WHO Drug Information Vol. 18, No. 2, 2004 - World Health ...

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WHO Drug Information Vol 18, No. 2, 2004 Regulatory and Safety Action SSRIs: behavioural and emotional changes and risk of self-harm Canada — Health Canada is advising that selective serotonin re-uptake inhibitors (SSRIs) and other new antidepressants now carry stronger warnings. These warnings indicate that patients of all ages taking these drugs may experience behavioural and/or emotional changes that may put them at increased risk of self-harm or harm to others. Health Canada has not authorized these drugs for use in patients under 18 years of age. The prescribing of drugs is a physician’s responsibility although off-label use of these drugs in children is acknowledged to be an important tool for doctors. In February 2004, a scientific advisory panel set up by Health Canada provided a clinical practice perspective on paediatric clinical trial safety data and spontaneous post-marketing reports for SSRIs and other newer antidepressants. The panel agreed that a contraindication was not warranted for these medications, and supported Health Canada’s recommendation for warnings. Consequently, the manufacturers of citalopram hydrobromide (Celexa ® ), venlafaxine (Effexor®), fluoxetine (Prozac®), mirtazapine (Remeron®), sertraline (Zoloft®), paroxetine (Paxol®), fluvoxamine (Luvox®) and bupropion (Wellbutrin®) (Zyban® for smoking cessation) have issued a class warning regarding the possibility that SSRIs (selective serotonin reuptake inhibitors) and other newer antidepressants may be associated with behavioural and emotional changes, including risk of self-harm. Potential association with the occurrence of behavioural and emotional changes, including self harm Patients under 18 years of age (paediatric): placebo-controlled clinical trial data • Recent analyses of placebo-controlled clinical trial safety databases from SSRIs and other newer antidepressants suggests that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo. • The small denominators in the clinical trial database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among these drugs. Adult and paediatric patients: additional data • There are clinical trial and post-marketing reports with SSRIs and other newer antidepressants, in both paediatrics and adults, of severe agitation-type adverse events coupled with selfharm or harm to others. The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, depersonalization. In some cases, the events occurred within several weeks of starting treatment. Given that bupropion may be prescribed as either an antidepressant or a smoking cessation product, these conditions affect the conditions of use of both products. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioural changes. Patients currently taking SSRIs should NOT discontinue treatment abruptly, due to risk of discontinuation symptoms. At the time that a medical decision is made to discontinue an SSRI or other newer antidepressant drug, a gradual reduction in the dose rather than an abrupt cessation is recommended. It should be noted that a causal role for SSRIs and other newer antidepressants in inducing selfharm or harm to others has not been established. The possibility of a suicide attempt is inherent in depression and other psychiatric disorders, and may persist until remission occurs. Therefore, patients should be closely supervised throughout therapy with appropriate consideration to the possible need for hospitalization. The warning informs practitioners that all patients being treated with SSRIs and other newer antidepressants 127
Regulatory and Safety Action should be rigorously monitored for clinical worsening, or onset/worsening of agitation-type adverse events, or other indicators of potential for suicidal behaviour. Reference: Health Canada advisories 26 May 2004, 3 June 2004 and 10 June 2004, on http://www.hc-sc.gc.ca Proposed rule on combination products United States of America —The Food and Drug Administration (FDA) has announced a proposed rule to assign a lead centre with responsibility for premarket review and regulation of a combination product. Combination products are considered as a combination of a drug, a device, or a biological product. They represent a growing category of products incorporating cutting edge, novel technologies that hold great promise for advancing patient care. Products, such as drug-eluting stents (which combine a drug with a medical device), orthopedic implants with genetically engineered human protein, and antibiotic bone cement, often do not fit neatly into traditional categories of FDA-regulated items. But such innovative combination products have the potential to make treatments safer, more effective, more convenient or more comfortable for patients. The purpose of the proposed rule is twofold: to codify the definition of “primary mode of action” (PMOA), the criterion the agency has used for more than a decade when assigning combination products for review; and to simplify the assignment process by providing a defined framework that sponsors may use when recommending and/ or considering the PMOA and assignment of a combination product to an FDA Center. Under the proposal, the “primary mode of action” would be defined as “the single mode of action (e.g., drug, device, biological product) of a combination product that provides the most important therapeutic action of the combination product.” This would be the mode of action that is expected to make the greatest contribution to the overall therapeutic effects of the combination product. In certain cases, it is not possible for either FDA or the product sponsor to determine, at the time a request for assignment is submitted, which mode of action of a combination product provides the 128 WHO Drug Information Vol 18, No. 2, 2004 most important therapeutic action. In those cases, the agency would assign the combination product to the FDA Center that regulates other combination products presenting similar questions of safety and effectiveness with regard to the combination product as a whole. References 1. FDA Talk Paper, T04–13, 6 May 2004. 2. Primary Mode of Action Assignment Flowchart. http:// www.fda.gov/OHRMS/DOCKETS/98fr/oc03366.pdf. European Medicines Agency : new name and advisory role European Union — The European Agency for the Evaluation of Medicinal products (EMEA) has recently undergone a review based on experience gained during the six years since its establishment. EMEA will now be renamed The European Medicines Agency and the Committee on Proprietary Medicinal Products (CPMP) is renamed the Committee for Human Medicinal Products (CHMP), both with effect from 1 May 2004. Among improvements to operations, an amendment concerning the scope of the Agency’s mandate to increase cooperation with the World Health Organization is reflected in Article 58, which states: “The Agency may give scientific opinion, in the context of cooperation with the World health Organization, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organization, draw up a scientific opinion in accordance with Articles 6 and 9. The provisions of Article 10 shall not apply), Additionally, Article 27 on pharmacovigilance provides that “The Agency shall collaborate with the World health Organization in matters of international pharmacovigilance and shall take the necessary steps to submit to it, promptly, appropriate and adequate information regarding the measures taken in the Community which have a bearing on public health protection in third countries ...” Reference: Regulation (EC) No 2003 of the European Parliament and Council
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