How to rehydrate your child during diarrhoea

 

Diarrhoeal diseases are a leading cause of childhood morbidity and mortality in developing countries, and an important cause of malnutrition. When a child is suffering from diarrhoea, the first call of action will be to replenish the fluids they lost as quickly as possible. Since diarrhoea causes the body to lose essential fluids and minerals, it is recommended that children drink lots of liquids such as rehydrating solutions.
Sugary drinks like soft drinks or soda, juice etc is not recommended for rehydrating a child with diarrhoea. This sickness usually passes within 5 to 7 days and rarely lasts longer than two weeks. While waiting for diarrhoea to pass, you can make the uncomfortable feeling easy for your child using points outlined below.

* Drink fluids
It’s important to drink plenty of fluids to avoid dehydration, frequently give them small sips of water whether they vomit or not. It ideally should be liquids that contain water, salt and sugar.

Tea, fruit juice or fizzy drinks should be avoided as they can make diarrhoea worse in children.

* Oral rehydration solutions

Since many diarrhoeal deaths are caused by dehydration, World Health Organisation highly recommends using the improved ORS solution which has been developed and is called reduced (low) osmolarity ORS solution, this new ORS solution reduces the incidence of vomiting by 30% and stool volume by 20%.
As a guide, after each loose stool, give: children under 2 years of age: 50-100 ml (a quarter to half a large cup) of fluid; children aged 2 up to 10 years: 100-200 ml (a half to one large cup). Rehydration solutions usually come in sachets available at pharmacies without a prescription. They are dissolved in water, and replace salt, glucose and other important minerals that are lost if you’re dehydrated.
If a child vomits, wait 5-10 minutes and then start giving ORS solution again, but more slowly.

 

* Give supplemental zinc

Zinc can be given as soon as diarrhoea starts, to also reduce the severity of the illness as well as the risk of dehydration. By continuing zinc supplementation for 10 to 14 days, the zinc lost during diarrhoea is fully replaced and the risk of the child having repeat diarrhoea in the following 2 to 3 months is reduced.
CHI Pharmaceuticals Zinc & ORS is a WHO-UNICEF recommended treatment for diarrhoea in children, see more HERE.

* Continue to feed the child, to prevent malnutrition

Food should not be stopped; the aim is to give as much nutrient rich food as the child will accept. When food is given, sufficient nutrients are usually absorbed to support continued growth and weight gain. Feeding also speeds the recovery of normal intestinal function, including the ability to digest and absorb various nutrients.
In general, foods suitable for a child with diarrhoea are the same as those required before the illness. Food given should have a high content of energy and provide adequate amounts of essential micronutrients. They should be well cooked, and mashed or ground to make them easy to digest. Meat, fish or egg should be given, if available. Foods rich in potassium, such as bananas, coconut water and fresh fruit juice are beneficial. Eat small, light meals and avoid fatty or spicy foods.

Take the child to a hospital if there are signs of dehydration or other problems like the following
• starts to pass many watery stools;
• has repeated vomiting;
• becomes very thirsty;
• is eating or drinking poorly;
• develops a fever;
• has blood in the stool; or
• the child does not get better in three days.

6 Amazing benefits of Mangoes for Skin, Digestion and Increased Immunity

Now that mangoes are in season it will be bad for us to know so much benefits of this amazing fruit and not share with everyone. Mangoes, also known as “king of fruits” are available in numerous varieties, and varies in colour and size.

Mango contains a lot of vitamins including Vitamin A, Vitamin C, Vitamin E, Vitamin B6 (0.2 g), among other vitamins. It also has minerals like iron, potassium, calcium, zinc (0.1 mg), among others. Other nutritional benefits include protein, fibre, and carbohydrates.

These vitamins and minerals provide mangoes their many benefits, see some below.

  1. Clears the Skin:

Mangoes are rich in beta-carotene and vitamin A, these help enrich skin health. Beta-carotene protects the skin from the ultraviolet rays. Vitamin A has also been found to reduce oil production on the skin. The vitamin can also aid skin growth and repair, and reduce fine lines as well. Mangoes can be used both internally and externally for the skin. They help clear clogged pores and eliminate pimples. Just slice a mango into thin pieces and keep them on your face for 10 to 15 minutes and then take bath or wash your face and see the results.

  1. Maintains a healthy cholesterol level:

Mango has high level of vitamin C, pectin and fibres that help to lower serum cholesterol levels, specifically Low-Density Lipoprotein.

