According to a US Food and Drug Administration advisory committee, a drug used to reduce the danger of a mother experiencing a preterm birth should be removed from the market. This drug, Makena, supposedly isn’t effective. The committee voted 9-7 to have the drug withdrawn.
Risks May Outweigh Effectiveness
The FDA isn’t required to follow the committee’s advice, but it often does so. Makena was approved by the FDA back in 2011. This medication is a progestin hormone, which is given by injection. It is usually prescribed to women who have a history of preterm birth to reduce the risk. However, it doesn’t work for women who have already begun premature labor or for women who are pregnant with twins, triplets or more.
Makena is one of the few treatment options for women with a history of preterm births. The active ingredient is the only treatment approved by the FDA for women who have had at least one previous preterm birth.
This medication does come with many restrictions. It shouldn’t be given to pregnant women who have had breast cancer, liver issues, unusual vaginal bleeding, a history of clots or uncontrolled high blood pressure. One study showed an indication of more miscarriages in women who were taking Makena. There were also more stillbirths, gestational diabetes, preeclampsia and oligohydramnios (low levels of amniotic fluid).
Pregnancy complications are considered a common side effect with Makena. This means up to 10 percent of people taking the drug could experience these complications.
Other common side effects include pain and swelling at the injection site. Patients have also experienced urinary tract infection, a shortened cervix and cervical dilation. Nausea and diarrhea are common as well.
Preterm birth is also known as premature birth. It can be caused by a long list of risk factors, including the following:
- Previous preterm birth
- Pregnant with multiple children
- Age of pregnant mother is below 17 or above 35
- Diabetes or high blood pressure
- Multiple miscarriages
- In vitro fertilization
- Less than six months between pregnancies
- Cigarette smoking
- Drinking alcohol
- Birth defects in baby
- Prolonged stress
- Issues with the placenta, cervix or uterus
- Infection of amniotic fluid
Preterm birth is defined as a baby that is born more than three weeks early. This condition occurs in 1 of 10 births in the US, according to the Centers for Disease Control and Prevention (CDC). The numbers are declining from statistics in the early 2000s. However, they have been rising since 2014.
The rate of preterm births is higher for certain ethnicities than for others. Babies that are born preterm haven’t had the chance for their lungs, liver and brain to develop, which usually happens in the final weeks of pregnancy. A preterm baby is at a higher risk for breathing issues, developmental delays and problems with vision. They may also be at a greater risk for cerebral palsy and other health conditions.
Preterm labor often begins unexpectedly, so it is difficult to prevent. However, doctors will monitor closely for anyone who has known risks for early birth.
Increased Risk for Opioid Addiction and Relapse with Pandemic
Along with the illness, the coronavirus outbreak has many potential secondary concerns. One of these is the likelihood of increased numbers of opioid addicts and relapses.
Most addicts attend some kind of meeting to help them maintain their recovery, whether it be Alcoholics Anonymous, Narcotics Anonymous or another 12-step program. Now that the majority of those meetings and groups have been suspended, the only option is online recovery for a lot of the recovering addicts.
For many of the addicts, online works well. For others, it just isn’t the same. They may not have access to online resources. They often say there is a disconnect online compared to being in the same room with people.
Recovering addicts may feel isolated and suffer from depression along with anxiety because of COVID-19 and the restrictions of social distancing. Even though they understand the need for it, many will be faced with mental health issues. It is these same mental health issues that often lead to addiction in the first place.
Addiction is an isolating situation with people hiding their drug use from others around them. This situation makes it easier for them to continue the behaviors.
A common part of addiction treatment for opioids is methadone and other opioid prescriptions. These medications are given to help prevent the cravings that go along with withdrawal from opioids like heroin. The government has relieved the restrictions of taking the medication daily at a treatment clinic with doctors being able to give prescriptions for 14 or 28 days to take at home.
The problem with this solution is that active addicts may take more than they should and overdose or relapse. They have the entire 28-day supply at their disposal, and they may not be able to withstand the temptation to take extra, especially if they are experiencing anxiety or depression from being alone.
The Risk of Addiction
Those who are prescribed opioid painkillers may face a greater risk as well. While they are monitored for medication use, the anxiety they feel at this pandemic may lead them to experience more physical pain as well. They may self-medicate by increasing the dosage over what was prescribed.
When this happens, people are at a higher risk for developing a dependency on the drugs, which can lead to addiction. With the stay-at-home orders throughout the country, friends and family may not even be aware of changes in mood and behaviors to recognize the indications of addiction.
Risks with COVID-19
Drug users are often a higher risk for developing complications from the virus because of compromised immunity systems and lung damage due to drug abuse. Their withdrawal symptoms can also mask the symptoms of COVID-19, which would lessen the likelihood that they would seek medical attention as quickly as they should.
