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Looking Good: Safe Use and Care of Contact Lenses

Approximately 30 million U.S. contact lens wearers use a variety of lens care products available in most pharmacies. Contact lenses may provide better vision and more freedom of movement for some users, but improper care and cleansing of these products can cause serious eye infections. Because pharmacists are frequently consulted by patients on health care issues, they should be aware of the following: CONTACT LENS WARNING

  1. Types of contact lenses and lens care products
  2. Proper cleaning of soft contact lenses
  3. Eye infections from contact lens care products
  4. FDA’s strategies for reducing risks of eye infections
  5. Tips for counseling consumers

Soft lenses are the culprits

There are two main kinds of contact lenses: soft and gas permeable. Soft contact lenses are made of a plastic polymer and contain at least 10% water. They contribute to more eye infections than rigid or gas-permeable contact lenses. Wearers of these lenses are at a greater risk of developing eye infections and corneal ulcers. These conditions can develop quickly—usually within 24 hours of exposure to the offending agent; they can be very serious and, in rare cases, cause blindness. Educating patients about the importance of proper lens care can help reduce the risks of eye infections.

The numerous contact lens care systems sold in the United States comprise four basic types: heat, chemical plus saline, peroxide, and multipurpose. The evolution of contact lens care systems, starting in 1973 with heat disinfection, has progressed to multipurpose contact lens care systems, which were introduced in 1995; heating units for heat disinfection are no longer readily available. Multipurpose products are those that can be used to clean and disinfect using one lens care product. Multipurpose contact lens solutions are the dominant disinfection method used by contact lens wearers today.


Proper cleaning is essential

Standard daily-wear soft contact lenses should be cleaned daily. Several professional groups that represent optometrists and ophthalmologists recommend rubbing each lens in the palm of the hand with a few drops of solution, even if using a “no rub”[1] product. James Saviola, OD, of the Division of Ophthalmic and Ear, Nose, and Throat Devices in the FDA’s Center for Devices and Radiological Health, which regulates contact lenses and lens care products as medical devices, stated, “FDA recommends that consumers rub and rinse contact lenses as directed by their eye care professionals.” The center requires manufacturers to conduct testing and obtain clearance from the agency before marketing these products.

After the lenses have been cleaned with the recommended solution, they should be rinsed for the specified length of time on the package insert and then placed in a clean case or lens holder filled with fresh disinfecting solution. Disinfection time varies from product to product, so check the package for details. Cleaning removes eye-produced protein, calcium build-up, and other debris, such as cosmetics. Disinfecting kills microorganisms on the contact lens. Some optometrists and ophthalmologists recommend a protein remover for specific kinds of contact lenses or for those patients whose eyes produce more than the average amount of protein. Typically, protein removal is necessary for contact lenses that are worn between 6 months and 1 year. Disposable contact lenses rarely need the addition of a protein remover.


Beware of eye infections

Improper care of contact lenses can lead to a variety of eye infections including infectious keratitis. Experts in the eye care field agree that estimated rates of microbial keratitis in the contact lens–wearing population has not substantially declined since the first disinfection method using heat, despite the evolution of contact lens disinfection systems. Risk factors associated with an increased risk for eye infections include inadequate hygiene, noncompliance with schedules for wearing contact lenses or contact lens care systems, and contamination of contact lens materials.

Over the past 3 years, there have been two major outbreaks of eye infections, both associated with a single brand of contact lens multipurpose care systems. In 2006, there was an outbreak of Fusarium keratitis, which is a rare but serious eye infection caused by a fungus. The implicated product was recalled and is no longer sold although it performed well in the tests FDA required prior to the product being cleared for marketing.

An outbreak of Acanthamoeba keratitis occurred in 2007; this is another rare but serious eye infection caused by a parasite commonly found in nature. It is one of the most painful and debilitating corneal infections. Patients could lose their eye as a consequence of the infection. It can cause permanent loss of vision that can require corneal transplants, a surgical procedure to replace the clear outer covering of the eye. Contact lens wearers represent 90% of A. keratitiscases. It is estimated that the U.S. incidence of this infection is between 1.49 and 2.01 cases per million per year. Corneal transplantation has a 15% to 20% occurrence rate during the course of the infection, and 15% to 20% of these infections result in corneal transplants.

The contact lens solution that caused this outbreak was not tested against the Acanthamoebaorganism because it had not been part of the current panel of organisms. These outbreaks led FDA to convene a meeting of the Ophthalmic Devices Advisory Committee in June 2008, to re-assess current guidance recommendations for testing multipurpose contact lens care products before issuing FDA marketing clearance.


