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Safety

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Important information for ARIXTRA® Starter Kit patients regarding
Triad Group’s alcohol prep products

 

Contact:
US Media Inquiries:
Stefanie Mendell (919) 483 2839
Lisa Behrens (919) 483 2839

FOR IMMEDIATE RELEASE - January 24, 2011 - GlaxoSmithKline (GSK) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus that could potentially lead to life-threatening infections.

Some of these alcohol prep pads from Triad may have been included in U.S. packaging for ARIXTRA Starter Kits manufactured by GSK. The Triad alcohol prep pads should NOT be used.

It is important to note that this recall does not affect or involve actual ARIXTRA (fondaparinux sodium). The Starter Kits do not contain ARIXTRA; they only contain dosing instructions, an education booklet, a needle box, and alcohol prep pads to wipe the injection site. Further, the alcohol prep pads involved in this recall were not manufactured by GSK.

Patient safety is a top priority and GSK wants to ensure that U.S. patients and physicians using ARIXTRA Starter Kits are aware of the Triad recall and what they should do.

Patients using ARIXTRA Starter Kits titled “Looking Ahead with ARIXTRA” should immediately discontinue using the Triad alcohol prep pads included in the ARIXTRA Starter Kit and should dispose of those pads in the trash. When preparing to take their ARIXTRA injection, patients should prepare the injection site in either of the following ways: By rubbing the area with (i) sterile gauze and 70% isopropyl alcohol, or (ii) alcohol prep pads – from another manufacturer – which are not the subject of a recall. These items are generally available at most retail pharmacies.

GSK is working with the U.S. Food and Drug Administration (FDA) on this recall. GSK has halted all shipments of ARIXTRA Starter Kits containing the Triad alcohol prep products to its distribution network.

Further information on this Triad recall can be found on the FDA website at
http://www.fda.gov/Safety/Recalls/ucm239219.htm If you have additional questions regarding ARIXTRA Starter Kits, please consult with your pharmacist or healthcare provider or contact the GSK Response Center at 1-888-825-5249.

Information about ARIXTRA (fondaparinux sodium):

WARNING: SPINAL/EPIDURAL HEMATOMAS
Epidural or spinal hematomas may occur in patients who are anticoagulated
with low molecular weight heparins (LMWH), heparinoids, or fondaparinux sodium
and are receiving neuraxial anesthesia or undergoing spinal puncture. These
hematomas may result in long-term or permanent paralysis. Consider these risks
when scheduling patients for spinal procedures. Factors that can increase the risk
of developing epidural or spinal hematomas in these patients include:
•    use of indwelling epidural catheters
•    concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-
       inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants
•    a history of traumatic or repeated epidural or spinal puncture
•    a history of spinal deformity or spinal surgery
Monitor patients frequently for signs and symptoms of neurologic impairment.
If neurologic compromise is noted, urgent treatment is necessary.
Consider the benefit and risks before neuraxial intervention in patients
anticoagulated or to be anticoagulated for thromboprophylaxis.  [See Warnings and
Precautions and Drug Interactions]
 

 

 

--------------------------------INDICATIONS AND USAGE--------------------------------
ARIXTRA is a Factor Xa inhibitor (anticoagulant) indicated for:
•    Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery
     (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or
     abdominal surgery.
•    Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction
      with warfarin.

---------------------------------- CONTRAINDICATIONS ----------------------------------
ARIXTRA is contraindicated in the following conditions:
•    Severe renal impairment (creatinine clearance <30 mL/min) in prophylaxis or treatment
      of venous thromboembolism.
•    Active major bleeding.
•    Bacterial endocarditis.
•    Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the
      presence of fondaparinux sodium.
•    Body weight <50 kg (venous thromboembolism prophylaxis only).

-----------------------------WARNINGS AND PRECAUTIONS -----------------------------
•    Use with caution in patients who have conditions or are taking concomitant medications
      that increase risk of hemorrhage.
•    Bleeding risk is increased in renal impairment and in patients with low body weight
     <50 kg.
      Thrombocytopenia can occur with administration of ARIXTRA.
•    Periodic routine complete blood counts (including platelet counts), serum creatinine level,
      and stool occult blood tests are recommended
•    The packaging (needle guard) contains dry natural rubber and may cause allergic
      reactions in latex sensitive individuals

----------------------------------ADVERSE REACTIONS----------------------------------
The most common adverse reactions associated with the use of ARIXTRA are bleeding
complications.  Mild local irritation (injection site bleeding, rash, and pruritus) may occur
following subcutaneous injection.
Anemia, insomnia, increased wound drainage, hypokalemia, dizziness, hypotension,
confusion, bullous eruption, hematoma, post-operative hemorrhage, and purpura may occur.

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at
1-888-825-5249 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

---------------------------------- DRUG INTERACTIONS ----------------------------------
Discontinue agents that may enhance the risk of hemorrhage prior to initiation of therapy
with ARIXTRA unless essential. If co-administration is necessary, monitor patients closely
for hemorrhage.

For important product information, log onto www.arixtra.com

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information go to us.gsk.com, follow us on twitter.com/GSKUS or visit our blog (www.morethanmedicine.us.gsk.com/blog/).

 

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