The University offers regular study and research programme leading to Ph.D. degree in the following disciplines:

1).Faculty of Biological Sciences

Field of specialization

2).Faculty of Natural Sciences

Field of specialization

 3).Faculty of Social Sciences

Field of specialization

 Eligibility

The minimum CGPA should be 3.00 or First Division in MS/M.Phil or equivalent Degree from a recognized University.

Those admitted have to complete/pass 18 credit hour course work within four semesters as per University rules.

Those admitted in Ph.D. programme and not passed M.Phil/MS OR MS from abroad have to pass 42 credit hours courses (24+18) within six semesters as per University rules.

A Govt. College/Public Sector University teacher or member of the research staff of a Govt. Research Organization who has shown undoubted promise for research and holds MA/M.Sc. degree may be recommended by the Admission Committee for admission directly to Ph.D. programme. However, the students would have to complete the course work required for M.Phil/MS.

Those who seek admission in Ph.D. without having obtained M.Phil or its equivalent degree must pass M.Phil entry test and interview (wherever available). The schedule for M.Phil entry test is already announced.

Admission to Ph.D. programme will only be given to those students who have achieved a score of at least 60% in the NTS GAT subject test of their respective discipline or should have scored International GRE with 50% percentile (valid for admissions until December 31, 2011).

If the Test is not available in NTS subject list, then University, as per HEC criteria will conduct the Test at par with GRE Subject Test and the qualifying score will be 70%.

No Objection Certificate from the employer is required to be attached with Admission Form and routed through Proper channel in case of in-service candidates.

Admission to Ph.D. programme is made on a competitive basis. The minimum period for completion of Ph.D. Programme shall be three years whereas maximum period shall be seven years.

Students applying for admission are required to submit a copy of synopsis/research work. Admission will be given subject to the availability of the Supervisor in the field of research strictly according to HEC’s requirements.

A student cannot be awarded two Ph.D’s. on the same research material/document.

The application shall be submitted directly to the respective Chairperson/Director of the department/centre/institute in which the student wishes to pursue his/her studies.

Short listed candidates will be called for interview/presentation of research proposals.

 A candidate seeking admission to Ph.D. programme shall apply on the prescribed form. The Admission Forms can be obtained from the University Admissions Section @ Rs.650/- or by sending self addressed envelope of 8.5” x 11” to the Assistant Registrar (Admissions) along with a Bank Draft of Rs.700/- in favour of ‘Treasurer, Quaid-i-Azam University’ by 17.01.2011.

Three copies of the prescribed Application Forms duly filled in and supported by the attested copies of Educational Certificates/Degrees and research work may be submitted to the respective Chairman of the Department/Director of the Institute/Centre by 26.01.2011. Applications that are incomplete OR received after due date shall not be entertained.

Eligibility

The minimum CGPA should be 3.00 or First Division in MS/M.Phil or equivalent Degree from a recognized University.

Those admitted have to complete/pass 18 credit hour course work within four semesters as per University rules.

Those admitted in Ph.D. programme and not passed M.Phil/MS OR MS from abroad have to pass 42 credit hours courses (24+18) within six semesters as per University rules.

A Govt. College/Public Sector University teacher or member of the research staff of a Govt. Research Organization who has shown undoubted promise for research and holds MA/M.Sc. degree may be recommended by the Admission Committee for admission directly to Ph.D. programme. However, the students would have to complete the course work required for M.Phil/MS.

Those who seek admission in Ph.D. without having obtained M.Phil or its equivalent degree must pass M.Phil entry test and interview (wherever available). The schedule for M.Phil entry test is already announced.

Admission to Ph.D. programme will only be given to those students who have achieved a score of at least 60% in the NTS GAT subject test of their respective discipline or should have scored International GRE with 50% percentile (valid for admissions until December 31, 2011).

If the Test is not available in NTS subject list, then University, as per HEC criteria will conduct the Test at par with GRE Subject Test and the qualifying score will be 70%.

