Drug News
The following articles are presented for informational
purposes only. The views and opinions expressed within these articles do
not necessarily state or represent those of Cerner Multum, our
management, or our associates.
U.S.
FDA Recalls
September 1 2010 -
Tygacil (tigecycline): Label
Change - Increased Mortality Risk
ISSUE:
FDA reminded healthcare professionals of an increased mortality risk
associated with the use of the intravenous antibacterial Tygacil (tigecycline)
compared to that of other drugs used to treat a variety of serious
infections. The increased risk was seen most clearly in patients treated
for hospital-acquired pneumonia, especially ventilator-associated
pneumonia, but was also seen in patients with complicated skin and skin
structure infections, complicated intra-abdominal infections and
diabetic foot infections. FDA has updated sections of the Tygacil drug
label to include information regarding increased mortality risk of
Tygacil.
BACKGROUND:
Tygacil is approved by FDA for the treatment of complicated skin and
skin structure infections, complicated intra-abdominal infections, and
community acquired pneumonia. Tygacil is not approved for the treatment
of hospital-acquired pneumonia (including ventilator-associated
pneumonia) or diabetic foot infection. The increased risk was determined
using a pooled analysis of clinical trials. See the Data Summary section
of the FDA Drug Safety Communication for additional details.
RECOMMENDATION:
Alternatives to Tygacil should be considered in patients with severe
infections. Healthcare professionals and patients are encouraged to
report adverse events or side effects related to the use of this product
to the FDA's MedWatch Safety Information and Adverse Event Reporting
Program:
-
Complete and submit the report Online:
www.fda.gov/MedWatch/report.htm
-
Download form or call
1-800-332-1088 to request a reporting form, then complete and return
to the address on the pre-addressed form, or submit by fax to
1-800-FDA-0178
Read the Medwatch
safety alert, including a link to the FDA Drug Safety Communication, at:
MedWatch Safety Information
August 31 2010 -
Aliskiren-amlodipine (Tekamlo
by Novartis), has been approved
by the FDA for the treatment of high blood pressure.
August 26 2010 -
atropine-pralidoxime (Duo-Dote by Meridian Medical Technologies), has
been approved by the FDA for the treatment of poisoning by organophosphorous
nerve agents as well as organophosphorous insecticides. Prescribing
Information
August 26 2010 -
Benzylpenicilloyl polylysine (PREPEN by ALK-Abello), has been approved by
the FDA for the assessment of sensitization to penicillin (benzylpenicillin or
penicillin G) in patients suspected to have clinical penicillin
hypersensitivity.
Prescribing Information
August 20 2010 -
Stalevo (carbidopa/levodopa and entacapone):
Ongoing Safety Review: Possible increased cardiovascular risk
Issue:
FDA
notified healthcare professionals that it is evaluating clinical trial data
that suggest patients taking Stalevo (a combination of carbidopa/levodopa
and entacapone) may be at an increased risk for cardiovascular events (heart
attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa
(sold as the combination product, Sinemet). FDA's decision to conduct
a meta-analysis was based on findings from the Stalevo Reduction In
Dyskinesia Evaluation – Parkinson's Disease or STRIDE-PD trial, which
reported an imbalance in the number of myocardial infarctions in patients
treated with Stalevo compared to those receiving only carbidopa/levodopa.
Although myocardial infarction, cardiac irregularities, hypertension, and
palpitations have been reported with levodopa, previous clinical trials with
Stalevo did not show an imbalance in myocardial infarction, stroke,
and cardiovascular death.
Background:
Both Stalevo and Sinemet have been shown to be effective
treatments for the symptoms of Parkinson's disease. The addition of
entacapone to carbidopa/levodopa has been shown to lead to a greater degree
of improvement in some of the symptoms of Parkinson's disease than treatment
with carbidopa/levodopa alone. Entacapone is also available as a single
ingredient product (sold under the brand name Comtan) to be always
administered in association with carbidopa/levodopa (entacapone has no
antiparkinsonian effect of its own). It is estimated that 154,000 patients
were dispensed a prescription for Stalevo from its approval in June 2003
through October 2009.
Recommendations:
At this time, FDA's review of the potential cardiovascular risk with
Stalevo is ongoing. Healthcare professionals should regularly evaluate
the cardiovascular status of patients who are taking Stalevo,
especially if they have a history of cardiovascular disease. Patients should
not stop taking Stalevo unless told to do so by their healthcare
professional. FDA is exploring additional ways to assess whether Stalevo
increases the risk of cardiovascular events, and will update the public when
this review is complete.
Read the complete
MedWatch 2010 Safety summary, including links to the Drug Safety
Communication with Data Summary and the previous related MedWatch alert from
March 2010, at:
MedWatch Safety Information
August 16 2010 -
Ulipristal (Ella by
Watson Pharmaceuticals), has been approved by the FDA
as new form
of emergency contraceptive pill that prevents pregnancies if taken as many as
five days after unprotected intercourse.
Prescribing Information
August 16 2010 -
Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
ISSUE:
FDA proposed to withdraw approval of the drug midodrine hydrochloride, used to
treat the low blood pressure
condition, orthostatic hypotension, because required post-approval studies that
verify the clinical benefit of the drug have not been done. To date, neither the
original manufacturer nor any generic manufacturer has demonstrated the drug’s
clinical benefit, for example, by showing that use of the drug improved a
patient’s ability to perform life activities.
BACKGROUND: |