FDA Cracks Down on Unapproved Uses for Chelation Drugs After Two Children Die

By October 22, 2010 July 23rd, 2019 Dangerous Drugs

I was interested to see that the FDA has announced that it is cracking down on unapproved uses of chelation drugs. These drugs, which bind to and remove heavy metals from the body, are prescribed legitimately to treat heavy metal poisoning. But the drugs have also been marketed for unapproved uses, most famously the treatment of autism. The FDA is disciplining these drugs’ makers for this in the wake of at least two deaths attributed to misuse of chelation drugs. As a pharmaceutical liability attorney, I believe it’s important that the public be protected from drug manufacturers’ attempts to market their products for dangerous, unapproved uses — which is ultimately about increasing their profits.
Sadly, these unapproved uses have had some tragic results. A five-year-old autistic boy died of a heart attack while a Pennsylvania doctor treated him with chelation drugs, using an unproven theory that autism is caused by heavy metal poisoning. The child’s parents sued the doctor and his medical license was suspended for three years. A two-year-old Texas girl also died of a heart attack attributed to chelation treatment.
Over-the-counter chelation drugs have also been marketed on the Internet to treat Alzheimer’s disease, Parkinson’s disease and heart disease. These drugs can cause kidney failure, dehydration and other serious health problems. A 2007 survey showed that 111,000 adults had used these treatments in the past year. The FDA sent warning letters to eight makers of these drugs notifying them that they are “unapproved drugs and devices,” and that their sale is a felony. These eight sellers — World Health Products; Hormonal Health; Evenbetternow; Maxam Nutraceutics/Maxam Laboratories; Cardio Renew; Artery Health Institute; and Dr. Rhonda Henry — have marketed the drugs as dietary supplements. The FDA said that patients receiving legitimate chelation treatment should use only prescription drugs, under the care of a medical professional who can respond to any complications.
As a defective medication lawyer, I agree completely. Two innocent children should not have had to die from the unapproved, dangerous use of any drug, whether prescription or over-the-counter. The drug makers may have intended to make their products sound harmless when they marketed them as mere dietary supplements. But that’s even more dangerous to unsuspecting consumers who are looking for medicines to help them, not make them even sicker. That kind of sneaky marketing is not just immoral, it’s illegal, and I am pleased that the FDA is paying attention to it.
Drug manufacturers are required by law to warn consumers of their products’ risks. If they fail to do so — or, worse, hide their drugs’ harmful effects — the people that get hurt by using those drugs can sue. Victims of dangerous drugs can require the manufacturer to pay for their medical costs, lost wages from missing work or being unable to work, and diminished quality of life, which the manufacturer ultimately caused. Consumers who trust that a medication will help them should not have to bear all the consequences alone if they find that the manufacturer hid important information from them about the drug’s risks.


The dangerous medication attorneys at Carey, Danis & Lowe help people who have been hurt by over-the-counter and prescription drugs. If you or someone you love have been seriously harmed by a medication, we can advise you about making the company that caused your injury pay for medical expenses, lost wages, permanent injuries and pain and suffering. If you have been hurt by a defective drug, please call Carey, Danis & Lowe for a consultation, toll-free, at 1-877-678-3400 or contact us through our website.