|
Selected
Significant Drug Safety Summaries: August 2001 to August 2002
|
Product
|
Safety
Issue
|
|
Droperidol
(Inapsine)
|
December 2001: New black box data added to the package insert based on
reports of death associated with QT prolongation and torsades de pointes in
patients treated with this drug.
Events have occurred during therapy at or below recommended doses.
Based on this information the drug should be reserved for treatment in
patients who are not responsive to other therapies. Baseline 12 ECG should be
performed prior to initiation of therapy.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2001/inapsine.htm
FDA Talk Paper:
http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01123.html
|
|
Enoxaparin (Lovenox)
|
April 2002: The warning and precaution
sections of the package insert to reflect that the use of enoxaparin is not
recommended for thromboprophylaxis in patients with
prosthetic heart valves. These changes were based on postmarketing
surveillance reports of thrombosis when the drug was used for thromboprophylaxis, particularly in pregnant women. Some
cases have resulted in maternal and fetal deaths. Pregnant women with
prosthetic heart valves may be at higher risk. In addition, the new package
information reflects new data on congenital anomalies and nonteratogenic
effects in infants born to mothers who received enoxaparin during pregnancy.
Manufacturer
Letter:
http://www.fda.gov/medwatch/safety/2002/lovenox.htm
|
|
Epoetin
alfa (Epogen,
Procrit)
|
May /June 2002: Health professionals were
notified of counterfeit drug product in the U.S, specifically the 40,000 U/mL
vials. Specific lot numbers and features of the counterfeit product are
provided.
Manufacturer Letter
(Amgen):
http://www.fda.gov/medwatch/safety/2002/epogen.htm
Manufacturer Letter
(Ortho Biotech):
http://www.fda.gov/medwatch/safety/2002/ProcrittamperDDL.PDF
|
|
Infliximab
(Remicade)
|
October 2001: Infection New boxed
data has been added to the package insert regarding the risk of tuberculosis,
invasive fungal infections, and other opportunistic infections. Some of these
infections have been fatal. Patients should be evaluated for latent
tuberculosis and treated prior to initiation of therapy with infliximab.
Additional cases or histoplasmosis, listeriosis, and pneumocytosis
have been reported.
Manufacturer
Letter:
http://www.fda.gov/medwatch/safety/2001/remicadeTB_deardoc.pdf
October 2001: CHF Preliminary
results of an ongoing phase 2 trial in patients with moderate to severe CHF
demonstrated higher incidences of mortality and hospitalization for worsening
heart failure in patients treated with infliximab, especially those treated
with the higher dose of 10 mg/kg. Based on these preliminary findings, and
pending additional data, precautionary measures are recommended.
Manufacturer
Letter:
http://www.fda.gov/medwatch/safety/2001/remicade_deardoc.pdf
|
|
Interferon-alfa
(Intron
A, Rebetron, Roferon-A)
|
March 2002: Post-marketing reports of fatal or
life-threatening neuropsychiatric, autoimmune, ischemic and infectious
disorders have been associated with drug use. A new boxed warning was added
to product inserts.
Manufacturer Letter
(Schering):
http://www.fda.gov/medwatch/safety/2002/Intron_deardoc.pdf
Manufacturer Letter
(Schering):
http://www.fda.gov/medwatch/safety/2002/roferon_deardoc.pdf
|
|
Immune Globulin IV (IGIV)
|
March 2002: The American Red Cross
and Baxter notified health professionals regarding the occurrence of
thrombotic events possibly associated with IGIV use. Risk factors may include
rapid infusion rates and high doses.
Manufacturer Letter
(Baxter):
http://www.fda.gov/medwatch/safety/2002/baxter_igiv.htm
Manufacturer Letter
(American Red Cross):
http://www.fda.gov/medwatch/safety/2002/ARC_igiv.htm
August 2002: In an interim statement
the FDA noted that previous manufacturer letters suggest that these products
are more safe than another product on the market.
The FDA noted that there is no conclusive evidence to support this suggestion
and that further investigation is ongoing.
FDA Interim Statement:
http://www.fda.gov/cber/infosheets/igiv082702.htm
|
|
Irinotecan (Camptosar)
|
May 2002: Changes in the product insert identify
patients at higher risk of severe toxicity, clarify
dose modification guidelines and information regarding management of
toxicity.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/camptosar.htm
|
|
Kava-Kava
|
March 2002: The FDA advised the public regarding the
potential risk of severe hepatototoxicity
associated with the use if kava containing dietary supplements. Specific reports
include hepatitis, cirrhosis, and liver failure.
