أعلنت
منظمة الأغذية و الأدوية
الأمريكية FDA في تقرير نشر لها أن عقار
tiotropium ,و المعروف في سوق
الدواء باسم spiriva الموجود على صورة
كبسولات أن له علاقة بزيادة احتمال
الاصابة بالجلطات الدماغية.
و
إليكم نص الخبر ...
Tiotropium
Linked to Possible
Increased Risk of Stroke
Laurie Barclay, MD
March 19, 2008 — The US Food and Drug
Administration
(FDA) is reporting a possible increased risk of
stroke with use of
tiotropium (Spiriva HandiHaler, Boehringer
Ingelheim
Pharmaceuticals, Inc), according to an ongoing safety
review posted
March 18 on MedWatch, the FDA's safety information and
adverse event
reporting program. Spiriva contains tiotropium
bromide and is used to
treat bronchospasm associated with chronic
obstructive pulmonary disease
(COPD).
"Boehringer Ingelheim and
[the] FDA notified healthcare professionals
that ongoing safety
monitoring has identified a possible increased risk
of stroke in
patients who take Spiriva," MedWatch states. "It is
important to
interpret these preliminary results with caution. FDA is
working
with Boehringer Ingelheim to further evaluate the potential
association
between Spiriva and stroke."
A pooled analysis by Boehringer
Ingelheim of the safety data from 29
placebo-controlled clinical
studies yielded preliminary estimates of
stroke risk of 8 of 1000
patients treated for 1 year with Spiriva and 6
of 1000 patients
treated for 1 year with placebo. In these trials, which
included
approximately 13,500 patients with COPD, the estimated excess
risk
of any type of stroke caused by Spiriva is 2 patients for each 1000
patients using Spiriva for 1 year.
The FDA cautions that it has not
yet confirmed these analyses with the
manufacturer. Although pooled
analyses are useful in highlighting
potential safety issues, they
have inherent limitations and uncertainty,
mandating further
investigation with other data sources.
"Patients should not stop
taking Spiriva HandiHaler before talking to
their doctor, if they
have questions about this new information,"
MedWatch concludes.
"This early communication is in keeping with FDA's
commitment to
inform the public about its ongoing safety reviews of
drugs."
الموضوع : spiriva المصدر :منتديات تقى الإسلامية الكاتب: El Helalya
