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Swiss Makers To Voluntarily Pull Their Unproven Birth Drug Makena From Market

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The maker of an unproven drug, Makena, has said it will voluntarily remove the product from the U.S. Manufactured by Covis Pharma, based in Switzerland, the drug is intended to prevent premature births. 

The company made the announcement Tuesday, according to ABC News. The decision to remove the drug comes after almost four years since Makena could not show any benefit to helping mothers carry pregnancies to term.

Makena is a synthetic version of the hormone progesterone, vital to maintaining a pregnancy. It is also the only drug with FDA approval to lower the risk of premature birth.

Taken via injection, the drug is the poster child of the challenges the FDA has to face to withdraw a medication when the manufacturer is not consenting.

The timeline for the removal of the drug from the market remains obscure. Covis said in its release that FDA regulators rejected its proposal to slash the drug’s use over several months.

The company said the extension would allow women who are on the prescription to finish their course of treatment, which starts after 16 weeks of pregnancy.

However, in a separate filing Wednesday, the FDA’s drug regulators strongly recommended making the withdrawal “immediately effective,” according to the outlet.  The agency added there was no reasonable “harm from discontinuing Makena, such as signs or symptoms of withdrawal.”

It all started in October in a public meeting when outside advisers concluded that Makena was not able to prove its efficacy and its approval should be revoked. The panel was unconvinced irrespective of hours of presentations and debate put forward by Covis trying to prove the drug could be useful for a subgroup of women.

It should be noted that hearings such as these are very rare and take place only after a drugmaker opposes initial FDA requests to remove its drug.

“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” said Raghav Chari, Covis’ chief information officer, in a statement, CBS News reported.

The drugmaker said it “remains ready to work cooperatively with the agency,” despite an impasse on the timeframe.

Makena was granted accelerated approval in 2011 by the FDA. The decision was premised on a small study of women who had a history of early deliveries. The approval was given on the condition that a larger follow-up study would be conducted to confirm the drug’s efficacy.

In 2019, an international study involving 1,700 patients found the drug neither reduced premature births nor resulted in healthier outcomes for babies.

The results notwithstanding, reproductive specialists, including members of the American College of Obstetricians and Gynecologists, are in favor of keeping the weekly injected drug in the market until further research is conducted.

The group stated that its guidelines will be effective until FDA makes a final decision.

“It is critical that other effective interventions be identified to prevent recurrent preterm birth for the health and well-being of our patients and their families,” the group said in a statement.





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Feeling Tired All The Time? Possible Causes And Solutions

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Long days of work, lack of sleep, and stress at the office can be the most common factors that make you feel tired. However, feeling “tired all the time” (TATT) without known reasons can be an indication of an underlying health issue that needs immediate attention.

Finding the exact cause of the lingering tiredness can be the first step toward solving the symptom.

Health conditions that cause fatigue:

1. Anemia – Anemia is one of the most common causes of fatigue. A person who has anemia does not have enough red blood cells in the body, causing symptoms such as tiredness, dizziness, feeling cold and crankiness.

Most often, anemia is caused by iron deficiency. Hence, the condition can be best resolved by including iron-rich foods in the diet and use of iron supplements.

2. Sleep Apnea – It causes the body to stop breathing momentarily during sleep. The condition can affect the quality of sleep and hence make you feel fatigued.

For milder cases of sleep apnea, lifestyle changes such as losing weight or quitting smoking can help solve the sleep disorder. In more severe cases where there is an obstruction in breathing, surgeries and therapies can help.

3. Diabetes – A person who has diabetes has changes in blood sugar level, which can cause fatigue. A patient who is already on diabetic medication can also experience tiredness as a side effect of the medication.

Early identification and taking the correct treatment is the key to managing diabetes. Losing extra weight and having a healthy diet also help in the treatment.

4. Thyroid – Thyroid diseases can be due to an overactive or an underactive thyroid gland. In people who have an underactive thyroid (hypothyroidism), the metabolism slows down leading to symptoms such as lethargy and fatigue. In people with an overactive thyroid (hyperthyroidism), the metabolism speeds up leading to fatigue and difficulty sleeping.

Right diet and lifestyle choices, along with medications, can help in thyroid management.

5. Infections – A person can show symptoms of fatigue when the body is fighting a viral or bacterial infection. Infections ranging from the flu to HIV can cause tiredness.

Along with fatigue, other symptoms such as fever, headache, body aches, shortness of breath and appetite loss can also accompany the infection. Treating the symptoms and taking adequate rest helps in faster recovery.

6. Food allergies – Fatigue may be an early warning sign of hidden food allergies and autoimmune disorders such as celiac disease. Identifying the allergen using a food allergy test or through an elimination diet can help in allergy treatment.

7. Heart disease – If you feel exhausted from an activity that used to be easy, then it is good to check your heart health, as fatigue can be an indication of underlying heart disease.

8. Depression/ anxiety – Fatigue can also be an indicator of a mental health disorder such as depression or anxiety. A combination of medication and psychotherapy can help relieve symptoms.

