Drug Safety Monitor

NEW DRUG SAFETY SUMMARY: 1999

Before drugs are approved by the FDA for marketing in the United States they undergo testing in a few thousand preselected patients in controlled trials with stringent criteria. Easily recognized and frequent drug reactions generally are discovered during these premarketing trials. However, new information regarding unexpected adverse reactions or drug interactions often is discovered only after the drug is marketed and used in larger, more varied populations. The importance of monitoring, documenting and disseminating information regarding postmarketing surveillance is essential in optimizing patient drug therpy. It is a monumental task, however, to keep up with new safety information regarding both older and newly marketed agents. With the advent of internet technology the FDA has implemented a web site which summarizes new safety information about drugs, dietary supplements, biologics, medical devices and other topics of interest. This site provides summaries of "Dear Health Professional Letters" and other safety notifications by the FDA. The summaries are alphabetically by brand name of the product under each of the following categories: Biologicals, Dietary Supplements, Drugs and Medical Devices. The site is maintained by the FDA and updated periodically. The site for 1999 safety information summaries may be accessed at the following URL:

http://www.fda.gov/medwatch/safety/1999/safety99.htm

This is an important resource that all health professionals should be aware of. Significant drug safety advisories for 1999 are briefly summarized in Table 1. Readers are encouraged to visit the particular website (specific URLs are provided) for more complete information.

 

TABLE 1 Summary of Significant Drug Safety Summaries: Janaury 1999- May 1999
Alatrovafloxacin
(Trovan)
January 1999		 Package labeling was changed to reflect the potential incompatibility of alatrovafloxacin with two common diluents, 0.9% Sodium Chloride injections and Lactated Ringer’s Solution.
Manufacturer’s Letter: http://www.fda.gov/medwatch/safety/1999/trovan.htm
Asian Remedy
(Koo Sar)
January 1999		 The FDA alerted health professionals about a case report of lead intoxication (blood lead levels up to 42 mcg/mL) in a 33 year old Cambodian woman who took an Asian remedy product (Koo-Sar) for one week per month for menstrual cramping over the last 3-4 years. Assay of the pills revealed lead concentrations varying from 1.2 to 3.5 ppm.
MMWR Weekly Publication: http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00056277.htm
Capecitabine
(Xeloda)
April 1999		 New information regarding altered coagulation parameters and/or bleeding in patients receiving capecitabine and concurrent coumarin derivatives has been added to the warning and drug-drug interaction section of the product information. The onset of adverse events occurred within several days to months after starting capecitabine therapy. Patients taking concurrent capecitabine therapy and coumarin derivatives should be regularly monitored for alterations in coagulation (PT or INR).
Manufacturer Letter: http://www.fda.gov/medwatch/safety/1999/xeloda.htm
DTaP Vaccine
(Tripedia)
January 1999		 Tripedia vaccine was voluntarily recalled because the diptheria component of the vaccine was discovered to be subpotent during routine testing of retained samples by the company. Specific recommendations about dosing for children who received vaccines from the affected lot number (0916490) can be found in the manufacturer’s letter.

FDA Announcement: http://www.fda.gov/cber/fprecalls/condtap012799.htm
Manufacturer Letter: http://www.fda.gov/medwatch/safety/1999/triped.htm
Ethanercept
(Enbrel)
May 1999		 The FDA and Immunex notified health care professionals regarding new postmarketing reports of serious infections (including sepsis) associated with the use of ethanercept (Enbrel), a recently marketed agent for moderate to severe rheumatoid arthritis. When initially approved, labeling indicated that this drug should not be used in patients with sepsis and discontinued if patient developed a serious infection. New labeling recommends that the drug should not be started in patients with active infections and should be used with caution in patients with history of recurring infections or predisposition to infections. Since its approval in 11/98, ~30 of 25,00 treated patients have developed serious infections (including sepsis) with six patients who died.
Manufacturer's letter: http://www.fda.gov/medwatch/safety/1999/enbrel.htm
FDA Announcement: http://www.fda.gov/bbs/topics/ANSWERS/ANS00954.html
Fluticasone
Propionate
(Flovent)
January 1999		 Revisions in the product information "Precautions" and "Adverse Reactions" sections reflect the documentation of rare cases of asthma patients developing systemic eosinophilia or clinical vasculitis similar to Churg-Strauss syndrome while on fluticasone therapy. Several cases occurred after the dosage reduction or withdrawal of concurrent cortiocsteroid therapy. Although a definite causal relationship has not yet been established, health care professionals should be aware of these potentially serious adverse events.
Manufacturer Letter:
http://www.fda.gov/medwatch/safety/1999/floven.htm
Fosphenytoin
(Cerebryx)
January 1999		 Because of vague and unclear package labeling regarding the concentration and total amount of phenytoin equivalents per vial, several overdoses have been administered. Both the vial and carton labels have been revised to more clearly detail the amount of phenytoin equivalents (PE) per vial. Although both vials contain the same concentration (50 mg PE/mL), the 2 mL vial contains 100 mg PE /2 mL and the 10 mL vial contains 500 mg PE/10 mL.

