MedWatch - 2002 Safety Information - Drug Reports

[Guest guest]

Hello All~

I have been viewing the eurrent MedWatch Safety Reports for

Medications/Drugs and I was concerned to see so many recalled meds that

are commonly used my members of our support network.

I wanted to bring this information to every one's attention so that

everyone can be made aware should one of these recalled drugs be one

they are taking or have taken recently.

Lany

Drugs:

Actos (pioglitazone HCl) (Posted 4/26/2002)

Albuterol Sulfate Solution for Inhalation (Posted 4/19/2002)

Avandia (rosiglitazone) (Posted 4/26/2002)

Clozaril (clozapine) (Posted: 2/20/2002)

Combivir (lamivudine plus zidovudine) (Posted 5/10/2002)

Cytotec (misoprostol) (Posted 4/17/2002)

Cytovene (gancyclovir) (Posted: 2/13/2002)

Depakote / Depakene / Depacon (divalproex sodium / valproic acid /

valproate sodium) (Posted 6/17/02)

Geodon (ziprasidone HCl) (Posted 4/3/2002)

Heparin Sodium Injection, USP (Posted 5/1/2002)

Lioresal Intrathecal (baclofen injection) (Posted 5/23/2002)

Lovenox (enoxaparin sodium) (Posted 4/3/2002)

Maxair Inhaler (pirbuterol acetate inhalation aerosol) (Posted 5/7/2002)

Mifeprex (mifepristone) (Posted 4/17/2002)

Nolvadex [tamoxifen citrate] (Posted 6/27/2002)

Rapamune (sirolimus) (Posted 4/24/2002)

Serostim [somatropin (rDNA origin) for injection] (Posted 5/17/2002)

Seroquel (quetiapine fumarate) (Posted 6/12/2002)

Serzone (nefazodone HCL) (Posted: 1/9/2002)

Thiazolidinediones [Actos (pioglitazone HCl), Avandia (rosiglitazone)]

(Posted 4/26/2002)

Versed Syrup (midazolam HCl) CIV (Posted: 3/1/2002)

Vioxx (rofecoxib) (Posted 5/6/2002)

Zerit (stavudine) (Posted 3/29/2002)

Zyprexa (olanzapine) (Posted 5/7/2002)

THIS IS A PARTIAL LIST OF SOME OF THE DRUGS BEING RECALLED AND THE

REASON FOR THE RECALL. FOR A COMPLETE LIST, USE THE LINK TO THE

ORIGINAL SOURCE LISTED AT THE END OF THIS ARTICLE.

Nolvadex [tamoxifen citrate]

Audience: Oncologists and other healthcare professionals caring for

women with breast cancer

FDA and AstraZeneca have added a boxed warning and strengthened the

WARNINGS section of the label to inform healthcare professionals about

new risk information of particular relevance to women with ductal

carcinoma in situ [DCIS] and women at high risk for developing breast

cancer and are receiving or considering Nolvadex therapy to reduce their

risk of developing invasive breast cancer.

Serious, life-threatening or fatal events associated with Nolvadex in

the risk reduction setting [women at high risk for cancer and women with

DCIS] include endometrial cancer, uterine sarcoma, stroke, and pulmonary

embolism. Healthcare providers should discuss the potential benefits

versus the potential risks of these serious events with women

considering Nolvadex to reduce their risk of developing breast cancer.

Depakote / Depakene / Depacon (divalproex sodium / valproic acid /

valproate sodium)

Audience: Neuropsychiatric healthcare professionals

FDA and Abbott strengthened the CONTRAINDICATIONS, WARNINGS and

PRECAUTIONS sections of the label for Depakote Tablets, Depakote ER

Tablets, Depakote Sprinkle Capsules, Depakene Capsules and Syrup and

Depacon for Injection. Healthcare professionals were informed that

hyperammonemic encephalopathy, sometimes fatal, has been reported

following initiation of valproate therapy in patients with urea cycle

disorders [uCD], a group of uncommon genetic abnormalities. Patient

criteria to consider in evaluation for UCD prior to initiation of

valproate therapy are offered.

Seroquel (quetiapine fumarate)

Audience: Neuropsychiatric healthcare professionals and Pharmacists

AstraZeneca received reports of medication errors involving confusion

between its atypical antipsychotic Seroquel (quetiapine fumarate),

indicated for the treatment of schizophrenia, and Serzone (nefazodone

hydrochloride), a product of Bristol-Myers Squibb, indicated for the

treatment of depression. In addition to the similarity in names between

Seroquel and Serzone, the overlapping strengths (100 mg and 200 mg), the

dosage forms (tablets), the dosing interval (BID), and the fact that

these two products were stocked close together in pharmacies were also

critical in causing these errors.

Procrit (epoetin alfa)

Audience: Oncologists and other healthcare professionals

Ortho Biotech Products, L.P., with the knowledge of FDA, notified

pharmacists, health care providers, and wholesalers/distributors of

counterfeit PROCRIT (epoetin alfa). Vials of PROCRIT labeled as 40,000

U/mL in four-pack boxes, lot number P002641 expiration date: 9/03 have

been found to contain active ingredient that is approximately 20 times

lower than would be expected for PROCRIT in 40,000 U/mL vials. Based on

inventory and historic use patterns it is thought that all existing

inventory of lot number P002641 may have been used. However, pharmacists

and health care providers should check the product lot number and

carefully examine all vials of PROCRIT before use. A brief description

of the differences between the actual product and the counterfeit are

provided in the letter. (posted 6/11/2002, 2:30 pm EDT)

UPDATE: In addition to lot number P002641, lot number P002384,

expiration: 03/2003 has also been determined to be counterfeit product.

