By; Roxanne Nelson

From Medscape Medical News. Posted: 06/21/2010

 June 21, 2010 — Pfizer Inc has announced that it will be discontinuing commercial availability of gemtuzumab ozogamicin (Mylotarg; Wyeth) for the treatment of relapsed acute myeloid leukemia (AML), in the United States. It will also voluntarily withdraw the new drug application for gemtuzumab, effective October 15, 2010.

The action is at the request of the US Food and Drug Administration (FDA) after results from a recent clinical trial raised new concerns about the drug’s safety profile and also failed to demonstrate clinical benefit to patients currently enrolled in trials.

“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” said Richard Pazdur, MD, director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research, in a statement. “However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML.”

Gemtuzumab was approved on May 17, 2000, under the FDA’s accelerated approval program, for the treatment of patients 60 years and older with recurrent AML, who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate that was observed in 142 patients with AML across 3 clinical trials.

However, hepatotoxicity; specifically severe veno-occlusive disease; and hypersensitivity reactions including anaphylaxis, infusion reactions, and pulmonary events were observed after initial approval. This resulted in a black-box warning issued less than a year after its approval. A confirmatory, post-approval clinical trial was begun in 2004, per FDA guidelines for accelerated approval. The randomized phase 3 comparative controlled trial (SWOG S0106) combined gemtuzumab with the chemotherapeutic agents daunorubicin and cytosine arabinoside vs chemotherapy alone in 627 patients younger than 61 years.

The trial was designed to determine whether adding gemtuzumab to standard chemotherapy demonstrated an improvement in survival time for patients with AML, but it was halted early when no benefit was observed. A greater number of deaths occurred in the cohort who received gemtuzumab vs those receiving chemotherapy alone. Among patients who were evaluable for early toxicity, the fatal induction toxicity rate was significantly higher in the combination therapy group vs the group receiving chemotherapy alone (16/283 = 5.7% vs 4/281 = 1.4%; P = .01).

“We are disappointed that the study did not confirm the clinical benefit of Mylotarg,” said Mace Rothenberg, MD, senior vice president of clinical development and medical affairs for Pfizer Oncology Business Unit, in a release. “Our primary concern is for patients who suffer from AML, which remains a very serious and difficult-to-treat disease with limited treatment options. We advise patients to contact their physicians for further information.”

As a result of this action, gemtuzumab will no longer be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy, after consulting with their physicians. Healthcare professionals should inform all patients receiving gemtuzumab of the potential adverse events associated with the agent, the FDA release notes.

All future use of gemtuzumab in the United States will require submission of an investigational new drug application to the FDA. Pfizer states that it is currently working the health authorities outside of the United States and will keep patients, regulatory authorities, investigators, and clinicians informed about FDA actions and appropriate next steps for gemtuzumab. More information is available on the FDA’s MedWatch .

Any adverse events associated with gemtuzumab should be communicated to the FDA’s MedWatch reporting program by telephone at 1-800-FDA-1088; by fax 1-800-FDA-0178, online at https://www.accessdata.fda.go v/scripts/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

By; Robert Lowes

From Medscape Medical News. Posted: 10/08/2010

 October 8, 2010 — Abbott Laboratories has withdrawn the obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction, the US Food and Drug Administration (FDA) announced today.

The agency asked Abbott Laboratories to pull the drug from the market after it evaluated data from a postmarketing study of the drug’s cardiovascular safety. The study, called the Sibutramine Cardiovascular Outcomes Trial (SCOUT), demonstrated a 16% increase in the risk for serious cardiovascular events such as nonfatal heart attack, nonfatal stroke, the need for resuscitation after the heart stopped, and death in a cohort of patients given sibutramine compared with another given a placebo.

In September, an FDA advisory panel reviewed the SCOUT results, with half of the members in favor of withdrawing sibutramine and the other half recommending stricter access to the drug and tougher label warnings.

Following the advisory panel vote, the FDA concluded that the cardiovascular risks posed by sibutramine outweigh the modest weight loss observed with the drug, which the agency had approved in 1997.

At a press conference today, John Jenkins, MD, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, said that roughly 100,000 people in the United States are currently taking sibutramine.

The FDA is advising physicians to stop prescribing sibutramine and for patients to stop taking it and talk to their healthcare provider about alternative weight-loss regimens. The agency does not know of any withdrawal syndrome associated with the drug, according to Dr. Jenkins.