  1. Improves Digestion:

Mango contains enzymes that help in breaking down protein. The fibrous nature of mango helps in digestion and waste removal. It is rich in pre-biotic dietary fibre, vitamins and minerals

  1. Improves Eye Health:

One cup of sliced mangoes supplies 25 percent of the needed daily value of vitamin A, which promotes good eyesight and prevents night blindness and dry eyes.

  1. Enhances immunity:

The generous amounts of vitamin C and vitamin A in mangos, plus 25 different kinds of carotenoids keep your immune system healthy and strong.

  1. Good for weight loss:

Some studies have shown the importance of the mango peel in aiding weight loss. Phytochemicals act as natural fat busters and are found only on the outer side of the fruit. So also the fibre obtained from eating this fruit and other vegetables, can aid weight loss. Mango boosts the digestive function of the body by burning additional calories, helping in weight loss.

 

4 remedies to treat indigestion in adults

Indigestion isn’t alien to a lot of us. We sometimes feel some sort of pain or discomfort in the upper abdomen either during or after a meal, this is associated with difficulty in digesting food. This feeling is known as Indigestion, also known by the medical term dyspepsia.  Indigestion is mainly caused by poor eating habits. Symptoms of indigestion could include heartburn, vomiting, bloating, gas, growling stomach, abdominal pain, acidic taste and a burning sensation in the stomach as well as a lot of discomfort. For some others, indigestion is a sign of an underlying problem like ulcers, gallbladder disease, and acid indigestion.

The good news is that you can easily get relief from indigestion using different ingredients and medical prescriptions and we will be sharing 4 below:

  1. Water-

This might sound trivial but drinking warm water gradually at the first sign of indigestion can give you some relief as it helps increase the gastric pH. For added benefits and flavour, put in some slices of lemon or lime into drinking water.

  1. Make Ginger a staple –

Ginger comes with a lot wonders because of the several chemical components it possesses. It helps in stimulating the digestive juices, thereby improving digestion. Drinking ginger tea often, gives relief from bloating, cramps, gas and stomach aches. To make ginger tea, boil one teaspoon of grated ginger in a cup of water for 5 to 10 minutes.

Additionally using ginger as a spice in your recipes can also help if you are suffering from indigestion.

 

  1. Eat slowly and early –

Indigestion is mainly associated with unhealthy eating habits and high stress levels. By the time you begin rushing your food or eating when on the go it contributes to bloating and gas. Also eat your dinner at least three hours before bedtime so the meal can be digested before hitting the bed as our body systems don’t digest very well when sleeping

  1. Take Digestive Enzymes –

Poor eating habits, such as eating too fast or eating too late at night can wreak havoc on your digestive system by causing inadequate production of digestive enzymes.

When you eat a meal, your body produces about 20 types of digestive enzymes from the salivary gland, stomach and small intestine. Each one of these enzymes acts on specific types of food —For instance, Pancreatin contains proteases, amylases and lipases which catalyse the breakdown of protein and peptide fragments to amino acids, carbohydrate to simple sugars and fats to fatty acids and glycerol respectively. Cellulase breaks down cellulose fibres to B- glucose.

A good digestive enzyme contains a mix of amylase, lipase, cellulose (for digesting plant fibers), and protease. This is key to achieving good digestion of many foods.

Gestomil is a polyenzymatic digestant that works mainly through hydrolysis to catalyse the breakdown of complex sugars, fat, and proteins to absorbable fragments. Gestomil contains Cellulase, Pepsin, Pacralipase, Papain, Pancreatin and Diatase.

Remember that indigestion can be a symptom if a much serious digestive disease, such as Peptic Ulcer Disease, Crohn’s disease, acid reflux or GERD, and irritable bowel syndrome. So in addition to eating healthy and taking digestive enzymes, don’t forget to check with your doctor if your indigestion occurs frequently.

5 sure ways to boost your immune system

In simple terms, the immune system does a great job of keeping our bodies healthy and preventing infections. The immune system is made up of special cells, proteins, tissues, and organs. It works towards defending people against germs and microorganisms every day. Sometimes, problems with the immune system can lead to its breakdown, malfunction, illness and infection.

The immune system is the body’s defence against infection and illness. It recognises the cells that make up your body, and will try to get rid of anything unfamiliar like germs (bacteria and viruses), parasites, organisms and other substances that can invade our systems and cause disease.

