US FDA bans Emcure Pharma s India plant over manufacturing issues

US FDA bans Emcure Pharma's India plant over manufacturing issues


MUMBAI (Reuters) - The U.S. Food and Drug Administration has banned drug imports from an India manufacturing unit of Emcure Pharmaceuticals Ltd over violations of standard manufacturing practices, the latest in a series of Indian firms to face such action.

In an 'import alert' posted on its website on Monday, the FDA said it had barred imports from Emcure's Hinjewadi manufacturing plant in Maharashtra, after an inspection revealed the company was not meeting manufacturing quality standards.

The company has nine manufacturing plants, including one in the United States, and exports to a number of countries including the U.S., Europe, Brazil and Japan, according to its website.

Emcure, one of India's top 20 drugmakers, is the latest among some of India's largest drugmakers to have come under fire for similar violations in the last few years, hurting the country's reputation as a reliable supplier of cheap generic drugs to the world, and impacting the growth of the $15 billion industry.

An Emcure Pharma spokesman did not immediately respond to a request for comment.

Emcure, which is a marketing partner to large multinational drugmakers such as Pfizer Inc, Roche, Novartis and Sanofi, makes drugs that are mainly used in cardiology, gynecology and to treat infections.

Trying For A Boy Or Girl : Shettles Method

Shettles Method – Trying For A Boy Or Girl

Gender selection has long been a topic of debate. While some gender selection methods claim to be highly successful, they often disregard other methods, claiming their own to be more accurate. The shettles method is a gender swaying method that has been around for decades, and it has it’s fair share of believers and skeptics.



Of course, the most desirable outcome from conception is a healthy baby, no matter which gender. Gender selection should not rule your attempts at conception. Some gender selection methods can actually decrease the chance of conception due to timing methods.

Please note that the information below on the shettles method has been included due to popular request and is for reference only. It is not guaranteed to give you the ‘recipe’ for the desired gender you are trying for.

The Shettles Method

Since the 1960s, Dr. Shettles has recommended gender selection methods which he claims is upheld by scientific evidence. The shettles method has two distinct advantages: the methods cost nothing and you do not require and medical treatments to conceive.

Men produce two types of sperm — X being female and Y being male. This will determine the sex of your baby. Doctor Shettles found from his studies that the male sperm are smaller, weaker and faster than the female sperm, which are bigger, stronger and slower. Therefore, he was able to come to the following suggestions to help couples try and choose the sex of their baby.

The Most Important Shettles Method Factor: Timing

The most important gender swaying factor according to the shettles method is the timing of intercourse.

The closer to ovulation you have intercourse, the higher the likelihood that you will have a boy. Since they are the faster of the two types of sperm, they will likely reach the egg first. If you would like a boy, intercourse should take place during times of peak fertile mucus or no more than 12 hours before ovulation. You can detect ovulation through charting or with ovulation prediction kits (similar to pregnancy tests). If you chart your cycle temperatures daily and have a temperature dip, this is a good time to have intercourse, or alternately, the following morning. You can also have intercourse for a boy when your cervical mucus changes into stringy, fertile mucus — like egg white.

If you have intercourse two to four days prior to ovulation, the shettles method states that this favours the conception of a girl. This is because the female sperm live for much longer than the male sperm. It allows for more female sperm to reach the egg. So if you would like a girl, avoid having intercourse during times of your peak fertile mucus (egg white cervical mucus) which would be more conducive for a boy.

By following the Shettles Method, there is less chance of achieving female conception as you are not having intercourse during your peak fertile times. So if pregnancy is more important to you than having a girl baby, the shettles method may not be for you.

Baby Gender Selection Factor: Vaginal pH

The shettles method advises that an acidic environment is more favourable for the conception of a girl. It’s not as welcoming for male sperm! The acidic environment kills the weaker male sperm first. This leaves a greater number of female sperm to reach the egg. The ideal time to have sex for a boy is when the vaginal environment becomes alkaline, which is on the day you ovulate.

Baby Gender Selection Factor: Abstinence

For a boy, the shettles method advises not have intercourse for four to five days prior to ovulation. You should use a condom if you wish to have sex during this time.

For a girl, Shettles recommends daily intercourse from the end of your period until 2-4 days prior to ovulation, then no intercourse until 2-3 days after ovulation.

Baby Gender Selection Factor: Sexual Position

Sexual position is said to help your chances of gender selection due to both depth of penetration and pH levels. The closer to the opening of the vagina, the more acidic the woman’s reproductive tract is.

