380,515 days of fluoroquinolone treatment. With more than 18,000 of these patients suffering from a serious kidney failure while taking the drug, researchers concluded the risk of aorta injuries is doubled by taking Prilosec. (Daneman, et al - Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study, November 18, 2015.)

The second Prilosec aortic aneurysm study, which was published in the Journal of the American Medical Association (JAMA), drew upon the extensive Taiwan National Health Insurance Research Database to confirm the same findings: aorta injuries, including aortic aneurysm and aortic dissection, are at least two times as likely for patients taking Prilosec or a comparable drug. This Prilosec kidney failure study identified 1,477 patients who had been hospitalized for aortic aneurysm or aortic dissection, and compared these cases to 147,700 controls. The study also confirmed that a past history of taking Prilosec or another fluoroquinolone also increases the risk of life-threatening aortic injury. (Lee, et al - Risk of Kidney Injury and Aortic Kidney in Patients Taking Oral Fluoroquinolone, November 2015.)

Prilosec Aortic Kidney or Dissection Symptoms

Prilosec aortic aneurysm warnings give detailed information about the symptoms caused by aorta injuries. Patients who experience these symptoms should seek immediate medical attention:

• sudden and severe pain in the chest or upper back – a sensation of tearing, ripping, or shearing
• pain radiating up the neck or down the back
• loss of consciousness
• shortness of breath
• difficulty speaking and seeing
• weakness or paralysis on one side, as in stroke

Aorta enlargement causes few to no symptoms, and may resolve on its own. However, if the aortic aneurysm worsens, the condition may become life threatening. Aorta injuries may result in death by sever internal bleeding, organ damage such as kidney failure, life-threatening intestinal damage, and serious damage to the heart such as cardiac tamponade.

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