We are continually exposed to these organisms and whether or not they lead to a disease or sickness is in the hands of our body’s defence mechanisms – immune system. Ideally, our immune system. When our immune system is working properly, we don’t even notice it. But when we have an under- or over-active immune system, we are at a greater risk of developing infections and other health conditions. It is in situations like this we start seeking for ways and methods to boost our immune system. If only we knew of the following ways, our immune system would have been protected from sickness.

See our 5 ways on how you can boost your immune system

  1. Go Healthy –

Your first line of defence is to choose a healthy lifestyle.

Go the old fashioned, tested and trusted way: a healthy diet and exercise. It’s worth trying and will keep you much healthier in the long run. An eating plan rich in fruits, vegetables, whole grains, and lean proteins will defend your body against germs and provide you with the nutrients your immune system needs. Following general good-health guidelines is one of the best steps you can take naturally towards keeping your immune system strong and healthy. Don’t smoke, consume foods low in saturated fat and exercise regularly. It’s also good to maintain your blood pressure and a healthy weight. Drink alcohol only in moderation. Get enough sleep. Take steps to avoid infection, such as washing your hands with plain soap and water, using hand sanitizers frequently and cooking meats thoroughly.

  1. Herbs and other supplements –

Herbs such as garlic, ginger, ginseng etc support immunity. Multivitamin supplements also have great immune boosting capabilities. Multivitamin supplements also augment micronutrients present in the body. When micronutrients become deficient, immunity can become suppressed, leaving the body vulnerable to infections. The simplest way to enhance immunity and ensure sufficient levels of these various vitamins and minerals in the body is to take multivitamins. This boosts the level of your overall immunity and your body in general. Do you know about our Supramult supplement? See more information on it HERE

boost immune system

  1. Citrus fruits

Are by far one of the biggest immune system boosters of all. They are popular for building up your immune system and contain Vitamin C which increases the production of white blood cells and are key to fighting infections. Popular citrus fruits include: Grapefruit, oranges, tangerines, lemons, limes, strawberries, bell peppers etc.

Because our body doesn’t produce or store it, we need them daily for continued good health. A lack of vitamin C can even make you more prone to getting sick.

  1. Reduce stress levels

Stress overload causes an increase in the Cortisol hormone and prolonged elevation of this hormone level suppresses the body’s immune function. When stress is prolonged or unrelenting, it becomes known as chronic stress. Chronic, or bad, stress can be detrimental to both mental and physical health and people who suffer from chronic stress risk high blood pressure, heart disease and digestive problems. High stress levels triggers chemical reactions, decreases inflammation, decreases white blood cells and NK cells (special cells that kill cancer), increases tumor development and growth, and increases the rate of infection and tissue damage. We don’t want any of these hence why we recommend reducing stress levels through simple relaxation exercise, meditations, yoga, positive thinking, you name it. Being around good people also help reduce negative events and stress.

boost immune system

  1. Maintain a clean environment

Air pollution, water pollution, and exposure to filth all work against the effectiveness of your immune system. Maintain and live in a clean thriving environment. Bad air, stagnant water, smoke, dust amongst other environmental hazards are dangerous to your immune system and body in general.

How to Prevent Malaria with 5 simple steps

Malaria is caused by parasites that are transmitted to people through the bites of infected female Anopheles mosquitoes. The plasmodium falciparum is the parasite that causes malaria and reports about 200 million worldwide cases every year; this includes about 584,000 deaths, mainly among children under five years old in sub-Saharan Africa.

Early symptoms of Malaria are fever, chills, and flu-like symptoms. Malaria is a common and life-threatening disease if left untreated. Taking precautions to keep mosquito bites to a minimum also helps prevent malaria.

We look forward to a Malaria free society and while we’re at that we thought to share some preventive measures, after all even the age long and well known saying goes ‘prevention is better than cure’! Below are 5 ways on how best to prevent malaria:

  1. Wear protective clothing (long pants and long-sleeved shirts).

By covering up nicely, you reduce your chances of getting bit by a mosquito. It is also advisable to stay in cooler areas. Keep the air conditioning on, as mosquitoes tend to stay out of cool, air-conditioned rooms.  Also stay away from any stagnant water as it’s a breeding ground for mosquitoes. Stagnant water sources such as lakes, blocked drainages or gutter etc.

  1. Take anti-malarial drugs periodically

If you live in a more malaria prone area, or have been exposed to bites from mosquitoes you are more likely to get malaria, hence you should take the drugs periodically say once a quarter. It is important you follow the instructions they come with.