Distinctions between this counterfeit lot and authentic PROCRIT are

still being analyzed. Distinctions may not be the same as those

identified in the Dear Healthcare Professional letter dated June 6,

2002. Thus, any product bearing this lot number in particular should be

considered suspect. (posted 6/11/2002, 3:40 pm EDT)

Lioresal Intrathecal (baclofen injection)

Audience: Neurologists, Neurosurgeons, and other healthcare

professionals

Medtronic and FDA added a BOXED WARNING and strengthened the WARNINGS

sections of the prescribing information of Lioresal Intrathecal,

indicated for use in the management of severe spasticity of cerebral and

spinal origin. The warnings inform healthcare professionals about rare

cases of intrathecal baclofen withdrawal that can lead to life

threatening sequelae and/or death in patients who abruptly discontinue

therapy.

Vioxx (rofecoxib)

Audience: Healthcare professionals treating patients with

osteoarthritis, rheumatoid arthritis, acute pain, and primary

dysmenorrhea

FDA and Merck strengthened the WARNINGS, PRECAUTIONS, and CLINICAL

STUDIES sections of Vioxx labeling to describe new cardiovascular and

gastroenterological safety information. This information reflected the

results of a prospective, active control study of Vioxx 50 mg daily

versus naproxen 500 mg twice daily and from a placebo-controlled trials

database. This information should be taken into consideration and

caution should be exercised when Vioxx is used in patients with a

medical history of ischemic heart disease.

Thiazolidinediones [Actos (pioglitazone HCl), Avandia (rosiglitazone

maleate)]

Audience: Primary care providers, endocrinologists, cardiologists and

other healthcare professionals treating patients with type 2 diabetes

mellitus

FDA approved changes to strengthen the labeling for Actos and Avandia.

The WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections have been

modified to more clearly describe the cardiovascular risks associated

with the use of thiazolidinediones as monotherapy and in combination

with other antidiabetic agents, particularly insulin.

Immune Globulin Intravenous (Human) (IGIV)

Audience: Healthcare professionals

There have been post marketing reports describing serious thrombotic

events (vascular occlusion) possibly associated with the administration

of Immune Globulin Intravenous (Human) (IGIV). Precautionary statements,

advising physicians to exercise caution in administering IGIV to

patients with cardiovascular disease or previous thrombotic events, have

been added to the labeling of both Baxter's Gammagard S/D and American

Red Cross' Polygam S/D. The letters remind healthcare professionals of

measures that may be important in reducing the risk of a thrombotic

event.

Albuterol Sulfate Solution for Inhalation (0.5%)

Audience: ICU staff, Respiratory Therapists, and other healthcare

professionals

FDA issued a Public Health Advisory notifying the medical community of

two recent hospital outbreaks of lower respiratory tract colonization

and infection with Burkholderia cepacia attributed to contaminated

multi-dose bottles of albuterol sulfate. In most cases, colonization or

infection occurred in the ICU setting, often in patients receiving

mechanical ventilation. The advisory reminds healthcare professionals of

measures that may be important in reducing the risk of contamination and

subsequent outbreaks of infections. (The link below opens a new browser

window with the advisory notice.)

Kava-containing Dietary Supplements (Piper methysticum)

Audience: Healthcare Professionals and Consumers

The FDA Center for Food Safety and Applied Nutrition (CFSAN) notified

healthcare professionals and consumers of the potential risk of severe

liver injury associated with the use of kava-containing dietary

supplements. Supplements containing the herbal ingredient kava are

promoted for relaxation (e.g., to relieve stress, anxiety, and tension),

sleeplessness, menopausal symptoms and other uses. Kava-containing

products have been associated with liver-related injuries, including

hepatitis, cirrhosis, and liver failure. Given these reports, persons

who have liver disease or liver problems, or persons who are taking drug

products that can affect the liver, should consult a physician before

using kava-containing supplements. [The links below open new browser

windows with the CFSAN safety alert pages.]

Alpha Interferons

Intron A (Interferon alfa 2b, recombinant)

Rebetron Combination Therapy (Rebetrol (Ribavirin, USP) Capsules and

Intron A)

Roferon-A (Interferon alfa-2a, recombinant)

Audience: Oncologists and other Healthcare professionals

Healthcare professionals are advised of important safety information for

all alpha interferons. A BOXED WARNING has been added regarding the

occurrence of neuropsychiatric, autoimmune, ischemic, and infectious

disorders in patients taking alpha interferons; additional safety

information and direction for patient monitoring is also provided in the

WARNINGS section of the prescribing information.

Audience: Urologists, Consumers

Consumers are warned to stop using the dietary supplement / herbal

products PC SPES and SPES capsules because they contain undeclared

prescription drug ingredients that could cause serious health effects if

not taken under medical supervision. Laboratory analysis of the products

by the California Department of Health Services found PC SPES contains

warfarin and SPES contains alprazolam, which are available only by

prescription and sold either by their generic names or the trade names,

Coumadin and Xanax. PC SPES and SPES are respectively marketed " for

prostate health " and strengthening the immune system. BotanicLab, the

manufacturer of the products, has voluntarily recalled PC SPES and SPES

nationwide.

Serzone (nefazodone HCL)

Audience: Psychiatrists, Pharmacists

FDA and BMS added a Black Box Warning and strengthened the WARNINGS,

CONTRAINDICATIONS, and PRECAUTIONS sections of the label for Serzone, an

antidepressant drug. Rare cases of liver failure leading to transplant

and/or death in patients have been reported. A new Patient Package

Insert is provided in the product packaging.

SOURCE:

MedWatch - 2002 Safety Information

Address:http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm

SBI Prayer Forum

http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm