Workshop on PHARMACOVIGILANCE by CliniLife

CliniLife conducting a one day "WORKSHOP on PHAMRACOVIGILANCE " on 12-12-2010

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Diabetes drug Avandia gets heart warnings

The diabetes drug Avandia now comes with warnings in Canada about heart risks, the drug's manufacturer said Thursday.

Canadians taking Avandia should make an appointment with their doctor as soon as possible about their treatment because of the Type 2 diabetes drug's potential risks, but not stop treatment abruptly, GlaxoSmithKline said.

The company, in consultation with Health Canada, announced new restrictions on the use of drugs containing rosiglitazone, such as Avandia, in people with Type 2 diabetes.

Package warnings say the drugs may increase the risk of serious heart problems, including heart failure, chest pain, heart attack and fluid retention.

The drugs should not be used in people who have or have had heart problems. People should talk to their doctor about other options before using the drug.

Based on Health Canada's review of recent data suggesting a higher risk of heart-related problems in patients treated with Avandia, the company has updated information for consumers and health-care professionals, including new restrictions on using the drug.

The restrictions include:

Avandia, Avandamet and Avandaryl, brand names for rosiglitazone, are now indicated only in patients with Type 2 diabetes when all other oral medicines have not lowered blood sugar enough or are not appropriate.
Patients currently taking the drugs should make an appointment with their doctor as soon as possible to discuss their diabetes treatment.
Patients should not abruptly stop treatment based on these new restrictions, since stopping medications can cause poorer diabetes control with high blood-sugar levels.
Patients should discuss treatment options and the benefits and risks of rosiglitazone with their doctor and then complete an informed consent form.

Before filling in the form, doctors will ask patients to read the consumer information for the product, read and sign the form to show they understand the heart-related risks of the medication.

In September, the drug was taken off shelves in Europe while U.S. regulators restricted its use because of heart attack risks. At the time, the company said Health Canada was reviewing the proposed warning changes that are now in effect.

Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity and afflicts 200 million people worldwide. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.

Avandia helps sensitize the body to insulin.

Gujarat Drug Control Administration to recruit 60 drug inspectors soon

The government of Gujarat will be recruiting 60 new drug inspectors as part of its strengthening of the state Drugs Control Administration. The state public service commission has almost finished the selection process and the appointment will take place in three months' time, said H G Koshia, Commissioner, FDA, Gujarat.

The total number of drug inspectors in the state will thus rise to 102, which is the sanctioned strength for the total 25 districts. Currently, the state has only 42 drug inspectors and senior drug inspectors are assigned to do the work of drug inspectors in certain areas.

While speaking to this reporter, the Commissioner said his department has recently started district offices in six more districts with ADCs in charge of each district. Previously these districts were looked after by the officers of neighbouring districts. Thus all the districts in the state got district drug control offices.

Koshia said the shortage of inspectors happened because of a recent promotion given to 50 drug control officials to the rank of ADCs and senior drug inspectors. So the staff strength of inspectors came down to 42. Along with the forthcoming recruitment, the department will create two more posts of Joint Commissioner and four posts of deputy commissioner. Now the department comprises five Joint Commissioners, six Deputy Commissioners and one Assistant Commissioner. Out of these, five JCs, one JC is looking after the state Drug Testing Lab. He further said, in 2010, the government has recruited 192 staff members through promotion and direct recruitment.

According to the Commissioner, the state has three drug testing laboratories with modern facilities located in Baroda, Rajkot and Bhuj. The department has sent a proposal to the government for a new laboratory with state-of-the-art facilities to be established in Gandhinagar.

Gujarat has a total of 26659 drug traders including retailers, wholesalers and both, he said. The number of licensed retail shops is 13235 and wholesalers are 11003. There are 2421 traders dealing in both retail and wholesale. The number of blood banks is 145, out of which 50 are under the control of Government and Red Cross Society. The state faces no shortage of any group of blood and all the blood banks and blood storage centres have surplus stocks.

He said his department has made many reforms for the convenience of the public. Now any person from any part of the state can receive the license within 24 hours of filing the application. The ADCs in the district head quarters have been given charge for issuance of drug licenses.

Gujarat has 3270 manufacturing companies for generics. Thirty one units have US FDA facilities, 475 companies have WHO GMP facilities and 175 units comply state GMP norms, the Commissioner said.

Dehydration

INTRODUCTION:-Dehydration (hypohydration) is defined as an excessive loss of body fluid. It is literally the removal of water (Ancient Greek: ὕδωρ hýdōr) from an object, however in physiological terms, it entails a deficiency of fluid within an organism.There are three main types of dehydration: hypotonic or hyponatremic (primarily a loss of electrolytes, sodium in particular), hypertonic or hypernatremic (primarily a loss of water), and isotonic or isonatremic (equal loss of water and electrolytes).[1] In humans, the most commonly seen type of dehydration by far is isotonic (isonatraemic) dehydration which effectively equates with hypovolemia, but the distinction of isotonic from hypotonic or hypertonic dehydration may be important when treating people who become dehydrated

CAUSE:-There are many things that can cause dehydration, the most common are vomiting, diarrhea, blood loss, malnutrition, and plain old failure to replenish liquids lost from sweating and urination (Not drinking enough water). Many illnesses and diseases can trigger acute dehydration due to the increased body temperature and sweating that usually occur. This is why your doctor tells you to drink plenty of fluids when you are ill. Your body uses fluids to expel toxins as well as to keep your system flexible, lubricated and running smoothly

SYMPTOMS:-Symptoms of dehydration usually begin with thirst and progress to more alarming manifestations as the need for water becomes more dire. The initial signs and symptoms of mild dehydration in adults appear when the body has lost about 2% of it's total fluid. These mild dehydration symptoms are often (but not limited to): Thirst,Loss of Appetite, Dry Skin ,Skin Flushing DarkColoredUrine,Dry Mouth ,fatigue or Weakness ,Chills ,Head Rushes

DIAGNOSIS:-In humans, dehydration can be caused by a wide range of diseases and states that impair water homeostasis in the body. These include:External or stress-related causes Prolonged physical activity with sweating without consuming adequate water, especially in a hot and/or dry environmentProlonged exposure to dry air, e.g., in high-flying airplanes (5%–12% relative humidity)Blood loss or hypotension due to physical traum.Diarrhea,Hyperthermia,Shock (hypovolemic),Vomiting,Burns,Lacrimation

TREATMENT:-If dehydration is the removal of water from an object, then the treatment of dehydration to reverse its effects would logically be rehydration. When a person becomes dehydrated they have also lost electrolytes so it is very important to replenish them along with the water. The type of electrolytes needed for rehydration are sodium and potassium salts usually found in sports drinks like Gatorade and pediatric formulas like Pedialite. Electrolytes are needed for electro-chemical reactions within cells. A lack of electrolytes in the body can interfere with the chemical reactions needed for healthy cell operation and is known as water intoxication. This can become a serious condition and has lead to death in extreme cases.

PREVENTION:-The average person loses between two and three litres of water a day through the breath, sweat, and urine. This number can increase or decrease based on the types of activities that a person engages in. Heavy exercise can cause a body to lose more than 2 litres an hour! To prevent dehydration you simply need to replenish the liquids that are lost throughout the day. Many resources and sites will tell you to drink 8 glasses of water a day, or give you a set number of litres to drink but the honest truth is that every BODY is different and only you will know how much your BODY needs.