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Health ministry bans manufacture, sale of controversial anti-depressant drug Deanxit

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The Union health ministry has banned the manufacture and sale of the controversial fixed dose combination (FDC) of Flupenthixol and Melitracen for human use with immediate effect in the  country. The combination of Flupenthixol and Melitracen is an anti-depressant drug, sold as deanxit in India.

Now, therefore, on the basis of the recommendations of the Drugs Technical Advisory Board and in exercise of the powers conferred by Section 26A of the Drugs and Cosmetic Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution of the following drug with immediate effect “Fixed dose combination of Flupenthixol and Melitracen for human use”, the ministry in its notification, G.S.R. 498(E), said.

This is the second time the government is banning this drug. Earlier on June 18 last year, the health ministry had banned ‘deanxit’ in the country along with two other drugs–anti-diabetic drug pioglitazone and pain-killer drug analgin.

But immediately after the ministry’s notification, two writ petitions were filed in the Karnataka High Court by Bengaluru-based Lundbeck India and New Delhi-based Mankind Pharma. The petitioners contended that the studies made on the drug has proved its safety, efficacy and benefits.

However, the government contended before the court that melitracen is reported as not efficacious as a single agent in depression and use of flupenthixol is associated with potentially serious neurological side effects. Besides, the government contended that the combination drug is not permitted in USA, UK, Denmark, Canada, Japan and Australia.

After hearing both the parties, the court in its order dated August 14, 2013, quashed the ministry’s notification, and remanded the matter back to reconsider afresh by the government and take a decision one way or other in accordance with the law.

The ministry then asked the Drugs Technical Advisory Board (DTAB, a statutory body under the Drugs and Cosmetics Act, 1940, to examine the issue of suspension of manufacture and sale of the drug. After detailed examination in its 65th meeting on 25th November, 2013, the DTAB, highest authority in the union health ministry on technical matters, recommended that the use of the drug should be discontinued in the country.

On the recommendation of the DTAB, the health ministry has once again banned the controversial drug as “the Central Government was satisfied that the use of the drug ‘fixed dose combination of Flupenthixol and Melitracen’ for human use was likely to involve risk to human beings and whereas safer alternatives to the said drug are available’.

Source: PharmaBiz

Roche introduces fully automated urine testing system, cobas 6500

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Roche has launched cobas 6500, a fully automated urine testing system that consists of two modular analyzers combining urine strip testing and digital urinary microscopy. The system tests for 23 parameters to help diagnose diseases such as urinary tract infection, kidney disease, and diabetes.  The cobas 6500 offers the highest throughput on the market, ensures high-quality results and increases laboratory productivity significantly, while reducing manual steps and contamination risks for laboratory staff.

“At the moment, many manual steps are still required for urine analysis. With the cobas 6500 we can offer fully automated urine testing to laboratories, processing more than one thousand urine samples per day, which is significantly more than what can be done today,” said Roland Diggelmann, COO of Roche Diagnostics. “Building on our 50 years of experience in urine analysis, Roche Diagnostics is now entering digital microscopy for urine testing, bringing even higher-quality solutions to the laboratories. This enables laboratories to generate faster and more reliable results for the benefit of people’s health.”

The system will be available in in Europe, the Asia Pacific region, the Middle East, Africa and Latin America. Roche is also planning to submit an application for the approval of the cobas 6500 in the United States.

Urinalysis has been an important diagnostic tool for more than hundred years. Urine remains a key indicator of many diseases such as urinary tract infection, kidney disease and diabetes. Urinalysis can reveal serious damage that is asymptomatic in early stages yet treatable when identified in time. The urine test strip is a key diagnostic tool that yields quick and reliable information on pathological changes in the urine. Its diagnostic significance lies primarily in first-line diagnosis, screening during routine or preventive examinations, and treatment monitoring.

The cobas 6500 consists of two modular analysers: The urine test strip analysis module quickly tests for the risk of diseases such as kidney disease and urinary tract infection. The second module replaces the manual steps involved in urine microscopy and allows for fully automated quantification and classification of urine particles such as blood cells by digital microscopy. The unit significantly speeds up the microscopy process with as many as 116 test samples per hour, while eliminating variability of test results, driving standardisation. For flexible use, the two modules can be operated separately or together as a single platform.

Source: PharmaBiz

USFDA – Sometimes Drugs and the Liver Don’t Mix

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human liver

The liver is a remarkable, if underappreciated, organ. It turns the nutrients in our diets to substances the body can use and converts toxins into harmless substances or makes sure they are removed from the body

When the liver is working well, our metabolism hums along in equilibrium. But drugs and dietary supplements can sometimes wreak havoc with that system, leading to dangerous liver problems. The Food and Drug Administration (FDA) is working to prevent drug-induced liver injuries.

“Any drug may cause dangerous liver problems but, fortunately, such problems only occur rarely,” says John R. Senior, M.D., an FDA gastrointestinal medical reviewer and consultant in hepatology, which includes study of the liver. “It is challenging to predict how drugs will affect the liver because each patient is different in how they respond to a given drug. Our goal is to prevent the toxicity of drugs.”

