UWMC/HMC Drug Alerts!

UW Safety-Related Drug Alerts!

1999 Archives

Table of Contents

Readme
#10: August 17 - September 10
#9: July 23 - August 17
#8: July 9 - July 23
#7: June 15 - July 9
#6: June 1 - June 15
#5: April 30 - June 1
#4: March 18 - April 30
#3: February 16 - March 18
#2: January 27 - February 16
#1: December 24, 1998 - January 27, 1999

(End of Table of Contents)

Safety-Related Drug Alerts! Compiled between 12/23/98 and 1/27/99 (#1)

LEVOCARNITINE [CARNITOR®] "Dear Doctor" Letter (Dated 1/13/99)
The adverse reaction section of the levocarnitine package insert has been revised to include information regarding the occurrence of seizures in patients receiving either IV or oral levocarnitine (Carnitor®). Seizures have been reported to occur in patients without pre-existing seizure activity and an increase in seizure frequency and/or severity has been reported in patients with pre-existing seizure activity.
ALLEGED TAMPON CONTAMINATION FDA response to allegations (Dated 1/21/99)
Allegations have been spread over the Internet that some tampons are contaminated by dioxin and asbestos, and that rayon fibers cause toxic shock syndrome. The FDA regulates tampons as medical devices and is aware of no evidence supporting any of these rumors.
Also: 1991 FDA Consumer article regarding toxic shock syndrome
GAMMA BUTYROLACETONE-CONTAINING PRODUCTS WARNING FDA Talk Paper (Dated 1/21/99)
The FDA is alerting consumers not to purchase or consume products containing gamma butyrolacetone (GBL) and has ordered companies that manufacture these products to issue recalls. To date, there have been reports of at least 55 adverse reactions, including one death, associated with the use of GBL-containing products. In 19 of these cases, the consumer became unconscious or comatose. Other reported side effects included seizures, vomitting, slow breathing, and bradycardia. GBL containing products, commonly sold in health food stores, fitness centers, or via the Internet, are labeled as dietary supplements and promoted with claims to build muscle, improve physical performance, enhance sex, reduce stress, and induce sleep. When taken orally, GBL is converted in the body to gamma hydroxybutyrate (GHB). GHB is a potent, unapproved drug that is currently being investigated as a possible treatment for narcolepsy. Because of potentially serious side effects, GHB should not be taken except in the context of the FDA-approved investigations.
FLUTICASONE PROPIONATE [FLOVENT®] "Dear Doctor" Letter (Dated 1/21/99)
The adverse reaction section of the fluticasone propionate (Flovent) package insert has been revised to include information regarding the occurrence of systemic eosinophilic conditions in patients receiving the drug via inhalation. Cases of systemic eosinophilia, with some patients exhibiting clinical features of vasculitis consistent with Churg-Strauss syndrome, have been reported primarily in patients with severe asthma who discontinued or reduced oral corticosteroid therapy prior to the onset of the adverse effects. Physicians should be alert to eosinophilia, vasculitic rash, cardiac complications, worsening pulmonary symptoms, and/or neuropathy presenting in patients being treated with fluticasone propionate.
VARIOUS DRUGS: SAFETY-RELATED LABELING CHANGES (Dated 1/21/99)
A total of 18 products had safety-related drug labeling changes during the month of November. No UW formulary drug products underwent extensive safety-related labeling revisions during the month.