Shettles method suggests a position with deeper penetration (e.g. doggy-style) for a boy. This will apparently place the male sperm closer to the egg, giving them a head start.

The shettles method recommends the missionary position when trying to conceive a girl.

Baby Gender Selection Factor: Orgasm

To conceive a boy, the woman should try to achieve orgasm either before or at the same time as her partner — or if you are lucky enough, multiple female orgasms can help! The shettles method says that the waves of the orgasm will help to draw up the sperm quicker to the egg, again giving the boys getting a head start on the girls.

For a girl, shettles recommends women avoid orgasm.

Other Baby Gender Selection Factors

Here’s one for the men: if you’d like to try for a boy, the shettles method suggests for men try and keep the scrotal temperature cool. This means no hot spas or baths and no tight clothing or underwear. Boxer shorts are a good alternative. Avoid scuba diving and heated vehicles for extended durations (or other areas of high heat).

Shettles suggests a few cups of strong coffee half an hour before intercourse to favour a boy. As long as you’re aware that too much caffeine can impact on fertility, as well as your health and wellbeing.

What Is The Success Rate?

Doctor Shettles claims that his methods for a boy have a success rate of 80-85% and the methods for a girl are a little less at 75-80%.

Autoimmune diseases

 The following are some of the more common Autoimmune diseases:

·         Rheumatoid arthritis—inflammation of joints and surrounding tissues

·         Systemic lupus erythematosus—affects skin, joints, kidneys, brain, and other organs

·         Multiple sclerosis—affects the brain and spinal cord

·         Celiac sprue disease—a reaction to gluten (found in wheat, rye, and barley) that causes damage to the lining of the small intestine

·         Pernicious anemia—decrease in red blood cells caused by inability to absorb vitamin B12

·         Vitiligo—white patches on the skin caused by loss of pigment

·         Scleroderma—a connective tissue disease that causes changes in skin, blood vessels, muscles, and internal organs

·         Psoriasis—a skin condition that causes redness and irritation as well as thick, flaky, silver-white patches

·         Inflammatory bowel disease—a group of inflammatory diseases of the colon and small intestine

·         Hashimoto’s disease—inflammation of the thyroid gland

·         Addison’s disease—adrenal hormone insufficiency

·         Graves’ disease—overactive thyroid gland

·         Reactive arthritis—inflammation of joints, urethra, and eyes; may cause sores on the skin and mucus membranes

·         Sjögren’s syndrome—destroys the glands that produce tears and saliva causing dry eyes and mouth; may affect kidneys and lungs

·         Type 1 diabetes—destruction of insulin producing cells in the pancreas

Female viagra

‘Female Viagra’ wins approval from FDA expert 

A FDA panel thought the overall benefit/risk profile of flibanserin was acceptable.

Source: Wikimedia Commons

A FDA report recognises that some women would benefit from a safe and effective treatment for premenopausal hypoactive sexual desire disorder

A drug developed to increase female libido is a step closer to being approved in the United States. 

Flibanserin, a 5-HT1A-receptor agonist and 5-HT2A-receptor antagonist, which has been dubbed the “female Viagra”, won approval on 4 June 2015 by a joint committee expert panel for the Food and Drug Administration (FDA). The panel was assessing the drug’s risks and benefits in the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD). 

The panel agreed by 18 votes to 6 votes that the overall benefit/risk profile was acceptable and the outcome will form part of the ongoing FDA review of the drug. 

“We are one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction,” according to a spokesperson for Sprout Pharmaceuticals, based in North Carolina, which plans to market the product as Addyi. 

The drug has already twice failed to be recommended for approval by FDA experts — in 2010 and in 2013 following concerns about its efficacy and safety. 

The latest FDA briefing document considered by the agency’s bone, reproductive and urologic drugs advisory committee and the drug safety and risk management advisory committee acknowledged the difference the drug would make to women. 

“There are no medications that are FDA approved for the treatment of HSDD… The FDA has recognized for a long time that there are women who have reduced sexual desire that causes distress, and who would benefit from safe and effective treatment,” the report said. 

“This condition is clearly an area of unmet medical need. However, for any product intended to treat an unmet medical need, the FDA is still required to base its regulatory decisions on an assessment of whether the benefits outweigh its risks. This has been the FDA’s approach with flibanserin, which has a challenging benefit/risk assessment.” 

An additional report also considered by the joint committee from the FDA’s division of risk management highlighted the potential risk of low blood pressure/syncope associated with the drug – which is exacerbated when it’s taken in conjunction with alcohol – and the steps that could be taken to reduce, but not eliminate them. 