No Objection Certificate from the employer is required to be attached with Admission Form and routed through Proper channel in case of in-service candidates.

Admission to Ph.D. programme is made on a competitive basis. The minimum period for completion of Ph.D. Programme shall be three years whereas maximum period shall be seven years.

Students applying for admission are required to submit a copy of synopsis/research work. Admission will be given subject to the availability of the Supervisor in the field of research strictly according to HEC’s requirements.

A student cannot be awarded two Ph.D’s. on the same research material/document.

The application shall be submitted directly to the respective Chairperson/Director of the department/centre/institute in which the student wishes to pursue his/her studies.

Short listed candidates will be called for interview/presentation of research proposals.

A candidate seeking admission to Ph.D. programme shall apply on the prescribed form. The Admission Forms can be obtained from the University Admissions Section @ Rs.650/- or by sending self addressed envelope of 8.5” x 11” to the Assistant Registrar (Admissions) along with a Bank Draft of Rs.700/- in favour of ‘Treasurer, Quaid-i-Azam University’ by 17.01.2011.

Three copies of the prescribed Application Forms duly filled in and supported by the attested copies of Educational Certificates/Degrees and research work may be submitted to the respective Chairman of the Department/Director of the Institute/Centre by 26.01.2011. Applications that are incomplete OR received after due date shall not be entertained.

Applications on the prescribed forms are invited for admission to the M.Phil programme of the University in the following subjects:-

 Eligibility

The candidate must have:- i) 1st Division in M.A/M.Sc. degree or its equivalent or in B.A./B.Sc. but no 3rd division in M.A./M.Sc. or B.A B.Sc. ii) In case of 3rd division in F.A/F.Sc., the candidate should have 1st division in both B.A/B.Sc. and M.A/M.Sc.or its equivalent degree.

 Faculty of Biological Sciences

a) Requirement of the subject studied for M. Phil Animal Sciences, Biochemistry, Biotechnology, Microbiology and Plant Sciences: –

i) M.Sc. degree or its equivalent in any field of Biological Sciences from a recognized University. ii) Candidates holding BS/B.Sc. Hons. (4 years), MBBS/ DVM/ B. Pharmacy/Agriculture  4 years with 1st Division may apply.

b) Requirement of the subject studied for M. Phil Bioinformatics: – M.Sc. degree or its equivalent in Molecular Biology/ Biochemistry from any recognized University. Candidates holding BS/ B.Sc.Hons. in Bioinformatics (4-years) with 1st Division may also apply. Computer knowledge holder will be preferable.

c) The M.Phil Biological Sciences programme offers the following specializations: –

The Admission Form can be obtained from the office of the Assistant Registrar (Admissions) @ Rs.650/- by hand or by sending self addressed envelope of 8.5 x 11(inches) along with a Bank Draft of Rs.700/- in favor of the Treasurer, Quaid-i-Azam University, Islamabad by 17-01-2011.

Three copies of application on prescribed forms duly supported by the attested Photostat copies of the certificates of academic qualifications, domicile, character, detailed marks, migration (in original required at time of admission) along with 5 (five) passport size photographs and No Objection Certificate from the employer, in case of in-service candidates, should reach the Chairman/Director of the respective Department/ Institute/ Centre by 26-01-2011 during office hours.

The date and time of interview shall be announced by each department/Institute/Centre/School after the test.

No separate call up letter for test/interview will be issued. Hostel accommodation will only be provided, if available. Applications that are incomplete or received after due date shall not be entertained. To avoid the inconvenience, please submit your admission form well before the last date.

