Europäer schlucken (fast) alles
In Europa sind einige Medikamente auf dem Markt, die in den USA und in anderen Ländern wegen Sicherheitsbedenken
nicht zugelassen worden sind. Nun hat es den Cox-2-Inhibitor Prexige® von Novartis erwischt. Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) hat ebenso wie die Arzneibehörden in Grossbritannien und Österreich das Ruhen der Zulassung für das Schmerzmittel (übrigens die gleiche Wirkstoffklasse wie Vioxx) angeordnet.Bei der Diätpille Acomplia® von Sanofi-Aventis, einem weiteren Präparat, dass in den USA nicht zugelassen ist, gibt es neue Erkenntnisse zu Nebenwirkungen. Eine Meta-Analyse fand ein mehr als 2-fach erhöhtes Risiko für Depressionen und Angststörungen und bestätigte die Entscheidung der amerikanischen Zulassungsbehörde FDA.
Taken together with the recent US Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions.
[Arzneimittel]
| Autor: strappato 2007-11-22 Link (2 Kommentare) Ihr Kommentar |
hockeystick 2007-11-22
...despite depressed mood being an exclusion criterion in these trials
Genauso wie bei Champix. Generell ist es eine interessantes Thema, warum es gängige Praxis ist, dass bestimmte Vorerkrankungen in den Phase-III-Studien ausgeschlossen werden (aus ethischen Gründen, wie gerne behauptet wird), die dann auf dem Beipackzettel nicht als Kontraindikation vermerkt sind. Auf Basis der Ausschlusskriterien der Champix-Studien kann man eine tropentaugliche Fremdenlegion zusammenstellen: Participants were excluded if they had a serious or unstable disease within the past 6 months; required treatment for depression within the past 12 months; had a history of or current panic disorder, psychosis, or bipolar disorder; had severe chronic obstructive pulmonary disease, a history of cancer, evidence or history of clinically significant allergic reactions, laboratory abnormalities, cardiovascular disease within the past 6 months, uncontrolled hypertension, or a history of drug or alcohol abuse or dependence within the past 12 months; used a smoking cessation aid (ie, nicotine replacement therapy [NRT], bupropion, clonidine, or nortriptyline) within the previous month; used tobacco products other than cigarettes or marijuana within the past month and did not agree to abstain from use of these products during study participation; had a body mass index of less than 15 or more than 38 (calculated as weight in kilograms divided by height in meters squared); or used any of the following medications: NRT, antidepressants, antipsychotics, mood stabilizers/anticonvulsants, naltrexone, steroids, or insulin.
Exclusion criteria were any serious or unstable disease within 6 months; seizure risk; diabetes mellitus requiring insulin or oral hypoglycemic medications; hepatic or renal impairment; clinically significant cardiovascular disease within 6 months; uncontrolled hypertension; severe chronic obstructive pulmonary disease; history of cancer (except treated basal cell or squamous cell carcinoma of the skin); and history of clinically significant allergic reactions. Other exclusion criteria were major depressive disorder within the past year requiring treatment; history of panic disorder, psychosis, bipolar disorder, or eating disorders; alcohol or drug abuse/dependency within the past year; use of tobacco products other than cigarettes; use of nicotine replacement therapy, clonidine, or nortriptyline within the month prior to enrollment; and body mass index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45.5 kg.
(Quelle1, Quelle 2)Exclusion criteria were any serious or unstable disease within 6 months; seizure risk; diabetes mellitus requiring insulin or oral hypoglycemic medications; hepatic or renal impairment; clinically significant cardiovascular disease within 6 months; uncontrolled hypertension; severe chronic obstructive pulmonary disease; history of cancer (except treated basal cell or squamous cell carcinoma of the skin); and history of clinically significant allergic reactions. Other exclusion criteria were major depressive disorder within the past year requiring treatment; history of panic disorder, psychosis, bipolar disorder, or eating disorders; alcohol or drug abuse/dependency within the past year; use of tobacco products other than cigarettes; use of nicotine replacement therapy, clonidine, or nortriptyline within the month prior to enrollment; and body mass index (calculated as weight in kilograms divided by the square of height in meters) less than 15 or greater than 38 or weight less than 45.5 kg.
Acomplia war ja eigentlich zum Einsatz bei der Nikotinentwöhnung vorgesehen. Der Abnehm-Effekt war Nebenwirkung.
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