Summaries of "Dear Health Professional" Letters and Other Safety Notifications

Cobe Centrysystem 3 Blood Tubing Sets -- Gambro Healthcare announced the immediate and urgent recall of COBE Centrysystem 3 Blood Tubing Sets with the Part Number 003210-500 and Lot Numbers of 04D15308, 04D15309, and 04D15310. [May 25, 1998 (Press Release)-Gambro Healthcare]

Vacuum Assisted Delivery Devices -- FDA advises that vacuum assisted delivery devices may cause serious or fatal complications and provides guidance to minimize risk.[May 21, 1998 (Public Health Advisory)-FDA]

Cholestin -- FDA has determined Cholestin, marketed as a dietary supplement, to be an unapproved drug. Cholestin contains lovastatin, an active ingredient in the approved prescription drug Mevacor used to lower cholesterol levels.[May 20, 1998 (Talk Paper)-FDA]

Epipen & Epipen Jr. (epinephrine) Auto-Injectors -- Meridian Medical Technologies Inc. has voluntarily recalled 47 lots of Epipen and Epipen Jr. because some may not provide effective doses of medication to treat acute allergic emergencies (anaphylaxis). The affected product was distributed in the US by Dey Laboratories between July 1997 and April 1998. The packaging indicates that the product was manufactured for Center Laboratories or Dey Laboratories by Survival Technology Inc. or Meridian Medical Technologies. [May 8, 1998 (Press Release)-Meridian]

Low Molecular Weight Heparins & Heparinoids -- In December 1997, FDA advised doctors to carefully monitor patients receiving low molecular weight heparin or heparinoids (marketed as Lovenox, Fragmin, Normiflo, and Orgaran). These drugs when used concurrently with spinal or epidural anesthesia, or spinal puncture may cause bleeding or hematomas within the spinal column. Increased pressure on the spinal cord may result in permanent paralysis if not detected and treated imme-diately.[December 15, 1997 (Talk Paper)-FDA], [December 15, 1997 (Public Health Advisory)-FDA], [February 5, 1998 (Advisory Committee Transcript)-FDA], [May 6, 1998 (Questions & Answers)-FDA]

Modudose Sodium Chloride Solution -- Various brands of Modudose Sodium Chloride Solution have been recalled based on the findings of two lots of this product (714430 & 7183315) containing the bacteria Rastonia pickettii (formerly Burkholderia pickettii, formerly Pseudomonas pickettii). While no injuries have been reported as a direct result of this contamination, Ralstonia pickettii has been associated with sepsis and could be life-threatening to people with lung disease or certain immunocompromised patients. [April 29, 1998 (Recall Notice)-FDA, April 17, 1998 (MMWR article)-CDC]

Abtox Plazlyte Sterilization System -- FDA warns hospitals and physicians against the use of the Abtox Plazlyte Sterilization System, because FDA is aware of at least 10 injuries associated with ophthalmic surgical instruments which had been sterilized with this system. These reports involved serious injuries to the cornea with damage to vision, and at least two cases have required corneal transplantation. [April 2, 1998 (Talk Paper)-FDA], [April 13, 1998 (Safety Alert)-FDA], [April 24, 1998 (MMWR Article)-CDC]

Hemodialysis Catheter Adapter -- FDA warns that the Extension Adapter for a Tesio hemodialysis catheter made or distributed by Medcomp, Harleysville, PA, may come apart, causing the patients on chronic hemodialysis to bleed to death at home. [March 27, 1998 (HHS News)-FDA]

Medical Telemetry Systems -- FDA alerts the health community to incidents involving digital television transmissions interfering with medical telemetry systems that use TV channels. [March 20, 1998 (Public Health Advisory) - FDA][March 25, 1998 (Joint Statement) - FDA and Federal Communications Commission]

Tegretol (carbamazepine) -- Novartis informs health care professionals that Tegretol suspension should not be administered simultaneously with other liquid medicinal agents or diluents. [March, 1998 (Letter)- Novartis]

Chlorhexidine-Impregnated Medical Devices -- FDA informs health care professionals about the potential for serious hypersensitivity reactions to chlorhexidine-impregnated medical devices. [March 11, 1998 (Public Health Notice) - FDA]

"Sleeping Buddha" -- FDA is warning consumers not to use a product called "Sleeping Buddha," which is marketed as a dietary supplement but has been determined to contain the prescription-strength drug ingredient estazolam. Estazolam is known to have serious side effects, including the potential to cause fetal damage if a pregnant woman consumes it. [March 10, 1998 (Statement) - FDA]

Seldane and Generic Terfenadine -- Hoechst Marion Roussel and Baker Norton Pharmaceuticals have voluntarily discontinued the distribution and marketing of all terfenadine-containing antihistamine product lines in the United States. These products will soon disappear from pharmacies as existing supplies are depleted. [February 27, 1998 (Talk Paper) - FDA]

Accutane (isotretinoin) -- Roche advises that the labeling for Acutane has been changed to add information in the warnings and adverse reactions sections about reported cases of depression, psychosis, and, rarely, suicide ideation, suicide attempts, and suicide associated with the use of Acutane. No mechanism of action has been established. [February 1998 (Letter) - Roche] [February 25, 1998 (Talk Paper) - FDA]

Isocam II (Dual-Headed Gamma Camera) -- FDA notifies nuclear medicine imaging facilities of a recent incident in which an Isocam II, dual-headed nuclear medicine gamma camera malfunctioned. A stainless steel plate from a harmonic drive motor failed, causing an arm of the system to fall into the gantry housing of the device. While no patient or operator was injured, a potential for serious injury from such a malfunction exists. [February 13, 1998 (Safety Notice) - FDA][March 12, 1998 (Supplemental Information) - FDA]

Duract (bromfenac Na) -- Wyeth-Ayerst has revised the Duract labeling to include a boxed warning about severe hepatic reactions, including jaundice, potentially fatal fulminant hepatitis, and liver failure (some requiring transplantation) that have occurred in patients taking Duract for longer than the recommended duration. [February 1998 (Letter)-Wyeth-Ayerst][February 10, 1998 (Talk Paper) - FDA]

Hismanal (astemizole) -- Janssen Pharmaceuticals notifies health professionals of important labeling changes concerning new contraindications, warnings, precautions, adverse events, and additional drug or food interactions with Hismanal. [February 1998 (Letter) - Janssen][February 9, 1998 (Talk Paper) - FDA]

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