Everything You Need To Know About The Ranitidine Recall
It is important for pharmaceutical companies to have their drugs approved by the FDA (Food and Drug Administration); otherwise, they can’t sell their product in the market. In order to get FDA approval, a company must conduct lab testing of its drug through animal and human trials. Once they do this, they must submit their data to the FDA. The FDA examines and evaluates the data collected from the company and determines whether it can be approved or not.
This approval is dependent on one major factor, which is, does the drug have higher risks than benefits? Once the FDA determines this factor, it proceeds with approval or rejection. We discuss why the Ranitidine recall occurred and what caused the FDA to disapprove of the drug for usage.
What Is Ranitidine (Zantac)?
Ranitidine is basically an oral medication that can slow the production of acid in the stomach. Ranitidine comes from a certain classification of drugs that people know as H2 blockers. Some other drugs in this category are Cimetidine, Nizatidine, and Famotidine. The discovery of Ranitidine drug happened in 1976, England. However, it became commercial in 1981, but the FDA approved it in 1984.
The drug has been quite popular in the US, as it is the most commonly prescribed drug with about 16 million prescriptions. Other than this, the WHO’s list of essential medicines claimed this drug as one of the safest and most beneficial medicines.
Doctors would usually prescribe Ranitidine for short-term treatment, like GERD. For long-term treatment, you have to consume it for many weeks. You can use it as a part of combination therapy, which means you have to take other medicines with Ranitidine.
What Are The Uses Of Ranitidine?
Before the FDA removed all the products that contained Ranitidine (Zantac) from the US, people used it for multiple purposes. Some used it to treat their intestine and stomach ulcers, and Zollinger-Ellison Syndrome, while others used it to prevent ulcerations.
Ranitidine helps in reducing the production of acid in the stomach. If excessive acid in the stomach is not treated, it can severely damage the stomach and result in inflammation and ulcers. This acidity can result in many severe conditions, which can be painful and irritating as well. Therefore, Ranitidine was the medication used in order to help patients with acidity issues in their stomachs.
A patient may take this medication orally, through an injection it into a muscle, or an injection it into a vein.
When buying any type of Zantac medication, it is essential for the patient to have a prescription. No medical store will provide this drug to you without a prescription from your doctor. Using the drug without prescription can be dangerous if you have any underlying health conditions that you aren’t aware of.
Why Is The Ranitidine Recall Occuring?
Well, as we mentioned earlier, it is up to the FDA to ensure a drug has higher benefits than risks. The FDA also looks into whether a drug can cause any side effects in the next five or ten years.
The FDA has made a request for withdrawing all prescriptions and over the counter Ranitidine drugs. Of course, after a thorough investigation, there is a valid reason for the FDA to come to this decision i.e. there is an impurity in Ranitidine products that may result in fatal medical conditions, such as cancer.
The impurity in Ranitidine is NDMA (N-Nitrosodimethylamine), which can result in cancer when humans consume it for a long time. As per the statement from the FDA, the levels of the impurity in the drug elevate at temperatures higher than normal room temperature. Since the impurity level of the drug is high, the FDA doesn’t want this product to reach buyers in any circumstances. The press release from the FDA to for the removal of the drug from the market became public on April 01, 2020.
Side Effects From Ranitidine (Zantac)
Every pharmaceutical drug has its side effects, but Ranitidine (Zantac) is quite harmful because of the unacceptable levels of NDMA (Nitrosodimethylamine). The FDA has put a restriction on Ranitidine because continuous use of the drug by people may result in the following.
Cancer in large and small intestines
Other than cancer, several ranitidine tablet users were also suffering from headaches, diarrhea, nausea, constipation, and stomach ache. However, these effects are not severe; they disappear within a few weeks or days.
But if they don’t go away and change their form e.g. you start having inflammation in your liver or abnormal heartbeat, contact your doctor immediately. Each drug affects people in different ways. Not every Zantac user can have liver cancer, but an over-dosage of Zantac can result in these side effects.
Potential Zantac Lawsuits Related To The Ranitidine Recall
The side effects associated with the presence of NDMA are a clear indication that people who use or have used Zantac for heartburn or other stomach-related issues may have a potential lawsuit. The side effects don’t have to appear immediately after the use of the drug. If you have any of the cancers stated above, they might be associated with your use of the drug at some point in life. Only a health professional can form a link between your condition and the use of Zantac.
The reality is, you cannot ignore any unusual symptoms in your body if you have used Zantac at any point. You don’t have to live in fear, pay huge medical bills, and lose the joy of life because of cancer just because you couldn’t file a lawsuit against the company on time. If you think you have a potential Zantac lawsuit, you should contact us today that so we can help you find the legal protection you need before it’s too late.
You should not use any medicine without a proper prescription. Don’t change, start, or stop any medicine dosage before verifying with your professional health care provider. You can always get more information about the Zantac lawsuit through these frequently asked questions. Visit our Zantac lawsuit (justice center) website for further assistance and information. We have a case specialist who will contact you immediately.