Islamabad (Pharmaceutical Review) Ministry of Health, Government of the Punjab has issued a notification, printed in the Punjab weekly gazette dated February 10, 2010, page No. 951, in exercise of power conferred upon him under Section 44 of the Drug Act. 1976 (XXXI of 1976) which empower government to make rules under Act subjected to previous publication, the governor of the Punjab has made amendments in the Punjab Drug Rules, 2007 after previous publication of these amendments. In rule 1, sub rule (3) for word “three” the word “ten” is substituted.  In Schedule A- From 9 at Serial No. 1, after the word “and sell” the word “or distribute” is inserted. In Form 10 at serial No. 1, after the word “or sale by way of wholesale” is inserted.

In response the this notification the executives of the Pharmacist Federation of Pakistan; Asad Imran – President Lahore, Syed Muzzamal Masood Zaidi – President Islamabad, Dr. Fawad Ali General Secretary Islamabad, Irshad Hussain Malilk President Punjab, Fiaz Ahmad Faizi General Secretary Punjab (and Vice President PPA Punjab), Muhammad Bin Ibrahim President Multan, Dr. Shoaib Zafar President Faisalabad, Aziz ul Rehman Farooqi President Sargodha, Dr. Tahir Farooq – Press Secretary, Malik Muahmmad Sharif – President Gujranwala, Abdul Rub Mujahid – President Bahawalpure, Dr. Taha Nazir – Secretary General (Pakistan) said that it is unfair to regularize the unlawful wholesale business of life saving drugs. These amendments are biased. Which are based on unrealistic approach of Government of the Punjab. They have secured the non-professional people to sell the life saving drugs. The way of distribution of drugs is totally different than grocery, vegetable, grains and garments. Thus; this amendments should be withdrawn instantly. The non-skilled people not allowed involve in health care profession in an improper way. They have protested against the suspension of Punjab Drug Rule 2007 and strongly emphasized the government to withdraw this notification soon as possible.

Lahore (Pharmaceutical Review), A written request is submitted to respected President of Pakistan Pharmacist Association (PPA), Pakistan; Khalid Saeed Bukhari by Hafiz Muhammad Siddique Saifi Community Pharmacist, Fazal Din Pharma Plus, Jinnah Branch, Lahore (Cell No. 03336844101, Email: akalay_hum@yahoo.com) regarding his unfair salary package. He was appointed as “Trainee Pharmacist” on 12^th August, 2010 at the salary package of Rs. 5000/ per month that was raised to Rs. 7000/- afterward. He protests against this disgrace of the profession and unfair salary package, therefore he decided to resign. He is competent/ full fledge pharmacist registered with Punjab Pharmacy Council, therefore this designation and salary package does not match with his qualification and professional prestige. Furthermore; he told that the total costs (expenditures) of his pharmacy graduation study is about Rs. 1000, 000/-. He was very ambitious and had sweet dreams for his career. Which were smashed when his employer asked him to sign a bond of two years at the price of Rs. 8000/- per month. He felt shame to request the executives of PPA to optimize the salary package equivalent to PBS-17 gazetted officer. He forcefully emphasized the existing stakeholders of Pakistan Pharmacist Association to solve this very basic problem of pharmacist community. If they can’t do that, they should resign from their current designations. The new elected leadership might have better mandate of community. They may resolve this issue in a better way.

In response of this application the executives of the Pharmacist Federation of Pakistan; Asad Imran – President Lahore, Syed Muzzamal Masood Zaidi – President Islamabad, Dr. Fawad Ali General Secretary Islamabad, Irshad Hussain Malilk President Punjab, Fiaz Ahmad Faizi General Secretary Punjab (and Vice President PPA Punjab), Muhammad Bin Ibrahim President Multan, Dr. Shoaib Zafar President Faisalabad, Aziz ul Rehman Farooqi President Sargodha, Dr. Tahir Farooq – Press Secretary, Malik Muahmmad Sharif – President Gujranwala, Abdul Rub Mujahid – President Bahawalpure, Dr. Taha Nazir – Secretary General (Pakistan) said that they will support Mr. Saifi. It is the part their ambitions, activities and objectives to enforce the salary package for new graduates (fresh pharmacists) equivalent to BPS 17 Pay Scale of Gazzited Officer of government of Pakistan. It is the disgrace of our life saving profession that an established organization offering unfair salary package. This package should be withdrawn instantly and offer the standard and suitable designation and salary for new pharmacy graduates.

