FDA recommended dose for certain sleep drugs containing zolpidem

13^th January, 2013, Hyderabad, India – The U.S. Food and Drug Administration  announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.

Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours. Since women eliminate zolpidem from their bodies more slowly than men, the FDA has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men. Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.

The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 milligrams (mg) to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products). These products are currently available on the market in both the higher and lower dosages.

“To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia,” said Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research. “Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate.”

In a Drug Safety Communication issued last Thursday, the FDA also reminded the public that morning impairment is not limited to zolpidem. Drowsiness is listed as a common side effect in the labels of all insomnia drugs, along with warnings that people may still feel drowsy the next day after taking one of these products. Moreover alertness can be impaired even in people who do not feel drowsy. 

People who are currently taking the higher doses (10 mg or 12.5 mg) of zolpidem-containing insomnia medicines should continue taking the prescribed dose as directed until discussing with their health care professional how to safely continue to take the medicine. Each patient and situation is unique, and the appropriate dose should be discussed with a health care professional. Patients should read the Medication Guide that comes along with their medication for additional information on the benefits and risks of these products.

“Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive,” said Dr. Unger. “Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”

The FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (nonprescription) drugs.  

Health care professionals and the public can report side effects from the use of zolpidem or other medicines to FDA’s MedWatch program.

FDA proposes new food safety standards for foodborne illness prevention and produce safety

5^thJanuary, 2013, Hyderabad, India – The U.S. Food and Drug Administration  proposed two new food safety rules that will help prevent foodborne illness. 

The proposed rules build on significant strides made during the Obama Administration, including the first egg safety rule protecting consumers from Salmonella and stepped up testing for E. coli in beef as well as existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow.

The rules follow extensive outreach by the FDA to the produce industry, the consumer community, other government agencies and the international community. Since January 2011, FDA staff have toured farms and facilities nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community.

“The FDA Food Safety Modernization Act is a common sense law that shifts the food safety focus from reactive to preventive,” said Health and Human Services Secretary Kathleen Sebelius. “With the support of industry, consumer groups, and the bipartisan leadership in Congress, we are establishing a science-based, flexible system to better prevent foodborne illness and protect American families.”

The burden of foodborne illness in the United States is substantial. One in six Americans suffer from a foodborne illness every year. Of those, nearly 130,000 are hospitalized and 3,000 die from their illness.Preventing foodborne illnesses will improve public health, reduce medical costs, and avoid the costly disruptions of the food system caused by illness outbreaks and large-scale recalls.

These two FSMA rules are part of an integrated reform effort that focuses on prevention and addresses the safety of foods produced domestically and imported, with additional rules to be published shortly.

The FDA is proposing that larger farms be in compliance with most of the produce safety requirements 26 months after the final rule is published in the Federal Register. Small and very small farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality. 

“The FDA knows that food safety, from farm to fork, requires partnership with industry, consumers, local, state and tribal governments, and our international trading partners,” said FDA Commissioner Margaret A. Hamburg, M.D. “Our proposed rules reflect the input we have received from these stakeholders and we look forward to working with the public as they review the proposed rules.”

Before issuing the two rules, the FDA conducted extensive outreach that included five federal public meetings and regional, state, and local meetings in 14 states across the country as well as making hundreds of presentations to ensure that the rules would be flexible enough to cover the diverse industries to be affected. The FDA also visited farms and facilities of varying sizes.

“We know one-size-fits-all rules won’t work,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system.”

Additional rules to follow soon include new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically produced food and accreditation standards to strengthen the quality of third party food safety audits overseas. Improving oversight of imported food is an important goal of FSMA. Approximately 15 percent of the food consumed in the United States is imported, with much higher proportions in certain higher risk categories, such as produce. The FDA will also propose a preventive controls rule for animal food facilities, similar to the preventive controls rule proposed today for human food.  

The FDA plans to coordinate the comment periods on the major FSMA proposals as fully as possible to better enable public comment on how the rules can best work together to create an integrated, effective and efficient food safety system.

FDA Approves Fulyzaq for Diarrhea in HIV/AIDS Patients

Fulyzaq for Diarrhea in HIV/AIDS Patients

5^thJanuary, 2013, Hyderabad, India – The U.S. Food and Drug Administration approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.

Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies. Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite. Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes and water in the gastrointestinal tract.

Derived from the red sap of the Croton lechleri plant, Fulyzaq is the second botanical prescription drug approved by FDA. A botanical drug product is often a complex mixture derived from one or more plant materials with varying degrees of purification. In 2006, the FDA approved the first botanical prescription drug, Veregen (sinecatechins), a treatment for external genital and perianal warts.

“Currently, there are no FDA-approved therapies for HIV-associated diarrhea,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition.”