FDA works to reduce risks of eye infections

FDA CONTACT LENSThe unexpected keratitis outbreaks prompted FDA to explore the various risk factors involved with using multipurpose contact lens solutions. In both outbreaks, FDA’s investigation revealed that reusing previously used solution and adding to it fresh, unused solution reduced the antimicrobial effectiveness of the lens care product. Therefore, FDA recommended that contact lens care solution should be emptied out of the contact lens case after each use. The solution left over in the contact lens case after a disinfection cycle is “dirty,” said Bernard Lepri, OD, MS, MEd, of the Division of Ophthalmic and Ear, Nose, and Throat Devices in the FDA’s Center for Devices and Radiological Health. Lepri stated, “The left-over solution can have little disinfecting chemical left to kill bacteria and other micro-organisms that may contaminate your contact lenses and lead to serious eye infections. The solution no longer has the same effectiveness for disinfection as when it was freshly placed in the case.”

On June 10, 2008, FDA sought additional input from the Ophthalmic Devices Advisory Panel on the preclinical and clinical tests and labeling for multipurpose contact lens care products. The discussions at the panel meeting supported FDA’s assessment that the current microbiological preclinical tests be updated to better evaluate the activity of contact lens care products againstAcanthamoeba and performance criteria for new or modified disinfection efficacy test methods that simulate real-world, worst-case use conditions.

Based on the recommendations of the advisory panel and a request from the ophthalmic community, the Microbiological Testing of Contact Lens Care Products Workshop convened on January 22–23, 2009, with the goals of reaching consensus on these issues. Data presented at the workshop revealed that multipurpose contact lens solutions can have a profound effect in either prohibiting or promoting the two previously described and usually rare infections. These findings differed from data previously presented in 2006 which identified the usual risk factors of poor patient hygiene practices, non-compliance with wearing regimens and lens materials as the causes of the increase in infectious keratitis.

The FDA workshop participants found that the lack of compliance to proper contact lens care procedures and improper patient hygiene practices did not change the incidence of the Fusariumoutbreak. Neither lens rubbing nor hand washing had a protective effect during either outbreak.

As a general rule, rubbing and rinsing contact lenses are beneficial in removing protein deposits and microorganisms, but it is not the only contributing factor to antimicrobial efficacy. To further protect consumers against eye infections, workshop participants made the following additional recommendations for lens care product labeling and directions for use:

  1. Contact lens solution manufacturers should include a discard date on their products in addition to the usual expiration date.
  2. Consumers should never use expired products.
  3. Contact lens wearers should rub and rinse their lenses for added effectiveness of cleaning and disinfection.

Counseling tips for Pharmacists

Pharmacists play a key role in patient education as it relates to contact lens care and safe use. Their knowledge of contact lenses and contact lens products is crucial in delivering accurate information to consumers. Pharmacists can advise patients of the following:

  1. Do not top off used lens cleaning solutions or reuse them.
  2. Use a contact lens solution to clean and rinse; then air dry contact lens cases after each use.
  3. Rub and rinse contact lenses for added effectiveness of cleaning and disinfection.
  4. Do not expose contact lenses or lens storage cases to any type of water or other non-sterile solutions.
  5. Do not use contact lens solutions beyond their expiration date.
  6. Consult an eye care professional in the event of eye irritation or infection.

Information on contact lenses and contact solutions

Information on the Advisory Committee Meeting

—Helene D. Clayton-Jeter, OD

By: Helene D. Clayton-Jeter, OD, is a member of the Health Professionals Liaison Program in the FDA Office of Special Health Issues. She acknowledges the help of Janelle Derbis, PharmD, Health Programs Coordinator, and Brenda L. Evelyn, SBB (ASCP), Deputy Director, Office of Special Health Issues, FDA; and Jim Saviola, OD, Office of the Center Director, Center for Devices and Radiological Health, FDA.

[1] No rub means rinsing instead of digitally rubbing the contact lens with a multipurpose solution; this is a passive type of cleaning.

Source: FDA [link]

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FDA Drug Safety : Withdrawal of Products that Contain Propoxyphene

On November 19, 2010 the Food and Drug Administration issued a drug safety communication about the withdrawal of products that contain propoxyphene.FDA has concluded that the safety risk of products that contain propoxyphene outweigh their limited benefits for pain relief at recommended doses. The Agency will ask companies to withdraw these products from the United States market.

