Children’s Supplement Recalled for Elevated Lead Exposure

A recent report published by the U.S. Food and Drug Administration (FDA) highlights the dangers of lead exposure in children.  The report was published following a series of recalls of children’s supplements.  All three supplements – DHZC-2, BRAIN-ECM, and Side Head Regulator TT – were manufactured by the brand Life Rising.  According to the FDA, the supplements all tested positive for elevated levels of lead, which can be dangerous to children.

Read on to learn more about these recalls and the dangers of lead exposure.  If your child has been harmed by a Life Rising product, or any other children’s supplement, contact MedMalFirm.com to speak with one of our medical malpractice attorneys about your legal rights.

FDA Recall Information

Life Rising is a Chicago-based brand owned by Ton Shen Health.  The most recent recall only includes the Side Head Regulator TT tablets, which were sold primarily in Chicago area stores, and through distributors via mail order.  This is not the first time, however, that a Ton Shen Health product has been recalled.  Reports indicate that at least two other products have been previously recalled for similar concerns about elevated lead levels.

The previous recalls have been linked to several reports of illness and two possible deaths among children due to excessive levels of lead. First, in August 2016, a recall was initiated after a series of adverse event reports were filed with the FDA. All of the reports involved children who had been diagnosed with elevated lead levels following blood sampling.  All of the children had been exposed to DHZC-2 tablets.

The second recall included all lots of the supplement BRAIN-ECM capsules, which also had tested positive for elevated lead levels. Finally, in November 2016, the Side Head Regulator TT tablets were also recalled. The series of recalls eventually lead to Ton Shen Health stopping all distribution or sale of Life Rising products.

Consumers who have used the tablets listed in the recall are asked to stop using the product and return it for a full refund.  The FDA also recommends consumers use their MedWatch Safety Information and Adverse Event Reporting Program to report any side effects, illness, injuries, or death associated with use of the product.

If you or your child have been harmed due to lead exposure, or exposure to any type of dangerous or contaminated pharmaceutical product, contact MedMalFirm.com.  Our attorneys are experienced in all areas of medical malpractice, including dangerous or defective drugs and medical devices.

Dangers of Lead Exposure

Lead naturally occurs in the human body, but when levels become elevated, it can be harmful.  If lead levels get too high or last too long, lead poisoning may occur, which can affect a number of systems throughout the body.  Lead poisoning is extremely dangerous, particularly to children, and may cause the following symptoms:

• Abdominal pain
• Muscle weakness
• Nausea or vomiting
• Diarrhea
• Weight loss
• Decreased or bloody urination

If not recognized and treated in a timely manner, lead poisoning can also have more significant, long-term side effects in children, including:

• Damage to the nervous system
• Organ failure
• Learning disorders
• Developmental defects
• Growth delays
• Seizures
• Coma

If you recognize any of the symptoms, it is important to seek medical attention right away.  If not properly treated, lead poisoning can cause permanent disability or even death.

Common Causes of Lead Poisoning

If you suspect that you or your child has been harmed by lead exposure or lead poisoning, your first step is identifying the source and preventing further exposure.  Some of the most common causes of lead poisoning are:

• Household items and toys manufactured prior to 1976
• Paint manufactured prior to 1978
• Household items or toys manufactured outside the U.S.
• Lead curtain weights, fishing sinkers, bullets, and other items
• Pipes and faucets containing lead, which contaminates water supply
• Art supplies, such as paint, jewelry, pottery, or figures
• Storage batteries
• Ethnic medicines and supplements

Lead poisoning can be acquired by ingestion, including drinking, breathing, or eating products containing excess lead.  In the U.S., lawmakers have worked for years to limit the amount of lead acceptable in manufactured products, but it is still a common ingredient in many everyday products.

Lead Poisoning: Diagnosis and Treatment

Diagnosing and treating lead poisoning usually starts with a blood test.  A blood test will tell your doctor if the level of lead in your blood is within safe, acceptable parameters.  Depending on the results of the blood test, your doctor may order additional tests, such as X-rays or a bone marrow biopsy.

To treat lead poisoning, the first step is removing the source of lead exposure from your home or daily routine.  Your doctor may be able to help with this, or you can contact your local health department.  Next, depending on your age and the levels of lead, your doctor will decide on a treatment plan.  For low levels of lead exposure, eliminating the source of lead may be enough to reduce lead levels and return your body to normal.

For more severe cases, your doctor may opt for more intensive treatment options, such as:

• EDTA therapy – Ethylenediaminetetraacetic acid (EDTA) is used to treat adults with blood lead levels of 45 mcg/dL. The number of treatments needed will depend on the lead levels and how your body reacts to treatment.
• Chelation therapy – Chelation therapy is a medication therapy that binds lead in your body together, and then allows your body to excrete it via urination or the digestive tract. This method of therapy can be used for adults and children, with the dosage and duration depending on age and other health factors.

Unfortunately, even with treatment, the effects of lead poisoning may be difficult, or even impossible, to reverse.  It is important to address concerns of lead exposure immediately and get help to prevent further exposure or devastating injuries.

Lead Exposure and Your Legal Rights

As a consumer, you trust manufacturers to abide by established standards for safety.  When they fail to do so, or are negligent in monitoring their products before distribution, you and your family are susceptible to harm.  These risks are particularly concerning when it comes to medications, supplements, or medical devices, which should improve or benefit your health and wellbeing, not risk it.

If you or your child have been diagnosed with lead poisoning, or have been injured as a result of lead exposure, you may find it helpful to contact an attorney to discuss your legal rights.  Not only is it irresponsible and unacceptable for a manufacturer to distribute dangerous products, it is also often a violation of your legal rights.

Contact MedMalFirm.com to find out more about your rights and see if you are eligible to file a medical malpractice claim.  Fill out our online form to schedule a free consultation.  Our attorneys can help you determine what your options are to protect your rights and get compensation for your injuries and losses.