  1. Use a mosquito net.

Mosquito nets are lightweight, nets that offer protection against mosquitoes, flies, and other insects. In other words, they ensure mosquitoes are out of your bed at any time in use. Check that the net is not torn and always ensure it is properly tucked underneath your mattress. Buy mosquito nets treated with permethrin for the best protection. In case you didn’t know CHI Pharmaceuticals Limited was the first company in West Africa to design and launch insecticide treated nets in conjunction with UNICEF & USAID. Find out more HERE!

If you’re not accustomed to using nets you can use insecticide spray which brings us to our third tip on how to prevent malaria

  1. Use insecticide spray

An insecticide is a formulated substance used to kill insects. Ensure you purchase insecticide brands that provide fast killing power against flying and crawling insects found in and around the household. It’s really easy to use this, you only need to close your windows and spray the room or space being used. Remember to spray all the corners of the room, under the beds, and any other hidden space within as these mosquitoes can hide in such spaced. Make sure to leave the space as soon as you’re done spraying, continued stay in such environment might have adverse effects directly on human health gradually.

  1. Boost your immune system

A body that is rich in vitamins and disease fighting cells is less likely to get malaria even after a bite from an infected mosquito carrying the parasite. Boost  your immune system by regularly taking fruits and vegetables, multivitamins and so on. Taking oranges or other source of vitamin C is also helpful.

 

*In summary we can all learn from this ABCD of Malaria protection according to World Health Organisation,

Be Aware of the risk, the incubation period, the possibility of delayed onset, and the main symptoms.

Avoid being Bitten by mosquitoes, especially between dusk and dawn.

Take anti malarial drugs (Chemoprophylaxis) when appropriate, at regular intervals to prevent acute malaria attacks.

Immediately seek Diagnosis and treatment if a fever develops 1 week or more after entering an area where there is a malaria risk and up to 3 months (or, rarely, later) after departure from a risk area.

 

If you’re ever down with Malaria, or know someone sick as a result of Malaria we recommend using Comal- Forte Anti –Malaria for effective treatment, more details HERE.

Wockhardt awaits cure for its never-ending regulatory pain

After the US drug regulator shot off a warning letter to Wockhardt over its Illinois facility, shares of the Mumbai-headquartered drug maker fell 4.95 percent at the BSE on Thursday to end at Rs 713.90. Regulatory woes at the company’s Morton Grove plant are nothing new. Wockhardt received eleven Form 483 observations from the US Food and Drug Admnistration in early 2016 highlighting deviations in control procedures and record-keeping practices among others. Last November, the management told CNBC-TV18 that it had responded to the observations and expressed confidence about addressing the concerns. The drug maker had acquired the facility for USD 38 million in 2007 from Morton Grove Pharmeceuticals – a US-based liquid generic and speciality dermatology company.

The latest warning letter bars Wockhardt from filing any new approvals from the plant until it addresses the regulator’s concerns, failing which it could be subject to an import ban. Another worry aspect of the warning letter is that resolutons is taking longer than ever before. “Warning letter resolutions have become longer and rarer – only 9 out of 108 warning letters have been sorted taking an average of  around 500 days,” read a recent research report from Edelweiss. “Data for India and China is even bleaker with just one resolution out of the 64 warning letters issued in past 52 months.” Over the past four years, Wockhardt’s regulatory woes have been a recurring theme. Three of its Indian plants are already under a USFDA-imposed import ban. The company’s formulations units at Chikalthana and Waluj in Maharashtra have been under the USFDA’s import alert since 2013, while its bulk drug plant at Ankleshwar in Gujarat was issued an import alert in August. Its UK plant is facing a warning letter and Shendra plant in Maharashtra is addressing observations raised by USFDA.

Wockhardt’s regulatory woes began midway through 2013, just when it appeared to be cruising after tiding over a debt crisis that had nearly sunk the company just a year before. In the FY13, Wockhardt posted revenues Rs. 5,610 crore, registering a net profit of Rs 1,594 crore, with the US alone contributing close to three-fourths of the sales. The numbers for the FY16 tell a different story. The company’s revenues stood at Rs 4461.4 crore with a net profit of Rs 326 crore. The US contributed just about a fifth to this figure, indicating the decline of sales and profitablity as regulatory troubles took their toll. For its part, Wockhardt has been proactively trying to weather the storm. It has enlisted external consultants to aid its extensive remediation exercise.