Islamabad (PPA Federal, Dr. Muzzamil Masood Zaidi) Pakistan Pharmacist Association (Federal) has rented an office at H. No 510, Gali 1, I-9/1, Islamabad. This pharmacist house would be used for professional purpose besides the secretariat of the PPA, Federal Branch. It is also claimed by officials of PPA Federal that this “Pharmacist House” will be remained opened for all the pharmacists intended to work for community. All expenditures; rent, utilities, maintenance etc (approximate 25000/- pm) besides expenditure required for rental advance, furniture, office equipments and minor repair/ maintenance shall be provided by the PPA (Federal) and donations (Rs 100/- pm which mean 3.3 rupees per day).  They also have assured the money will be utilized honestly and sincerely.

A professional “GET TO GETHER” was organized by the Pharmacist Federation Pakistan, Islamabad and Rawalpindi on 10th January, 2011 (Monday) at Markez-e-Islami, House No. 1, St. 38, G 6/2, Malodi Market, Islamabad. The function was hosted by Dr. Syed Muzzamil Masood Zaidi President; Pharmacist Federation Pakistan, Islamabad, Khursheed Alam President; Pharmacist Federation Pakistan, Rawalpindi, Dr. Fawad Ali Bungush General Secretary; Pharmacist Federation Pakistan, Islamabad and Muhammad Sabbir Hussain General Secretary; Pharmacist Federation Pakistan, Rawalpindi and chaired by Muhammad Akhtar Abbas, Deputy Drug Controller, Ministry of Health, Islamabad and Dr. Taha Nazir General Secretary; Pharmacist Federation of Pakistan and Associate Dean of School of Pharmacy, the University of Lahore Islamabad Campus. The pharmacists of all discipline of pharmacy profession; hospitals, industries, marketing and academics have participated. They have envisaged the prevailing professional problems and their possible solutions. Mr. Naveed Anwer Drug Inspector Rawalpindi and Hafiz Abdul Raheem have shared their experience. A resolution regarding the notification issued by Ministry of Health, Government of the Punjab by the order of the Governor of the Punjab; (printed in the Punjab weekly gazette dated February 10, 2010, page No. 951) and appointment of pharmacist in each department of hospitals was presented by Hafiz Muhammad Arshad. This resolution was passed unanimously by all participants. At the end of the function an opportunity of open talk was provided to all percipients to speak whatever they want followed by the formal dinner.

Islamabad (Dr. Syed Muzzammal Zaidi, Dr. Fawad Ali) One day workshop entitled “Skills Enhancement of Clinical Pharmacy” held on 22 December, 2010 (Wednesday) at School of Pharmacy, University of Lahore (Islamabad Campus), Pakistan. More than hundered persons participated and listened the presentations of scholars. This workshop was chaired by Dr. Taha Nazir (Associate Dean of School of Pharmacy, University of Lahore – Islamabad campus), hosted by Mr. Wajahat Latif (Director University of Lahore – Islamabad Campus) and chief guest Mrs. Amna Bibi (Hospital Pharmacist Poly Clinic Hospital, Islamabad). The distinguieshed speakers focused teh most current issues of clinical pharmacy as under;

1. Mr. Tahir Aqeel; Therapeutical significance of drug usage.

2. Mr. Muhammad Sabbir; Role of hospital Pharmacist in clinical setup.

3. Mr. Fawad Ali; Clinical pharmacy education, hospital pharmacy practice and regulation.

4. Dr. Taha Nazir; Professional challenges in clinical pharmacy practice

5. Mr. Muhammad Akhtar Abbas; Drug registration; legislation and procedure

 The participating pharmacist arrived from all discipline of pharmacy profession; community pharmacy, pharmaceutical marketing, research & development, ministry of Health, pharmaceutical institutions and industrial segment of this profession. The honorable guests; Mr. Adbul Sattar Sorani (Deputy Drug Controller), Mr. Zia Husnain (Deputy Drug Controller), Mr. Bilal Sorani has also shared the experiences. At the end of the workshop souvenirs were awarded to all speakers followed by refreshment.