Acute liver failure is a rapid deterioration of the organ’s ability to function. Data suggest that prescription and over-the-counter drugs (OTC) and dietary supplements cause more acute liver failure cases than all other reasons combined.

FDA has identified several instances of liver damage caused by dietary supplements. For example, the agency has issued public health warnings and sent warning letters to companies marketing supplements for weight loss and muscle building. In one instance, a Texas-based company agreed to recall and destroy certain dietary supplement products after discovering a link between the supplement and cases of liver failure and non-viral hepatitis.

No Easy Way to Identify the Vulnerable

Finding even a few cases of serious liver toxicity in clinical trial subjects exposed to a drug can be a reason for discontinuing the trial. Also, cases of serious liver toxicity have prompted FDA to request sponsors to withdraw their approved drugs from the market.

Senior explains there’s no easy way to identify the people who might be vulnerable. “The drug-disease relationship is not so simple,” he says. “Identifying drugs that may cause liver injury only solves half the problem. The other half: Drugs that appear to be safe in pre-clinical studies still may be harmful to some patients.”

Meanwhile, we have an aging population that is more dependent on drugs. “The more medications you take, the more likely you are to have trouble,” Senior says.

A few drugs are toxic to the liver only when used in excess. One example is acetaminophen.

“Acetaminophen when used as labeled is generally considered to be safe. But overdoses of acetaminophen are the most common cause of drug-related liver injury, whether these occur accidentally or otherwise,” says Mark Avigan, M.D., a medical reviewer at FDA with a background in gastroenterology and hepatology. “With acetaminophen overdoses, some people get a more severe reaction than others.”

Acetaminophen is an active ingredient in hundreds of OTC and prescription medicines commonly used to treat musculoskeletal pain and fever, allergies, coughing, colds, flu, and even sleeplessness. Overdoses leading to serious liver injury have resulted from consumers inadvertently taking both OTC and prescription drugs containing acetaminophen.

Inadvertent overdoses with prescription drugs that contain acetaminophen and a narcotic have been responsible for a significant proportion of all the cases of acetaminophen-related liver failure in the United States, some of which have resulted in liver transplant or death.

FDA has taken steps to keep consumers safe. In early 2014, FDA requested withdrawal of over 120 applications for combination prescription acetaminophen drug products containing more than 325 mg acetaminophen per dosage unit. The agency also has reminded pharmacists and physicians to stop prescribing and dispensing combination prescription acetaminophen products containing more than 325 mg. It is FDA’s understanding that as a result, all manufacturers have discontinued marketing combination prescription drug products that contain more than 325 mg of acetaminophen.

Some antibiotics and nonsteroidal anti-inflammatory medications also have been tied to liver damage.

Hepatitis, a liver inflammation, can have several potential causes. Drugs may induce a form of hepatitis that closely resembles viral hepatitis (liver inflammation caused by viral infection).

Signs and Symptoms

How can you recognize the signs of liver problems?

Avigan says you might feel tired and have a poor appetite. In more extreme cases, your eyes and skin become yellowish (jaundice) and your skin becomes very itchy. “Your skin itches because the liver is not properly clearing toxins from the body,” he says.

When patients taking a drug they have not used before get those symptoms, they should seek immediate medical attention and stop using that drug if it is identified as the cause, Avigan cautions.

If the symptoms surface and the patient has been taking a medication for a long time, there could be another cause. Senior says it’s difficult to be certain that the symptoms were caused by a drug and not something else. Obesity and excessive consumption of alcohol also can damage the liver.

Considering Risks and Benefits

Patients should discuss the risks and benefits of any drug with their doctors when they start treatment, Avigan says. They should also discuss dietary supplements with their clinician before taking them.

Some life-saving drugs are the only options for very sick patients.

“Before approving or denying approval of a drug, we evaluate its risks and work to identify its liver injury potential, even if only one in 10,000 people will be badly affected,” Avigan says. “With some drugs, for example for cancer patients, the benefits of treatment might far outweigh the risks.”

The liver can regenerate even when 65% of it is destroyed or surgically removed, as in a cancer treatment. This versatile organ is often capable of adapting and becoming tolerant of various foreign agents, including drug products. But if the liver isn’t healthy, complications from drug interactions can be even worse.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Source: PharmaBiz

India, US to begin bilateral collaborative research partnerships on diabetes

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Both India and the US will soon begin bilateral collaborative research partnerships (CRPs) on diabetes research to advance science and technology important to understanding, preventing, and treating diabetes and its complications through the collaborative efforts of Indian and US investigators and their institutions.

The collaboration of India and the US on diabetes is significant as in both the nations, diabetes is striking increasingly in younger age groups, with potentially devastating implications for the health, well-being, and productivity of future generations. To reduce both the human toll and the societal burden of diabetes in both countries, affordable, practical, and effective approaches and technologies for preventing and managing diabetes and its complications are urgently needed.

