WHO Drug Information articles from June 2000

WHO Drug Information archives from June 2000

General Policy Issues.
June 22, 2000... International harmonization of regulatory activities: future options The World Health Organization (WHO) has traditionally supported the process of international harmonization by directing and coordinating health work and in encouraging...

Current Topics.
June 22, 2000... Declaration of Helsinki The World Medical Association (WMA) General Assembly has recently revised the Declaration of Helsinki, the most widely accepted guideline on medical research involving human subjects. This set of principles forms...

Misoprostol and pregnancy: reminder of dangers.
June 22, 2000... A letter has been circulated by the manufacturer of misoprostol (Cytotec[R]) to remind health care providers that misoprostol administration by any route is contraindicated in women who are pregnant because it can cause abortion. ...

Southern hemisphere influenza vaccine composition.
June 22, 2000... World Health Organization -- The composition for the southern hemisphere influenza season (2001) has been decided and communicated to vaccine manufacturers. It is recommended that the influenza vaccine will contain the following three...

Zafirlukast: labelling changes.
June 22, 2000... With increased use over the past three years, additional events have been reported for zafirlukast (Accolate[R]), a leukotriene receptor antagonist indicated for the prophylaxis and chronic treatment of asthma in adults and children 7 years...

Thioridazine: major labelling modifications.
June 22, 2000... Important labelling changes have been made for all dosage forms of thioridazine hydrochloride (Mellaril[R]) by the manufacturer. A boxed warning has been added to prominently advise clinicians that thioridazine has been shown to prolong...

Mesoridazine besylate: new warning.
June 22, 2000... The manufacturer of mesoridazine besylate (Serentil[R]) has advised doctors and pharmacists of important prescribing information changes to the 25 mg and 50 mg tablets. Mesoridazine besylate has been shown to prolong the QTc interval in a...

Lopinavir and ritonavir for HIV infection.
June 22, 2000... United States of America -- An accelerated approval has been issued for Kaletra[R], a combination of the protease inhibitors lopinavir and ritonavir for HIV infection in adults and children over 6 months of age. Lopinavir's antiviral...

Arsenic trioxide for leukaemia.
June 22, 2000... United States of America -- The Food and Drug Administration has approved arsenic trioxide (Trisenox[R]) for the treatment of patients with acute promyelocytic leukaemia who have not responded to first-line therapy with transretinoic acid and...

International plasma trafficking.
June 22, 2000... World Health Organization -- Several newspaper articles have reported on international trafficking of contaminated human plasma emanating from southern Africa. The articles refer to investigations under way since 1996 when the Austrian...

Cardiac failure and pioglitazone hydrochloride.
June 22, 2000... Japan -- Pioglitazone hydrochloride (Actosc[R]) was approved for marketing in 1999 for the treatment of diabetes and is considered to improve resistance to insulin. The Ministry of Health and Welfare in Japan has received five case reports of...

New dosing for didanosine.
June 22, 2000... The manufacturer of the nucleoside analogue reverse transcriptase inhibitor, didanosine (Videx[R]), has advised health care providers of a change in prescribing information. The results of a recent clinical trial have demonstrated that the...

Alosetron: guide and labelling improve risk detection.
June 22, 2000... United States of America -- The Food and Drug Administration (FDA) has developed a Medication Guide for distribution by pharmacists to help ensure that patients using the prescription drug alosetron hydrochloride (Lotronex[R]) for treatment...

Meningitis C vaccines.
June 22, 2000... United Kingdom -- In November 1999, a mass national immunization campaign to vaccinate all children under 18 years of age with the new meningococcal group C conjugate vaccine commenced. Two vaccines were used (Meningotec[R] and Menjugate[R])....

Mifepristone approval linked to stringent conditions.
June 22, 2000... United States of America -- The Food and Drug Administration has approved mifepristone (Mifeprix[R]) for the termination of early pregnancy, defined as 49 days or less from the beginning of the last menstrual period. Under the approved...

Proposed withdrawal of enrofloxacin in poultry.
June 22, 2000... United States of America -- The Food and Drug Administration has proposed to withdraw use of the fluoroquinolone antimicrobial enrofloxacin for use in poultry on the grounds that it has not be shown to be safe. This action is put forward by...

Consultative Document.
June 22, 2000... Operational issues in the procurement of essential drugs and medical supplies Medical supply is a complex and competitive area. A buyer is not only expected to obtain the right goods at the right price but to be aware of the many other...

NIH guidelines for stem cell research.
June 22, 2000... The US National Institutes of Health (NIH) has published its Guidelines for Research Involving Human Pluripotent Stem Cells. The Guidelines describe the documentation and assurances that must accompany requests for NIH funding for research...

Opioid control policy: self assessment guidelines.
June 22, 2000... The purpose of these self-assessment guidelines is to encourage governments to achieve better pain management of cancer patients by identifying and overcoming regulatory barriers to opioid availability. The guidelines are intended for those...

Australian therapeutic guidelines on antimicrobials.
June 22, 2000... The Eleventh edition of Therapeutic Guidelines: Antibiotics has now been published. The guidelines are endorsed by the Royal Australian College of General Practitioners and the National Prescribing Service. They cover principles of...

Reliable quality information and the Internet.
June 22, 2000... Guidelines for medical and health information sites on the Internet have been published by the American Medical Association (AMA). Access to medical information through the Internet has the potential to speed the transformation of the...

Standards for Internet pharmacies.
June 22, 2000... The Council of the Royal Pharmaceutical Society in the United Kingdom has published standards of good professional practice for those who wish to provide pharmaceutical services via the Internet. For some time the Council has been aware of...

International Nonproprietary Names for Pharmaceutical Substances (INN).
June 22, 2000... RECOMMENDED International Nonproprietary Names (Rec. INN): List 44 Notice is hereby given that, in accordance with paragraph 7 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical...