מתןך אתר medicontext.co.il WESTPORT, CT (Reuters Health) – German drug pharmaceutical producer Bayer AG is voluntarily withdrawing its lipid-lowering drug cerivastatin (Baycol) from distribution worldwide, the US Food and Drug Administration announced today.
Cerivastatin is being withdrawn due to reports of sometimes-fatal rhabdomyolysis, particularly among older patients receiving high doses and especially when cerivastatin is used in combination with gemfibrozil. According to the FDA, there have been 31 deaths in the US attributable to cerivastatin, of which 12 involved concomitant use of gemfibrozil.
"The FDA and Bayer have acted in a very responsible manner," Dr. Sidney Smith from the University of North Carolina in Chapel Hill told Reuters Health.
Dr. Smith, who is a past president of the American Heart Association, and currently chief science officer for the association, said "it is frustrating to hear that this particular statin has the problems that are being reported. But is reassuring that there are at least five other statins available with proven track records."
The withdrawal comes shortly after Bayer agreed to amend cerivastatin's label to highlight that patients should not receive more than 0.4 mg as a starting dose regardless of previous lipid therapy, and to reinforce the drug's association with myopathy and rhabdomyolysis. (See Reuters Health report, June 26.)
Bayer is recalling the drug from all pharmacies and offering refunds upon return of the drug.
"We have decided on this action in the interest of patient safety," Dr. David Ebsworth, head manager of Bayer's Pharmaceuticals Business Group, said in a company statement. "We will continue to conduct further assessments over the next few months to evaluate the benefit/risk ratio of cerivastatin," he added.
-Westport Newsroom 203 319 2700
e-Med Tools
קצר קולע וממוקד
e-Med סמינרים
אי-מד תחקירים
Medscape Tools
Journal Club
מרכזי מידע ושירות
Facebook
מידע למפרסם
מאגר תרופות
מאגר אנשי המקצוע
אינדקס שימושי
חדשות משה"ב
eMed HealthClub
מחקרים קליניים
השאירו תגובה
רוצה להצטרף לדיון?תרגישו חופשי לתרום!