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L-Citrulline

The supplement injury attorneys at the Drug Law Center are encouraging anyone who is been injured by a dangerous supplement to contact us today to discuss your legal options for compensation.

What is L-Citrulline?

L-Citrulline Drug RecallL-Citrulline is a non-essential amino acid that is converted into nitric oxide and L-arginine, and essential component to ensure health and vitality of the heart and blood vessels. Nitric oxide and L-arginine are known to boost the health of the body’s immune system.

Many individuals take an L-Citrulline supplement to boost the body’s nitric oxide production that is known to relax arteries and improve the flow of blood in the body. In addition, nitric oxide can assist in the prevention or treatment of many diseases. Research studies have shown that the supplement can lower blood pressure in individuals suffering from pre-hypertension, which is considered a precursor to hypertension.

Who Takes L-Citrulline?

Individuals with prehypertension often experience blood pressure ranging from 120/80 to 139/89. Reducing elevated blood pressure levels can diminish the potential risk of developing heart disease and high blood pressure. Other research studies have revealed that intervenous drips of L-Citrulline can prevent many of the complications associated with high blood pressure in children who just undergone heart surgery.

Many men suffering the common symptoms of modern erectile dysfunction take L-Citrulline supplements. However, the effects of the supplement tend to be less effective from other erectile dysfunction medications including Viagra, Cialis, Levitra, and others. However, the supplement appears to be far safer to use that the prescription medications.

Animal researchers have shown that L-Citrulline supplements enhance muscle protein levels and may assist in the treatment of intestinal problems like celiac disease, short bowel syndrome, and small bowel damage caused by radiation. Additionally, early study results have shown that taking L-Citrulline may be highly beneficial. Others take the supplement to treat vascular cardiovascular disease, heart failure, diabetes mellitus, sickle cell anemia, poor immunity response, ischemia-reperfusion (restoring blood flow) injury, and Reye’s syndrome (confusion caused by liver damage and swelling of the brain).

L-Citrulline Recall

In the past, L-Citrulline supplements made by Plattsburgh, New York-based Medisca, Inc have been recalled from public consumption. The company has sold the supplement powder to hospitals, clinics, medical centers, pharmacies, and other healthcare facilities to be distributed to patients, including those suffering from urea cycle disorders and children requiring surgery.

It was not the Food and Drug Administration that recalled the L-Citrulline powdered supplement in February 2014t, but they manufacture who called for a voluntary recall their products. This came after many adverse events reported to the FDA revealed that there may be faulty lots of the supplemental amino acid being used by consumers.

The Food and Drug Administration had notified the company they had received reports of sub-potent L-Citrulline products and warned Medisca that patients being treated with urea cycle disorders could acquire dangerously high ammonia levels caused by the defective product. Working closely with the FDA, Medisca announced the voluntary recall a few days after they received the warning and informed the public that certain lots of their product were sub-potent and potentially dangerous for use. These included:

  • Lots 95482-A, B, C, & D
  • Lots 96453-A, B, C, & D

The supplement manufacturer and the Food and Drug Administration alerted medical health professionals and pharmacists that had used or provided L-Citrulline to identify any affected products and send them to the FDA for analysis. After extensive testing, it was revealed that the product contained N-acetyl-leucine, a substance used in the treatment of dizziness. The test results of the sample sent to the FDA showed no L-Citrulline amino acid in the product at all.

Why the Recall Was Necessary

The 2014 L-Citrulline recall was necessary because some pediatric patients rely on taking the medication in the treatment of their urea cycle disorder, a life-threatening condition. In addition, some children are given L-Citrulline to maintain low blood pressure post-surgery. If the drug is less potent, it places the health and well-being of the child at risk and has the potential of causing their wrongful death. This is because children that do not receive proper treatment for their urea cycle disorder could experience extremely high levels of blood -related ammonia that could cause brain damage, coma, seizures, and even death.

The quick action that was taken by the pharmaceutical company and the Food and Drug Administration to pull the effective lots of L-Citrulline from the medical marketplace saved lives. However, this was not before some patients were given the product had already suffered serious injury. Why there was a defect in the product is still not known by the FDA or the manufacturer. At the time, the FDA recommended that “healthcare professionals quarantine lots of L-Citrulline from Medisca and not administer to patients until [the federal agency] provides additional information.”

While the recall was necessary, many children requiring the treatment for their illnesses missed doses that might have led to additional harm. The National Urea Cycle Disorders Foundation Executive Director Cynthia Le Mons said this likely affected more than half-dozen children in the United States. This included a 14-year-old girl who was sick and by the missing doses and lost clumps of head hair. In addition, the child suffered severe stomach pains prior to being hospitalized to treat the effects of low levels of L-Citrulline.

