April 22, 2024

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Pharmacists Warn of Risks: Safety Concerns Surrounding New Drugs and Vaccines

Pharmacists Warn of Risks: Safety Concerns Surrounding New Drugs and Vaccines

Pharmacists Warn of Risks: Safety Concerns Surrounding New Drugs and Vaccines

People  tend to take more medication as getting age. Seniors, in particular, often take several medications at once.

According to the Japan Ministry of Health, Labour and Welfare, about 40% of people aged 75 and older are prescribed five or more medications. However, the issue with medication isn’t just the quantity being taken.

About 40% of seniors take five or more medications

New drugs, such as the COVID-19 vaccine that caused a global stir, and medications for conditions like dementia, which affects one in five people, are being developed one after another. New drugs are developed to help many people suffering from difficult symptoms, but…

To what extent do you know how safe they really are?

To answer questions about the safety and management of medications, the reporter spoke with Suzuki Sokun, a pharmacist who has lectured at 32 universities and has sent about 30,000 pharmacists into the world.

Pharmacists Warn of Risks: Safety Concerns Surrounding New Drugs and Vaccines

Pharmacists Warn of Risks: Safety Concerns Surrounding New Drugs and Vaccines

How safe are new drugs really?

In September 2023, the Japan Ministry of Health, Labour and Welfare officially approved the manufacturing and sale of a new drug for dementia developed in the United States.

“This new drug, Lecanemab, has the ability to remove amyloid beta (beta), a protein that causes Alzheimer’s-type dementia,” Suzuki said.

However, during the removal process, there were reports from clinical trials in the United States that about 10% of patients experienced slight bleeding from the brain’s blood vessels due to increased fragility.

“Such side effects are expected to occur in a certain percentage of drugs like Lecanemab, but there are concerns about whether it is really safe,” Suzuki said.

Every drug has both revolutionary effects, known as benefits, and a few side effects, known as disadvantages.

“Especially with new drugs, there is little data on the actual use of the drug in clinical trials, so it is unclear how many side effects there are,” Suzuki said.

It is said to take 9 to 16 years to develop a single drug. Despite the long time and enormous cost, the effectiveness and safety of the drug are maintained. However…

“Clinical trial data is based on results from a limited number of people. It is not based on data from people taking the drug under various conditions, such as age, sex, constitution, and long-term use with other medications in a hospital or other treatment setting,” Suzuki said.

In other words, while there is ample data for drugs that have been on the market for several years, there is less for new drugs.

New drugs require special attention to allergies

“New drugs with limited clinical data are actually difficult for researchers to assert their safety. Therefore, the country has established rules to prevent side effects from new drugs,” Suzuki said.

There are three rules: a post-marketing surveillance for new drugs for one year after approval, conducting surveillance of use for children, the elderly, and people with kidney or liver diseases who were not included in the clinical trials, and restricting the use of new drugs to less than 14 days for one year.

“When you are recommended a new drug, you may be unsure whether to use it or not. If you expect your symptoms to improve with the new drug, ‘use it.’ However, if you are concerned, ‘wait a year and decide after obtaining information on the extent of effectiveness and side effects,'” Suzuki said.

Also, if you experience discomfort after taking a new drug, it is important to contact your doctor immediately.

“What is dangerous is allergic symptoms. It is said that it is difficult for any doctor to judge allergies to drugs at the prescription stage,” Suzuki said.

In particular, it is important to be cautious about allergies to new drugs with limited clinical data.

“If you are worried, please inform your doctor or pharmacist in advance if you have any allergies. It is reassuring to confirm how to deal with changes in your condition after taking the medication.

“If health damage occurs due to side effects of a new drug and hospitalization is required, there is a ‘System for Relief from Health Damage due to Side Effects of Drugs,’ which provides medical expenses, medical treatment, and disability pensions, so it is good to remember this,” Suzuki said.

Three rules for new drugs

(1) Post-marketing surveillance

Pharmaceutical companies conduct surveillance intensively for the first six months after marketing.

(2) Special surveillance

Conduct surveillance for use in children, the elderly, and people with kidney or liver diseases who were not included in the clinical trials.

(3) Restrictions on new drug administration

New drugs are prescribed for a maximum of 14 days for one year.

So, was it better to get the COVID-19 vaccine after all?

The novel coronavirus, which began spreading in 2020, prompted the rapid development of vaccines as an emergency measure, but there were still many people who hesitated to get vaccinated.

“Some people may have had doubts about whether thorough clinical trials were conducted since the vaccine was put into practical use in less than a year. However, according to reports from the government, the vaccine has undergone the usual trial process, and its safety and efficacy have been evaluated.

“However, since vaccine development has typically taken about 10 years, there are indeed concerns about long-term side effects and effectiveness,” Suzuki said.

Three years have passed since the start of vaccination, and as the virus continues to mutate, vaccines are also changing to cope with it. Some people seem to be cautious after seeing reports of adverse reactions and posts on social media.

“Unfavorable symptoms that occur after vaccination are called ‘adverse events.’ On the other hand, ‘adverse reactions’ refer only to those adverse events for which a causal relationship with vaccination has been recognized.

“In other words, adverse reactions are those adverse events that have been shown to be causally related to vaccination. However, it is important to note that there are reports and social media posts that confuse this distinction,” Suzuki said.

So, how likely are adverse reactions to occur after vaccination?

“After vaccination, rare but serious adverse reactions such as myocarditis and pericarditis have been reported. However, the rate of complications of pericarditis and myocarditis in unvaccinated individuals is higher than that of these adverse reactions.