Medical professionals could also misdiagnose those with COVID-19 as drug withdrawal symptoms. It may take longer for an accurate diagnosis, which could increase the risk of serious health issues or even death.
Could Johnson & Johnson Start Testing a Vaccine by Fall?
Johnson & Johnson, a major pharmaceutical company, has made plans to begin clinical trials on people of a vaccine for Covid-19 that it has developed. The company suggests it could be ready by September with the first batches of the vaccine ready for public use in an emergency early in 2021.
Hope for a Successful Vaccine
The company stated it had started work on a vaccine for the coronavirus early in January. It is working with BARDA, Biomedical Advance Research and Development Authority, which is a part of the Department of Health and Human Services. The two partners are committing $1 billion for research and development of the vaccine, along with testing.
The chairman of Johnson & Johnson, Alex Gorsky, says his company wants to do what they can to bring a vaccine to the public as quickly as possible. Manufacturing capacity around the world will be expanded if its approved to begin producing the vaccine immediately.
Early tests show the vaccine to be both safe and effective. The hope is that the partnership with BARDA will allow the vaccine to move through testing and approval faster. If approved, the vaccine would be distributed as not-for-profit.
Other Treatments and Vaccines
Another company has also been working on a vaccine. Moderna, a biotech firm based in the US, shipped a test vaccine to the government in February. The first dose has already been administered in a clinical trial in March. It uses material from DNA, which is injected into the body. Immune cells begin to make proteins that mark the virus cells for destruction.
Testing has also begun on a drug which could be used to treat patients with Covid-19. This drug, known as remdesivir, has been used in treatment of Ebola. It was given in a test to a patient who has Covid-19 and is the first drug to be tested for treatment. Other people who have tested positive for the virus will be part of the study.
The study will include volunteers who will either be given the drug or a placebo and monitored. The drug will be given intravenously over a ten-day period. Tests will be taken every other day to determine the amount of the virus in the system. If the drug shows some ability to prevent the growth of the virus, it could reduce the spread of Covid-19.
Experts warn the public not to rely on these early tests to make vaccines available right away. Even if they are viable, it’s expected that it could take at least a year before they would be readily available to the general public. Before this, specific people, such as medical care workers, may have access. Other methods will be necessary to control the spread of the disease in the meantime. However, a treatment for the disease may reduce the death rate. Researchers are working diligently to develop solutions to the coronavirus, but it’s not expected to see dramatic results overnight.
Opioid Addiction Patients May Take Medications Home
The United States Substance Abuse and Mental Health Services Administration, otherwise known as SMAHSA, has made some significant policy changes for patients who are currently in an opioid treatment program. They are now allowed to take home medication due to the impact of the COVID-19 pandemic.
Treatment Drugs Being Made Available to Recovering Addicts
Patients who are in a treatment program for opioid addiction may have the ability to take home medications, including buprenorphine and methadone. These medications are given to patients as part of the treatment plan. Treatment centers may send home a 28-day supply of the drugs. For those who aren’t quite as stable, they may request up to 14 days of medications.
These medications are given to patients to help wean them off opioid drugs. While the medications contain some opioid ingredients, it is at a lower rate than with heroin and other opioids. It can help the patient stop using drugs without the severe withdrawal symptoms often seen if they stop without the aid of medication. These medicines also help reduce cravings, which can mean the difference in relapse for the patient.
Doctors say it’s critical that patients have access to these medicines with the reality of fewer in-person visits while the pandemic continues. Without the medications, the patients are more likely to regress and return to their former drug use. They also have an increased risk for overdose.
While doctors say there is still some risk for overdose or even abuse of the drugs, the benefits outweigh the disadvantages. They believe it will be a great help to those who are stable in their treatment, but even those who are less stable will benefit, according to many experts.
Another change for drug treatment was announced recently from the Drug Enforcement Administration. Dispensing restrictions are being relaxed while the public health emergency lasts. Instead of just licensed doctors being able to administer or even dispense OUD medications, other professionals will also have that ability. This includes law enforcement and other treatment program staff members as well as members of the national guard.
How Buprenorphine and Methadone Work
Buprenorphine is given to people who are in treatment for opioid use disorder or OUD. It is generally given at the first signs of withdrawal symptoms. If given too soon, it can cause an acute withdrawal. The dosage is adjusted until the person has fewer or no symptoms. A maintenance dose is often continued through treatment.
Methadone is often given during detoxification to lessen withdrawal symptoms. It may also be used as part of maintenance because it helps people stay in treatment. It’s standard practice for the person to go to a treatment center daily to receive the methadone dose to risk them diverting the drug. The medication may be given for months or even years. In fact, some patients continue it throughout their lives to reduce the risk of relapse on heroin or other opioids.
The risk with these medications is in overdose or misuse because they are also opioids. In the time of a pandemic, it causes professionals to change the way they handle the drugs to provide the best care for those who are in treatment for opioid addiction.
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