FDA Consumer Advisory:
http://www.cfsan.fda.gov/%7Edms/addskava.html
FDA Health Professional
Letter:
http://www.cfsan.fda.gov/%7Edms/ds-ltr29.html
|
|
Lamivudine/Zidovudine
(Combivir)
|
May 2002: Notification of possible counterfeit
labeling of Combivir tablets that actually
contained Ziagen tablets. Health professionals are
encouraged to examine the contents of each bottle.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/combivir_deardoc.pdf
Press Release:
http://www.fda.gov/medwatch/safety/2002/combivir.htm
|
|
Lamotrigine (Lamictal)
|
August 2001: Health professionals were notified of
medication errors regarding misdispensing of
products with similar names including Lamictal, Lamisil, Lamivudine, Ludiomil, Labetalol, and Lomotil. Suggestions for prevention of medication
errors are provided.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2001/lamic_pharm.pdf
|
|
Liopkinetix
|
November 2001: The FDA notified health professionals of
reports of serious liver toxicity associated with the use of this dietary
supplement. Onset of liver disease has
occurred within 2 weeks and 3 months after the initiation of the product.
FDA Letter to Health
Professionals:
http://www.fda.gov/medwatch/safety/2001/lipokinetix_deardoc.pdf
CFSAN Warning and
Website:
http://www.cfsan.fda.gov/~dms/ds-warn.html
|
|
Mifeprostone
(Mifeprex)
|
April 2002: New safety information in the package insert
re-emphasizes that the drug is not effective treatment of ectopic
pregnancy. These changes were based on reports of ruptured ectopic pregnancy. In addition, reports of serious
infection and myocardial infarction were described.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/mifeprex_deardoc.PDF
FDA Question/Answer
Website:
http://www.fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa_4_17_02.htm
|
|
Misoprostol
(Cytotec)
|
May 2002: Revised safety
information clarifies contraindication statement in pregnancy to use for
prophylaxis of NSAID induced ulcers. New information included on other safety
issues and uterine rupture.
FDA Summary:
http://www.fda.gov/medwatch/safety/2002/cytotec_changes.PDF
|
|
Nefazodone (Serzone)
|
January 2002: New black box warning
added to product labeling, which describes cases of life-threatening hepatic
failure associated with therapy. The drug should not be started in patients
with active liver disease or elevated baseline serum transaminases. Patients
should be counseled regarding signs and symptoms of liver dysfunction.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/serzone_deardoc.PDF
Patient Package Insert:
http://www.fda.gov/medwatch/safety/2002/serzone_PPI.pdf
|
|
Nettle Capsules
|
June 2002: A recall of four lots of
Nature's Way brand Nettle capsules because the product contained excessive
amounts of lead. The affected lots of the product were distributed nationwide
primarily in health food retail establishments between October
2001and May 2002. (Recalled lot numbers: 131237, 131238, 140738 and 215229)
FDA Press Release:
http://www.fda.gov/oc/po/firmrecalls/nettle06_02.html
|
|
Olanzapine (Zyprexa)
|
May 2002: Product tampering consisted of substitution
of aspirin tablets in bottles of 10 mg and 15 mg Zyprexa.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/zyprexa_deardoc.PDF
|
|
PC SPES, SPES
|
February 2002: The FDA warned consumers
to stop using this dietary supplement / herbal product because they contained undeclared
prescription drug ingredients that could cause serious health effects.
Laboratory analysis of the products by the California Department of Health Services found PC
SPES contains warfarin and SPES contains alprazolam.
FDA Summary:
http://www.fda.gov/medwatch/safety/2002/safety02.htm#spes
|
|
Pioglitazone
(Actos)
Rosiglitazone
(Avandia)
|
April 2002: Revisions in package
insert safety labeling based on reports of cardiac complications.
Specifically, therapy with either drug was associated with fluid retention
(which can contribute to heart failure) when the drugs were used alone or in
combination with insulin. Most patients had underlying cardiac disease or a
history of cardiovascular conditions. Therapy not recommended for patients
with NYHA Class III or IV cardiac status.
