Supplements in addition to prescription medications can be the subjects of lawsuits over potential health complications and recalls because of poor manufacturing processes. L-citrulline is a substance that is mostly used as a supplement, but may also be used rarely as a prescription medication. It has been the subject of recalls and has been known to cause side effects that may eventually lead to lawsuits against the manufacturers, of which there are several.
L-citrulline is an amino acid that can be used as a supplement for various conditions, although its effectiveness for these purposes is not verified. It can also be used in children undergoing surgery who are at risk of developing dangerously high blood pressure. When the U.S. Food and Drug Administration (FDA) issued a warning and a recall of defective L-citrulline, children were put at serious risk.
What is L-Citrulline?
Amino acids are the building block molecules that make up proteins, and L-citrulline is one type of amino acid. It was found and isolated in the 1930s and is now known to be an amino acid that is made in the body. It can also be found in foods and it is a crucial component in making nitric oxide, an essential compound in the body for controlling blood pressure. The name for the amino acid is derived from the Latin name for watermelon because L-citrulline is found abundantly in watermelon rinds.
Uses for L-Citrulline
As a supplement, L-citrulline can be bought over the counter in many stores and online. Whether it is effective for any of the purposes people take it as a supplement is questionable. The FDA does not test or regulate supplements, only medications. However, because it is known to be related to nitric oxide, some people take L-citrulline as a supplement to help lower blood pressure. There is some evidence that it can help, but not significantly.
Other reasons people take L-citrulline supplements include treating erectile dysfunction, heart failure, dementia, and to increase exercise performance. Research shows that it may be effective in treating dementia, gastrointestinal disorders, slow wound healing, sickle cell anemia, liver disease, Alzheimer’s disease, and Parkinson’s disease. While some evidence suggests these conditions may be improved by L-citrulline supplementation, the evidence is by no means overwhelming.
Another very important use for L-citrulline is as a pharmaceutical grade drug used to prevent high blood pressure in certain children. When children have to have heart surgery they are at serious risk for dangerously high blood pressure afterwards. This risk can be lowered with L-citrulline. Children with urea cycle disorders are also treated with L-citrulline, and it is this use for the drug that was put in jeopardy when recalls were conducted.
Urea cycle disorders are genetic and rare, but serious. They affect the ammonia excretion cycle by eliminating one or more enzymes essential to the process. Without those enzymes the child may accumulate toxic levels of ammonia, and this can be fatal, cause brain damage, and lead to coma. L-citrulline can stimulate the cycle of excreting ammonia in some forms of the disease. For children using L-citrulline for this condition, it is essential. If access is restricted, like during a recall, a child may be at serious risk for complications or even death.
The L-citrulline recalls that have occurred in the past were products made by Medisca Inc. This Plattsburgh, New York-based manufacturer is a major supplier of L-citrulline. It sells L-citrulline powder to hospitals, pharmacies, clinics, and other locations which make it into pills to be used by patients, including children undergoing surgery and suffering from urea cycle disorders.
The recall of L-citrulline occurred in February of 2014 and was not forced by the FDA. The agency reported on adverse events and warned about the possibility of faulty lots of the substance, but Medisca spearheaded the voluntary recall. The FDA announcement stated that it had received reports of L-citrulline products that were sub-potent. The agency warned that someone using one of these samples to treat a urea cycle disorder may end up with dangerously high ammonia levels because of the lack of potency.
A few days after the first announcement, Medisca and the FDA listed the affected lots, which included lots 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C, and 96453/D. Medisca issued a voluntary recall at that time of each one of these lots. The FDA announced the recall and recommended that all pharmacists and other professionals stocking L-citrulline check for any of the affected samples.
Once the FDA had gotten a hold of some of the affected samples, the agency tested them and found that they contained N-acetyl-leucine, a substance used to treat dizziness. The agency also found that these particular samples had no L-citrulline at all. With this new information the FDA suggested that all health professionals responsible for administering L-citrulline for patients check to see which may be at risk from having received the faulty doses.
Defective Lots Pose Serious Risk
The L-citrulline recall that occurred in 2014 was essential because of the children who rely on the medication to treat their life-threatening urea cycle disorders. It was also important because of those children relying on it to keep blood pressure low after surgery. Without the medication, all of these children are at risk of serious health complications and even death.
A child who needs L-citrulline for a urea cycle disorder is at serious risk if that medication is not available or if it is not as potent as it is supposed to be. Without treatment a child may end up with seriously high levels of ammonia in the blood, which in turn can cause seizures, coma, brain damage, and ultimately death. The FDA was able to target the faulty L-citrulline from Medisca because some patients had already received the sub-potent doses and had suffered adverse events.
The quick action of the FDA and Medisca in recalling the affected lots of L-citrulline likely saved lives, but some patients had already suffered. The mistake should never have happened in the first place and Medisca put the health and safety of children in serious danger. What caused the manufacturing error is still not known.
If you have a child who suffered because of a sub-potent dose of L-citrulline or because doses were not available because of the L-citrulline recall, you may have been scared for your child’s life. This is necessary medication for a small number of children suffering from rare conditions. A lawyer can tell you if you have a case to make against Medisca for putting your child in harm’s way and for putting him or her at risk of dangerous complications.