Dr. Jenkins also said he is not aware of any long-term consequences for patients who stop taking the drug. The cardiovascular events observed in SCOUT, he said, probably stem from sibutramine increasing blood pressure and heart rate. These adverse effects disappear once the drug is withdrawn.

In the wake of the sibutramine decision, there are still a limited number of FDA-approved drugs for losing weight, said Mary Parks, MD, director of the agency’s Division of Metabolic and Endocrine Drug Products, at today’s press conference. Prescription drugs for short-term weight loss include phentermine and diethylpropion. Orlistat is available in both an over-the-counter form (Alli; GlaxoSmithKline) and prescription form (Xenical; Hoffman-La Roche) at a higher dose, Dr. Parks added. Last May, the FDA revised the label for both versions of orlistat to warn about rare cases of severe liver injury associated with the drug.

Dr. Jenkins suggested Friday that the nation would benefit from more weight-loss drugs. “We’re still very committed to working with (manufacturers) to help them to develop and gain approval of safe and effective drugs to help patients manage weight,” Dr. Jenkins said. “Obesity is a serious health problem. More information about today’s announcement is available on the FDA’s Web site.

In a related action, the FDA warned consumers today not to use a weight-loss product called Slimming Beauty Bitter Orange Slimming Capsules, sold over the Internet, because they contain sibutramine. The drug is not listed on the product label.

To report adverse events related to sibutramine or Slimming Beauty capsules, contact MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Lahore (Dr. Tahir Aziz Mughal, Fayaz Ahmad Faizi) A very successful meeting of Pharmacist Federation of Pakistan held on at Mansoora, Lahore. The pharmacists from all over the Pakistan and every field of the pharmacy discipline have participated in meeting. The meeting was chaired by Dr. Addul Aleem Khan and conducted by Mr. Fayaz Ahmad Faizi. Executives of Pharmacist Federation presented the reports of their area for the year 2010 and decided the goals for the year 2011. They also have disclosed that the membership of Pharmacist Federation is online, free and open for everyone at https://www.pharmacistfed.pk/master/Members.aspx.  

There also an electoral procedure conducted for Punjab provinces; session 2011 as mention in their constitution. The new body elected is as under;

Malik Irshad Husain (president Punjab), Mr. Fazya Ahmad Faizi General Secretary Punjan, Dr. Syed Muzzammil Masood Zaidi (president Islamabad), Hafiz Muhammad Abdullah (president Bhakkar), Mr. Khursheed Alam (president: Rawalpindi), Aziz Ur Rehman (president Sargodha), Dr. Shaoib Zafar (president Faisalabad division) Malik Muhammad Waheed (President Jehlum), Muhammad Bib Ibrahim (president Multan) and Asaad Imran (president: Lahore).

Islamabad (Dr. Taha Nazir, Syed Muzzammal Zaidi, Khursheed Alam) 2nd annual meeting of Pharmacist Federation of Pakistan is going to be held on 19th December, 2010 (Sunday) at Mansoora Multan Road, Lahore, Pakistan. The press secretary of Federation Dr. Tahir Farooq, Arqam Pharmacy, Sargodha, Pakistan said; the meeting will start at 1:00pm to review the performance of 2010 and planed the lines of action for 2011. They will also complete the electoral procedure for 2011-2012 as mention in constitution of Pharmacist Federation of Pakistan. The participants pharmacists are expected from all over the Pakistan and every field of the pharmacy discipline; community pharmacy, hospital pharmacy, Pharmaceutical industries, research & development and marketing segment. At the end of this meeting a grand dinner is offered by executives of Pharmacist Federation of Pakistan Lahore; Mr. Fayaz Ahmad Faizi, Malik Muhammad Irshasd, Dr. Abdul Haleem Khan, Ashfaq Ahmad Mehr, M. Iftikhar Ahmad, Muhammad Shamoon Chaudhary, Asad Imran and Hafiz Abdul Salam.

Lahore (PPA Administration, Dr. Tahir Aziz Mughal) Pakistan Pharmacist Association decided an international Pharmacy conference in March, 2011 at Lahore. The theme of this conference has not yet been decided and most probably it would be broad and covers all disciplines of this life saving profession. The focal areas of this conference would be the clinical pharmaceutical practice, enforcement drug rules and appointment of pharmacist as focal person in clinical, pharmaceutical   and therapeutical setups.