FDA Summary:
http://www.fda.gov/medwatch/safety/2002/summary-actos-avandia.PDF
|
|
Pooled Plasma (PLAS+SD)
|
March 2002: Strengthened warnings in product information
stating that pooled plasma should not be used in patients undergoing liver
transplants or in patients with severe liver disease and known coagulopathies. These recommendations are based on
reports of thromboembolic complications or severe bleeding in such patients.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/plassd_deardoc.pdf
|
|
Quetiapine (Seroquel)
|
May 2002: Reports of dispensing medication errors
involving Seroquel and Serzone, resulting in serious adverse events,
requiring hospitalization. According to the reports, verbal and written
prescriptions were incorrectly interperted,
labeled, and/or filled due to the similarity in names.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/seroquel.htm
|
|
Rofecoxib (Vioxx)
|
April 2002: A higher incidence of serious adjudicated
cardiovascular thrombotic events reported in the VIGOR trial when rofecoxib
was compared to naproxxen. Adjudicated events
included sudden death, myocardial infarction, unstable angina, ischemic
stroke, transient ischemic attack, and peripheral venous and arterial
thromboses. New labeling advises caution with use in patients with ischemic
heart disease.
FDA Talk Paper:
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01145.html
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/vioxx_deardoc.pdf
|
|
Sirolimus (Rapamune)
|
April 2002: Addition of new black box
warning regarding the risk of hepatic artery thrombosis when used in
combination with cyclosporine or tacrolimus. Most cases occurred within 30
days post-transplantation and resulted in graft loss or death. The safety and efficacy of this drug as
immunosuppressive therapy has not been established in liver transplant
patients and thus, is not recommended.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/Rapamune_Deardoc.pdf
|
|
Sodium Phosphate Oral Solution
|
September 2001: The FDA posted a
statement regarding the safety of sodium phosphate oral solution. Cases of
accidental overdosing and death have occurred when excessive amounts have
been administered. The FDA has limited the bottle size to a 90 mL container.
FDA Paper:
http://www.fda.gov/cder/drug/safety/sodiumphospate.htm
|
|
Somatroprin (Serostim)
|
May 2002: Reports of counterfeit
product (injectable).
Manufacturer Letter:
http://www.fda.gov/oc/po/firmrecalls/serono05_02.html
|
|
Stavudine
(Zerit)
|
February 2002: Warnings regarding the risk of lactic acidosis were restated. In
addition reports of rare occurrences of rapidly ascending neuromuscular
weakness have been associated with stavudine in combination with other
antiretrovirals. Some cases were fatal. The majority of cases occurred with
lactic acidosis.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/ZERIT_deardoc.pdf
|
|
Tamoxifen (Nolvadex)
|
May 2002: New boxed warning for
women with ductal carcinoma in situ and women at
high risk for breast cancer. Serious and life-threatening events associated
with tamoxifen in the risk reduction setting include uterine malignancies,
stroke, and pulmonary embolism. Some cases were fatal. Patients should be
advised regarding the potential risks when used to reduce the risk of
developing breast cancer. The benefits of this drug outweigh risks in women
with breast cancer.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/nolvadex_deardoc.pdf
|
|
Topiramate (Topamax)
|
September 2001: Changes in the safety
labeling have been made based on reports of acute myopia and secondary angle
closure glaucoma. Symptoms include acute onset ocular pain and decreased
vision.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2001/topamax_deardoc.PDF
|
|
Valproic Acid
and derivatives
|
June 2002: New safety information
regarding hyperammonemic encephalopathy, sometimes
fatal, have been reported with valproic acid use in
patients with urea cycle disorders. Asymptomatic elevations of ammonia may
require close monitoring of plasma ammonia levels.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/depakote_deardoc.pdf
|
|
Ziprasidone
(Geodon)
|
April 2002: Warnings regarding QT prolongation are
clarified. Ziprasidone use should be avoided with
drugs that prolong QT inerval, in patients with
congenital long QT syndrome and in pateints with a
history of cardiac arrhythmias.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/geodon.htm
|
|
Zonisamide
(Zonegran)
|
July 2002: New safety data in
package insert based on reports of ogliohidrosis
and hyperthermia in pediatric patients. Patients,
especially pediatric patients should be monitored for decreased sweating and
increased body temperature, particularly in hot or warm weather. Oligohidrosis has resulted in heat stroke and
hospitalization.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/2002/Zonegran_deardoc.pdf
|
|
Prepared by: Joyce Generali, MS, FASHP
Drug
Information
Center
jgeneral@kumc.edu
|