Manufacturer Letter: http://www.fda.gov/medwatch/safety/1999/cereby.htm
Gamma-Butryolactone

January 1999

May 1999

 The FDA notified health professionals and consumers not to purchase or consume dietary supplements containing gamma butyrolactone (GBL) because of several reports of serious adverse events (~55 cases), including loss of consciousness, seizures, vomiting, dyspnea, and bradycardia. This product is marketed under several brand names including Renewtrient, Gamma G, Blue Nitro or Revivarant.
FDA Announcement:
http://www.fda.gov/bbs/topics/ANSWERS/ANS00937.html
MMWR Weekly Publication: http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00056563.htm

May 1999
The FDA warned the public regarding a new group of products, marketed as sleep aids, that have been associated with at least three deaths and 122 reports of severe adverse reactions. These products are chemically related to gamma butyrolactone (GBL) and gamma hydroxybutryic acid (GHB). The FDA considers these products unapproved new drugs.
FDA Announcement: http://www.fda.gov/bbs/topics/ANSWERS/ANS00953.html
Hemodialysis
Equipment
Contamination

May 1999

 Recent incidents of blood contamination of internal components of
hemodialysis equipment at a number of treatment centers have raised
concerns about patient safety. The cause of the contamination is still
being determined and may include many factors, including faulty blood linesand transducer protectors. FDA will provide updates as to the cause of this problem as soon as proper information becomes available.
FDA Announcement: http://www.fda.gov/cdrh/safety/althin.html
Althin Medical Recall Notice: http://www.fda.gov/medwatch/safety/1999/hemodi.htm
Pooled Plasma Recall
April 1999		 Vitex Technologies voluntarily recalled seven lots of PLAS+SD (solvent detergent treated) because of several seroconversions to parvovirus B19 or high titers of parvovirus B19 in normal volunteers during postmarketing saftey studies. Although no evidence of clinical disease developed as a result of these seroconversions, health care professionals should be aware of these changes.
FDA Announcement: www.fda.gov/cber/fprecalls/plasvit041699.htm
Urokinase
(Abbokinase)
January 1999

March 1999

 January 1999: The FDA recommended that Abbokinase be reserved only for cases determined to be critical because of the potentially increased (but very low) risk of transmitting infectious agents. Mothers or neonate donor materials (neonatal kidney cells) used in previously marketed lots were not tested for hepatitis C and could also possibly contain other infectious agents.

March 1999: On March 16, 1999, the FDA notified health professionals about a shortage of Abbokinase due to increased mandatory testing procedures required by the FDA. In addition, reovirus, an infectious agent known to produce minor respiratory or gastrointestinal symptoms, was detected in in-process products. Although the FDA was not currently aware of any infectious diseases associated with the use of Abbokinase, repeated recommendations regarding the use of this product in only critical cases was re-emphasized.
FDA Recall Announcement: http://www.fda.gov/cber/ltr/abb012599.htm
Update Announcement: http://www.fda.gov/cber/infosheets/abb032299.htm

Prepared by: Joyce Generali, MS, RPh: Drug Information Center-ext 2328

 

 

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