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Posts with tag side effects

Reporting drug side effects - One click away!

A recent study found that 87% of patients who experienced an adverse symptom from a prescribed drug spoke to their doctor. However less than half of the doctors went through with filing the adverse event paperwork to notify the drug manufacturer. Why is this?

The research was published in the latest issue of Drug Safety. Doctors dismissed patients' complaints, and told them their symptoms were not connected to use of the drug. One doctor commented that the time it takes to complete the adverse event drug paperwork is time-consuming, and often not worth it unless it is life threatening. Would Hippocrates have accepted that answer? Please review your Hippocratic Oath, doc.

Your doctor is too busy to file the necessary paperwork to notify the FDA a drug is potentially harmful. What is a patient to do? Good question and here's an answer! If you experienced any adverse side effects from the use of a prescription drug, please let the FDA know. Click BEGIN and bring this monkey business to an end!

A Knockout Cure for Diabetes

Hold on to your seats, folks. This story is pretty controversial but fascinating enough to make an appearance on Prime Time television 2x tonight on the evening news! A treatment involving the annihilation of the immune system, followed by a period of rebuilding the immune system is being tested in Brazil as a cure for type 1 diabetes.

The patients involved were newly diagnosed with type 1 diabetes, and between the ages of 14 to 31 years old. The 15 diabetics were treated at a bone marrow center at the University of Sao Paulo. Timing is key in this method of therapy because if you wait too long - the window of opportunity where the body's ability to repair itself closes. The procedure involves stimulating the body to produce new stem cells and harvesting them from the patient's blood. Next comes several days of high-dose chemotherapy, which shuts down the patient's immune system. This also stops destruction of the few remaining insulin-producing cells in the body. This requires hospitalization and potent drugs to fend off infection. The harvested stem cells, when injected back into the body, build a new healthier immune system that does not attack the insulin-producing cells. Patients were hospitalized for about three weeks. Many had side effects including nausea, vomiting and hair loss.

For the record (and the Freedom of Information Act) the study was partly funded by the Brazilian Ministry of Health, Genzyme Corp. and a maker of blood sugar monitoring products.

The first urine test to detect insulin doping in athletes

Scientists in Germany are reporting development of a urine test that finally can identify athletes who misuse certain kinds of insulin in an illicit attempt to enhance performance.

An article scheduled to appear in an April edition of Analytical Chemistry says it is possible to detect the misuse of insulin in a urine sample. Scientists had not attempted to develop a test in the past because of the presumption that it was impossible to detect misuses of insulin. Because insulin is rationed and used efficiently by the body, a byproduct of insulin would be theoretically undetectable. However, with the advent of the newer long-acting insulin analogues, scientists are now able to identify degradation product in the urine.

The test does not identify residue from the use of two other forms of long-duration insulin. However, the test does identify the misuse of Lantus, manufactured by Sanofi-aventis. Determination of long-acting insulin analogues in urine is especially helpful for doping control purposes. The procedure provides a fast and reliable way to identify the misuse of the long-acting insulin analogue LAN in regular doping control specimens.

Novartis Holdup on New Diabetes Drug

Novartis SA reports the U.S. FDA has demanded additional data, including a clinical study in patients with kidney impairment, before giving Galvus its approval. Why the holdup?

The FDA wants more data studying Galvus in patients with impaired kidneys. It had been thought that Galvus might have an advantage because it is not processed by the kidneys, while Januvia is. But another molecule created when the body metabolizes Galvus does build up in the kidney.

In the Feb. 1 issue of The New England Journal of Medicine, David M. Nathan, a Harvard Medical School endocrinologist, noted that it was surprising that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan is a consultant for Novartis and other drug makers but not Merck.

There are several potential concerns about DPP-4 drugs, clear evidence has not turned up in clinical trials so far. The medicines could affect the immune system, because a receptor on immune cells is very similar to DPP-4. Merck says that Januvia was designed to bind only to the DPP-4 enzyme, reducing the chances of these side effects. Patients with impaired kidneys have more of the drug in their bloodstream and would be more likely to experience side effects.

DNA profiling Drug Disasters

Genomas has identified potential DNA markers for risk factors involved in diabetes-related metabolic side effects from treatment with common antipsychotic drugs. A day late and a few million dollars short, eh Eli Lilly?

The study found that DNA variations could predict a patient's likelihood for developing pre-diabetic side effects such as weight gain. Atypical antipsychotic drugs (AAPs) can induce diabetic symptoms in nearly one third of patients, most notably characterized by increased weight gain in some patients but not in others. However, the side effect profiles for these drugs even within the same drug class may differ, raising the possibility of drug-specific side effects.

Genomas develops systems for DNA-guided diagnosis and treatment of metabolic disorders induced by drugs in cardiovascular and psychiatric medicine. They have the capability to select the safest drug treatment for each patient. A company like Genomas has the right idea. The use of antipsychotic drugs is on the rise, with an estimated 14 million patients for which these drugs are increasingly being prescribed. AAPs are a dime a dozen. The million dollar question is which of these drugs is NOT the one for you?

A Shot in the Eye for Diabetic Retinopathy

Treatments that use tiny amounts of new drugs injected directly into the eye are having a dramatic impact on diabetic retinopathy, the most common cause of blindness in middle-age Americans. Excessive capillary growth and fluid leakage are the culprits that gradually erase vision in many diabetics. The problem arises when the retina - a high-energy tissue requiring much oxygen and nutrition doesn't get the blood it needs, so it sends out a chemical signal ordering blood vessel growth. The new vessels formed will ultimately leak, causing vision loss.

The treatment is shown to halt abnormal blood-vessel growth that gradually destroys the eye's light-sensing organ, the retina. Unlike macular degeneration, which erases central vision, diabetic retinopathy starts by ruining peripheral vision. The injections are given with tiny needles and require only a local anesthetic. Several trials were done to test the safety and efficacy of Macugen and another new eye drug, Lucentis, which is made by Genentech. So far, no major side effects from treatments with Macugen and Lucentis have been noted.

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