Based on postmarketing experience, the Norvir Product Information has
been updated to reflect new information about drug interactions. Ergot
alkaloid preparations and pimozide have been added as contraindications.
Cardiac and neurologic events have been reported with coadministration
of disopyramide, mexiletine, nefazadone, or fluoxetine. Saquinavir plasma
concentrations increased greater than 20-fold when coadministered with
ritonavir 400 mg and 600 mg b.i.d. dosing regimens. However, the
appropriate doses for this combination, with respect to activity and safety,
have not been established.
Additionally, the WARNING and ADVERSE REACTION sections have been revised
to include information regarding allergic reactions, hepatic transaminase
elevations and postmarketing reports of hepatic dysfunction, seizure,
hyperglycemia, syncope, orthostatic hypotension and renal insufficiency.
Also, the PRECAUTIONS and OVERDOSAGE sections have been updated.
Also included is a review of the importance of dose titration upon
the initiation of Norvir therapy to reduce treatment-emergent adverse
events while maintaining appropriate plasma levels.
[November, 1996 (letter) - Abbott Laboratories]
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Trancopal (chlormezanone)
Sanofi Winthrop is discontinuing Trancopal worldwide. A recent retrospective
European inquiry confirmed the low incidence of serious
cutaneous reactions (toxic epidermal necrolysis) associated with the use of chlormezanone.
[November 7, 1996 (letter) - Sanofi Winthrop]
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Vistide (cidofovir)
There have been several reports of severe renal impairment associated
with the use of Vistide. Guidelines are provided that reinforce the
importance of appropriate patient selection,treatment administration and
monitoring therapy in order to ensure that Vistide is used safely and
to alert prescribers about two new contraindications (preexisting renal
disease and concomitant administration with agents having nephrotoxic
potential).
[September, 1996 (letter) - Gilead Sciences, Inc.]
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Albuminar and Plasma Plex Recall
Centeon announced a voluntary recall of all in-date lots of Albuminar and Plasma Plex
which expire prior to September 30, 1999. No other Centeon products are affected by this
voluntary action. Centeon is taking this action as a precaution due to manufacturing concerns
related to these two products. For more information call Centeon at (800) 551-0120.
[October 9, 1996 (announcement) - Centeon]
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Antihemophilic Factor (Factor VIII)
Recall
One lot of antihemophilic factor, Lot P72304, is being recalled by Centeon. The
product may have been damaged as a result of a manufacturing problem creating a risk for
contamination. No illnesses associated with this product lot have been reported to FDA, but
the lot has been recalled as a precautionary measure.
[October 4, 1996 (talk paper) - FDA]
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Glucophage (metformin HCl)
Letter reinforcing the importance of appropriate patient selection in order to minimize
the risk of lactic acidosis. The risk of lactic acidosis with Glucophage therapy can be
minimized by avoiding its use in patients at risk for significant drug accumulation (e.g. renal
impairment) or in patients at an increased risk for developing lactic acidosis independent of
therapy because of impaired ability to clear lactate (e.g. conditions associated with tissue
hypoperfusion or hypoxic states, or substantial liver impairment). There are also clinical
circumstances under which Glucophage therapy should be withheld or discontinued: patients
with evidence of renal disease or dysfunction, prior to procedures using intravenous iodinated
contrast media, acutely ill patients and/or those who are hemodynamically unstable, and
patients with impaired hepatic function or excessive alcohol intake.
[September 11, 1996 (letter) - Bristol-Myers Squibb]
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Injectable Adrenal
Cortex Extract
At least 54 cases have been reported in the US of abscess formation at injection sites
where patients have received adrenal cortex extract (30 ml vials) distributed by Phyne
Pharmaceuticals. Adrenal cortex extract is not approved for use by FDA for any indication,
but the product has been promoted for a wide variety of uses including weight loss, burn
treatment and lessening substance abuse addictions. Physicians or consumers with adrenal
cortex extract products bearing "Hallmark Labs" on the label should immediately stop using
the product and contact FDA.
[August 30, 1996 (alert) - HHS News]
Prelimary findings were summarized in the August 23, 1996 MMWR article "
Infection with Mycobacterium abscessus
Associated with Intramuscular Injection of Adrenal Cortext Extract--Colorado and
Wyoming, 1995-1996
Download as PDF file
Directions for downloading PDF
files
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Halcion (triazolam) and Xanax
(alprazolam)
Prescribing information has been changed to indicate that triazolam and alprazolam are
metabolized via the cytochrome P450 3A (CYP 3A) pathway and may interact with other
drugs and foods that use this pathway. Halcion is contraindicated with ketoconazole,
itraconazole, and nefazodone, medications that significantly inhibit oxidative metabolism
mediated by CYP 3A. Xanax is contraindicated with ketoconazole and itraconazole.
[August 23, 1996 (letter) - Pharmacia & Upjohn]
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Redux (dexfenfluramine HCl)
Prescribing information is being updated to be consistent with the final report of the
International Primary Pulmonary Hypertension Study which looked at the relationship between
anorexigens and primary pulmonary hypertension. Patients should be advised to report
immediately any deterioration in exercise tolerance, and treatment should be discontinued in
patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope, or lower
extremity edema. Redux should not be used in patients hypersensitive to dexfenfluramine or
related compounds; in patients with diagnosed pulmonary hypertension; or in patients taking (or
within 14 days of discontinuing) monamine oxidase inhibitors.
[August 22, 1996 (letter) - Wyeth-Ayerst Laboratories and Interneuron Pharmaceuticals, Inc.]
