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FDA Orders Zantac Pulled from the Market

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On Wednesday April 1, the US Food and Drug Administration (FDA) ordered that Zantac be pulled from the market. Zantac is a well-known drug used to treat heartburn, but it has been in the middle of controversy for the past six months.

The Risks of Cancer with Zantac

About six months ago, several pharmacies began pulling Zantac and its generic versions from shelves due to a potential carcinogen. Now, the FDA supports this decision and has requested any pharmacies still selling the drug to remove the prescription and OTC versions of the drug, which is basically anything with ranitidine in it. Ranitidine is the active ingredient in Zantac and its generic versions.

Studies show that ranitidine has N-Nitrosodimethylamine (NDMA), which is a contaminant. This substance is also found in some foods, such as cured meats. However, the amount present in ranitidine is above what is allowed by federal regulations.

Back in September 2019, the FDA sent out a warning about the possibility of such an issue. Many large-scale pharmacies, such as Walgreens and CVS, stopped selling Zantac and the equivalents.

According to the FDA, the issue is not with the way it has been manufactured. Instead, it’s the way the ingredient breaks down while it’s being stored. The agency conducted tests of samples, which didn’t have any unacceptable levels of the substance. However, the tests showed that the drug was able to degrade into the substance while sitting in storage. Testing showed it could happen while in tablet form or after it had been consumed by humans.

The problem first came to light in the summer of 2019 when a company known as Valisure did a test on the medication. Valisure is a company that does various safety tests on medications. The results showed the presence of NDMA in alarming levels.

Find New Treatment Options

The FDA is going to be sending out letters to all companies that manufacture ranitidine under any name to have them stop production and pull the product from the market. The manufacturer of Zantac, Sanofi, has already issued a recall in the US and Canada.

The FDA recommends that anyone taking the OTC version of Zantac should switch to another type of heartburn medication immediately. For those who are on a prescription version, they need to talk to their doctors right away about what they can switch to. According to the agency, NDMA has not been found in other medications which act similarly to Zantac, such as Prilosec, Pepcid and Prevacid.

Zantac is most often given for gastroesophageal reflux disease, which is when the acid from the stomach backs up into the esophagus. The medication may also be given for peptic ulcers and Zollinger-Ellison syndrome, which is when the stomach produces too much acid. It mainly comes in two forms, Zantac 75 and Zantac 150. The medication reduces the amount of acid the stomach produces.

NDMA doesn’t cause cancer immediately, but it can build up in the system over time. The risk is long-term if a person continues to take this medication while also being exposed from other ways.

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Prescription Drugs

Results from Remdesivir Clinical Trial to Come Soon

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A clinical trial of remdesivir for treatment of coronavirus is expected to end in the next week or two with results to be available in the next two to three weeks. Remdesivir is an antiviral drug being tested to see the effectiveness against COVID-19.

Final results of the clinical trial are expected to be available by late May, but preliminary results may come in within one or two weeks. The first step will be analysis of the test, which will tell researchers if the drug performed better than the placebo.

Remdesivir was first tested as a possible treatment for another disease, Ebola. Researchers say it has shown promise for the treatment of the coronavirus in test tubes. Current information is conflicting as there are limitations on the knowledge available.

The Study

The current study is being conducted by the National Institutes of Health. It uses a placebo and is a double-blind trial with patients being chosen randomly. What this means is that all participants in the trial receive a treatment. It is either a dose of the drug or a placebo, but neither the patients or the doctors know who is getting remdesivir and who is getting the placebo.

The purpose for this kind of trial is to ensure the results are accurate and unbiased. They will be more believable for experts and the general public.

The target was to have 572 participants for the clinical trial, but researchers say they were over that goal. Participants came from all over the world. While the trial started with the University of Nebraska Medical Center, it has expanded to almost 70 other sites. There are sites in Germany, South Korea and many other places.

The hope is that the results will mean a big improvement for those who suffer from the virus. Researchers are hoping to see a shortening of the timeline for how long someone is sick as well as a reduction in the severity of symptoms. If the results don’t show what researchers hope for, they will remove it from the list of drugs and move onto another treatment for the next trial.

Previous Trials

Gilead Sciences is the maker of the drug, and it has completed its own testing. The company released information from the results of 53 patients, which indicated they had shown improvement after being given remdesivir. The manufacturer is encouraged by the results, but the trial is inconclusive because there was no secondgroup to act as the control group.

The World Health Organization published results from another trial with the same drug. In this trial, patients had severe symptoms from the virus. The summary showed that the drug didn’t have significant results in the treatment of the illness. However, the results were published accidentally and critics say that the trial was
terminated earlier than planned because fewer people had enrolled. Gilead stated that the study was inconclusive. Regardless of past trials and results, many people are waiting anxiously for the results of the current trial.

