FDA Safety Information
Spiriva, Medtronic Neuromodulation Pumps Recalled
Tiotropium (marketed as SpirivaHandiHaler):
BoehringerIngelheim and FDA notified health care professionals that ongoing
safety monitoring has identified a possible increased risk of stroke in patients
who take Spiriva. This product contains tiotropium bromide and is used to treat
bronchospasm associated with chronic obstructive pulmonary disease.
BoehringerIngelheim reported to the FDA that it has conducted an analysis of the
safety data from 29 placebo controlled clinical studies (“pooled analysis”).
Based on data from these studies, the preliminary estimates of the risk of
stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6
patients per 1000 patients treated for one year with placebo. This means that
the estimated excess risk of any type of stroke due to Spiriva is 2 patients for
each 1000 patients using Spiriva over a one year period.
Read the complete MedWatch
2008 Safety Summary.
Medronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable
Infusion Pumps: FDA and Medtronic notified healthcare professionals of the
Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps,
implantable devices for administering drugs to a specific site in the body to
treat pain, spasticity and cancer. The company updated the labeling for the
devices to include current patient management and treatment recommendations. The
company received reports of inflammatory mass formations at or near the distal
tip of intrathecalcatheters which infuse opioids, baclofen, or chemotherapy
drugs into patients. On January 28, 2008, Medtronic sent a letter to doctors who
implant these devices and/or provide care to patients with the implanted device.
The letter described the problem, patient risks, patient management,
recommendations, and next steps. Medtronic’s representatives will complete a
reply card to document their communication with each doctor regarding this
recall, as well as asking the doctors to sign and return a reply card.
Read the complete MedWatch
2008 Safety Summary.
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