Azithromycin Drug Safety Communication

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FDA is warning the public that azithromycin can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.  FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.

 FDA previously released a Statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin and levofloxacin or no antibacterial drug. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.

Change to “FDA-approved indications for azithromycin include: acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, genital ulcer disease

 RECOMMENDATION: Doctors should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events.  FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.

Source: -Drug Safety Communication – FDA

Ketoconazole Drug Safety Communication

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Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems

USFDA is taking several actions related to Ketoconazol oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Ketoconazol oral tablets should not be a first-line treatment for any fungal infection. Ketoconazol should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.

 Liver Injury (Hepatotoxicity)

Ketoconazole tablets can cause liver injury, which may potentially result in liver transplantation or death.  FDA has revised the Boxed Warning, added a strong recommendation against its use (contraindication) in patients with liver disease, and included new recommendations for assessing and monitoring patients for liver toxicity.

 Adrenal Insufficiency

Ketoconazole tablets may cause adrenal insufficiency by decreasing the body’s production of corticosteroids.

 Drug Interactions

Ketoconazole tablets may interact with other drugs a patient is taking and can result in serious and potentially life-threatening outcomes, such as heart rhythm problems.

Medicine prices going beyond reach

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Inflation in medical costs has been growing in double digits, a bit higher than the overall inflation in India, for six years now. Yet, if hospitalisation costs and insurance premiums were to be set aside, medical inflation is something that usually escapes even the discerning eye. Medical inflation is not just about operation costs and post-operative bills, it is as much about drugs, their prices, and the market forces that determine the shape of things.

Priya Mehra’s fight with breast cancer is restricted not just to chemotherapy, its side-effects and the long-drawn battle. It extends to the exorbitant amount she and her husband shell out each time they visit the hospital.

“It is frustrating to know that very good medicines are available in the market, but buying them means paying through our nose,” says Mehra.

The Mehras have to pay Rs75,000 for each vial of the drug trastuzumab. “And Priya might require 1 vial every three weeks, depending on her course,” says her husband, Ravish.

That works out to over Rs12.75 lakhs a year (if 17 vials are needed annually).
The Mehras say it is a constant struggle to meet the cost requirements. What is even more frustrating is that hospitals insist patients buy the vials from them and not from distributors who are ready to offer discounts.

Mehra says distributors are ready to sell each vial for Rs55,000. “But hospitals say they won’t administer the medicine if we purchase it from anywhere else.

Thus, we end up paying Rs20,000 more each time, even though some discounts are available.”

Even Rs55,000 per vial proves highly expensive for most Indians, since treatment may be lifelong, says Kalyani Menon Sen, coordinator for the Campaign for Affordable Trastuzumab.

“From where can patients arrange so much money each time!” asks Sen, who works closely with Mehra.

The loot

Cancer, HIV/AIDS, hepatitis C often require life-long treatment for survival, and with medicine prices in thousands and lakhs, it often means investing the entire family income.

Banker S Bhatt, who recently lost his wife to Hodgkin’s Lymphoma, a cancer of white blood cells, says he invested more than Rs20 lakh during the entire course of treatment. Only a part of that amount is reimbursable, while the rest was a loan.

Even though discounts are available, and government programmes talk of free treatment, most patients are unable to avail of such benefits owing to various lacunae in the healthcare system.

Loon Gangte, who has been on HIV/AIDS treatment for 11 years, says the government’s programme gives only first-line and second-line treatment free. “Patients requiring third-line HIV/AIDS treatment have to buy it themselves.”
And drugs for third-line treatment like Raltegravir cost Rs98,550 annually.

Same medicine, different price
Beyond the cancer and HIV/AIDS medicines, even medicines for heart ailments, hypertension, antibiotics, diabetes seem to be getting unaffordable for some people.

Like every product category, even in medicines, multiple brands exist for each drug. Just that patients are unaware since unlike other products, here the decision to buy lies with doctors.

“Patients will take whatever doctors prescribe and doctors prescribe by brand name,” says Bejon Misra, founder of HealthyYou Foundation.

“Even if cheaper alternatives are available, patients will spend more since the prescription demands a costlier brand,” says Misra. And when health insurance covers just a fraction of people, the financial repercussions are huge.

Reference: http://www.dnaindia.com/bangalore/1855997/report-medicine-prices-going-beyond-reach

 

Most Common Drugs that cause Weight Gain

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Here is a list of commonly used drugs associated with weight gain:

1) Benadryl

Benadryl (Diphenhydramine) is an antihistamine, which is used for allergies and as a sleep aid. Histamine is a chemical crucial for regulating food intake, causing appetite suppression when it binds to a specific receptor in the brain. It may also increase the breakdown of fat. When the histamine receptor is blocked, its effect on appetite is decreased, leading to increased food intake and weight gain. A large review study found that people who used antihistamines had higher weights, waist circumferences, and insulin concentrations than those who did not.

Alternatives: Ask your doctor about inhaled medications for allergies which are not generally associated with weight gain. If you have trouble sleeping, consider natural remedies and better sleep habits (i.e. no caffeine late in afternoon, no TV in bed room, etc.).