By; Laird Harrison.

From Medscape Medical News

November 17, 2010 — Looking back, historians may mark 2010 as the most significant year for US medicine in decades. The healthcare reform legislation signed into law by President Barack Obama March 23 profoundly changes the way care is provided, and even if opponents succeed in repealing the legislation, the debate itself will shape the way we think about the issue for years to come.

The law didn’t come out of nowhere. Stresses and discontents in healthcare have been building for decades. Costs are rising at the same time that budgets are getting leaner. Most sophisticated tests are forcing physicians and patients to decide whether and how to treat diseases that previously went ignored. And new research calls old guidelines into question. Such tensions are reflected in nearly all the stories that surfaced as the most viewed by Medscape readers during the past year.

1. Cuts Loom in Medicare Reimbursement

The conflict over healthcare stems largely from a gap between the care we expect and the care we can afford. That gap is now threatening to undermine Medicare, which is scheduled for a 25% cut in reimbursements if Congress doesn’t act soon. The reduction would be triggered by the sustainable growth rate formula used for setting physicians’ pay. It could force many physicians to drop Medicare, which would send shockwaves throughout the system, as Medicare patients make up about a third of the practices of 70% of physicians. Almost no one wants to see the cuts take place, but the Congressional Budget Office estimates that keeping reimbursements at current levels through 2020 will cost $276 billion. Under pressure to reduce the national deficit, Congress so far hasn’t been able to agree on a source for that much money. Throughout 2010, it kept delaying the cut with a series of short-term fixes. What’s likely to happen next? More delays. With the Republicans controlling one chamber of Congress and the Democrats the other, gridlock could doom long-term “doc fix” legislation for the coming year.

2. Healthcare Reform

Whatever else you might say about healthcare reform, it’s a big deal. The most comprehensive overhaul of the nation’s healthcare system at least since Medicare, the Affordable Care Act seeks to dramatically expand the number of people who can afford healthcare. It does that by subsidizing the cost for those who can’t afford it, penalizing those who refuse to buy it, and limiting the cases in which insurers can deny coverage. Among scores of other provisions, it boosts pay for primary care physicians, encourages compensation based on quality of care, and bars copayments for most preventive services. As the law is implemented, questions about these and other provisions are cropping up. For starters, do we have enough physicians, nurses and other healthcare workers to care for an estimated additional 32 million insured? Also, who will make up the difference if fewer copayments are collected? These questions and more are certain to arise as legislators critical of the law attack it with renewed vigor.

3. New Guidelines for Prostate Cancer Screening

The advent of better tests — such as prostate-specific antigen (PSA) screening — can in some cases save lives with early treatment. However, these tests can also pose new dilemmas, as the American Cancer Society (ACS) emphasized on March 3 when it updated its prostate cancer screening guidelines. The test picks up benign disease in addition to cancer, and it can’t distinguish between aggressive and mild forms of the disease, the ACS pointed out. In some cases, PSA screening has led to expensive and invasive treatments in patients who might never have experienced symptoms. So the ACS is calling on physicians to spend more time counseling patients about their options (despite the difficulty of billing for such counseling). The PSA controversy intensified when the scientist who discovered PSA in 1970, Richard Ablin, PhD, from the University of Arizona College of Medicine in Tucson, said categorically that the test should not be used to screen all men older than 50 years. That’s a direct contradiction of the ACS guidelines. Controversy about the value of PSA testing continued when results of studies on both the effectiveness of the test and on chemoprevention were reported.

