WHO Drug Information Vol17, No. 1, 2003
Regulatory and Safety Action
commonly reported and associated with the use of interferon beta-1 a and to include a new subsection to address safety information obtained from post-marketing reports. Reference: Dear Healthcare Professional Letter from Biogen. 7 March 2003 on http://www.fda.gov
Epigal/ocatechin gallate marketing suspension Fra~c~- The French Agency for Safety of Med1c1nes has suspended the marketing authorizati?n for Epigallocatechin gallate (Exolise®), a particularly strong phytotherapeutic extract of green tea (Camellia sinensis). lt is indicated as an adjunct to weight-loss programmes and has been on the market since 1999. Since this date, 13 cases of hepatic failure, of which 4 were serious have been reported both in France and Spain. ' These rare cases (approximately 1 in 100.000 packages sold) have appeared some 50 days after beginning treatment. In the majority of cases, discontinuation has led to favourable recovery, but in one case has resulted in liver transplantation.
Palivizumab: prescribing information changes United States of America -At the time Palivizumab (Synagis®) was licensed, there were no observed cases of anaphylaxis. However, because of the protein nature of the product, such reactions could be anticipated and was presented as a. theoretical risk statement in the Warnings sect1on. Post licensure information based on :-vorldwide post-marketing experience representIng over 400 000 patients and 2 million doses administered have been reviewed, and a total of 2 patients with anaphylaxis have been reported. Both patients made a full recovery with appropriate therapy. Because the risk of anaphylaxis has changed from a theoretical to an actual, but very rare occurrence, the warnings section has been modified to read: Very rare cases of anaphylaxis (<1 case per 100,000 patients) have been reported following re-exposure to palivizumab. Rare severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure to palivizumab. If a severe hypersensitivity reaction occurs, therapy with palivizumab should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on readministration of palivizumab. If anaphylaxis or severe allergic reactions occur, administer appropriate medications (e.g., epinephrine) and provide supportive care as required. Additionally, the following statement was added Limited information from post-marketing reports suggests that, within a single RSV season, adverse events after a sixth or greater dose of palivizumab are similar in character and frequency to those after the initial five doses. Reference: Dear Healthcare Professional Letter from Medlmmune, Inc. November 26, 2002 on http:// www.fda.gov
All other green tea extract products which are synthesized normally remain unaffected by this decision. Reference: French Agency for Safety of Medicines (AFSSAPS). Press Release dated 7 April 2003.
Pergolide mesilate: strengthened warning United States of America- During postmarketing surveillance of pergolide mesilate (Permax®), a small number of individuals have been identified as developing cardiac valvulopathy involving one or more valves. Pergolide is indicated as adjunctive treatment to levodopa/ carbidopa in the management of symptoms of Parkinson disease. Of the estimated 500 000 people who have been treated with pergolide since 1989, valvulopathy has been reported in less than 0.005%. The pathological assessment of valves that were surgically removed was consistent with valvulopathy associated with carcinoid syndrome and with the use of other ergot alkaloid drugs. In the reports made to the manufacturer, aortic, mitral and tricuspid valves were involved. In some cases the symptoms or manifestations of valvulopathy improved with cessation of pergolide therapy. Valve replacement was required in two patients. lt is not known whether the fibrotic valvular changes are related to retroperitoneal, pleural, or pericardial fibrosis, which are very rare but recognized adverse effects seen with pergolide mesilate.
37