 2) Antidepressants

The most widely prescribed antidepressants are from a class called SSRIs, or selective serotonin reuptake inhibitors. Simply, serotonin is thought to play a role in mood, and brain levels are low in many depressed patients. SSRIs allow serotonin to stay active longer, contributing to enhanced mood in many people. Serotonin is also well known to be an appetite suppressant, so it stands to reason that these drugs will help with weight loss. It turns out that the opposite is true. This paradoxical effect is not completely understood, though likely has to do with the complex interaction between serotonin and other appetite regulating mechanisms. Certain SSRIs, like Fluoxetine, are associated with short term weight loss, though this is temporary and long-term data show a weight-neutral or weight gain effect.

Alternatives: These should be discussed with your doctor.

 3) Beta Blockers

These drugs are used to treat high blood pressure as well as certain heart conditions. While it is unclear exactly how these drugs contribute to weight gain, it is likely at least partially related to metabolic slowdown. One of the ways these drugs work is by slowing down the heart, which decreases exercise capacity. Additionally, they may cause fatigue, which will then lead to decreased activity and less caloric expenditure.

Alternatives: If you are taking a beta blocker for high blood pressure, discuss other medication options with your doctor.

 4) Prednisone

A synthetic corticosteroid, prednisone has potent anti-inflammatory properties. It is used to treat asthma flares and allergic skin conditions, as well as certain autoimmune diseases and arthritis. Prednisone causes water retention and increased appetite. And while prednisone is a catabolic hormone, meaning it causes the breakdown of fat and protein, these effects are more than offset by its appetite stimulating properties. To make matters worse, excess calories consumed in the setting of elevated corticosteroid levels tend to be preferentially deposited around the middle.

Alternatives: Doctors should prescribe prednisone when there is no option for a less potent drug. If you must take prednisone or any steroid, it is very important to be aware of its ability to increase appetite and watch your calorie intake very carefully.

 5) Seizure Drugs & Mood Stabilizers

These drugs include Risperidone, Olanzapine and divalproex sodium. The weight gain associated with these medications is often rapid and significant, with research showing as much as a 37 pound weight gain during the course of treatment. Scientists believe the drugs’ action on the histamine receptor in the brain is responsible for the effect.

Alternatives: Discuss this with your doctor. People taking these medications need to be aware of the potential for weight gain and work with a qualified professional to mitigate this side effect as much as possible. Since weight gain can be rapid, it is a good idea to start as soon as treatment commences.

 6) Insulin & Other Diabetes Drugs

Since weight loss is a primary goal of treating type 2 diabetes, it seems illegal that some of the most commonly used drugs to lower blood sugar can cause significant weight gain. When a patient is diagnosed with diabetes, there is often a frantic rush to get the blood sugar down using any means necessary. By giving insulin or insulin releasing agents, sugar is removed from the blood stream and often stored as fat. The result is a lower blood sugar but often 10 or more extra pounds of fat, which can then increase medication requirements and cause more fat storage.This vicious cycle continues and makes it essentially impossible for many patients to ever get off medication. Additionally, aggressive blood sugar lowering effects can often cause hypoglycemia, or too low blood sugar, when must be remedied by eating sugar (Often diabetics will need to eat candy or drink juice to get their blood sugar up.) which causes more fat gain from the extra calories.

Alternatives: There is no easy answer here. Short-term blood sugar lowering must be viewed in a long-term context. This is certainly a controversial area where mainstream medicine often differs in opinion from complimentary or alternative medicine. If you find yourself familiar with the scenario laid out above, educate yourself and find a qualified professional whom you trust to work with.

This is not to propose that you should not take a medication if your doctor says it is necessary. But if you are taking a medication that can contribute to weight gain, it helps to know ahead of time and create a plan to attempt to negate some of the weight gain side effect.

Administering medicine to your child safely and effectively

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Children are more sensitive to medications than adults are. If given in the wrong dose or at the wrong time, even some of the most benign over-the-counter (OTC) medicines can be ineffective or harmful. Here’s how to give medicine to your kids with confidence

 Ask the Doctor / Pharmacist

Talk with your doctor or pharmacist about the medicine you’ll be giving your child. If it’s a prescription medication, ask what, specifically, it’s for and what side effects might occur. Find out how soon it should begin to take effect and how long the prescription should last. Will it interact with any other medications your child takes? Does the medicine need to be kept in the refrigerator, or out of the heat or light? Can you put it in food, or should you avoid giving your child certain foods at the same time he takes the medicine?

Some medicines have to be taken after eating or, conversely, on an empty stomach. Are there other precautions to take, like keeping your child out of the sunlight while he’s on the medicine? If the package doesn’t specify a child’s dose, it may not be appropriate. Again, ask about possible side effects and interactions with other medications.

 Get the dose right

How can you make sure your child is getting the amount of medicine he needs? Read the label very carefully. Read it when you buy or pick up a new medicine, when it’s time to administer it, and while you’re pouring it out.