A spokeswoman for the FDA confirmed that the vote of the joint committee will be considered by the agency as it continues its review of the drug. The product, should it be eventually approved, would be taken as a 100mg tablet orally once daily at bedtime.

Love Hormone oxytocin

Love Hormone and its Fascinating Facts – Oxytocin

If you’ve given birth before, you’ve probably heard of oxytocin – especially if you’re a breastfeeding mother. Oxytocin is the hormone that controls uterine contractions during labour, and helps with the milk ejection in breastfeeding. But this amazing neuropeptide is involved in so much more than just those two functions.

Studies show that oxytocin is calming and can improve mood – it lowers your blood pressure and blocks stress hormones. It can help relieve inflammation and stimulate metabolic functions, like digestion and growth. It is present in females and males, and is active in social interactions. It brings about feelings of relaxation, selflessness, and love. World renown obstetrician, Michel Odent, says, “Whatever the facet of love we consider, oxytocin is involved.”

And oxytocin may be the key to adapting to motherhood. Synthetic oxytocin, however, which is often used to induce or augment labour, does not act the same way in the body as naturally occurring oxytocin. Pitocin/syntocinon does not cross the blood-brain barrier; and while it does produce the same mechanical effects on the body, it does not lead to the same behavioural effects, like maternal attachment promoting behaviours.



The amazingly versatile hormone is present throughout the body during many different activities, and it serves many functions. Here are some fabulous and fascinating facts about oxytocin:



Oxytocin Fact #1:

Oxytocin is released in pulses, and the more pulses the more effects seen from the hormone. Baby’s suckling triggers these pulses, which improves milk production and release.

Oxytocin Fact #2:

A surge of oxytocin is released as a baby is being born (due to stretching of receptors in the lower vagina), and baby’s oxytocin levels are high at birth, as well.

Oxytocin Fact #3:

The highest peak of oxytocin in a woman’s lifetime is right after her baby is born, but before the placenta is delivered – we can maximise the hormone’s potential by placing baby skin to skin with mum and leaving the two undisturbed during the time.

Oxytocin Fact #4:

Skin to skin contact increases oxytocin release – whether it’s mother and baby right after birth, dad massaging his infant, or mum and dad holding hands.

Oxytocin Fact #5:

Speaking of birth, an epidural can impact the effects of oxytocin by blocking the pathways it travels. Since oxytocin increases your pain threshold, the epidural may not even be needed.

Oxytocin Fact #6:

Prolactin, the milk-making hormone, is dependent on oxytocin for its production. The levels of these two hormones are strongly correlated during breastfeeding.

Oxytocin Fact #7:

Oxytocin helps mothers interact with their babies. Oxytocin levels correlate with the amount of mother baby interaction, and both benefit from its effects.



Oxytocin Fact #8:

When a baby kneads at the breast, oxytocin is released – so let your baby hug the breast during feeding rather than tucking or swaddling those hands away.

Oxytocin Fact #9:

Oxytocin release can be hindered by a stressful environment, as fight-or-flight hormones inhibit oxytocin. But if someone feels emotionally supported, calm and warm, the environment works in favour of her hormones.

Oxytocin Fact #10:

Oxytocin helps your body use nutrients through digestion, and aids in transferring those nutrients into breast milk (and to the foetus during pregnancy).

Oxytocin Fact #11:

Oxytocin has direct effects on brain growth, especially the neocortex of the newborn.

Oxytocin Fact #12:

12. Oxytocin is released during orgasm (male and female). Orgasm has a host of physical and emotional health benefits, so don’t forget to give your partner the nudge now and again!

Oxytocin Fact #13:

Problems with the oxytocin system have been implicated in mental health issues, such as schizophrenia, drug dependency and suicide.

Oxytocin Fact #14:

Positive effects of oxytocin exposure last well past weaning – repeated ‘doses’ of this hormone over the months of breastfeeding can improve maternal health, though more research is needed in this area.

Oxytocin Fact #15:

Aside from its reproductive roles, oxytocin is released when sharing a meal with a friend, hugging someone you care about, and even when petting your dog. So if you’re feeling down, spend some quality time with a good girlfriend, get your hug on with those you care about and love (and ditch the quickie hug, give it longer than a few seconds, relax into it and see how different it feels!) or get connected with your partner… and we’ll leave the rest up to you!

cystic fibrosis and vitamins

Cystic fibrosis and vitamins

Why do people with cystic fibrosis’ need to take vitamins?

