Medicine Recalls and New LUDICROUS Vaccine Schedule!

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Recalls and Alerts 2002

Click here for past Recalls and Alerts.

2/26/02

 

Lyme Vaccine Withdrawn from Market

A decrease in demand of lyme vaccine (LYMErix) resulting in poor sales has

prompted Glaxo SmithKline to withdraw it from the market. The company's

decision was announced despite federal health officials warning that Lyme

disease cases had reached record highs in recent years.

 

2/20/02

Pentothal Ready-To-Mix Syringe 500 mg 2.5% (25 mg/mL)

The voluntary recall by Abbott Hospital Products Division is due to a single

400 mg pentothal vial found in a single 500 mg pentothal kit within a case

of 25 kits. The NDC number affected is 0074-6420-01 and the lot number is

80-076-DK. Only the referenced lot number is affected. Institutions who have

pentothal supplies with that referenced lot number are encouraged to contact

Abbott Customer Service (1-800-222-6883) to obtain return information..

 

For more information contact Abbott Hospital Products Division

(1-800-222-6883).

 

2/20/02

Clozapine Associated with Fatal Myocarditis

Post-marketing surveillance data of patients taking clozapine in the United

States, Canada, United Kingdom, and Australia show a myocarditis incidence

of 5, 16.3, 43.2, and 96.6 cases/100,000 patient years, respectively.

Fatalities were reported to occur at a rate of 2.8, 2.3, 11.5, and 32.2

cases/100,000 patient years, respectively. The increased risk of fatal

myocarditis is particularly prevalent within the first month of treatment.

Individuals taking clozapine who experience unexplained fatigue, dyspnea,

tachypnea, fever, chest pain, palpitations, other signs or symptoms of heart

failure, or electrocardiographic findings such as ST- T wave abnormalities

or arrhythmias should be evaluated for myocarditis.

 

2/08/02

CDC Updates Childhood Immunization Schedule

New recommendations include an annual influenza vaccine for children with

risk factors (eg, cardiac or sickle cell disease, diabetes mellitus, HIV),

which may increase the likelihood of influenza complications. Also

emphasized is vaccine coverage for adolescents who have missed vaccine

doses. Administering missed doses of hepatitis B vaccine for age 11-12 years

was expanded to include the entire " preadolescent " period (ie, 2-18 years).

Those 14-18 years old are now part of the age groups that should be brought

up-to-date on MMR. The catch-up ages for varicella vaccination were expanded

to include children up to age 18 years. The new guidelines also mention that

administering a dose up to 4 days earlier than the minimum interval of age

is unlikely to have a significant negative impact on the immune response to

that dose. In addition, aspiration prior to injecting a dose IM, is no

longer recommended in the " 2002 General Recommendations on Immunization "

because no data exist to document the necessity of this procedure. All

preterm infants born to mothers that are HbsAg positive or whose HbsAG

status is unknown should be given hepatitis B vaccine and HBIG within 12 h

of birth and receive additional doses at 1, 2, and 6 months. The birth dose

of hepatitis B should not be counted. MMWR 2002;51(No. RR-2):1-34

 

1/15/02

Oseltamivir (Tamiflu) suspension unavailable this flu season

Roche Laboratories Inc. has announced a production problem at a

manufacturing site in Switzerland will prevent distribution of Tamiflu

powder for suspension during the current flu season in the United States.

The production problem does not affect distribution of the capsules, which

may be used in children >40 kg, adolescents, and adults.

 

 

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.

 

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.

 

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