Propoxyphene is an opioid pain medication used to relieve mild to moderate pain; it has been marketed in approved drugs since 1957. Propoxyphene is sold under various names as a single-ingredient product such as Darvon and as part of a combination product with acetaminophen, such as Darvocet.
FDA’s recommendation to withdraw propoxyphene is based on new data that shows when propoxyphene is taken at approved doses, there are significant changes to the electrical activity of the heart. These changes can increase the risk for serious abnormal heart rhythms.

FDA recommends that consumers taking products that contain propoxyphene should:

  • Talk to their healthcare professional about discontinuing propoxyphene and switching to alternative pain medicines.
  • Contact their healthcare professional right away if they experience an abnormal heart rate or rhythm or other symptoms including dizziness, lightheadedness, fainting or heart palpitations.
  • Dispose of unused propoxyphene by following recommendations outlined in the Federal Drug Disposal Guidelines.

FDA recommends that healthcare professionals:

  • Stop prescribing and dispensing propoxyphene-containing products.
  • Contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug.
  • Inform patients of the risks associated with propoxyphene.
  • Discuss alternative pain management strategies other than propoxyphene with patients.
  • Be aware of the possible risk of cardiac conduction abnormalities in patients taking propoxyphene and assess patients for these events if they show signs or symptoms of arrhythmia.

FDA urges healthcare providers and patients to report any adverse events or side effects that may be associated with the use of propoxyphene-containing products to FDA’s MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at Web site www.fda.govdrugs

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Antibiotics Resistance and know about Antibiotic

Antibiotics are drugs used for treating infections caused by bacteria. Also known as antimicrobial drugs, antibiotics have saved countless lives.Misuse and overuse of these drugs, however, have contributed to a phenomenon known as antibiotic resistance. This resistance develops when potentially harmful bacteria change in a way that reduces or eliminates the effectiveness of antibiotics.

Antibiotics Fight Bacteria, Not Viruses

Antibiotics are meant to be used against bacterial infections. For example, they are used to treat strep throat, which is caused by streptococcal bacteria, and skin infections caused by staphylococcal bacteria.

Although antibiotics kill bacteria, they are not effective against viruses. Therefore, they will not be effective against viral infections such as colds, most coughs, many types of sore throat, and influenza (flu).

Using antibiotics against viral infections

  • will not cure the infection
  • will not keep other individuals from catching the virus
  • will not help a person feel better
  • may cause unnecessary, harmful side effects
  • may contribute to the development of antibiotic-resistant bacteria

Patients and health care professionals alike can play an important role in combating antibiotic resistance. Patients should not demand antibiotics when a health care professional says the drugs are not needed. Health care professionals should prescribe antibiotics only for infections they believe to be caused by bacteria.

As a patient, your best approach is to ask your health care professional whether an antibiotic is likely to be effective for your condition. Also, ask what else you can do to relieve your symptoms.

Follow Directions for Proper Use

When you are prescribed an antibiotic to treat a bacterial infection, it's important to take the medication exactly as directed. Here are more tips to promote proper use of antibiotics.

  • Complete the full course of the drug. It's important to take all of the medication, even if you are feeling better. If treatment stops too soon, the drug may not kill all the bacteria. You may become sick again, and the remaining bacteria may become resistant to the antibiotic that you've taken.
  • Do not skip doses. Antibiotics are most effective when they are taken regularly.
  • Do not save antibiotics. You might think that you can save an antibiotic for the next time you get sick, but an antibiotic is meant for your particular infection at the time. Never take leftover medicine. Taking the wrong medicine can delay getting the appropriate treatment and may allow your condition to worsen.
  • Do not take antibiotics prescribed for someone else. These may not be appropriate for your illness, may delay correct treatment, and may allow your condition to worsen.
  • Talk with your health care professional. Ask questions, especially if you are uncertain about when an antibiotic is appropriate or how to take it.

It's important that you let your health care professional know of any troublesome side effects. Consumers and health care professionals can also report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at MedWatch.

Source: FDA

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On Friday 12 November 2010, Kerala High Court Division bench comprising justice C N Ramachandran Nair and justice K Surendra Mohan issued the direction to stop practise by those in government service going on long leaves by asking the government to terminate their services and employ others. The order was issued by the bench while dismissing a writ appeal by Jainamma K Joseph, an Indian citizen of Kerala state, who was a nurse in government service and was employed in Saudi Arabia. When she applied for further leave after 10 years of long leave, the government rejected her plea following which she approached the high court. Honorable Court upheld the government action and filed appeal dismissed.

WorkThis post is an Off topic, guest post by an Indian Pharmacist working in Ministry of Health, Saudi Arabia

imageKerala State Government asked Advocate Generals opinion in the matter, to analyze the Court Order and to suggest steps to implement the order.

