Some histamine-2 receptor blocker medications like Zantac were initially ruled out as safe by the FDA. It was a drug for patients who experience heartburn and other gastrointestinal illnesses. Individuals with gastroesophageal reflux disease (GERD) and excessive stomach acid could also take the medicine to keep their health condition under control.
However, laboratories like Valisure determined that it contained compounds that may harm a person’s health. There was an abnormally high level of n-nitrosodimethylamine (NDMA) found in the medicine, making it dangerous. If consumed in high doses, NDMA is a volatile compound that can cause cancer. This means those who are taking Zantac regularly may have been at risk of developing a life-threatening disease due to the drug.
Due to its potential health risks, FDA pulled out Zantac and other ranitidine medications from the market. The drug manufacturers also faced repercussions after many patients filed lawsuits for the inconveniences they’ve experienced.
Lessons For The Drug Industry
To prevent similar cases from occurring in the future, here are some things the drug industry should learn from the Zantac incident:
External Factors May Affect Medicine Composition
The manufacturing and transportation process of the ulcer medication exposed it to various temperature changes, which affected its composition. Two drug manufacturers were located in Australia and India, where the temperature can go as high as 139 degrees Fahrenheit during the summer. The NDMA found in ranitidine can significantly increase when stored in heat, and its manufacturing process made it prone to changes.
This means some ranitidine products sold in the market may have been exposed to heat several times before it even arrives in stores. Additionally, there weren’t any instructions indicating the proper storage temperature of the drug during transport. Thus, there’s no guarantee that the drug was kept in cool storage at all times.
It wasn’t long before experts determined that Zantac may be dangerous to the health of people who took it regularly. Thus, it may be best for drugmakers to consider how their products are transported and distributed as this can affect the efficacy and safety of drugs. Furthermore, it may be helpful to provide detailed instructions on how to handle a medicine to ensure it won’t be compromised before it even reaches consumers.
Drug Makers Shouldn’t Withhold Information From Patients
After Zantac was pulled out from the market, various patients who claimed to have developed cancer due to the drug filed lawsuits against its manufacturers. Cases were filed in court against companies that produced and distributed the drug. Sanofi, Boehringer Ingelheim, Pfizer, and GlaxoSmithKline received various complaints from patients.
Some plaintiffs claimed that the people behind the drug knew about its potential risks but chose not to disclose it to the public. The lack of information led some individuals seeking relief for their gastrointestinal problems to take medicine without fully knowing its risks.
Other than the possibility of developing various forms of cancer, some patients who took Zantac also showed severe side effects. Taking ranitidine medication may also cause liver failure, blurred vision, hepatitis, and stomach pain.
Those who wish to ask for compensation for their losses can stay updated through reliable sources, like Drug Injury News, or keep in touch with lawyers handling Zantac cases.
Alternatives Can Be Given To Patients
Patients who were previously prescribed Zantac were advised to seek medical help if they’ve been experiencing adverse effects from taking the drug. Additionally, FDA suggested other over-the-counter medicines as substitutes to ranitidine.
Some medications like Pepcid (famotidine), Nexium (omeprazole and esomeprazole), or Prevacid (lansoprazole) can be given to individuals who need medicine to regulate their stomach acid. These products are confirmed as safe substitutes to ranitidine and aren’t affected by the contaminants in Zantac products.
Although these over-the-counter drugs are ruled as safe for consumption, patients who need a Zantac are still advised to consult a physician before buying a new ulcer medication. It’s best to get their condition checked to ensure they won’t encounter problems when taking their new prescription.
Furthermore, those who regularly take the drug to prevent heartburn and overproduction of stomach acid should report any adverse effects to their doctor. Doing so will help avoid any health problems from developing.
The Zantac case is an unfortunate incident that affected the lives of many people. Some patients claimed to have developed long-term health problems due to the medication.
Fortunately, the ulcer medication is no longer available in stores. Instead, safer alternatives are prescribed to those who need relief from gastrointestinal problems. Furthermore, individuals who wish to receive compensation for the troubles they’ve experienced can file lawsuits against the manufacturers of the drug.