Specific areas of interest for this programme include studies that may address or be focused within one or more of the broad research areas such as prevention and management of diabetes or its complications; pathogenesis and pathophysiology of diabetes and its complications; diabetes in youth; innovative technologies for management and prevention of diabetes and/or its complications; and gestational diabetes.

The CRP must be based on interactive relationships that maximise the expertise of the individual Indian and US research teams and interactions between their parent institutions and granting agencies. It is expected that the unique opportunity available through the India-US collaborative research programme will foster collaborative partnerships that may subsequently mature and expand beyond the scope of the work proposed in current application. It is anticipated that some of these partnerships will also be relevant to translation into public health activities in India and/or the United States.

Indian and US collaborating investigators should work together to develop and submit corresponding applications to ICMR and NIH. Indian investigators will respond to this announcement from ICMR and US investigators will respond in parallel to a separate funding announcement from the NIH.

Indian and US investigators seeking support for a collaborative research partnership under this programme are instructed to submit their proposals to the respective agencies not later than 18th September 2014.

Source: PharmaBiz

FDA Takes Final Step on Infant Formula Protections

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The Food and Drug Administration (FDA) oversees manufacturers of infant formulas and helps ensure that these products are safe and support healthy growth in infants who consume them.

In keeping with that mission, FDA announced on June 9, 2014 that it is finalizing a rule—first published as an interim final rule on February 10, 2014—that sets standards for manufacturers of infant formula. In light of comments received after the interim rule published, the final rule provides some modifications and clarifications, and sets a date of September 8, 2014 for manufacturer compliance.

Under the final rule, standards include:

  • Current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter.
  • A requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth.
  • A requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products shelf life.

“FDA sets high quality standards for the safety and nutritional quality of infant formulas during this critical time of development,” says Stephen Ostroff, M.D., FDA’s acting chief scientist.

The final rule applies only to infant formulas intended for use by healthy infants without unusual medical or dietary problems. The agency notes that many companies now manufacturing infant formula for the U.S. market have been producing safe products and have voluntarily applied many of the current good manufacturing practices and quality control procedures included in the final rule. But this rule will set in place federally enforceable requirements for the safety and quality of infant formula.

FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements, which are not changed by the new rule. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula.

FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. FDA also inspects new facilities. If FDA determines that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

Products on the Market

While breastfeeding is strongly recommended and many mothers hope to breastfeed their infants, most infants in the U.S. rely on infant formula for some portion of their nutrition. An estimated 1 million infants in the United States are fed formula from birth, and by the time they are three months old, about 2.7 million rely on formula for at least part of their nutrition.

Infant formula comes in three forms:

  • Powder—the least expensive of the infant formulas. It must be mixed with water before feeding.
  • Liquid concentrate—must be mixed with an equal amount of water.
  • Ready-to-feed—the most expensive form of formula that requires no mixing.

The protein source varies among different types of infant formula.

FDA’s nutrient specifications for infant formulas are set at levels to meet the nutritional needs of infants. In addition, formula manufacturers set nutrient levels that are generally above the FDA minimum requirements. Thus, babies fed infant formulas do not need additional nutrients unless they are fed a low-iron formula.

The infant formulas currently available in the United States are either “iron-fortified”—with approximately 12 milligrams of iron per liter—or “low iron”—with approximately 2 milligrams of iron per liter. The American Academy of Pediatrics (AAP) recommends that formula-fed infants receive an iron-fortified formula as a way of reducing the prevalence of iron-deficiency anemia.

Safety Issues

  • Formula preparation. In most cases, it’s safe to mix formula using ordinary cold tap water that’s boiled for one minute and cooled. Remember that formula made with hot water needs to be cooled quickly to body temperature—about 98 degrees Fahrenheit—if it is to be fed to the baby immediately. If the formula is not being fed immediately, refrigerate it right away and keep refrigerated until feeding.
  • Bottles and nipples. The Mayo Clinic says you may want to consider sterilizing bottles and nipples before first use. After that, you can clean them in the dishwasher or wash them by hand with soapy water.
  • Water. Use the exact amount of water recommended on the label.
  • Formula warming. This isn’t necessary for proper nutrition. The best way to warm a bottle of formula is by placing the bottle in a pot of water and heating it on the stove until warm (at body temperature). Never use microwave ovens for heating infant formulas. Microwaving may cause the bottle to remain cool while hot spots develop in the formula. Overheated formula can cause serious burns to the baby.
  • Use by” date. This is the date after which a package or container of infant formula should not be fed to infants. It indicates that the manufacturer guarantees the nutrient content and the general acceptability of the quality of the formula up to that date. FDA regulations require this date to be specified on each container of infant formula.
  • Storage. Manufacturers must include instructions on infant formula packaging for its handling before and after the container is opened. They must also include information on the storage and disposal of prepared formula.
  • Freezing formula. This is not recommended, as it may cause a separation of the product’s components.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Source: PharmaBiz