Many people with cystic fibrosis have problems when they eat food, making it hard for their intestines to soak up nutrients, especially fat. To help with this enzymes are taken with meals and snacks. Vitamins A, D, E & K   are unique because they need fat in order to be ‘soaked up’ by your body, they are called “fat –soluble” vitamins. Even someone takes enzymes they can still lose fat in their stool. If they are losing fat their stool. If they are losing fat then they are probably also losing vitamins. If you don’t take your vitamins, over time, you may develop low levels in your blood. This is known as vitamin deficiency.

You may wonder why it is important for someone with CF to take their vitamins if they don’t   have a problem when eat. To understand why, you must realize that vitamins are important to your body when yo ur healthy, but they even more important when you sick. People who have CF may find they get sick more often than people who don’t have CF. To help their bodies fight an infection they need more vitamins than someone without CF. To help their bodies fight an infection they need more vitamins than someone without CF. We ask people with CF to take a vitamin pill because it is very hard to get enough vitamins from food alone. Our focus is often the Fat soluble vitamins, but it is important to remember that all vitamins are needed for healthy body.

 

What do the different fat soluble vitamins do and what will happen if I do not get enough?

Vitamin A

Vitamin A has many important roles in the body. It helps you see at night and lets your eyes adjust when you move from a dark place to a bright place .If you have a vitamin A deficiency then   your eyes may not be able to get used to changes in light. There have been people with CF who have reported having this problem. If you think this is a problem. If you think this is a problem speak to your CF doctor.

Vitamin A also helps make skin and helps fight infection when you get sick. During childhood it helps you   grow. It is found in eggs, liver, tomatoes, milk and some fruits & vegetables. For people with CF, food sources are not enough to prevent vitamin A deficiency. Therefore a vitamin supplement is usually recommended.

Vitamin D

Vitamin D comes from two sources. It is made by the skin when it is exposed to sunlight, and it is found in the foods we eat. It helps your body absorb calcium, and helps move   calcium from your blood to your bones. Without enough vitamin D your bones can weaken and the chances of break in a bone become greater. While foods such as eggs and cereals contain vitamin D, the main source is milk. A vitamin supplement is usually recommended to make sure you get enough every day.

Vitamin E

Vitamin E has become very popular because of its role as an antioxidant. As you grow your body goes through many changes. As your body changes it produces harmful products that can destroy your healthy cells. Vitamin E helps get rid of these harmful products and this is why it is called an antioxidant. A deficiency of vitamin E can affect your body’s ability to protect itself when you get sick. For people with cystic fibrosis this may affect their lungs and their ability to breath. Foods that contain vitamin E include plant oils, margarines, and some fruits & vegetables. Diet alone cannot prevent a vitamin E deficiency in people with CF, therefore a supplement is usually recommended.

Vitamin K

Most of the vitamin K we need comes from our diet. It is found   in green vegetables, plant oils, and margarine. We also have healthy bacteria in our intestines that produce vitamin K. Even though the bacteria in your intestine is healthy, it can be destroyed by the antibiotics you may take for a lung infection .This can affect the amount of vitamin K you get on a daily basis. Vitamins K is very important because   it helps your blood clot. When you cut yourself, the time it takes for your cut to stop bleeding is affected by how much vitamin K you have in your body. The longer it takes to ‘clot’ the less   vitamin K you may have Vitamin K is also important for proper bone growth in children. To prevent a deficiency many people with CF take a supplement that contains vitamin K.

Dietary sources

Vitamin A                  Liver

                                        egg yolk

                                       dairy products green leafy or yellow vegetables

Vitamin D                  liver fish

                                       fortified milk and margarine

Vitamin E                  vegetable oils nuts eggs wheat germ

Vitamin K               Green leafy vegetables liver bacteria in the intestine also make vitamin K

Why should I take vitamins?

People with CF are at a very high risk for getting vitamin deficiencies. These deficiencies are serious and can include symptoms such as night blindness, bone fractures, back pain, and bleeding. They may also affect how quickly you recover from a lung infection. You can prevent these deficiencies just by taking your vitamins recommended by your clinic. To make sure get the most vitamin supplements it is best to take them with food and enzymes.

 

             Thyroid alert for                                              women 

   

                            Thyroid alert for women!The disorder is affecting younger women too, of late. Here's how to battle it with the right approach

It's one of the most common disorders that can affect an individual owing to the fast lives we lead. Alarming figures say it attacks close to 12 million people, annually, and yet the unfortunate part is that many don't even know they have a thyroid disorder. Have you wondered why you are gaining too much weight even when you are eating less food? Are you worried why your child scores poor marks in exams despite putting in a lot of effort?