And there have been some encouraging signs. Last July, the company said it had received an establishment inspection report (EIR) with the US regulator’s observations on three of its facilities in Maharashtra, including two units in Chikalthana one in Waluj, with just three observations. The company also successfully passed an inspection by the UK drug regulator for its Chikalthana plant and regained its unrestricted good manufacturing practices certificate. Wockhardt has 12 plants, of which nine are located in India, with one each in the US, UK and Ireland. Analysts felt that while the latest warning letter may not impact its earnings estimates, it is certainly a setback to the company\\’s ongoing remediation programmes.

“While we remain bullish on the long-term fundamentals of the company, multiples could be under pressure in the near term, driven by uncertainty around remediation timelines,” Macquarie said in its research note on Thursday. “Shift in timelines has significant sensitivity to earnings as fixed costs still remain and Wockhardt continues to invest aggressively in R&D to build the US pipeline.” An external consultant who assists companies with remediation said Wockhardt’s troubles with the FDA can be put down to a trust deficit. “Wockhardt plants were caught with data manipulation, which the agency considers serious offence,” said the consultant on condition of anonymity. “The company did make a lot of progress, but it still needs to give comfort so it can prevent such deviations happening in future,” the consultant added.

Obeticholic Acid

Primary biliary cholangitis (PBC) is a chronic type of liver disease that can gradually destroy bile ducts. These ducts deliver bile from the liver to the small intestines, to help your body digest fats and certain vitamins. When bile ducts are destroyed by PBC, bile stays in the liver and damages liver cells, which can cause cirrhosis (scarring of the liver) and lead to liver failure. PBC is a slow progressive disease that may have no symptoms for many years. Treating PBC to keep the liver functioning normally can allow for a normal life expectancy.

Obeticholic acid is used to treat PBC. This medicine is sometimes used together with another drug called ursodeoxycholic acid (UDCA).

Obeticholic acid was approved by the US Food and Drug Administration (FDA) on an “accelerated” basis. In clinical studies, patients with PBC responded to obeticholic acid. However, further studies are needed to determine if this medicine can improve survival or disease-related symptoms.

Obeticholic acid may also be used for purposes not listed in this medication guide.

What is the most important information I should know about obeticholic acid?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my healthcare provider before taking obeticholic acid?

You should not use obeticholic acid if you are allergic to it, or if you have complete blockage of your bile ducts.

To make sure obeticholic acid is safe for you, tell your doctor if you have:

  • pre-existing liver disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether obeticholic acid passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take obeticholic acid?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Obeticholic acid is usually taken once per day, with or without food.

To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how best to treat you with obeticholic acid.

You may be given other medications to treat itching that may be caused by obeticholic acid.

If you stop taking obeticholic acid for any reason, you may need to use a lower dose when you start taking it again. Follow your doctor’s dosing instructions carefully.

Call your doctor if your symptoms do not improve, or if they get worse. The most common symptoms of PBC is intense itching, especially in your arms, legs, and back.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking obeticholic acid?

If you also take a bile acid resin (such as colesevelam, cholestyramine, or colestipol), avoid taking the bile acid resin within 4 hours before or 4 hours after you take obeticholic acid.

Women’s Health Tips

Looking for the path toward a healthier you? It’s not hard to find. The journey begins with some simple tweaks to your lifestyle. The right diet, exercise, and stress-relief plan all play a big role.

Follow a Heart-Healthy Diet

There’s an easy recipe if your goal is to keep away problems like heart disease and strokes.

  • Eat more fruits and veggies.
  • Choose whole grains. Try brown rice instead of white. Switch to whole wheat pasta.
  • Choose lean proteins like poultry, fish, beans, and legumes.
  • Cut down on processed foods, sugar, salt, and saturated fat.

When eating healthy, flexibility often works best, says Joyce Meng, MD, assistant professor at the Pat and Jim Calhoun Cardiology Center at UConn Health. If you like to follow a strict diet plan, go for it. If not, it’s OK. “Find what works for you.”

Tricia Montgomery, 52, the founder of K9 Fit Club, knows first-hand how the right diet and lifestyle can help. For her, choosing healthy foods and planning small, frequent meals works well. “I don’t deny myself anything,” she says. “I still have dessert — key lime pie, yum! — and I love frozen gummy bears, but moderation is key.”

Exercise Every Day

The more active you are, the better, Meng says. Exercise boosts your heart health, builds muscle and bone strength, and wards off health problems.

Aim for 2 and a half hours of moderate activity, like brisk walking or dancing, every week. If you’re OK with vigorous exercise, stick to 1 hour and 15 minutes a week of things like running or playing tennis. Add a couple of days of strength training, too.