4. Whistle-Blowing Nurses Prosecuted

Healthcare is not without its scandals, perhaps the biggest of which in 2010 was the criminal prosecution of 2 nurses who reported Rolando Arafiles Jr, MD, at Winkler County Memorial Hospital in Kermit, Texas, to the Texas Medical Board for low quality of care. As it turned out, Dr. Arafiles was friends with the local sheriff, who arrested Anne Mitchell, RN, and Vickilyn Galle, RN, for misuse of official information — a third-degree felony. Prosecutors dropped charges against Galle, and a jury quickly acquitted Mitchell, but the hospital fired both of them. Subsequently the medical board charged Dr. Arafiles with 9 instances of substandard care. In one charge, it accused him of suturing the rubber from suture-kit scissors to a patient’s torn and broken thumb in an unorthodox attempt to stabilize the digit. The nurses sued Dr. Arafiles and the hospital in federal court for, among other things, violating their freedom of speech, but dropped the suit after the defendants agreed to pay them $750,000 as part of a settlement.

5. Centers for Medicare and Medicaid Services Appointment Stirs Controversy

When Obama nominated Donald Berwick, MD, administrator of the Centers for Medicare and Medicaid Services, critics pointed to comments Dr. Berwick had made in admiration of Britain’s National Health Service and in calling for the redistribution of wealth “from the richer among us to the poorer and less fortunate.” However, Dr. Berwick has a track record of success in helping many organizations to solve practical healthcare problems, which earned him support among groups of physicians, consumers, businesses, and insurers, including the American Medical Association. Facing opposition in the Senate, Obama took advantage of a loophole allowing him to appoint Dr. Berwick without the need for confirmation while the Senate was in recess.

6. Revised Diabetes Guidelines Highlight A1c

Screening technology popped up in the news again in December 2009 when the American Diabetes Association published new clinical practice recommendations. (Despite the timing, the news story quickly moved to into the top 10 most-read topics on Medscape.) The guidelines promote the use of the hemoglobin A1c (A1c) as a faster, easier diagnostic test that could help reduce the number of undiagnosed patients and better identify patients with prediabetes. A1c measures average blood glucose levels for a period of up to 3 months. Previously it was used only to evaluate diabetic control with time, but because it doesn’t require fasting, A1c testing will encourage more people to get tested, leading to treatments and lifestyle changes that could prevent the worst effects of the disease, the American Diabetes Association said.

7. Calcium Boosts Heart Attack Risk

Prevention guidelines also made headlines when a large study found that calcium supplements taken without vitamin D may increase the risk for heart attack as much as 30%. Researchers reported the finding online July 29 in BMJ, based on their meta-analysis of 15 randomized trials with up to 11,921 participants. Most guidelines for osteoporosis currently recommend the supplements, despite relatively small benefits in bone health, but senior author Dr. Ian R. Reid, from the University of Auckland in New Zealand, said that in most cases, “discontinuation of calcium would seem appropriate.” The study raised many questions, such as why calcium could have this effect during a relatively short period of time. Pending further research, some experts advised eating foods high in calcium, rather than taking supplements.

8. Volunteers Moved by Haiti Earthquake

When an earthquake devastated Haiti on January 12, thousands of physicians and other healthcare professionals started packing their black bags and booking airplane tickets. Experts at a webinar held by the American Medical Association warned against a rush, pointing out that volunteers without the proper preparation could hinder relief efforts. During the next 10 days, however, the need for specialists in emergency medicine, orthopaedic surgery, and neurology became increasingly clear. By the end of the month, more than 600 relief organizations were working in Haiti, and the American Medical Association established a physician registry for volunteers.

9. FDA Warns Against Quinine for Cramps

What do you do when no one pays attention to your guidelines? Issue them again. That was the approach taken by the US Food and Drug Administration (FDA) July 8 after it noticed that most of the quinine being prescribed in the United States isn’t for the approved indication — uncomplicated malaria — but, rather, for leg cramps. Taking quinine (marketed by AR Scientific as Qualaquin) may result in serious and life-threatening hematologic adverse effects, the FDA said. The statement reiterated a 2006 warning about the off-label use of this drug that apparently fell on deaf ears.