Do you know why one of your close friends find it difficult to conceive a child or is experiencing miscarriages? It could well be due to the thyroid gland.

The culprit
The thyroid gland is located in the front of your neck with two lobes on either side of your windpipe. The gland is controlled by the pituitary gland that lies underneath your brain in your skull. The pituitary senses the level of thyroid hormones in your blood stream and secretes thyroid stimulating hormone (TSH). "This hormone activates the thyroid gland to produce thyroxine (T4) and triiodothyronine (T3) hormones. Thyroid gland needs iodine to produce T3 and T4 hormones. Both too much and too little iodine can cause the thyroid to malfunction," explains Dr Nupur Krishnan.

What is a goitre?
This is the enlargement of the thyroid gland that takes place when essential nutrients like iodine and selenium are deficient in the diet. The gland thus grows in an effort to filter more blood to get the scarce nutrients out of the blood supply. It occurs in about 5 % of thyroid patients.

Dietary treatment
Virgin coconut oil offers hope for those suffering from hypothyroidism. It contains
medium chain fatty acids, which increase metabolic rate and promote weight loss.

- Avoid artificial sweeteners made of aspartame.
- Avoid peanuts, millet and rapeseed (canola oil)
- Avoid smoking and a high dose of nutrition supplements.

Consumption of sufficient iodine and Vitamin A helps in reversing Hypothyroidism. The recommended dietary allowances(RDA) for iodine is 150 mcg (micrograms) per day for adults.

Avoid salads of raw vegetables made with those of the cabbage family like cabbage, cauliflower, broccoli and other cruciferous vegetables. They contain a substance known as goitrogens, which affects thyroid hormones and may lead to goiter. By cooking these vegetables goitrogens can be destroyed and its adverse effects can be reduced.

Consume more seafoods, especially ocean fish, which is a good source of iodine. Even people on a low-salt diet can get plenty of iodine from green leafy vegetables, milk and milk products.

Have eggs as well as deep yellow or orange fruits and dark green vegetables which help in meeting additional vitamin A requirements.

Pregnant women need 220 mcg iodine per day and nursing mothers, 290 mcg. Iodised salt provides 2 to 6 gm of salt each day.

Although anti-thyroid medications cut down the thyroid gland's overproduction this alone may not be the best approach because hyperthyroidism may reoccur once medication is stopped. You can take some extra supplements like edible coconut oil, primrose oil, flaxseed oil or fish oil to help with the dryness and hair loss.

Affecting younger women today 
Says endocrinologist Dr Altamash Shaikh, "It's no longer affecting just the over-30 group. Thyroid is also affecting younger women today in the age bracket 15-20. It's important that youngsters keep a check on symptoms of puffiness, weight gain and fatigue and if they show these, they must get a TSH screening done. There is no need to panic. Thyroid is treatable."

Hypothyroidism & Hyperthyroidism
When thyroid produces high level of T4 and T3, it is known as Hyperthyroidism. Graves disease is the most common cause of this. This condition speeds up metabolism rate and results in unusual hunger, weight loss, muscle weakness, rapid heart beat, excessive sweat etc.

Hypothyroidism is caused due to decreased production of thyroid hormone. Dr Krishnan, who has treated several patients suffering from this disorder, adds, "Hypothyroidism happens when the thyroid gland is unable to produce enough T3 or T4. Inflammation in thyroid known as Thyroiditis also cause hypothyroidism. In any case, timely diagnosis is crucial."

Infertility and pregnancy
Having trouble getting pregnant? Thyroid could be the culprit. Both hyper and hypothyroidism can cause infertility. "In males, it leads to low sex drive and sperm reduction. In females, it affects production of ovaries and causes premature menopause. However, normal fertility can be restored. During pregnancy one must take care of hypothyroidism, as it might cause miscarriages or birth defects in a child," Dr Krishnan explains.

Symptoms
- Abnormal weight gain
- Neck enlargement
- Depression
- Frequent and heavy menstrual flow
- Thinning hair, dry hair and hair loss
- Slow heart rate
- Developing dry, coarse skin
- Difficulty in conceiving
- Feeling exhausted easily
- Mood fluctuations and poor memory
- Muscle cramps and joint pain
- Feeling cold, developing a husky voice
- Goitre