The administration of PPA has invited the pharmacists all over the world to suggest the theme for the conference before December 18, 2010. A prize will be awarded at the conference if the theme is accepted. It can be mailed (PPA House, Johar Town, Lahore, Pakistan,), email (info@ppapak.com) or SMS (0333 404 5602).

Islmabad (Syed Muzzamal Zaidi) Hashoo Foundation (HF) is a progressive and dynamic non-profit organization, leading the way in human development and poverty alleviation by implementing viable economic development, educational and capacity building programs in Pakistan since 1988. The Foundation is also focused on the needs of children with disabilities and provides care and support services including full boarding, therapeutic, educational facilities and skills development training. With presence in USA, UK and Tajikistan, HF is constantly striving to reach out to the less privileged and vulnerable members of society.

 As part of its education services the Hashoo Foundation has set up bursaries to support students from poorer background who may otherwise have no access for attaining higher education to build a better future. In this regard, Hashoo Foundation is pleased to announce its 2010-2011 scholarship awards for undergraduate degrees. Applications are therefore invited from talented and deserving students who have scored more than 75% marks and are pursuing a Bachelor level course from an HEC recognized University.

 The last date for the submission of the scholarship application is December 25, 2010.  For further information please visit Hashoo Foundation  Website:  www.hashoofoundation.org    or contact to: Shukoor Ullah Baig, Program Officer  Education, Hashoo Foundation; House No. 7-A, St No. 65, F-8/3, Islamabad, Pakistan. Phone: 051-2287712, Fax: 051-2287718, Email: shukur@hashoofoundation.org

Islamabad (Shakir Zia, Press Secratory, PPA Federal) The first ever “Get-To-Gather” of the female pharmacists held in Islamabad on 6^th December, 2010 at I-8 Markaz, Islamabad. which was organized by the PPA Federal. The pharmacist community is happy and congratulate to female pharmacists for succeful function. Furthermore; it is a considered an encouragement for female pharmacy graduates and students. They gained a confidence for organizign their functions independently.

A seminar “Skill Enhancement of Industrial Pharmacists” held on December 07, 2010 at Amsons Vaccines & Pharma, Islamabad, Pakistan. This seminar was organized by Pakistan Pharmacist Association (Federal) in collaboration with Amsons Vaccines & Pharma, Islamabad, Pakistan.

Ministry of narcotics control has launched a massive campaign against drug abuse from 1st November to 30th December 2010. Mr. Mohammad Shahid Director General of Ministry of Narcotics Control (Planning & Monitoring Unit), Government of Pakistan has issued notification No. 1(3)2010/PMU dated November 8, 2010 in this context. Peoples Sustainable Development Programme (PSDP) is engaged in creating awareness in collaboration with Ministry of Narcotics Control. As part of the massive awareness, PSDP will create awareness through picture, poster, slogan, essay writing etc at public and private institutions at Islamabad. Mr. Mohammad Shahid Director General has requested all concerned to support this complain of awareness against drug abuse among youth at education institutions of Islamabad.

Islamabad (Dr. M. Zaman , Mr. Hassan, Mrs. Shuamaila Zed). An Eid Millan Party held on 1^st December, 2010 at Islamabad Club. The party was arranged by Progressive Pharmacists, Islamabad and more than five hundred pharmacist participated from miscellaneous pharmacy disciplines; ministry of health, pharmaceutical industry, retail pharmacies, hospitals and academics institutional. The party was chaired by Mr. Muhammad Hanif Abbassi MNA Rawalpindi & Chairman Chemist Association, Mr. Haseeb Ahmed Senator & chairman Brooks Pharma Karachi, presided by Mr. Rouf Khalid DC (Reg.), Sheikh Ansar DC (QA) and hosted by Mr. Faqir M. Sheikh (DDG), Mr. Adbul Satar Sorani (DDC), Mr. Sayyad Ahmed (DDC), Mr. Naveed Anwar (drug inspector rewalpinid), Mr. Shifa Bangash, Mr. Ahmed Bilal, Mr. M. Imran Khanzada, Mr. M. Amir. The exectives of different pharmaceutical industries has also participated and announced to revise the salary package of presently working pharmacists.

All pharmacists’ participants has emphasized to revise the service structure, salary package, clinical setup and medical system of the country. They are ambitious to participate enthusiastically in every professional activity of federal area of Islamabad. At last the enjoyed the grand dinner and musical night.