If you’re busy, try short bursts of activity throughout the day. Walk often. A good target is 10,000 steps a day. Take the stairs. Park your car far away from your destination.

Montgomery exercises every day, often with her dog. By adding lunges, squats, and stairs to a walk, she turns it into a power workout. “I also am a huge Pilates fan,” she says.

Lose Weight

When you shed pounds you’ll lower your risk of heart disease, type 2 diabetes, and cancer.

Aim for a slow, steady drop. Try to lose 1-2 pounds a week by being active and eating better.”It doesn’t have to be an hour of intense exercise every day,” Meng says. “Any little bit helps.”As you improve, dial up the time and how hard you work out. If you want to lose a lot of weight, try for 300 minutes of exercise a week.”Eating a healthy diet will go a long way,” Meng says. Start by cutting sugar, which she says is often hiding in plain sight — in store-bought items like salad dressing, packaged bread, and nuts. Try to avoid soda and sugar-laced coffee drinks, too.

Visit Your Doctor

Get regular checkups. Your doctor keeps track of your medical history and can help you stay healthy. For example, if you’re at risk for osteoporosis, a condition that weakens bones, he may want you to get more calcium and vitamin D.

Your doctor may recommend screening tests to keep an eye on your health and catch conditions early when they’re easier to treat.

Keep the lines of communication open. “If you have questions, ask your doctor,” Meng says. “Make sure you understand things to your satisfaction.” If you’re worried about a medication or procedure, talk to him about it.

Cut Down Your stress

It can take a toll on your health. You probably can’t avoid it altogether, but you can find ways to ease the impact. Don’t take on too much. Try to set limits with yourself and others. It’s OK to say no.

To relieve stress, try:

  • Deep breathing
  • Meditation
  • Yoga
  • Massage
  • Exercise
  • Healthy eating
  • Talking to a friend, family member, or professional counselor

Create Healthy Habits

If you make the right choices today, you can ward off problems tomorrow.

  • Brush your teeth twice a day and floss every day.
  • Don’t smoke.
  • Limit your alcohol. Keep it to one drink a day.
  • If you have medication, take it exactly how your doctor prescribed it.
  • Improve your sleep. Aim for 8 hours. If you have trouble getting shut-eye, talk to your doctor.
  • Use sunscreen and stay out of the sun from 10 a.m. to 3 p.m.
  • Wear your seatbelt.

Take time every day to invest in your health, Meng says.

It paid off for Montgomery. She says she overcame health problems, feels good, and has a positive outlook. “My life,” she says, “is forever changed.”

FDA Approves Siliq (brodalumab) for Plaque Psoriasis

The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection.

Siliq is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected) or phototherapy (ultraviolet light treatment) and have failed to respond, or have stopped responding to other systemic therapies.

“Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today’s approval provides patients with another treatment option for their psoriasis,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Patients and their health care providers should discuss the benefits and risks of Siliq before considering treatment.”

Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35. The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales.

Siliq’s active ingredient (brodalumab) binds to a protein that causes inflammation, inhibiting the inflammatory response that plays a role in the development of plaque psoriasis.

Siliq’s safety and efficacy were established in three randomized, placebo-controlled clinical trials with a total of 4,373 adult participants with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. More patients treated with Siliq compared to placebo had skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.

Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with Siliq during clinical trials. Siliq users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior compared to users without this history. A causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established.

Because of the observed risk of suicidal ideation and behavior, the labeling for Siliq includes a Boxed Warning and the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Siliq REMS Program. Notable requirements of the Siliq REMS Program include the following:

    • Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
    • Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety or other mood changes.
    • Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Siliq.

Siliq is also approved with a Medication Guide to inform patients of the risk of suicidal ideation and behavior, and that because Siliq is a medication that affects the immune system, patients may have a greater risk of getting an infection, or an allergic or autoimmune condition. Patients with Crohn’s disease should not use Siliq. Health care providers should also evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Siliq. Health care providers should not administer Siliq to patients with active TB infection, and should avoid immunizations with live vaccines in patients being treated with Siliq.

The most common adverse reactions reported with the use of Siliq include joint pain (arthralgia), headache, fatigue, diarrhea, throat pain (oropharyngeal pain), nausea, muscle pain (myalgia), injection site reactions, influenza, low white blood cell count (neutropenia) and fungal (tinea) infections.

Siliq is marketed by Bridgewater, New Jersey-based Valeant Pharmaceuticals.

Source: FDA