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HIV Protease Inhibitors
FDA and the drug manufacturers recommend that health care providers
monitor
hemophiliac patients for spontaneous bleeding episodes whenever any of
the protease inhibitors is
used as part of treatment for HIV. There are three HIV protease inhibitors
currently approved for
marketing in the U.S. for the treatment of HIV infection: INVIRASE,
(saquinavir), NORVIR,
(ritonair) and CRIXIVAN, (indinavir).
[July 17, 1996 (letter) - FDA]
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Patient Examination
Gloves
Concern over the potential for fires involving powder-free latex patient examination and
glove quality during warehouse storage. FDA provides several recommendations including
powder-free latex patient examination gloves should not be stored in conditions of extreme heat,
and cartons should be stacked to facilitate cooling ventilation.
[June 27, 1996 (Public Health Advisory) - FDA]
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Oxycontin (Oxycodone HCl controlled-release)
and
MS Contin (Morphine sulfate controlled-release)
An urgent notice to discard all dosage conversion slide card calculators for both products at
once. A small but unknown number of the slide card conversion calculators were not correctly
cut. A misaligned reading could cause the recommended conversion dose to be potentially toxic in
a very small number of patients. The company has distributed new dosage conversion calculators,
and additional copies are available by calling (203) 853-0123.
[June 14, 17996 (letter) - Purdue Pharma L.P.]
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Seldane (terfenadine)
Two recent studies published in JAMA suggest that the concomitant use of
Seldane/Seldane-D and macrolide antibiotics or azole antifungal agents still exists. A reminder
that Seldane/Seldane-D is contraindicated in patients taking ketoconazole, itraconazole,
erythromycin, clarithromycin or troleandomycin, or in patients with significant hepatic
dysfunction. Concomitant use may result in serious cardiovascular events, including death, cardiac
arrest, torsades de pointes and other ventricular arrhythmias.
[June 1996 (letter) - Hoechst Marion Roussel]
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Street Drugs Containing Botanical Ephedrine
FDA is warning consumers not to purchase or consume ephedrine-containing dietary
supplements with labels that often portray the products as apparent alternatives to illegal street
drugs such as "ecstasy." Possible adverse effects of ephedrine range from clinically significant
effects such as heart attack, stroke, seizures, psychosis and death, to clinically less significant
effects that may indicate the potential for more serious effects (for example, dizziness, headache,
gastrointestinal distress, irregular heartbeat, and heart palpitations).
[April 10, 1996 (press release) - FDA]
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Lindane-Containing Lice
Treatments
Lindane is generally safe and effective when used according to the approved directions, but
its overuse can be harmful. FDA has recommended labeling changes that encourage lindane's use
only for patients who have either failed to respond to adequate doses, or are intolerant of, other
approved therapies. In addition, lindane products' labeling will advise health care providers and
parents not to confuse prolonged itching with reinfestation. The drug's label already warns
parents that neurotoxicity is a possibility among certain patients, especially infants.
[April 3, 1996 (talk paper) - FDA ]
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Hismanal (astemizole)
The administration of quinine (doses of 430 mg or higher) is now contraindicated with
Hismanal. This is based on pharmacokinetic data and case reports which indicate that this agent
may alter the pharmacokinetic parameters of astemizole, which may result in elevated plasma
levels of astemizole and desmethylastemizole which is accompanied by electrocardiographic QT
prolongation. Product labeling has been revised to include this information.
[March 25, 1996 (letter) - Janssen]
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Ultram (tramadol HCl)
Prescribing information has been updated regarding the potential for abuse, seizures, and
anaphylactoid reactions. This information is based on experience obtained from the use of
Ultram for the treatment of moderate to moderately severe pain in an
estimated five million patients in the United States.
[March 20, 1996 (letter) - Ortho-McNeil Pharmaceutical]
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Fosamax (alendronate sodium)
There are a number of case reports of esophagitis and esophageal
ulceration in patients
taking Fosamax. In a large proportion of cases reported, there is evidence
that Fosamax
was not dosed in the manner recommended in the Product Circular (for example, patients were
taking Fosamax with little or no water, taking it at bedtime and/or lying down within minutes
after taking it, etc). Merck has revised the Product Circular (and Patient Package Insert) to advise
strict compliance with the dosing instructions.
[March 15, 1996 (letter) - Merck & Co., Inc.]
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Over-the-Counter PPA
Products
FDA proposes additional warnings that will advise consumers not to take a PPA-containing drug with any other
product that contains PPA, phenylephrine, pseudoephedrine or ephedrine. The proposed labeling
would also require that PPA-containing weight control products be used by
adults only (i.e., over
18 years of age).
[February 14, 1996 (talk paper) - FDA]
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Thrombocytopenia after Immunization with Measles Vaccines: Review of the Vaccine
Adverse Events Reporting System
The article is a summary of VAERS data reviewing 55 cases of thrombocytopenia after
measles immunization in the United States. This report shows that severe thrombocytopenia with
platelet counts of less than 20,000 per cubic mm may occur in children and adults 1-40 years of
age, and may on rare occasions result in severe gastrointestinal or pulmonary bleeding.
Thrombocytopenia has been reported to reoccur with the second dose of vaccine.
[January 1996 (journal publication) - The Pediatric Infectious Disease Journal
1996;15(1):88-90 - FDA Staff (Boyce, T, Pemberton, A, and Addiss, D)].
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Onset of Adverse Patient Responses during the Placement of
Landmark Midline Catheters
Reports have been received of adverse events either during or within 30 minutes of the
placement and flushing of the Landmark Midline Catheter. These events range from minor
signs and symptoms to rare life-threatening incidents. The frequency of reports is such that health
professionals should be prepared to initiate appropriate medical intervention if an adverse event
occurs.
[January 12, 1996 (letter)- Menlo Care, Inc.]