10. Task Force Revises Mammography Guidelines

For those who follow such things, 2010 also may also be remembered as the year of the mammoth mammography muddle. On November 17, 2009, the US Preventive Services Task Force called for an end to routine mammography for women younger than 50 years, citing a lack of evidence for benefits in women that young, sparking outrage from screening advocates. On January 6, 2010, however, the American College of Radiology and the Society of Breast Imaging directly contradicted the task force, recommending routine mammography at age 40 years and older. The debate got further fuel from a Swedish epidemiological study of breast cancer, touted as the largest ever, which found that mammography produced a 26% reduction in mortality from breast cancer in women aged 40 to 49 years. Another study from Norway found that the benefits from mammography screening were modest, however, and an accompanying editorial highlighted the delicate balance between potential benefit and potential harm, concluding that the decision to undergo mammography is “a close call.”

By; Patricia A. Howard; James L. Vacek

From American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions. Posted: 03/02/2010; Am J Cardiovasc Drugs. 2009;9(6):353-359. © 2009 Adis Data Information BV

 Clopidogrel is widely used in patients with acute coronary syndromes and following percutaneous coronary intervention with stent implantation. The antiplatelet action of clopidogrel is felt to be of critical importance for the reduction of abrupt thrombotic occlusion of stents, particularly with drug-eluting devices. When clopidogrel is used alone or in combination with aspirin (acetylsalicylic acid), the benefits of antiplatelet therapy must be weighed against the potential for serious bleeding, particularly gastrointestinal (GI) bleeds. To minimize the risk of GI injury, proton pump inhibitors (PPIs) are considered the drugs of choice. However, a growing body of evidence suggests that PPIs may adversely interact with clopidogrel, diminishing the antiplatelet effect. Although the current evidence remains controversial, the potential for increased risk of thrombotic complications warrants cautious use of this drug combination until further research can determine the extent of this interaction and whether it is a drug-class effect.

Clopidogrel is a potent antiplatelet drug with actions mediated through irreversible inhibition of the platelet ADP receptor, P2Y₁₂. Clopidogrel is widely used to prevent thrombotic complications in patients with acute coronary syndromes (ACS), with or without percutaneous coronary intervention (PCI), and is particularly effective for patients with drug-eluting devices. Clopidogrel monotherapy has been associated with an increased risk of bleeding. Several clinical trials have shown that the risk of bleeding, especially gastrointestinal (GI) bleeding, is further increased in high-risk coronary patients who often require dual antiplatelet therapy with both clopidogrel and aspirin (acetylsalicylic acid). Guidelines for the prevention or treatment of antiplatelet drug-associated GI injury recommend proton pump inhibitors (PPIs) as first-line agents.

Recently, concerns have been raised over a potential drug interaction between clopidogrel and PPIs that may diminish the antiplatelet activity of clopidogrel. Because of the serious clinical implications of a decreased antiplatelet response in high-risk coronary patients, reports of this potential interaction with PPIs must be further explored.

By; Shelley Wood, Lisa Nainggolan, Sue Hughes

From Heartwire > Alerts. Posted: 09/23/2010

 September 23, 2010 (Updated September 24, 2010) (Silver Springs, Maryland and London, United Kingdom) — The US FDA has decided that rosiglitazone (Avandia, GlaxoSmithKline) can remain available, but only under a very stringent restricted-access program. However, the European Medicines Agency (EMA) has recommended the suspension of the marketing authorizations for all rosiglitazone-containing antidiabetes medications licensed in the EU–Avandia, Avandamet, and Avaglim.

“These medicines will stop being available in Europe within the next few months,” the agency said in a statement. “Patients are advised not to stop their treatment without speaking to their doctor. Doctors should stop prescribing rosiglitazone-containing medicines, and patients taking rosiglitazone-containing medicines should be reviewed in a timely manner to amend their treatment.”

