Tag Archives: Food and Drug Administration

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Nonetheless, the previous inhaled insulin Exubera had been withdrawn from the market before because of poor sales.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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Nanotechnology to detect blood clots

Photo Credit: Christine Daniloff/MIT

Blood clots in the legs are commonly called the Economy Class Syndrome, whereas passengers in the coach class develop potentially life-threatening blood clots in their legs when they sit around not moving for a long time. The other group of people at risk are patients who just have surgery in the pelvis or legs, and cannot walk around.

Sometimes those blood clots break and travel to the lungs and block the big lung arteries, killing the patient.

Now, a group of researchers led of Sangeeta Bhatia, a doctor and a bioengineer, had found a way to detect these clots early, by using nanotechnology.

Blood clots are rich with thrombin. So iron oxide particles coated with special peptides are injected into mice. Should the particles encounter thrombin, the special peptides react with thrombin, releasing substances that can be detected in the urine. Iron oxide particles have already been approved for human use by the FDA.

At the moment, doctors have to look for late signs of blood clots in the leg which includes a swollen feet, and breathing difficulties (late stage). It is then confirmed by an ultrasound of the leg veins which is labor-intensive. This technology has the potential to greatly help us pick up the blood clots before they arise.

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.

The Artificial Pancreas – Hope for Type 1 Diabetes

The artificial pancreas has just been approved by the American Food and Drug Administration (FDA).

Patients with type 1 diabetes cannot make insulin because their pancreas has been damaged by their own immune system, and have to have external insulin supplied to them. An insulin pump can provide insulin constantly through a needle that is secured just under the skin and typically lasts for 3 days. The problem had always been that patients can get hypoglycemia, or low blood sugar, especially during the night or during vigorous exercise.

Now the FDA had approved a new Medtronic pump that also has a sensor which can switch off the pump when the patient’s sugar drops too low. This pump now behaves like our real pancreas: provide insulin when the sugar is high, stopping insulin when sugar is low. However, it is not fully automated: unlike our body which knows how much carbohydrates we have taken, the pump user still needs to enter the amount manually into the machine.

Nonetheless this is a much safer machine than the old ones. Hopefully it will be brought to Singapore soon!