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Testing Results for Antiviral Drug are Positive for COVID-19 Treatment

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The antiviral drug remdesivir from Gilead Sciences shows positive preliminary results for treating the novel coronavirus. According to information from the manufacturer and others, the drug helps patients recover faster from the illness.

Hope for COVID-19 Patients

Data from the clinical trial shows that the medication cuts down the recovery time of patients, according to Dr. Fauci. The National Institute of Allergy and Infectious Diseases sponsored the study, which used a double-blind placebo trial to ensure the most accurate and unbiased results. Over 1000 patients were part of the study in many countries.

Even though the results have not been published, the information was announced, so that the placebo group could now have access to the drug since it showed evidence of working. The term recovery was defined to mean the patient was able to be discharged or return to their normal routine.

According to preliminary results, patients recovered 31 percent faster than those who received the placebo. This cut the time down from a median time of 15 days to 11 days. Early analysis indicates it may also lower the mortality rate, but the data must be analyzed completed to know for sure.

Fauci indicates the significance of the study isn’t just in how much recovery time improves, but in the fact that a drug can be effective for the virus. One of the doctors involved in the study explained another significance of the data. Time spent in the ICU causes stress on the body and increases the time needed for recovery. It’s important to have a drug that can decrease that time and hopefully lessen the impact the illness has on the body.

While researchers and many other experts are excited about the potential for remdesivir being the first drug capable of treating patients with COVID-19, the study must go through an in-depth analysis in a peer review. Even though no patients in the study showed evidence of serious side effects, the safety data hasn’t been received. This information is essential to determining how the medication would be used with the public.

Not a Cure All

Experts want people to understand that this drug isn’t a miracle drug to cure coronavirus. It works slowly in the system by preventing the illness from spreading. Other medical care is still necessary, especially for those who has suffered damage to organs from the virus. More studies are expected to begin which will combine remdesivir with other drugs to determine if they are more effective than using the drug alone.

A previous study done in China didn’t show improvement from use of the drug, but experts suggest it was because the study was stopped early due to not enough patients being recruited. The latest study offers hope to the public and researchers are cautiously optimistic about the impact it may have on treating COVID-19 going forward.

Other studies are in progress with various medications and vaccines are also being tested to prevent the virus in the future. It is expected that it may be another year before a vaccine is available for the general public.

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Anti-parasite Drug Being Tested for Use Against COVID-19

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The popular anti-parasite drug, ivermectin, is being tested to see if it is beneficial against COVID-19. This medication is often given for pinworm as well as nematode infections in humans. It can also be prescribed as a treatment for head lice. A version of the medication is also used as treatment of parasites in animals.

Hope for Treatment with COVID-19

The test hasn’t been performed on humans, but it was tested on a cell culture in a laboratory, which had been infected with COVID-19. The results showed that the viral colonies were reduced within two days by 5000 times.

The medication attaches to the nerve cells and muscles of parasites to cause paralysis and finally, death. The study was published in Antiviral Research and indicated the same medication has shown promise in limiting infection of other viruses. It may be used to treat influenza and West Nile virus.

While the medication targets roundworms with muscles and nerve cells, viruses don’t have these same cells to be targeted. However, they do contain a specific protein, which the ivermectin also targets.

The Benefits of Using Ivermectin with COVID-19

More testing is needed to determine if it can, in fact, help treat COVID-19. If testing is positive, it will provide several benefits for Americans. The drug is easily accessible because it’s listed as an essential medicine by the World Health Organization (WHO). The FDA has already approved it for humans back in 1996.

Ivermectin has already been determined to be safe for use in humans. On the other hand, it hasn’t been deemed as safe for pregnant women or in children under 33 pounds.

One of the risks with this medication is that it can increase the risk of bruising and bleeding if it is taken with Coumadin or warfarin. The most common side effects with the medication are fairly minor and include the following:

  • Nausea and vomiting
  • Abdominal pain
  • Constipation
  • Dizziness
  • Insomnia
  • Itching and rash

Side effects that are less common include swelling of the face, increased heart rate and low blood pressure.

The most popular use for ivermectin in the US is in animals. It is a commonly used treatment for parasitic worms in grazing animals, such as cattle. It’s also used for heartworm prevention in dogs and cats. It can also be used with some reptiles.

The research was conducted in Australia with the Biomedicine Discovery Institute from Monash University and Peter Doherty Institute of Infection and Immunity. According to the research, the coronavirus could be killed within 48 hours and significant improvement seen in 24 hours.

The next step, according to the researchers, is to find a dosage that is safe and effective in humans and test it on people. Since there isn’t an approved treatment for COVID-19 and a vaccine won’t be readily available for at least a year, researchers say it’s critical to find a current medication for treatment in a pandemic.

Even with positive testing, it can take some time for a drug like ivermectin to be used in a new treatment in the US.

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