Just as for other types of drugs, the safety and efficacy of a botanical drug product are established through clinical trials. In addition, manufacturers of a botanical drug product must ensure rigorous control of raw materials, and good agricultural and collection practices, together with analytical testing of the complex mixture.

The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapywith a history of diarrhea lasting one month or longer. The median number of daily watery bowel movements was 2.5 per day.  Patients who had diarrhea caused by an infection or a gastrointestinal disease were excluded from participating in the trials. Patients were randomly assigned to take Fulyzaq or a placebo twice daily.

The trial was designed to measure clinical response, defined as the number of patients who had two or fewer watery bowel movements weekly. Results showed that 17.6 percent of patients taking Fulyzaq experienced clinical response compared with 8 percent taking placebo. In some patients, a persistent anti-diarrheal effect was seen for 20 weeks.

Before treating patients with Fulyzaq, health care professionals should conduct proper testing to confirm the diarrhea is not caused by an infection or a gastrointestinal disease. Common side effects reported in patients taking Fulyzaq in the clinical trial were upper respiratory tract infection, bronchitis, cough, flatulence, and increased levels of the liver enzyme bilirubin.

Sky Rider" to be integrated within the DAP (Digital Army Program)

3^rdJanuary, 2013, Hyderabad, India –The Artillery Corps "Sky Rider" Unit is preparing to deploy a new UAS (Unmanned Aircraft Systems) which will introduce a significant improvement in its takeoff, flight and visual capabilities, transferring aerial footage of the situation directly to the battalion.  The system comprises a new version of "Skylark^@", the UAS operated by the Unit, and a new operating system called "Version 10", which will be integrated within the Unit in the coming days.

The Israeli Ground Forces have specified an objective by which Sky Rider soldiers recruited in November 2012, whose dedicated training will commence this March, will be trained to operate the new version of the system.  "The new version will be substantially better than the currently existing systems", said Sky Rider Commander, Lt. Col. Uri Gonen.  "Among other capabilities, it will provide a link between the new "Tamnoon" command and control (C2) system intended for the Unit and between the DAP (Digital Army Program) system, thus enabling the "Sky Rider" system to continuously operate in the "Massuah" environment", he added.  Once attached to the DAP, battalion commanders will be able to pinpoint UAS location on their screens and determine the area it is observing.

In addition to the presently operated regimental UAS, the Unit is currently involved in the development of an additional UAS for the Brigade level, along with the Department of Military Equipment and the Israeli Ground Forces' Technology Division, as well as the defense industries.  The approval of the development of this new UAS follows a "Sky Rider" flight trial that was held between the months of November 2011 to March 2012, examining the operational need for such a UAS.  "The aim is to create a force within the unit, platoon or company, which will operate in the brigade level", explained Lt. Col. Gonen.   This UAS will address more comprehensive visual needs suiting the activity of a brigade, as compared to a battalion, which examines a smaller area.  "I believe that this UAS' operational capabilities will be evident in the field within 18 months", he added.

Doing Business with Argentina: Trade, Tourism & Investment Opportunities

31^stDecember, 2012, Hyderabad, India –The Federation of Andhra Pradesh Chambers of Commerce & Industry (FAPCCI) in association with the Consulate General and Promotion Center of Argentina,Mumbai and EXIM Bank of India Organized an Seminar on “Doing Business with Argentina: Trade, Tourism & Investment Opportunities” on December 17, 2012 at FAPCCI, Hyderabad. Mr. Tomas Ferrari, Consul General of Argentina was the chief guest for this occasion. 

Mr. Devendra Surana, President, FAPCCI, Mr. A. Subrahmanyam, Deputy General Manager, EXIM Bank of India, Ms. Medha Sampat, Argentina Tourism Consultant (INPROTUR), Mr. T.V. Rao, representative of EXIM Bank of India, Mr. Shyam Sunder Pasari, Chairman, International Trade Committee, FAPCCI and Mr. M.V. Rajeshwara Rao, Secretary General, FAPCCI have participated at the interactive meeting. 

Addressing a Seminar His Excellency Tomas Ferrari, Consul General of Argentina

Speaking on the occasion Tomas Ferrari, Consul General of Argentina said, “inviting investments to invest Agri, Bio-Mass, coal, sugar, solar, soya and wine sectors. Argentina was the largest wine exporter worldwide and India was the largest consumer for it. The India and Argentina had set a trade target of $3 billion by 2012 from $1.3 billion in 2008. Indian exports to Argentina in 2008 amounted to $289.7 million, while Argentina’s exports to India were valued at $ 906 million. Chemical products account for about 40 % of India's total exports to Argentina, while edible oils constitute 75 % of total imports from Argentina”.