Category Archives: Prescription Drugs

FDA approved Inhaled Insulin Afrezza

Damion Edwards for Mannkind

The Food and Drug Administration (FDA) of America had just approved the new inhaled insulin Afrezza for patients with both types of diabetes. It can replace the short acting insulins but not the long acting ones, so patients with type 1 diabetes would still need to inject the basal insulin, but would then just need to inhale before meal times, effectively saving themselves 3 injections.

Afrezza, or technosphere insulin, has a short time to maximum blood concentration of 14 minutes, resulting in improved control of postprandial (after meal) blood sugars, less weight gain and lower risk of hypoglycemia (blood sugar level too low). Side effects include transient cough, and a small reversible reduction in forced expiratory volume in 1 second (FEV1) (a measure of a person’s ability to blow) by 37ml. An expected FEV1 calculated for a Chinese man measuring 174cm and 72kg was about 4 litres, making this a drop of less than 1%.

However, bronchospasm (airway narrowing) had occurred in patients with previous asthma and chronic lung disease, so Afrezza is contraindicated in those patients. FDA had also mandated post-marketing studies of the drug.

This is great news for patients who are currently injecting insulin multiple times a day, as inhaled insulin was much more acceptable to patients with type 2 diabetes.  This means that more patients with poorly controlled diabetes would be willing to be started on insulin, which no longer requires painful injections.

Nonetheless, the previous inhaled insulin Exubera had been withdrawn from the market before because of poor sales. The high price, and the huge size of the inhaler were cited as reasons of its failure.

Provided this is not priced too high, the fact that this inhaler is palm-sized should help Afrezza escape the fate of Exubera. Hopefully it will arrive in Singapore soon.

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A New Class of Diabetes Medication Arrives in Singapore

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Despite current treatment including insulin, only 40% of patients in Indonesia35% of patients in Singapore and 22% of patients in Malaysia have good diabetes control.

A new class of medication called the SGLT2 inhibitor has been approved in Singapore, the first one being Invokana (canagliflozin). It has a unique mode of action for the treatment of type 2 diabetes mellitus.

In the kidneys when blood is pushed through a glomerulus (the smallest operating unit in the kidney), glomerular filtrate (earliest urine) is formed. It contains glucose (sugar), different ions, water and waste products. The good stuff is retained through reabsorption. Glucose is reabsorbed through the SGLT2 channels.

SGLT2 inhibitors block the action of the SGLT2 channels, so glucose is lost in urine. Thus the blood glucose drops and diabetes control improves. Patients also lose weight as they are losing energy in the urine. The glucose in the urine also drags water with it and thus patients’ blood pressure drops.

The most important benefit is that it is not dependent on insulin secretion, so the risk of a dangerously low blood sugar (hypoglycemia) is prevented. With this extra class of oral medication, patients may be able to delay their use of insulin.

There are side effects though. First, the sugar in the urine increases the risk of a urine tract infection and fungal infection around the urethra. Second, patients can get dehydrated unless they replenish their fluids with an extra glass of water.

I am very glad that we now have another weapon in the treatment of diabetes.

The Latest ACC/AHA Cholesterol Guideline: A sea change

Cholesterol check

Photo Credit:  Stuart Miles/freedigitalphotos.net

The American College of Cardiology/American Heart Association published their latest cholesterol management guideline last month. It is a complete change of the prior American guidelines that aim at a particular cholesterol target.

First of all, it recommends treatment for the 4 groups of patients:

1. All who already have heart disease, stroke or peripheral blood vessel disease (“cardiovascular diseases”)

2. Everyone with diabetes between 40-75 years of age

3. Those with an LDL (bad) cholesterol of 190 mg/dl (5.0 mmol/l) or more

4. Those with a calculated 10-year risk of cardiovascular disease of 7.5% or more.

Secondly, they suggest using only statins, and no other cholesterol-lowering medication.

Thirdly, they recommend stopping the routine monitoring of cholesterol levels after treatment, because of the lack of evidence.

Lastly, they place far less emphasis on additional screening tests such as hsCRP, a mark of inflammation in the body and cardiovascular risk

Since then Dr Nancy Cook and Dr Paul Ridker had published an article in the New York Times that call into question the calculator used, unusally before their critique paper in the journal Lancet has been published. Cook and Ridker pointed out that the calculator overestimates the cardiovascular risk in their own data set of patient population. Dr David Goff, co-chair of the guideline committee, explained that the population set used by Cook and Ridker are more recent and those patients have reduced risk probably because they are volunteers, and might have already taken statins and so their risk became lower. Interestingly, Goff was also puzzled by Ridker’s lack of comment in 2012 when the guidelines were sent to Ridker, and revealed that Ridker’s suggestion to use hsCRP in the risk calculation was rejected. Ridker receives royalties as co-holder of patent on hsCRP, which is a blood test used for risk-stratification for cardiovascular risk.

Hmm. I had not seen a guideline critique being so personal before. Previously, lead authors exchange disagreements in the journals, in an usually courteous manner.

The American Association of Clinical Endocrinologists had just rejected the guideline. They disagree with removing the cholesterol targets, the out-dated risk calculator, and the omission of medication other than statins in lowering cardiovascular risk.