This order, may create huge impact in the Government Sector of Kerala State. Approximately, 30000 Government employees are working abroad in different countries. Terminating all of them will create a huge vacancies especially in healthcare sector. This will be a blessing for all those who are still remaining unemployed.Government also will get benefitted by denial of Pension money upon termination.

If Kerala Government show such a bold step, then other State Government may also follow this. After several salary revisions, the most of the State Governments salaries are  now almost half of the pay in Gulf Countries.

A recent survey have shown that  many Indians who are already Indian Government staff but working in Gulf countries have same salary scale in India also. Most of such staff keeping their Indian Government just for the sake of getting Pension. Many posts in Kerala Government are now vacant due to this situation. Staff enter into long leave and Government is not able to fill the post because of the uncertainty whether the staff will join back or not.

Terminating staff on long leave is not a final solution for this. Instead of that, Government may consider temporary filling of those vacant posts and partial pension system for those on long leave.


UCC was established in 1845 as one of three Queen’s Colleges at Cork, Galway and Belfast.  The site chosen for the college is particularly appropriate given its connection with the patron saint of Cork, St Finbarr.  It is believed his monastery and school stood on the bank of the river Lee, which runs through the lower grounds of the university.  The University’s motto is  ‘Where Finbarr Taught, let Munster Learn.’ If you are interested in applying to University College Cork as a postgraduate international student, we advise that you initially determine your status, as either a non-EU applicant or an EU applicant.  You can do this by clicking on the following link: Am I an EU or a Non-EU Student?.

To apply as a Non-EU applicant please follow the following links:

How Do I Apply to Taught Programmes?

How Do I Apply to Masters by Research and PhD's?

View of UCC Main Gates' BridgeCollege of Medicine and Health
PAC Course Code: CKX03
Qualification: MSc
Duration:  2 years part-time by Distance Learning   
EU Fees: The 1 year part-time EU fee for this programme in 2010/2011 is €3,850.00. A similar fee will be payable in the second year of the programme in 2011/2012.

Entry Requirements (Pathway I)

  • Students must hold a primary pharmacy degree from a School of Pharmacy that is approved by the Programme Committee.
  • They must be registered with the professional accreditation authority in the country in which they are practising.
  • Ideally candidates should have practical experience in their area of qualifications of at least two years post-registration.
  • All students will be required to have full access to computer and internet facilities and to be computer literate.
  • Students must be employed by an approved hospital and must have a letter of consent from the hospital of employment before registration.
  • In some exceptional circumstances candidates, who by virtue of their training and experience, may, at the discretion of the Programme Director and the Head of School, be deemed suitable for entry to the degree.

Entry Requirements (Pathway II)
In addition to the above:

  • The Programme Management Committee may permit graduates holding a Postgraduate Diploma (equivalent to Level 9 award) in Clinical Pharmacy from an appropriately accredited School of Pharmacy to enter a one-year programme. To be considered for entry to this programme, candidates must have completed their Clinical Pharmacy Diploma no more than five years prior to the date of registration for this programme.
English Language Requirements:

IELTS 6.5 or TOEFL equivalent

Programme  (Pathway I)

Year I
Students take 30 credits as follows:
PF6001 Biostatistics/Critical Appraisal (5 credits)
PF6009 Pharmacotherapy I (15 credits)
PF6010 Pharmacology, Therapeutics and Rational Use of Drugs (10 credits)

Year II
Students take 30 credits as follows:
PF6005 Pharmacoeconomics (5 credits)
PF6006 Pharmacotherapy II (15 credits)
PF6007 Pharmacotherapy III (10 credits)

Upon completion of the above 60 credits students may opt to be conferred with a Postgraduate Diploma in Clinical Pharmacy, or may complete a research project/thesis (PF6008 Thesis 30 credits) to be conferred with the MSc in Clinical Pharmacy.

Programme Requirements (Pathway II - one year only)
Students take 45 credits as follows:
PF6001 Biostatistics/Critical Appraisal (5 credits)
PF6007 Pharmacotherapy III (10 credits)
PF6008 Dissertation (30 credits)


Further Information:

School of Pharmacy
University College Cork
Tel: (021) 4901662


Our blog also, pays much hearty thankfulness to His Majesty for all the support and kindness offering to the civilians. As we have seen in, Royal Grant has been announced. As in the source website,

Two basic salaries for grade 4 and below, one for grade 3 and above - MUSCAT — On the occasion of the 40th glorious National Day, His Majesty Sultan Qaboos has awarded a Royal grant for employees at the state administrative apparatus and pensioners among government employees. This came in a statement issued by the Diwan of the Royal Court.
The Royal grant is as follows:
One basic salary for Omani civilians who are occupants of the third financial grade and above — at the Civil Service schedule of grades and its equivalent at the other service systems — and military personnel from the rank of 1st lieutenant and above. Two basic salaries for Omani civilians who are occupants of the fourth financial grade and below — at the Civil Service schedule of grades and its equivalent at the other service systems — and military personnel from the rank of 2nd lieutenant and below.
Financial grants equivalent to 40 per cent of the pension salary for pensioners among government civil and military employees. The Diwan of the Royal Court took the opportunity to express best wishes for His Majesty the Sultan on the occasion.