L-Citrulline and Bodybuilding

L-arginine was once the mainstay of bodybuilding supplements and pre-workout formulas because it is known to stimulate an O (nitric oxide) production to open body blood vessels through vacillation and increase the flow of blood to muscle mass. However, in recent years, many of these formulas have left L-arginine out completely and instead replace it with L-Citrulline. This is because unlike L-arginine, L-Citrulline does not need to be absorbed into the small intestines and liver before it can be released into the bloodstream.

Because of its energy producing blood vessel dilating properties, many bodybuilders take L-Citrulline, the natural form of citrulline that can be found in watermelon. The active ingredient dilates blood vessels and elevates nitric oxide levels, which helps allow more nutrients and oxygen to enter muscle mass. The substance also removes built up exercise-produced ammonia that often causes body fatigue. Some bodybuilders choose to take L-Citrulline because it:

  • Reduces the buildup of lactic acid when exercising
  • Supports optimal blood flow to muscle and tissue
  • Is a nonessential protein

While the drug seems beneficial for exercise and boosted energy, it should not be taken if the individual suffering from a kidney abnormality or has any health concern or is taking a health-related medication due to unknown contraindications.

L-Citrulline Erectile Dysfunction

Doctors often recommend prescription erectile dysfunction (ED) medications like Viagra, Cialis, and other drugs to dilate blood vessels and assist in easing common symptoms of ED. However, L-Citrulline is naturally produced in the body and creates nitric oxide known to increase the flow of blood to the man’s genitals. Because of that, many men wanting and erectile dysfunction drug without serious side effects or potential risks will often choose L-Citrulline to be used over a short period of time.

Overall, L-Citrulline is safer than prescription medications and has no known side effects or potential interactions when used alone. However, the product has been recalled in the past due to manufacturing problems, which led to the injury of many patients who depended on the powder forms of the amino acid. To avoid any or action, doctors will recommend some other form of erectile dysfunction treatment including penile pumps, penile implants, DHEA, acupuncture, and ginseng.

Too Much of a Good Thing

Many athletes take L-Citrulline to improve their workout by increasing blood flow to muscle mass. However, taking too much of the nonessential amino acid can be dangerous. This is because the medication is known to increase nitric oxide levels and dilate blood vessels that lower the body’s blood pressure. While this can be of great help to the individual suffering from pre-hypertension (slightly elevated blood pressure), individuals that typically have low blood pressure can be seriously harmed.

Another potential problem of taking too much L-Citrulline is the damaging effects it has on the body’s kidneys. While the damage is not directly caused by L-Citrulline, the nonessential amino acid can increase creatinine levels to a dangerous point.

Individuals with kidney conditions or low blood pressure could experience serious problems when taking L-Citrulline. To be sure, it is essential to have a discussion with your doctor involving exactly how much to take or to receive a recommendation of an alternative method of producing the same effects.

Taking the medication and large dosages tend to create serious intestinal problems. Because of that, doctors recommend not exceeding the recommended dose of any amino acid, including L-Citrulline. It is important to note that not all L-Citrulline products are the same. Some product labels claiming to contain the nonessential amino acid were found to have sub-potent levels or no L-Citrulline in the product at all.

Additionally, taking L-Citrulline can be extremely detrimental to individuals suffering from kidney abnormalities or diseases. If this is you, it is best to consult with your doctor prior to taking L-Citrulline to ensure that the product does not negatively interact with other drugs or supplements you are on.

Filing an L-Citrulline Lawsuit

The defective amino acid injury attorneys at the Drug Law Center’s encourage anyone suffering injuries by an effective bad supplement lot to speak with our attorneys to protect their rights of receiving financial compensation for their damages. Our attorneys have successfully resolved many cases involving bad drugs, defective medical devices, and other product liability claims.

If you have suffered injury or lost a loved one due to a drug or supplement that has been recalled voluntarily or by the Food and Drug Administration, contact us today to schedule a free case consultation. We are currently accepting all product liability, medical malpractice, wrongful death lawsuits through contingency fee arrangements. This means we provide immediate legal services and handle every aspect of your case while postponing payment of our fees until your claim is successfully resolved.

Sources:

http://www.nucdf.org/

http://www.nbcnews.com/health/health-news/fake-supplement-may-endanger-kids-fda-warns-n31266

http://nordphysicianguides.org/wp-content/uploads/2012/02/NORD_Physician_Guide_to_Urea_Cycle_Disorders.pdf