Statin Use and the Risk of ALS
A recent FDA analysis provides new evidence that using statins does
not increase the risk of amyotrophic lateral sclerosis (ALS), a
neurodegenerative disease also known "Lou Gehrig's Disease."
Cholesterol-lowering statins such as Lipitor (atorvastatin calcium) and
Zocor (simvastatin) have been shown to reduce the risk of heart disease
in a wide variety of patients.
FDA undertook its review after
receiving a higher than expected number of reports of ALS in its
adverse event reporting system. FDA's report, which was published
recently in the journal Pharmacoepidemiology and Drug Safety, was a
pooled analysis of 41 clinical trials ranging from 6 months to 5 years
duration. In this analysis, the incidence of ALS was 4.2 cases per
100,000 patient-years in trial patients treated with statins, and 5.0
cases per 100,000 patient-years in patients receiving placebo. These
results showed that patients treated with a statin did not have an
increased incidence of ALS compared with placebo patients. FDA will
continue to evaluate additional data as it becomes available.
FDA MedWatch Safety Alert. Statin drugs and amyotrophic lateral sclerosis (ALS). September 30, 2008.
Leukemia Risk with Intra-Articular Use of Phosphocol P 32
Covidien and Mallinckrodt, the manufacturers of Phosphocol P 32,
have informed healthcare professionals that this drug may increase the
risk of leukemia in certain situations. Phosphocol P 32 is used to
treat peritoneal or pleural effusions in patients with metastatic
cancer. It is instilled into the peritoneal or pleural cavities, where
it locally irradiates tissues.
The manufacturers report that
two children, ages 9 and 14, developed acute lymphocytic leukemia about
10 months after they received Phosphocol P 32 by intra-articular
injection. Phosphocol P 32 is not indicated for intra-articular
injection in treating hemarthroses, and its safety and effectiveness in
children have not been established.
Phosphocol P 32 can also
cause radiation injury to the small bowel, cecum and bladder when it is
instilled into the peritoneal cavity.
FDA MedWatch Safety Alert. Phosphocol P 32 (Chromic Phosphate P 32 Suspension). September 18, 2008.
Problems with Medtronic Intrathecal Catheters
Medtronic has alerted healthcare professionals about the potential
for misconnections between certain sutureless intrathecal catheters and
the implanted infusion pumps to which they're attached. The four
affected products are:
• INDURA 1P Intrathecal Catheter, model 8709SC
• Intrathecal Catheter, model 8731SC
• Sutureless Pump Connector Revision Kit, model 8578
• Intrathecal Catheter Pump Segment Revision Kit, model 8596SC
affected catheters are used in conjunction with implanted Medtronic
infusion pumps to deliver medications directly to the intrathecal space
in the spine. They are used primarily to treat chronic, intractable
pain and severe spasticity. The affected pumps are the SyncroMed II,
SyncroMed EL and IsoMed. This action does not include Medtronic MiniMed
The company says it has received reports of
misalignment or incomplete connection between the sutureless pump
connector and the catheter port. This can cause the catheter to
disconnect from the infusion pump, or it can cause an occlusion between
the catheter and the pump. In either case, the patient can experience
severe underdosing. In those receiving baclofen, this can result in a
withdrawal syndrome that can be fatal.
Medtronic is stressing
the importance of using proper techniques when connecting the pump and
catheter. This includes verifying that there is backflow of CSF through
the catheter, ensuring that the sutureless connector and the pump are
aligned, snapping the sutureless connector to the pump firmly, and
tugging on and rotating the connection to be sure the attachment is
The firm also recommends that patients and caregivers
be educated to recognize the symptoms of drug underdose and withdrawal
and to seek immediate medical assistance. Clinicians should keep in
mind that patients who have had intrathecal therapy interrupted may be
drug naïve when the therapy is resumed and so may need an adjustment in
MedWatch Safety Alert. Medtronic INDURA 1P Intrathecal Catheter
Sutureless Pump Connector Revision Kit Intrathecal Catheter Pump
Segment Revision Kit. October 2, 2008.
FDA Classifies Medtronic’s Notification
Related to Improper Connection of Sutureless Intrathecal Catheters as a
Class I Recall. September 26, 2008.
Hepatic Failure and Hepatorenal Syndrome with Tarceva
OSI Pharmaceuticals and Genentech are alerting healthcare
professionals about hepatic failure and hepatorenal syndrome with the
use of Tarceva (erlotinib), particularly in patient with baseline
hepatic impairment. Tarceva is approved to treat certain patients with
lung or pancreatic cancer.
Patients with hepatic impairment who
are treated with Tarceva should be closely monitored during therapy.
Treatment should be interrupted or discontinued if patients have severe
changes in liver function. Tarceva should be used with extra caution in
patients with total bilirubin greater than three times the upper limit
FDA MedWatch Safety Alert. Tarceva (erlotinib). September 23, 2008.
Filter Ammonul to Remove Particulates
Ucyclyd Pharma is notifying healthcare professionals that
particulate matter has been detected in Ammonul Injection. Ammonul is
used as an adjunct in treating hyperammonemia in certain patients with
urea cycle disorders.
The company says that the particulates may
affect the safe use of Ammonul. Because of this, a specific filter [the
Millex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm] must used
when Ammonul is admixed into the 10% Dextrose IV bag. Since
particulates may not be visible, the filter must be used in all cases,
even when particulates cannot be seen. As a precautionary measure, the
company will package these filters with all future shipments of Ammonul
until further notice.
FDA MedWatch Safety Alert. Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%. September 23, 2008.