Source of the above news.

Free Online Continuing Education Courses for Pharmacists

Many Pharmacists asked me ways to get updated by Continuing Education Programs.  Most of them are attending some useless old topic based CPE, which they believe will do no help to their job. I suggest all Pharmacists to undergo some online Continue Education Courses specially designed for health workers. Some course are free of cost but some others are not. Select according to your desired topic, and attend the Course and Test online.

CONTINUE EDUCATION PROGRAMRxSchool is such a website where you had to register free to get a login and then attend continuing education courses of your choice.   RxSchool is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Here in this post, I am providing you some links for Free Online Continuing Education Courses. 


Happy dispensing…

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Job of Pharmacist - Boots - Abu Dhabi

M.H. Alshaya Co. is a leading international franchise operator for over 55 of the world's most recognized retail brands, including Starbucks, H&M, Mothercare, Debenhams, American Eagle, Pottery Barn, Pottery Barn Kids, P.F. Chang's, Office Depot and Boots. The company operates 1,800 stores across 7 divisions: Fashion & Footwear, Health & Beauty, Food Services, Optics, Pharmaceuticals, Office Supplies and Home Furnishings. At Boots, Pharmacists are required to manage the store and all functions related to the pharmacy. At all times, the best interests of the patient should be considered and the advice given by the pharmacist must reflect this. You need to understand and develop your understanding of the local practices and customer expectations in the UAE and Abu Dhabi in particular.



Division: Pharmacy

Brand: Boots
Country: United Arab Emirates

Location: Abu Dhabi (U.A.E.)
Closing Date: 31-Dec-2010



  • Responsible for providing customers with safe, legal and effective pharmaceutical service.
  • Decide how best to sustain legal and ethical requirements and best treatment available.
  • To develop the effectiveness of the operation of the pharmacy by highlighting areas of current practice where improvement may be gained.

Skills & Experience:

  • Ministry of Health certification is required. If you do not possess the UAE MoH Certificate it is possible you could be employed as a Pharmacist on condition that you pass the MoH (UAE) exam (sitting November).
  • UAE experience preferred though if you have 2 years or more experience as a Pharmacist in another Middle East country this will be acceptable.
  • Staff management experience is preferred.

Note: you will be required to attach the following:
1. Resume / CV

Apply Now


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King Khaled Eye Specialist Hospital (KKESH) is a tertiary care ophthalmic facility operated by the Ministry of Health (MOH) of the Kingdom of Saudi Arabia. The hospital provides quality tertiary ophthalmic care to the patients it serves and promotes the delivery of Kingdom-wide ophthalmic care through its outreach, educational, and research programs. There are many vacancies available in KKES hospital, in various departments. As their website announces, the vacancy of Pharmacist and the details are given below.


Post of Job: Pharmacist I


  • Bachelor Degree in Pharmacy from an accredited University (Essential).
  • Minimum of four (4) years experience working in a capacity of a Pharmacist in health care/hospital setting.
  • Demonstrates full understanding of new trends, practices, skills, and techniques of pharmacist job and stay current and updated (Essential).
  • Computer literate and familiar in the use and application of MS Office program (Essential).
  • Fluent in oral and written English (Essential).

Employment Type :  Contract

How to Apply:

Please complete and send your application form specifying the position to which you are applying, along with an up-to-date curriculum vitae, to one of the following addresses:

Fax:  +966-1-482 1908
Mail: Recruitment Office
         Human Resources Department
         King Khaled Eye Specialist Hospital
         PO Box 7191
         Riyadh 11462
         Kingdom of Saudi Arabia

Your application will be reviewed and qualified candidates will be contacted with further instructions. You will be advised of the progress of your application by telephone, e-mail, fax, or letter, or through your recruitment agent.

Your application will be valid for 1 year.

