Caution on three life saving drugs

IPC recommends caution on 3 life saving drugs in market to CDSCO based on ADRs

Indian Pharmacopeia Commission’s (IPCs) signal review panel recently submitted strategic recommendation to the Central Drugs Standard Control Organisation (CDSCO) on the 3 important life saving drugs running in the market. These reports were submitted based on the detailed observation made by the expert panel following the adverse drug reaction (ADR) report generated from different ADR centres across the country.

Based on the evaluation report received from different AMCs under the Pharmacovigilance Programme of India (PvPI), it was found that use of carbamazepine is associated to cause Stevens Johnson Syndrome (SJS) in some patients. Dr V Kalaiselvan, principal scientific officer from the Indian Pharmacopoeia Commission informed that considering the safety of the patients, the review panel recommended the CDSCO to direct all the manufacturers to insert a clear warning on its label on the possible side effects of the drug, to caution the patients.

It is understood that carbamazepine which is available in different brands like Carbatrol, Epitol, Equetro, TEGretol, TEGretol XR etc. is a commonly prescribed anticonvulsant drug for epilepsy, which works by decreasing nerve impulses that cause seizures and pain. It is also used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy along with treating bipolar disorder.

Dr Kalaiselvan further stated that this report has been submitted after extensively analysing and studying ADR reports generated from more than 100 ADR centres across the country. SJS is a clinical syndrome presumed to be a hypersensitivity reaction manifested initially with prodromal symptoms of fever, malaise and a sore throat. The prodromal phase is then followed in some days by an acute polymorphous dermatologic syndrome manifested as erythematous maculo-papular like lesions, target lesions, bullae, vesicles, involvement of at least two mucous membranes, conjunctivitis and an associated systemic toxic state.

“Considering the seriousness of this matter, the panel has suggested the DCGI to take the above requisite steps for public safety. Apart from carbamazepine, IPC has also submitted recommendation to the Centre on two anti cancer drugs sunitinib and pazopanib as well. Based on the panels observation it has recommended the CDSCO to closely monitor these two drugs as there have been several incidents of ADRs reported from the use of these drugs,” he stressed.

Sunitinib is used to treat gastrointestinal stromal tumours (GIST) that grows in the stomach, intestine (bowel), or esophagus tube that connects the throat with the stomach in people with tumours that were not treated successfully with imatinib or people who cannot take imatinib. It is also used to treat advanced renal cell carcinoma (RCC), a type of cancer that begins in the cells of the kidneys and treat pancreatic neuroendocrine tumours (pNET), a type of tumour that begins in certain cells of the pancreas in people with tumours that have worsened and cannot be treated with surgery.

While pazopanib is used to treat advanced RCC in adults, it works by slowing or stopping the spread of cancer cells.

These observations were made based on report collected from over 60 ADR centres across the country. Signal detection in pharmacovigilance comprises of selection of drug adverse reaction, preliminary assessment of available evidence and a follow up on how the signal develops.

The Night Before An Exam

The Night Before an Exam - What Should You Do? 

 

Exam Anxiety Tip 1: Be Prepared Early

The most common cause of exam anxiety is lack of preparation for the exam. Set up a study schedule at least three weeks before your first exam. You may find that you actually need to start studying very early due to other commitments. Planning ahead also assists you to avoid cramming which can be a major cause of exam anxiety.

Exam Anxiety Tip 2: Sleep Well

Regular sleep is one of the best ways to control stress. Getting up and going to bed each day at the same times ensures that your body and brain are getting the rest they need for optimal functioning. Students who follow a regular sleeping pattern have been shown to perform 30% better than students who stay up late or get up early to study.

Exam Anxiety Tip 3: Same Caffeine & Sugar Intake

Keep caffeine and sugar intake the same during exam time. Don’t increase or decrease the amount of coffee, tea or cola that you normally drink as your body and brain are accustomed to getting a certain amount. Keep things in your life as stable as possible, especially during exam time.

Exam Anxiety Tip 4: Learned Relaxed Breathing

When you display any symptoms of anxiety during studying or during the exam, use relaxed breathing to calm yourself. Take your attention away from the task and take a few slow breaths. Say to yourself, “calm and relaxed” as you exhale. Practice relaxed breathing before the exam.

Exam Anxiety Tip 5: Don’t Study the Night Before

Studying the night before an exam causes your anxiety level to increase. Unfortunately, it doesn’t decrease when you go to sleep. Reduce anxiety by taking the evening off to relax ”“ watch TV, see a movie, read a novel, etc.

Exam Anxiety Tip 6: Review Main Themes

If it causes you anxiety NOT to study the night before an exam, review the main themes of the course earlier in the day. Of course, that implies that you should have already studied well.

Exam Anxiety Tip 7: Have a Plan before the Exam

As part of your studying, think about how you will approach the exam, and what you will do when you run into trouble. Having a plan in place will assist you to worry less about failing, and help you to concentrate more on passing.

Exam Anxiety Tip 8: Aim to Do Your Best

Often, students start thinking negatively when things aren’t going well on an exam. This can lead to lower self-confidence and increased self-doubt. Recognize and turn off your negative internal dialogue. Focus on the task instead of on yourself. Do not try for perfection ”“ aim to do your very best.

 

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!