Ammonul web site
Drug Name Confusion: Ephedrine and Epinephrine
The Institute for Safe Medication Practices (ISMP) is warning again
about the possibility of mix-ups between ephedrine and epinephrine. Not
only do the names of these drugs look and sound similar, but since
they're both used as vasopressors and vasoconstrictors, they're often
stored next to each other. Also, both drugs may be packaged in 1 mL
ampuls or vials.
ISMP cites a recent case in which a
57-year-old patient was admitted for excision of a neuroma on her foot.
She became hypotensive and nauseated soon after an IV was started
preoperatively. An anesthesiologist gave a verbal order for ephedrine,
but the nurse taking the order heard epinephrine, and that is what the
patient was mistakenly given.
ISMP makes several recommendations for reducing the chance of these mix-ups. Here are some of them:
• Avoid storing epinephrine and ephedrine side-by-side.
• Use tall man letters on computer inventory listings, shelf labels and other places where the drug names appear.
• Use screen alerts on automated dispensing cabinets.
• Where possible, use prefilled epinephrine syringes.
• Keep large vials of epinephrine out of clinical areas to reduce chances of preparing large amounts of the drug.
To ensure an independent double-check, have the pharmacy prepare
infusions and bolus doses for these drugs, except in emergencies.
finally, when conveying orders verbally, use the "read back" technique.
"Read back" means the person receiving the order transcribes it
directly onto the patient's record or prescription as it is being
given. Then the order is read back to the prescriber, rather than
repeating it back from memory. Also, spelling drug names helps assure
that the message has been heard and transcribed correctly. ISMP notes
that the "read back" technique may not be fully understood, even though
it is required by The Joint Commission.
ISMP Medication Safety Alert! Worth Repeating…Epinephrine-Ephedrine mix-ups. Volume 13, Issue 16. August 14, 2008.
Removing Insulin from Cartons
The Institute for Safe Medication Practices warns that storing
insulin vials inside their cardboard cartons after the packages have
been opened can be a medical emergency waiting to happen. If the vial
is accidentally returned to the wrong carton after being used, that
sets the stage for a serious insulin mix-up. That is because the next
person looking for a particular insulin product could read the label on
the carton, assume that it accurately reflects what's inside, and end
up administering the wrong product.
So ISMP recommends that
the cartons be discarded, either in the pharmacy before the insulin is
dispensed, or when it is received at the nursing station. This holds
true whether the insulin is labeled for a particular patient, or
whether it is going into floor stock. The bottom line? Do not dispense
or store insulin vials in their cartons on patient care units.
ISMP Medication Safety Alert! Remove Vials from Cartons. Volume 13, Issue 9. May 8, 2008.
Recognizing Warfarin Brand Names
A recent report by the Institute for Safe Medication Practices
(ISMP) notes that some health professionals and patients may not
realize that Jantoven is a brand name for the drug warfarin. That could
result in inadvertently prescribing and dispensing two
warfarin-containing medications for the same patient.
cites the case of a patient who had been taking warfarin at home and
continued the drug while in the hospital. On discharge, the physician
instructed that the patient continue warfarin at home, and he wrote a
new warfarin prescription. The community pharmacy dispensed Jantoven
without discussing the nature of the drug with the patient or asking
whether the patient was already taking warfarin. The patient, not
realizing that the newly prescribed drug was warfarin by another name,
took both medications, and that resulted in a severely elevated INR.
ISMP suggests several ways to avoid these kinds of errors, including:
• If a brand name warfarin is prescribed, show both the brand name and the generic name on the prescription label.
When dispensing the prescription, discuss the nature of the drug with
the patient to be sure that he or she is not already taking another
• When patients are discharged from
the hospital, counsel them about the prescriptions they are receiving
and what each of them is for.
ISMP Medication Safety Alert! Warfarin by Generic Name. Volume 13, Issue 19. September 25, 2008.
More Heparin Dosing Errors with Neonates
The Institute for Safe Medication Practices (ISMP) reports that
serious dosing errors continue to occur when heparin is administered to
neonates. ISMP cites an incident in Texas where as many as 17 infants
in a neonatal intensive care unit received heparin overdoses. According
to ISMP's analysis, the infants may have received up to 100 times more
heparin than intended.
ISMP notes that when preparing solutions
in the pharmacy, calculation errors are especially prone to occur when
heparin is stocked in unfamiliar concentrations e.g., for example, if
the pharmacy were to switch from vials containing 1,000 units per mL to
vials containing 10,000 units per mL. The possibility of a dosing error
increases if the pharmacy fails to verify the concentration of a
solution before dispensing.
Another problem, according to ISMP,
is that there is no standard dosing protocol when it comes to using
heparin for maintaining the patency of venous and arterial lines in
neonates. This means a hospital might have to stock heparin solutions
in several concentrations ranging from 0.5 units per mL to 10 units per
mL, and this can make errors more likely.
In this report and
an earlier one, ISMP offered several suggestions to help avoid these
potentially tragic errors. For example, the pharmacy could prepare and
dispense heparin flush solutions, rather than having nurses do this in
patient care areas. Or a hospital could consider using pre-filled
heparin flush syringes, which are now available in several
ISMP notes that some hospitals use a
refractometer to measure the specific gravity of the solutions as they
are prepared, and that spectroscopy equipment can also be used to check
accuracy. This can differentiate between abnormally high concentrations
and the lower concentrations needed for babies. According to ISMP,
other hospitals are choosing to outsource the preparation of neonatal
heparin flush products, using commercial manufacturers who meet FDA
Good Manufacturing Practices and assay their solutions before
ISMP Medication Safety Alert! Heparin Errors Continue Despite Prior, High-Profile, Fatal Events. July 17, 2008.