Application Form (Microsoft Word , 248 KB)

Prepare effective Cough Syrup at home

After the suggestion of various medical authorities in different countries to withdraw cough syrups, cough expectorants and other cough preparations (contains so-called cough relieving allopathic medicines), people are in big confusion to find an alternative for treating cough. Here in this post we are trying to suggest you an effective natural cough syrup that can be prepared in your home by yourselves. Please remember to maintain clean conditions while preparing this instant cough syrup. This natural ginger-honey cough syrup is indicated for Cough, both dry and productive, mild throat infections and throat inflammation.

How to prepare natural cough syrup

Ingredients required:

1. Fresh natural Ginger: 100 gm Clean the surface properly and then remove the external skin and grate it into small pieces as shown in the picture.



2. Natural Honey : One table spoon, 15 ml




Take the grated pieces of Ginger, place it into a clean glass bowl and add 5 ml of cool water. (previously boiled and kept on room temperature to cool). Then crush the Ginger pieces and extract out full juice from Ginger. Use a clean fine sieve to remove fibers from the Ginger juice. Keep that filtered Ginger juice in a clean bowl.

Now mix two table spoon full of Ginger juice with one tablespoon full natural honey. Mix well. the color will become  similar to the picture given below.



That's all. Your Ginger Honey cough syrup is ready. Now for adults, consume 10 ml three or four times daily and for children aged between 2-12 can consume 5 ml 3-4 times daily. Under two years of age can consume 1- 2 ml three times daily. If the spicy taste of Ginger is more then you may add more honey because children love the taste of honey.

Points to Remember:

  1. Use glass utensils to prepare this syrup.
  2. Keep your hands clean while preparing this cough syrup.
  3. Store this Ginger Honey natural cough syrup in a glass bottle, after preparation.
  4. Store in a cool and dry place. You may keep the prepared cough syrup in 2- 8 degree Celsius for three days. But in room temperature, it can be stored for only one day.
  5. For getting ideal cough relieving activity, you must slowly swallow so that the prepared syrup will stay for more time in the throat area.

Cough and Cold Products: Not For Infants and Children Under 2 Years of Age

Recently the cough expectorants and other cough preparations were undergoing huge criticism that they are of no therapeutic importance. Many countries are withdrawing the license to manufacture and market such products among their own public. So I decided to re publish a post from FDA that strictly warns people about the various aspects of Over The Counter Cough and Cold products. Further updates about the topic can be obtained from FDA website. Definitely we will re publish the same at here also.


Q. What is FDA recommending about use of over-the-counter cough and cold products for infants and children under 2 years of age?

A. FDA strongly recommends that over-the-counter (OTC) cough and cold products should not be used for infants and children under 2 years of age because serious and potentially life-threatening side effects could occur.

Q. What are these side effects?

A. There are a wide variety of serious adverse events reported with cough and cold products.  They include death, convulsions, rapid heart rates, and decreased levels of consciousness. 

Q. What ingredients may cause these effects, and what should I look for on the label to tell if these ingredients are present in an OTC product?

A: OTC cough and cold products include these ingredients: decongestants (for unclogging a stuffy nose), expectorants (for loosening mucus so that it can be coughed up), antihistamines (for sneezing and runny nose), and antitussives (for quieting coughs). The terms on the label include "nasal decongestants", "cough suppressants", "expectorants" and "antihistamines."

Q.  How did FDA arrive at its decision to issue these recommendations?

A. FDA’s recommendation is based on the review of reports the agency has received about serious side effects, as well as a review of information presented at a joint Nonprescription Drugs and Pediatric Advisory Committee meeting on Oct.18-19, 2007. FDA has determined that OTC cough and cold medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in infants and children under 2.

Q. Not effective?  Does that mean they don’t work?

A. FDA does not have any data to support that these products work in children less than 2 years of age.
Q. My child has allergies. Does this alert affect the medicines for my child?

A. This advisory relates only to the use of OTC products for the treatment of cough and cold.

Q. What should parents do if infants and children under 2 years of age experience cough and cold symptoms?

A. A cold is a respiratory illness that is usually self-limited and lasts about a week. Cold symptoms typically include sneezing, coughing, runny or stuffy nose, and sore throat. Children may also experience a fever. Most of the time, a cold will go away by itself.  If you are concerned about making your child feel more comfortable, talk with your doctor about what approaches to take. Your doctor may recommend drinking plenty of fluids to help loosen mucus and keep children hydrated, and using saline nasal drops and gently suctioning mucus from the nose with a bulb syringe.  Your doctor may also recommend fever reducers such as acetaminophen or ibuprofen. If your child’s cold symptoms do not improve or get worse, contact your doctor. A persistent cough may signal a more serious condition such as bronchitis or asthma.