Do we doctors agree on anything now about cholesterol? Well there are:

1. High cholesterol is associated with blood vessel blockage (atherosclerosis), heart attacks and stroke.

2. Lowering cholesterol generally lowers that risk. Most studies were done on statins, but other studies on other medication, such as niacin,  fibrates and Vytorin, had also shown benefits before.

3. The relative benefits are rather constant. So patients with high risk benefit more. For example, if a patient has a 50% risk of having a heart attack in 10 years, lowering the cholesterol can reduce the risk to 25-30%. So 1 in 4 patients are saved. But for a low risk person with 1% risk of having a heart attack in 10 years, lowering the cholesterol reduce the risk by 0.4-0.5%. So 200 people needs to be treated before one is saved.

4. All cholesterol-lowering medication has a small risk of side effects. Muscle ache, increased liver enzymes, and diabetes are the commonest.

Ultimately, it is best that you discuss with your doctor whether you need treatment. You should ask about the benefits and the risks of taking the drug.

Avoid Glibenclamide for patients who are elderly or have renal failure

Finger prick meter

Photo credit:  Gualberto107/freedigitalphotos.net

Glibenclamdie (glyburide in America) is a common and useful drug for type 2 diabetes. It is effective and the blood sugar lowering effect long-lasting. However, the strength is also a weakness: it can sometimes be so powerful that the patient can suffer prolonged hypoglycemia (low blood sugar level).

The Health Sciences Authority of Singapore had looked at the data and found that in Singapore, patients who are above 60 or those with kidney failure have a much increased risk of severe and protracted hypoglycemia. They have now advised all doctors to avoid using glibenclamide in those patients.

There are many other alternative drugs in the same class such as gliclazide and they are also generics, available at a low price at our clinics.

If you are taking glibenclamide and had recently turned 60 or have renal failure, please do not stop your medicine immediately, but talk to your doctor about it.

Urine Spills in Factories Making Generic Drugs

capsulesPhoto credit: antpkr

I love the US Food and Drug Administration (FDA). They set the standards for generic drug safety, allowing small countries like Singapore to save a lot of time and money to check on the quality of generic drug manufacturing. Unfortunately, what they found in the Wockhardt factory was not pretty: urine on the floor, dirty uniform, moldy storage areas.

Yikes! I would not give my patients these drugs, no matter how cheap they are!

On the other hand, this piece of news creates a problem for doctors and patients. Generic drugs are much cheaper than the originals and allow governments to treat a lot more patients. While the rich patients would of course demand genuine medication, it is not feasible to treat everyone with expensive branded medication. We need the generics and we need to make sure that their standard of quality is good.

The best way to ensure quality compliance is spot checks. Keep up the good work, FDA!

Problem of Slimming Drugs sold as “Supplements”

ImagePhoto Courtesy: Health Sciences Authority Singapore

If you are taking Oxylite Pro now, stop taking them immediately. The Health Sciences Authority of Singapore had issued an alert after Oxylite Pro had been found to cause liver injuries. An analysis of the ingredients found the potent chemicals 1,3-dimethylamylamine (DMAA) and yohimbine. Those chemicals have caused liver injuries.

Oxylite Pro is marketed as a magic weight loss supplement. Looking at the ingredient from its website, it probably works to some extent, as it contains DMAA and yohimbine which are stimulants and caffeine that increases the metabolic rate, and certain plant extracts that increases thyroid hormone which in turn increases the metabolic rate.

Mainstream Western medication can be toxic if taken inappropriately. That is why even paracetamol (Panadol) in overdoses can harm the liver. That is the reason only doctors can prescribe registered medication as we need to carefully weigh the potential pros and cons of any single medication. We must help, not harm patients.

A healthy diet (low in saturated fat and refined carbohydrates, high in good protein and fibre) and regular exercise is the best way of weight loss. Please discuss with your doctor before you want to take any of the over-the-counter supplements that promise quick fixes for weight loss.

Counterfeit Drugs a problem in Indonesia

fake drugsPhoto courtesy:  Victor Habbick,

I am sometimes asked about the huge price difference of drugs between Indonesia and Singapore. Rent, labor, the strong Singapore dollar, and differential pricing are all factors. However, there is one very important factor – fake or counterfeit drugs. Counterfeit drugs have become a huge problem in Indonesia. The pharmacies used to buy drugs from “independent medication sellers”, but are now buying them simply online.

I had come across instances when I simply switched medication from overseas to Singapore ones, and saw huge differences in the effect of lowering blood pressure and blood sugar. I can only surmise that the “strengths” of the medications are different.

Part of the problem reported was that the pharmacies find it difficult to differentiate between genuine and fake medication. I totally agree. There is no way for even pharmacists and doctors like us to differentiate between the fake and real thing, since boxes, logoes can all be faked. The only way to ensure that the drugs are genuine is to buy direct from the Big Pharmaceutical Companies themselves.

Pharmacists and doctors must realize that fake drugs may not contain any active ingredients, and can also contain harmful ingredients. They must make a stand to sell the real thing to their patients. Patients must also buy medication from registered pharmacies and not from dodgy ones.