As previously reported by heartwire , rosiglitazone has been under mounting scrutiny both in the US and Europe, culminating in an FDA advisory hearing where 12 out of 33 panel members voted to recommend removal of the drug from the US market and an additional 10 panelists voted to recommend that rosiglitazone stay on the market, but with severe restrictions on its use.

In response to both the FDA and EMA statements issued today, GlaxoSmithKline said that the EMA has “stated that the suspension will remain in place unless convincing data are provided that identify a group of patients in whom the benefits of the medicine outweigh its risks.” In the US, all rosiglitazone-containing medicines will remain available with additional safety labeling and restrictions for use, which includes the FDA requiring a risk evaluation and mitigation strategy (REMS) program with additional measures to ensure the safe use of the medicine.

At a telephone press briefing, EMA senior medical officer Prof Hans-Georg Eichler explained that the agency had now concluded that the benefits of rosiglitazone no longer outweighed its risks, so that is why it has decided to suspend the drug. He said the recommendation for suspension would now be passed onto the European Commission, who will make a formal legally binding decision. That would happen in the next couple of weeks. The drug would then not be available anymore. Letters would go out to advise doctors to discuss with patients on a case-by-case basis the best therapeutic alternatives to use.

Eichler noted that a suspension is different from a withdrawal. “Suspension can be a temporary measure. It can be lifted if a company comes up with convincing and robust data that rosiglitazone benefits outweigh its risks in certain populations.”

Asked about the safety profile of pioglitazone, Dunder noted that “there is large probability that the cardiovascular safety of pioglitazone is different from rosiglitazone, and we have biological plausibility to confirm that.” She added that the risk of bladder cancer with pioglitazone has now been raised and is being investigated. “For the time being, there is absolutely no reason to think that bladder cancer is a real risk, but a question has been raised about this, and we are consistently reviewing this with the FDA.”

At an FDA telephone briefing, FDA Commissioner Dr Margaret Hamburg explained that the REMS restriction on rosiglitazone will allow new patients access to the drug only if they are unable to achieve glycemic control using other medications and, in consultation with their healthcare professional, decide not to take pioglitazone for medical reasons. Current users of rosiglitazone will be able to continue using the medication, again through a REMS program, only if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns. The FDA’s explanation of its action is also detailed in a “Perspective” published online earlier today in the New England Journal of Medicine.

The agency anticipates that the REMS will limit use of rosiglitazone significantly. Hamburg estimated that about 600 000 patients are currently taking rosiglitazone in the US, but this number is now expected to “fall significantly,” she said. However, the REMS programs will take several months to set up. The rosiglitazone label will also be strengthened to include even stronger warnings of cardiac risk, but Hamburg said that because new label warnings are not always read, the “significant questions” about the drug’s cardiovascular safety justified stronger measures to support good clinical decision making and protect patients–hence the REMS program.

Echoing the EMA’s comments on the different action in Europe, Hamburg said both the FDA and EMA had reached similar conclusions about the safety of rosiglitazone, but the different actions taken reflected different tools available in Europe and the US. She added: “We [the FDA and EMA] are taking somewhat different strategies, but both are trying to ensure the goal of safety.” Dr Janet Woodcock (director, FDA Center for Drug Evaluation and Research) elaborated: “We have a signal of increased cardiovascular risk with rosiglitazone from the meta-analyses, but there is still considerable uncertainty about the existence and magnitude of that risk. Data from randomized studies have not provided enough reassurance that the drug meets the required standard of safety. Therefore, as a matter of prudence, we have decided to restrict access to the drug. But we have heard very clearly from patients and doctors that some patients were unable to tolerate other diabetes medications and this drug was effective for them. Our approach will enable those patients to continue taking rosiglitazone as long as they are fully informed of the risks.”