Q. Are particular products being recalled?

A. No. This public health advisory does not mean that products are being recalled. In October 2007, the Consumer Healthcare Products Association (CHPA), on behalf of leading manufacturers of OTC cough and cold medicines, announced voluntary market withdrawals of OTC products for infants and children under 2 years of age.  FDA strongly supports the actions taken by many manufacturers to voluntarily withdraw cough and cold medicines that were being marketed for infants.

Q. Is FDA making a recommendation about whether cough and cold products should be used in age groups other than infants and children under 2 years of age at this time?

A. No. This public health advisory does not include FDA’s final recommendation about use of cough and cold medicines in children ages 2 through 11 years. FDA's review of the data for these age groups is continuing. The agency is committed to making a timely and comprehensive review of the safety of OTC cough and cold medicines in children. FDA plans to issue its recommendations on use of the products in children ages 2 to 11 as soon as the review is complete.

Q. While FDA is completing its review for children ages 2 through 11, what should parents of children in this age group know about using cough and cold products?

A.  Giving too much cough and cold medicine can be dangerous. OTC cough and cold products can be harmful if more than the recommended amount is used, if they are given too often, or if more than one product containing the same active ingredient is being used. Parents need to be aware that many OTC cough and cold products contain multiple ingredients (for nasal congestion, cough, and fever). Giving more than one product could result in an overdose. There are many products that have similar names, so it is critical to identify the active ingredient(s) in the product, select the proper medicine, and use the correct dose.  Reading the DRUG FACTS section of the label will help caretakers learn about what active ingredients are in the products. Also, children should not be given medicines that are packaged and made for adults. 

Pending completion of its review, FDA recommends these steps for consumers who use OTC cough and cold products in children 2 years of age and older:

    • Check the "active ingredients" section of the DRUG FACTS label.
    • Be very careful if you are giving more than one OTC cough and cold medicine to a child. If you use two medicines that have the same or similar "active ingredients," a child could get too much of an ingredient which may hurt your child.
    • Carefully follow the directions in the DRUG FACTS label.
    • Only use the measuring spoons or cups that come with the medicine or those made specially for measuring drugs. 
    • Choose OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of reach of children.
    • Understand that OTC cough and cold medicines do not cure or shorten the duration of the common cold.
    • Do not use these products to sedate your child or make children sleepy.
    • Call a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children 2 years of age and older.

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

Date Posted: January 17, 2008

Source: FDA

FDA warns three companies to stop making unproven claims on mouth rinses

The FDA today issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.

Warning letters were sent to, Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash), and Walgreen Company (Walgreen Mouth Rinse Full Action).

These mouth rinse products contain the active ingredient sodium fluoride. The FDA has determined that sodium fluoride is effective in preventing cavities but has not found this ingredient to be effective in removing plaque or preventing gum disease.

“It is important for the FDA to take appropriate enforcement action when companies make false or unproven product claims to ensure that consumers are not misinformed or misled,” said Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research.

Under federal law, a company cannot claim its product is effective in treating a disease unless those claims have been reviewed and approved by the FDA in a new drug application or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter (OTC) drug monograph.

The FDA actions are part of the agency’s effort to curtail an increasing number of Federal Food Drug and Cosmetic Act (FFDCA) violations among the makers/marketers of mouthwashes concerning unproven claims of therapeutic benefits.

To date, the FDA is unaware of any injuries or adverse health effects related to the use of these mouth rinse products. Consumers who have these products may continue to use the products for cavity prevention without risk of injury but should be aware that the FDA has no data to show that these products can prevent gum disease.

Companies that received FDA warning letters are required to take appropriate action to correct these violations within 15 days.  Failure to do so may result in seizure of the product, or other civil or criminal penalties.

For more information:

Media Inquiries: Elaine Gansz Bobo, 301-796-7567,
Consumer Inquiries: 888-INFO-FDA


Source: FDA

More informations to read:

Vacancy of Pharmacists in Badr al samaa hospitals, Oman

Badr Al Sama, is a fast growing hi-tech hospital group currently present at important cities like Al Khuwair, Sohar, Salalah, Al Khoud, & Barka in Sultanate of Oman, with sister concerns like Al Hilal Hospital in Bahrain and Shifa Jeddah Polyclinic in Saudi Arabia. This group now announced vacancies of Pharmacists, GP Doctors, Internist, Super Specialty Doctor, Staff Nurses, Lab Technicians and X-ray Tech for their various branches.

As they say in their website, all these posts requires minimum three years post qualification experience. Salary will not be a constrain for the right candidate.

Candidates will have to pass the respective examination conducted by the Ministry Of Health,Sultanate Of Oman.

