The U.S. Food and Drug Administration issued a statement on January 25, 2019, updating the public on the ongoing investigation into valsartan blood pressure medications that are contaminated with impurities that are probable human carcinogens. The FDA warns that these drugs are in shortage and that other blood pressure medications may also fall into short supply soon.
What is Valsartan
Valsartan is a blood pressure medication that belongs in a class called angiotensin II receptor blockers, or ARBs. Recently, valsartan, losartan, and irbesartan were all recalled from the U.S. market after it determined that these drugs contained an impurity that poses a risk of cancer to patients.
The FDA discovered in July 2019 that some valsartan blood pressure drugs were contaminated with nitrosamine impurities such as N-Nitrosodimethylamine or NDMA, and N-nitrosodiethylamine or NDEA, chemicals deemed possible carcinogens. And while these are environmental contaminants typically found in dairy products, meats, and vegetables, and water, these substances are not acceptable in medications.
According to the statement, the FDA determined the medications were contaminated during the manufacturing process, and the contamination could have come from the reuse of materials like solvents.
How Is the Blood Pressure Medication Tainted?
Some of the ingredients imported from a pharmaceutical company in China were tainted with the impurities, according to the federal watchdog agency. The pharmaceutical company was put on an import alert that will flag all pharmaceutical and finished products to prevent them from entering the U.S. The FDA said it made this decision to flag these products after finding that supervision issues at the pharmacy could have created conditions that allowed the quality issues to occur.
When the FDA determined that ARB medications were tainted with impurities, the agency started gathering samples of all ARB medications and found NDEA in valsartan products made by different manufacturers.
To detect and quantify the amount of NDMA and NDEA in this class of medications, the FDA developed special testing methods including the headspace method, the combined headspace method, and the combined direct injection methods.
What Patients Should Know
As far as exposure to the tainted medications, the FDA said it appears small. However, the agency is working to balance patients consuming low-level impurities over a short period of time with the risk that some ARBs are in short supply and could impact how patients get the medications they need.
Unfortunately, the long-term health implications posed by NDMA are uncertain, as the amount that is consumed is what matters. According to CNN, NDMA is a toxin that, when consumed in large enough doses can cause liver fibrosis and liver tumors in rats. Unfortunately, most of what is known about the potential carcinogen has been determined in animal studies.
FDA scientists estimate in a worst-case scenario that if 8,000 patients consumed the highest valsartan dose for four years, only one additional patient would develop cancer above the average cancer rate for 8,000 people.
Patients who are affected by the short supply of ARB medications should speak with their physician as soon as possible for advice and possible alternative therapies.
Safer Class of Painkillers Identified
A new class of pain medication has been identified which has a lower risk for addiction or to cause damage to internal organs. This discovery was reported by researchers at LSU Health New Orleans Neuroscience Center of Excellence and published online. The hope is that they will be safer than opioids and more effective.
Studies into Safer Pain Medication
Recent studies have indicated that opioid medications may not be any more effective at pain relief than other drugs while often leading to addiction. Acetaminophen is effective at pain relief, but overuse of the medication can cause damage to the liver. Non-steroidal anti-inflammatories, also known as NSAIDs, can damage the kidneys.
The study began with the goal of identifying why acetaminophen causes liver damage and to create a new drug similar in structure that is safer. During the research, 21 different compounds were tested that were similar to acetaminophen. Two models showed promise of relieving pain without creating toxicity in the liver and kidneys. They also resulted in a reduction of fever, another benefit with acetaminophen.
According to the US Centers for Disease Control and Prevention, about 20 percent of adults were diagnosed with chronic pain in 2016. Of those, around 8 percent had high-impact chronic pain. Pain management is one of the costliest issues in public health around the world. One of the researchers believe this new class of drugs could lead to a safer and more effective treatment option for both acute and chronic pain.
The new drug is being developed by a life science startup known as South Rampart Pharma, LLC. It is currently in the later pre-clinical stages of development. An application to the FDA of investigation of a new drug by the third quarter of 2020. The researchers’ hope is that the drugs will prove to be effective in pain management without the risk of addiction and damage to the health of the patient.
Common OTC drugs include aspirin, naproxen, and ibuprofen, along with acetaminophen. Aspirin is a NSAID, and it can cause a variety of problems, including ulcers. Ibuprofen is another NSAID that hasn’t been around as long as aspirin, but it can lead to stomach and kidney issues. Naproxen is similar.
Prescription pain medications are more powerful and often used with chronic or severe pain. One of the most powerful is the opioid class of drugs. They work by blocking the nerve signals that tell your brain you’re in pain. However, they are highly addictive.
Some medications you may be aware of as opioids while others may surprise you. All the following are opioid prescription drugs:
- Demerol or Meperidine
- Dilaudid or Hydromorphone
- Darvon or Propoxyphene
Vicodin is a mixture of hydrocodone and acetaminophen. Fentanyl is another drug which is generally only given to patients near death who are in extreme pain. The risk for overdose is higher with opioid medications because it often takes an increased dosage to continue to see results when a patient develops a dependency on the medication.
It will be some time before these new medications will be available for use in patients.
Cost Revealed for First Coronavirus Drug
Remdesivir is the first medication that has proven to be effective at treating COVID-19. The US government has reached an agreement with Gilead Sciences, the manufacturer of the medicine, on the price tag.
This agreement between the government and the manufacturer includes pricing that is not negotiable. It is expected that the agreement for remdesivir will influence future agreements with other medications as they become available.
The Cost of Treatment
The Department of Health and Human Services says that the cost for this drug will be $520 per vial, which translates into just over $3000 per course of treatment. It will go to hospitals and this is the cost for patients with private insurance. If the patient is on insurance through the government, the cost will be $390 per vial or just over $2300 per course.
Gilead is selling the first round to the US only through September, which will amount to around 500,000 courses of treatment. Currently, HHS and state health departments have determined where the drug goes to treat COVID-19 patients. After the end of the initial agreement period in September, they will have no impact on the decision of where the drug will be going.
This agreement is unique in that it guarantees the drug for the US first. Demand in other areas could overtake the amount of supply available.
While the drug is the first to show a positive impact on the illness, it doesn’t prevent it or reduce fatalities. Research studies show that it cuts down on the length of recovery time by about four days.
The price of the drug has been anticipated since it showed effectiveness against the virus. Gilead had been providing it free of charge to hospitals for the treatment of COVID-19, but the last free shipment has been sent out. Experts say the cost isn’t extreme. It is estimated that the manufacturer would need a cost of $1600 per vial to cover the costs of manufacturing.
Gilead had the ability to charge whatever price it wanted for remdesivir and no insurer could ignore it. Analysts say the chosen price showed a responsible decision for the manufacturer, which has often been accused of price-gouging for new medications in the past. However, some consumer advocacy groups aren’t happy with the price because they say public money was used for part of the development of the drug.
Hope in a Vial
Some experts feel the drug comes with an intangible benefit, which is making Americans feel more secure about treatment of the virus. They say it is difficult to put a price tag on that benefit. Gilead has said there is an adequate supply of the drug now for anyone who needs it. It is unknown at this time how the drug will be distributed once the HHS and state health departments are no longer involved, which comes in September.
With more information coming available about remdevisir, the uncertainty and fear surrounding the virus may lessen. Americans may find they have more hope even if the virus continues in a second wave.
FDA Orders Zantac Pulled from the Market
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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