“Therefore, many people have considered the benefits of vaccination to outweigh the risks, and as of last year, about 80% of the population has been vaccinated at least once.”

Free vaccinations will end in March this year

The novel coronavirus was designated as a Category 5 infectious disease on May 8 last year, but there are still a significant number of people who have been infected. Will it be better to get vaccinated in the future?

The World Health Organization (WHO) gives the highest priority to healthcare workers, the elderly, people with underlying conditions such as diabetes and heart disease, immunocompromised individuals, and pregnant women, recommending regular vaccination every six months or once a year.

However, for healthy adults under 60 years old and young people, additional doses (booster shots) are recommended only once. Regular vaccination is not recommended.

“For those under 60 years old who are healthy, it is not recommended to receive regular vaccinations. Consult your primary care physician if you have an underlying condition or are concerned about your health. For healthy individuals, it is good to gather information and make your own decision,” Suzuki said.

In addition, vaccination against the novel coronavirus at public expense is scheduled to end in March of this year. Vaccination after April will be basically charged in Japan.

“From April, many people will have the option of whether or not to get vaccinated voluntarily, so the decision to get vaccinated or not will be up to you.

“Information about the novel coronavirus is being updated daily, so please find reliable sources of information such as the Ministry of Health, Labour and Welfare, WHO websites, or TV news and newspapers,” Suzuki said.

Turmeric supplements are good for the body, right?

While some people may be anxious about taking medication continuously, they may not be as concerned about using supplements or health foods regularly. The market for these products is said to exceed 1 trillion yen, with turmeric being particularly popular, accounting for about 30 billion yen.

“Turmeric contains a component called curcumin, which improves liver function, and there have been reports that it can reduce the blood concentration of acetaldehyde, which causes hangovers,” Suzuki said.

However, when the Japan Society of Hepatology investigated the causes of liver damage from drugs and health foods other than those prescribed at hospitals, they found that turmeric was the most common cause.

“Further investigation revealed that people with liver damage were using over-the-counter drugs almost every day. In other words, even though they were taking turmeric to improve their liver function, it could actually worsen their condition,” Suzuki said.

People who already have liver damage or a disease should absolutely avoid taking large amounts of turmeric in an attempt to improve their liver.

“While I have talked about the negative aspects of turmeric due to its large market size, if you are healthy and taking a drinkable turmeric product from a drugstore, you don’t need to worry,” Suzuki said.

The purpose of health foods and wise usage

Health foods and supplements are intended for maintaining health when taken by healthy individuals and are not intended to cure diseases. While some products claim to help people recover from illness, they are generally considered food.

“The health food industry has seen many entrants from other industries, with little knowledge and experience of ingredients. Therefore, there may be concerns about the manufacturing process. Also, it is not always true that ‘high price equals high quality.’

“The government has established systems such as ‘nutritional supplement foods,’ ‘functional foods,’ and ‘specified health foods’ to allow for labeling of functions, so products with approved labeling are easy to understand. It is also one way to refer to such products,” Suzuki said.

Another thing to be careful about is starting to use a product based on online posts or hearing from acquaintances.

“Online posts and acquaintances’ comments are personal experiences and do not necessarily apply to everyone. When considering using supplements, it is a good idea to consider them when recommended by a doctor or pharmacist based on your condition,” Suzuki said.

Moisturizing cream for dry skin in winter. Which one is correct?

From winter to early spring, the skin tends to dry out. At such times, moisturizers come in handy. Many people buy them at drugstores, but few may be checking the ingredients when they purchase.

In fact, if you do not choose a moisturizer according to your skin condition, dryness may not improve, and in some cases, it may worsen.

“There are various ingredients in moisturizers. ‘Vaseline,’ which is often seen on store shelves, has low skin irritability, so it can be used all over the body. It also has the effect of protecting the skin from friction with clothing and other factors.

“Also, when used on minor abrasions, it prevents the abrasion from drying out and promotes quick healing,” Suzuki said.

However, since Vaseline has low moisturizing properties, the key is to apply it frequently. It is also affordable, ranging from 150 to 400 yen for 100g.

“Another ingredient with higher moisturizing effects is ‘Heparin-like substances.’ It has about 2.5 times the moisturizing effect of Vaseline and is often prescribed for dry skin irritation and frostbite.

“However, it can increase bleeding and cause irritation when applied to wounds. Avoid applying it to wounds,” Suzuki said.

Heparin-like substances penetrate deep into the skin’s horny layer and have few side effects, but they are expensive, ranging from 2,000 to 3,000 yen for 100g.

“Urea, often found in moisturizing creams for elbows and heels, is a natural moisturizing ingredient. A cream containing 10% urea is used for moisturizing, and 20% urea is higher in moisturizing properties and has the ability to dissolve keratin,” Suzuki said.

Urea is cheaper than Heparin-like substances, ranging from 600 to 1,400 yen for 100g. However, since it is irritating, it is better to avoid using it on inflamed areas or areas with wounds.

“You may want to use a moisturizing cream for dry, cracked skin in winter. Since there are differences in effectiveness depending on the ingredients, it is important to use them wisely.

“Moisturizers containing these ingredients can be purchased at drugstores, but in many cases, medications prescribed at hospitals are cheaper. For serious skin problems, be sure to consult a doctor,” Suzuki said.

Person who provided information… Suzuki Sokun, Pharmacist, MBA (Master of Business Administration). He has lectured at Tokyo University and Keio University, among others. He has launched a consulting business for pharmacies and supports pharmacy management. He is the author of “The Dark Side of Drugs” (Sogei Law Publishing).

Pharmacists Warn of Risks: Safety Concerns Surrounding New Drugs and Vaccines

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