No last dates mentioned in the website. The links were checked on 28/09/2010.

Interested candidates may forward their resume to :

E-mail :,
Phone : +968 - 24799760, 24799761, 24799762, 24799763, 24799764.
Fax : +968 - 24799765.



European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim – (Rosiglitazone)

The European Medicines Agency today recommended the suspension of the marketing authorizations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months.Patients who are currently taking these medicines should make an appointment with their doctor to discuss suitable alternative treatments. Patients are advised not to stop their treatment without speaking to their doctor.Doctors should stop prescribing rosiglitazone-containing medicines. Patients taking rosiglitazone-containing medicines should be reviewed in a timely manner to amend their treatment.

AVANDIAThe current review of rosiglitazone by the Agency’s Committee for Medicinal Products for Human Use (CHMP) was initiated on 9 July 2010 following the availability of new studies questioning the cardiovascular safety of the medicine. Since its first authorisation, rosiglitazone has been recognised to be associated with fluid retention and increased risk of heart failure and its cardiovascular safety has always been kept under close review. Consequently, the use of rosiglitazone was restricted to a second-line treatment and contra-indicated in patients with heart failure or a history of heart failure when it was first granted a marketing authorisation as Avandia in 2000.

Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone. Further restrictions on the use of these medicines in patients with ischaemic heart disease were introduced.

The availability of recent studies has added to the knowledge about rosiglitazone and overall, the accumulated data support an increased cardiovascular risk of rosiglitazone. In view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk. The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.

The suspension will remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks. The Committee’s recommendation has now been forwarded to the European Commission for the adoption of a legally binding decision.


  • Rosiglitazone was initially authorised as Avandia in the European Union in July 2000 as second-line diabetes type-2 treatment to be used when other treatments have either failed or are unsuitable for a patient. It was subsequently approved in combination with metformin as Avandamet and with glimepiride as Avaglim.
  • The review of the marketing authorisations of Avandia, Avandamet and Avaglim was initiated on the request of the European Commission under Article 20 of Regulation (EC) No 726/2004, following the publication of two studies on 28 June 2010. References for the two studies are as follows: Graham DJ et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA doi:10.1001/jama.2010.920. Nissen SE et al. Rosiglitazone revisited. An updated meta analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med doi:10.1001/archinternmed.2010.207.



A home use device is a medical device intended for users in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a licensed health care provider in order to be used safely and effectively.


Why is FDA's Center for Devices and Radiological Health (CDRH) interested?

Changes in health care have moved care from the hospital environment to the home environment.  In fact, according to results of the 2000 National Home and Hospice Care Survey “approximately 1,355,300 patients were receiving home health care services from 7,200 agencies.” In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually.
As patients move to the use of home health care services for recuperation or long-term care, the medical devices necessary for their care have followed them. As a result, complex medical devices are used more frequently in the home, many times under unsuitable conditions. This in turn has implications for the safe and effective operation of these devices, especially those with sophisticated requirements for proper operation or maintenance.

CDRH regulates medical devices; however, the regulatory authority alone is not enough to ensure that devices are safe and effective when used in the home. CDRH has been receiving an increasing number of adverse event reports about medical devices that are used in the home.

What can CDRH do?

CDRH wants to decrease the number of problems that occur in the home environment; but the issues are  complex. To be successful, the government agencies involved in home care need to collaborate with relevant stakeholders:

  • Manufacturers and Distributors
  • Health care professionals
  • Health care organizations
  • Accrediting bodies (Private or governmental bodies that grant recognition that an institution has met certain standards or requirements)

What information does this website provide?

This website will provide safety information and resources about medical products used in the home environment geared for a variety of audiences – consumers, patients, healthcare providers and manufacturers.

Courtesy: FDA


The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as “Generic Tamiflu” sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.

The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions.
There is no FDA-approved generic drug for the prescription product Tamiflu.

FDA Warns About Fraudulent Tamiflu
Fraudulent product is dangerous to patients allergic to penicillin

The FDA bought the fraudulent “Generic Tamiflu” without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however.

“A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient.”

The FDA-purchased product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder (see photos below). The foil backing is printed, and labeled in part, “Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules” and “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.”

Tamiflu caps in blister_r#1F8Tamiflu foil back

Although the FDA actively monitors the Internet and when appropriate purchases and analyzes drug products, consumers who purchase drugs using an online pharmacy can protect themselves by knowing how to recognize a legitimate Internet pharmacy and how to buy medicines safely online. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations.

Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at

The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by calling 800-551-3989, or by visiting the OCI website (

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these fraudulent products to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

For more information:

Courtesy Source: FDA

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