In September 2019, the FDA announced concerns that the heartburn medication, Zantac could cause testicular cancer in children. This announcement came after an online pharmacy tested Zantac tablets and found a cancer-causing chemical, NDMA, at levels up to 3,000 times greater than the FDA’s legally allowable limit.
Zantac (Ranitidine) decreases the amount of acid created by the stomach. OTC ranitidine is approved to prevent and relieve heartburn, and prescription ranitidine is approved for a number of uses, including treatment and prevention of ulcers of the stomach and intestines, and treatment of gastroesophageal reflux disease.
About NDMA
The carcinogenic chemical in Zantac (ranitidine) is called N-nitrosodimethylamine (NDMA). The FDA, the U.S. Environmental Protection Agency (EPA) and the World Health Organization (WHO) all classify NDMA as a carcinogen (a substance that has the potential to cause cancer).
NDMA is a semi volatile organic chemical that belongs to a family of chemicals known as N-nitrosamines. According to the EPA, N-nitrosamines are “a family of potent carcinogens.” There is a 96 ng daily limit of NDMA. However, recent testing of Zantac found more than 2,500,000 ng of NDMA in a Zantac 150 mg tablet, the dosage countless people take every day.
NDMA & Testicular Cancer in Infants
Testicular tumors on babies or toddlers differ than those occuring on older boys or teens. For children under the age of 2, most tumors are benign. However, these still require surgical intervention. There are malignant testicular cancer in many cases. This means the cancer cells can spread through the bodies especially to the lymph nodes, liver, lungs, brain and other areas.
Experts have traced testicular cancer in infants to in utero exposure to Zantac. Zantac is still in FDA’s category B for birth defects. This means it is considered safe for mothers to take during pregnancy.
Symptoms of Pediatric Testicular Tumors
The most common signs of pediatric testicular tumors are:
- Painless lump in testicle
- Weight in the scrotum
- Testicle swelling with pain or without
- Ache or pain in the testicles or groin area
If you see any of these signs on your child, report it immediately to a medical professional. It is important to rule out other potential causes for the symptoms including epididymitis, inguinal hernia, testicular torsion, or hyrdocele.
The most common testicular tumors in young children are teratomas and yolk sac tumors. A teratoma is a germ cell tumor that, when seen under a microscope, looks like the three layers of a growing embryo. These are the most common benign testicular tumors. Children usually show signs of a teratoma at around 14 months of age.
Zantac Testicular Cancer Recall
In September 2019, the FDA found low levels of the nitrosamine impurity N-nitrosodimethylamine (NDMA) in some Zantac (ranitidine) dosages. The agency recalled 14 lots of prescription ranitidine capsules from manufacturer Sandoz, Inc.
Then two days later, the FDA announced an expanded recall of various OTC versions of ranitidine manufactured by Apotex Corporation and generics labeled by Walgreens, Walmart, and Riteaid due to NDMA contamation.
Similar contamination in heart medicines is also under investigation.
Testicular Cancer Attorneys
The Zantac testicular cancer attorneys from The Michael Brady Lynch Firm and Milstein, Jackson, Fairchild, & Wade believe that unsuspecting mothers took Zantac, and the cancer-causing NDMA transferred to their babies in the womb. This unknowing exposure could have caused their child’s testicular cancer.
If you or a loved one took Zantac (by prescription or Zantac OTC) while pregnant and your son was diagnosed with testicular cancer, compensation could be available. Our firms will hold the Zantac manufacturers (Boehringer Ingelheim, Sanofi, Chattem, Pfizer, and GlaxoSmithKline) accountable for failing to warn pregnant mothers and consumers about the testicular cancer risk associated with Zantac.
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