Follow the directions on the package to the letter to ensure that your child is getting the right dose for his age and weight. If you don’t understand the instructions, call the pharmacist or doctor.

 Here are a few more specifics to keep in mind:
 

  • Examine the numbers in the directions very carefully so you don’t accidentally double or halve a dose.
  • Be aware that some over-the-counter medication for babies, like infant acetaminophen, is concentrated. (Don’t use it to give an older child his normal dosage.)
  • Know your child’s weight. Some dosages are based on weight, or weight and age. It might help to note your child’s current weight on a scrap of paper in your medicine cabinet. Don’t worry if the most recent number you have is a couple of weeks old — go with the figure you got at your child’s last doctor visit.
  • Be sure to shake liquid medicines before giving them to your child if it says to do so on the label. That way you can be sure all the ingredients are evenly distributed, so your child won’t get too much or too little of them.
  • Don’t confuse teaspoons (tsp. or t) and tablespoons (Tbsp. or T). In any case, there’s almost no medicine your child will need a whole tablespoon of, so think in terms of teaspoons.
  • Never give your child more medicine than is recommended on the label or in the instructions. Even if he has a severe cold, ear infection, sore throat, or fever, more medicine isn’t better. Dosages are based on the amount of medicine that’s safe, not on the severity of the illness.
  • Call your child’s doctor if you notice any unexpected side effects. 
  • If for some reason your child can’t or won’t take the right amount of medicine, perhaps because he’s vomiting and can’t keep anything down, let his doctor know. The doctor may choose another method — by injection or suppository, or intravenously, for example — to make sure your child gets the treatment he needs.
  • One of the best ways to ensure that your child gets the right amount of medicine is to use the right tool. That means using a dosage spoon, medicine dropper, dosage cup, or oral syringe specifically designed to help you measure and administer the right dose. Your best bet is to use a plastic oral syringe marked with different measurements. For babies, syringes work better than spoons because you can be sure you’re getting all the medicine into your child’s mouth and down his throat
  • Finally, don’t give your child another child’s prescription or any old prescription. 

Timing is everything 

Read labels carefully to find out how often you should be giving your child a particular medicine. If it says “four times per day,” give it four times during your child’s waking hours — you don’t have to wake him up for another dose. If, on the other hand, the directions say “every six hours,” you’ll have to find out whether that means your child needs the medicine around the clock, waking or sleeping.

Remember to follow the directions about whether the medication should be given with meals or on an empty stomach, and if there are foods you should avoid or partner with the medication.

Be sure to give your child the full course of any antibiotic he’s prescribed, continuing for as long as your doctor recommends, even if he seems fully recovered. Otherwise you can’t be sure that the bacterial infection is really gone.

 Store drugs safely

Try to keep medicines in their original packaging. If you do lose a label or a set of directions, don’t use the medicine. Giving it your best guess isn’t worth the risk.

Many antibiotics (and some other medicines) need to be refrigerated. Others need to be kept cool constantly, at home and on the go.

Ask your pharmacist to go over any specific guidelines and storage recommendations with you. Keep medicines that don’t need to be refrigerated in a cool, dry place. Don’t keep them in your bathroom medicine cabinet, which can get warm and moist from the shower.

Keep all medicines safely out of reach of kids,

Important facts about METFORMIN- One of the most common used anti-diabetic drug

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Metformin is an oral diabetes medicine that helps control blood sugar levels.Metformin is for people with type 2 diabetes. Metformin is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.

Important information about metformin

You should not use this medication if you are allergic to metformin, or if you are in a state of diabetic ketoacidosis.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired. To make sure you can safely take metformin, tell your doctor if you have any of these other conditions – liver disease; or a history of heart disease.

What should I avoid while taking metformin?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis while taking metformin.

Metformin side effects

Get emergency medical help if you have any of these signs of an allergic reaction to metformin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • slow or uneven heart rate.

Also call your doctor at once if you have any other serious side effect such as:

  • feeling short of breath, even with mild exertion;
  • swelling or rapid weight gain; or
  • fever, chills, body aches, flu symptoms.

 

Important facts about IBUPROFEN- One of the most common used drug

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Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body. Ibuprofen is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.

Important information about ibuprofen

Ibuprofen may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use ibuprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG). This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking ibuprofen, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds or chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance..

Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines. Use only the smallest amount of medication needed to get relief from your pain, swelling, or fever.

What should I avoid while taking ibuprofen?

Avoid taking ibuprofen if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

What other drugs will affect ibuprofen?

Ask your doctor before using an antidepressant such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine or sertraline. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Also tell your doctor about all other medicines you use, especially:

  • Aspirin or other NSAIDs such as naproxen, celecoxib, diclofenac, indomethacin;
  • heart or blood pressure medicine such as benazepril, enalapril, lisinopril, quinapril, ramipril, and others;
  • Diuretics such as furosemide;
  • Methotrexate
  • Steroids (prednisone and others); or
  • A blood thinner such as warfarin