Lifestyle causes

Apart from serious health conditions, certain lifestyle habits such as dehydration, poor diet, stress and insufficient sleep can cause exhaustion. Having a well-balanced diet, regular exercise and routine sleep can help solve fatigue caused by lifestyle habits.

Published by Medicaldaily.com



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How To Overcome Your Sleep Debt And Reclaim Energy

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Picture this: you’re burning the midnight oil, studying or binge-watching your favorite shows, all at the expense of a good night’s sleep. Have you ever stopped to think about the toll it takes on your body and mind? The consequences can be more serious than you might realize.

Not getting enough sleep can translate into a multitude of issues, including weight gain, lack of focus, tiredness, a haze of confusion, and even depression. If you too are encountering similar issues lately then chances are you have a sleep debt.

Wondering what is sleep debt?

People from 13-18 years of age need 8 hours of sleep, whilst adults beyond that age will require at least 7 hours of snooze.

Sleep debt is a collection of the total hours you haven’t slept or traded your sleep for something else. Sleep debt keeps piling up as a person falls short of the total hours of sleep recommended for an adult, according to the Centers for Disease Control and Prevention.

And when you keep letting go of your sleep for other activities, the body adapts to the new normal and effects start to reflect on the energy levels, which deplete.

“However, like every other debt out there, this too has a repayment option,” Dr. Kunal Kumar, medical director of the Sleep Center at Einstein Medical Center in Philadelphia, told Livestrong.

Below are some expert-vetted ways you can pay back the sleep debt. (Courtesy: Livestrong and Sleepfoundation)

Just like financial debt, imagine sleep debt as a debt you owe to your body. It needs to be repaid. The good news is that catching up on sleep is indeed possible.

  • Maintain a set sleep schedule: Overhauling the sleep schedule is a pretty difficult task to achieve, and it’s best to do that gradually. Create a set sleep schedule by making some small changes to your routine. Instead of making abrupt shifts in your bedtime or wake-up time, adjust them gradually by 15 to 30-minute increments.
  • Minimize your gadget usage: Wind down activities and minimize electronic usage before bed to promote better sleep. Relax and prepare for quality sleep by dimming the lights and setting an alarm for 30 minutes to an hour before bed.
  • Reshuffle your sleeping arrangements: Are you finding it hard to get a good night’s sleep due to excessive sweating? Well, here’s a handy solution: consider upgrading to a cooling mattress or opting for cooling sheets. These innovative sleep essentials can help regulate your body temperature, and keep you comfortably cool throughout the night, ensuring a more blissful slumber. Memory foam pillows can work wonders in relieving neck and back discomfort in case you are struggling with backache.
  • Improve the bedroom environment: Create a sleep-friendly bedroom environment by adjusting the temperature for comfort, and blocking out disruptive lights, or noises that might disturb your restful slumber. And if your mattress, pillow, or sheets are worn out or no longer providing the support you need, consider treating yourself to new ones.

Published by Medicaldaily.com



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Omega-3 Fatty Acids Slow The Progression Of Amyotrophic Lateral Sclerosis: Study

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Omega-3 fatty acids are known for a range of health benefits, from promoting brain and heart health to reducing inflammation and protection against several chronic conditions.

In a new study, researchers found that omega-3 acids, especially the type found in foods like flaxseeds, walnuts, chia seeds, canola oil and soybean oil, can slow down the progression of amyotrophic lateral sclerosis (ALS).

It is a debilitating nervous system disease that gradually worsens over time and can be fatal. The condition results in a loss of muscle control and affects the nerve cells in the brain and spinal cord. It is also known as Lou Gehrig’s disease after the baseball player who was diagnosed with it.

The initial symptoms of the disease include muscle weakness, difficulty in walking and hand movements. The symptoms can slowly progress to difficulties with chewing, swallowing, speaking and breathing.

The exact cause of ALS is not known. However, around 10% of people get it from a risk gene passed down from a family member. It is estimated that more than 32,000 people in the U.S. live with the condition.

In the latest study, researchers from Harvard T.H. Chan School of Public Health in Massachusetts evaluated 449 people living with ALS in a clinical trial. The team assessed the severity of their symptoms, the progression of their disease, along with the levels of omega-3 fatty acids in their blood, for 18 months.

The study suggested that alpha-linolenic acid (ALA), a type of omega-3 found in plants, is particularly beneficial in slowing the progression of ALS. The participants with the highest levels of ALA had a 50% reduced risk of death during the study period compared to those with the lowest levels of ALA.

Researchers also found a reduction in death risk in participants who had eicosapentaenoic acid, the type of omega-3 fatty acid found in fatty fish and fish oil, and linoleic acid found in vegetable oils, nuts and seeds.

A previous study conducted by the same team suggested that a diet high in ALA and higher blood levels of the nutrient could reduce the risk of developing the condition.

“In this study, we found that among people living with ALS, higher blood levels of ALA were also associated with a slower disease progression and a lower risk of death within the study period. These findings, along with our previous research suggest that this fatty acid may have neuroprotective effects that could benefit people with ALS,” said Kjetil Bjornevik, the lead author of the study.

Published by Medicaldaily.com



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