VACCINE & Medical Recalls

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Medicine Recalls and Alerts-

http://www.emedicine.com/recalls_and_alerts.htm#DTaP -

 

Recalls and Alerts

1/9/02

Liver failure warnings and nefazodone (Serzone)

Rare cases of liver failure leading to transplant and/or death in patients

have been reported. The package insert now includes a Black Box Warning

explaining the observation of an observed rate in the United States is about

1 case of liver failure resulting in death or transplant per 250,000 -

300,000 patient-years on postmarketing experience in more than 7.2 million

patients in the United States.

 

Find more information at FDA MedWatch.

 

1/4/02

CDC Advises Deferring DTaP Vaccine in Older Children

In an effort to reserve enough diphtheria, tetanus toxoids, and acellular

pertussis adsorbed vaccine (DTaP) for young infants, the CDC's Advisory

Committee on Immunization Practices (ACIP) has asked health care providers

to defer administering doses of the vaccine to older children. Health care

providers who lack sufficient DTaP stocks and cannot maintain all of their

young patients on the five-dose childhood immunization schedule should defer

the fourth DTaP dose.

 

If deferring the fourth dose (usually given at age 15-18 mo) does not free

up enough DTaP for infants to receive their first 3 doses on schedule, ACIP

recommends deferring the fifth dose (administered between age 4-5 y).

 

In areas where the shortage of DTaP is " severe, " ACIP said local public

health authorities could recommend community wide deferral of the fourth

dose and possibly the fifth. MMWR 2002; 50(51):1159

 

Find more information at Centers for Disease Control and Prevention.

 

12/21/01

Hepatitis A vaccine recall

Persons vaccinated with VAQTA in prefilled syringes after May 29, 2001 with

the adult formulation (50 U/mL), and after June 16, 1999 with the

pediatric/adolescent formulation, (25 U/0.5 mL) may not be protected against

the virus. Tests have shown decreased antigen content in some syringes below

the established minimum specification. Merck & Co., Inc. is voluntarily

recalling the affected lots. More information is available at FDA MedWatch.

Lots reported originally incorrectly by the Food Drug and Administration

include lots with the expiration date of October 24, 2002 lot numbers 1802J

and 1802JSA2.

Merck & Co., Inc. telephone: 1-800-672-6372

FDA MedWatch.

 

 

12/19/01

Kava and serious hepatotoxicity

German authorities have asked that supplements containing kava extracts

(also known as kava kava or Piper methysticum) be removed from the market.

At least 25 cases of serious liver toxicity were reported in Germany and

Switzerland. Signs of liver toxicity include hepatitis, cirrhosis, or liver

failure. The FDA is investigating whether the product poses similar public

health concerns in the United States.

Kava products are promoted for a variety of uses, including relaxation (eg,

stress relief, anxiety, tension), insomnia, and premenstrual syndrome (PMS).

The products are marketed to all segments of the population, including

children, women, men, and the elderly. Healthcare professionals are being

asked to review cases of liver toxicity and report those possibly associated

with kava-containing dietary supplements to the FDA MedWatch program. More

information is available at FDA MedWatch.

MedWatch telephone: 1-800-322-1088

MedWatch Internet Reporting.

 

 

12/7/01

DROPERIDOL (INAPSINE) ALERT

May cause QT prolongation (delayed recharging of heart between beats) within

min following injection at doses at or below recommended levels. Prolonged

QT can cause potentially fatal heart arrhythmia known as torsades de pointes

(TdP). All patients should undergo a 12-lead ECG prior to administration of

drug to determine if prolonged QT interval (i.e., QTc >440 msec for males or

450 msec for females) is present. If there is prolonged QT interval,

droperidol should NOT be administered. For patients in whom potential

benefit of droperidol treatment is felt to outweigh risks of potentially

serious arrhythmias, ECG monitoring should be performed prior to treatment

and continued for 2-3 h after completing treatment to monitor for

arrhythmias.

 

 

11/20/01

Liver Failure with Weight Loss Nutritional Supplement

The FDA has received at least 6 reports of liver injury and failure of

patients taking Lipokinetix, a weight loss nutritional supplement by Syntrax

Innovations, Inc. It contains phenylpropanolamine (PPA), caffeine,

yohimbine, diiodothyronine, and sodium usniate. Patients should discontinue

taking Lipkinetix immediately and contact their physician if they are

experiencing symptoms (eg, nausea, weakness or fatigue, fever, abdominal

pain, any change in skin color). More information is available at FDA

MedWatch.

 

 

11/5/01

CAPECITABINE (XELODA)

Clinically significant increases in prothrombin time and INR have been shown

in patients stabilized on anticoagulants. Patients receiving concomitant

capecitabine and oral coumarin-derivative anticoagulant therapy should have

their anticoagulant response (INR or prothrombin time) monitored frequently

in order to adjust anticoagulant dose as needed.

 

 

11/5/01

Sodium phosphate solutions and electrolyte shifts

Patients taking more than 45 mL of oral sodium phosphate as a prescribed

bowel preparation are vulnerable to electrolyte shifts. Reports of serious

electrolyte disturbances (ie, hypernatremia, hypokalemia, hyperphosphatemia,

hypocalcemia) dehydration, metabolic acidosis, renal failure, tetany, and

death have been attributed to prescribing more than the 45 mL as a bowel

preparation for colonoscopy, surgery, or barium enema and/or prescribing it

for people at medical risk. More information is available at FDA CDER.

 

 

10/25/01

Infliximab (Remicade) - 2 new warnings

Tuberculosis and other serious opportunistic infections, including

histoplasmosis, listeriosis, and pneumocystosis, have been reported in

clinical research and post-marking surveillance of infliximab (Remicade).

Some of these infections have been fatal. More information is available at

FDA MedWatch.

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 those treated with infliximab. The risk is

especially observed in those treated with the higher dose of 10 mg/kg. More

information is available at FDA MedWatch.

 

10/2/01

Flu vaccine distribution update

Distribution delays of the 2001 influenza vaccine are expected, but the

amount of vaccine remains greater than the 2000 season. Check the updates on

flu vaccine distribution from the Centers for Disease Control.

 

 

9/26/01

TOPIRAMATE (TOPAMAX) ALERT

Patients taking topiramate should seek immediate medical attention if they

experience blurred vision or periorbital pain. Continued usage after

symptoms develop, can lead to glaucoma. Primary treatment is discontinuation

of topiramate, If left untreated, serious sequelae, including permanent

vision loss, may occur.

 

 

9/17/01

Hip Prosthesis Recall

Voluntary recall of unimplanted inventory of zirconia ceramic femoral heads

used by French and United States manufacturers that have included these

components in their products. The femoral heads were recalled due to an

higher than expected rate of fractures 13-27 months following implantation.

.. See details at: FDA MedWatch.

 

 

8/24/01

Neumega (oprelvekin) - Papilledema dose-limiting adverse reaction in

pediatrics

Preliminary data from a safety and pharmacokinetic study in 47 children has

identified papilledema as a dose-limiting adverse reaction in the pediatric

population. There are no controlled clinical studies that have established a

safe and effective dose in children. The manufacturer suggests that

administration in children be restricted to controlled clinical trials with

closely monitored safety assessments. See details at: FDA MedWatch.

 

 

 

8/8/01

Baycol (cerivastatin) withdrawn from United States market

August 8, 2001 - Bayer Pharmaceutical Division is voluntarily withdrawing

Baycol (cerivastatin) from the US market because of reports of sometimes

fatal rhabdomyolysis, a severe muscle adverse reaction. Cerivastatin is

hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor that is used

to lower cholesterol. See details at: FDA MedWatch.

 

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