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FDA MedWatch – ShoulderFlex Massager: Warning – Risk of Strangulation

ISSUE: FDA is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks. Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation. There have been reports of one death and one near death, due to strangulation, associated with the use of this device.

BACKGROUND: The ShoulderFlex Massager is a personal massage device sold in retail stores, catalogs and over the Internet. It is intended to provide users with a deep tissue massage to the neck, shoulders and back area while lying down.

King International recalled the ShoulderFlex Massager on Aug. 31, 2011; however, during a recent compliance audit, the FDA found that the company has gone out of business. King International has not followed through with recall procedures; the 800 number established by the firm for this recall is no longer in service; and many of the companies that sell this device are not aware of the recall or did not properly notify customers who purchased the massager.

RECOMMENDATIONS: The ShoulderFlex Massager poses serious risks. Consumers should stop using this device, health care providers should not recommend it to their patients and businesses should stop distributing and selling the device,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

The FDA recommends that customers and consignees safely dispose of the ShoulderFlex Massagers so that the device cannot be used. The massage fingers should be removed and disposed of separately from the device; the power supply should be disposed of separately, as well.

CLICK HERE to read the MedWatch safety alert, including links to the FDA Safety Communication and News Release.

FDA MedWatch – St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall

ISSUE: FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads. The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation. Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death.

The recall includes the following model numbers:
• Riata (8F) Silicone Endocardial Defibrillation Leads
Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
• Riata ST (7Fr) Silicone Endocardial Defibrillation Leads
Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042

BACKGROUND: The leads connect an implantable cardioverter defibrillator (lCD) or cardiac resynchronization therapy defibrillator (CRT-D) to cardiac tissue in order to monitor and regulate a patient’s heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.

RECOMMENDATION: On November 28, 2011, St. Jude Medical sent a Medical Device Advisory letter to physicians via certified mail. The letter is an update to St. Jude Medical’s Important Product Information letter, dated December 15, 2010. The current Medical Device Advisory letter provides an update on the failure rates associated with externalized conductors of Riata and Riata ST leads. The letter also includes updated recommendations and mitigations for patients implanted with Riata and Riata ST leads.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

CLICK HERE to read the MedWatch safety alert, including a link to the FDA Class I Recall notice.

FDA MedWatch – Gilenya (fingolimod): Drug Safety Communication

ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient’s death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.

BACKGROUND: Gilenya (fingolimod) is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. Gilenya is used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.
RECOMMENDATION: At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. Patients with MS should not stop taking Gilenya without talking to their healthcare professional.

FDA will communicate any new information on Gilenya and this case when it becomes available.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

CLICK HERE to read the MedWatch safety alert, including a link to the Drug Safety Communication.

FDA MedWatch – Multaq (dronedarone): Drug Safety Communication

[UPDATED 12/19/2011] FDA completed a safety review of Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The review was based on data from two clinical trials, PALLAS and ATHENA. FDA is providing new information and recommendations for the use of Multaq to manage the potential serious cardiovascular risks with the drug.
The Multaq drug label has been revised with the following changes and recommendations:

• Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
• Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
• Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF)
• Patients prescribed Multaq should receive appropriate antithrombotic therapy.

CLICK HERE to read the MedWatch safety alert, including a link to the Drug Safety Communication

FDA MedWatch – Pradaxa (dabigatran etexilate mesylate)

ISSUE: FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

RECOMMENDATION: At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.
Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

CLICK HERE to read the MedWatch safety alert, including a link to the Drug Safety Communication.

FDA MedWatch – CooperVision Avaira Aquaform Sphere Soft Contact Lenses: Class 1 Recall

ISSUE: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Aquaform Sphere contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

BACKGROUND: Used for the correction of myopia or hyperopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

On November 19, 2011, the firm sent a recall notification letter to the US distributors and health care practitioners. These lenses were manufactured from February 1, 2011 through August 24, 2011 and distributed from March 2, 2011 through November 15, 2011.

RECOMMENDATION: Affected contact lens wearers should stop wearing their lenses immediately and contact their eye care practitioner for advice. Avaira Sphere contact lens wearers should check CooperVision’s recall web site www.coopervision.com/international-recall to enter the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled. Alternatively, consumers can contact CooperVision’s toll-free consumer hotline at 1-855-526-6737 (M-F, 9:00 am – 5:00 pm EST). If you discover your lenses are among the recalled lots, return them to the point of purchase or to your eye care practitioner.

FDA MedWatch – November 2011 Safety Labeling Changes

The MedWatch November 2011 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm282966.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Cerebyx (fosphenytoin sodium)
Dilantin (phenytoin sodium, USP)
Dilantin (phenytoin)
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release)
Mytelase (ambenonium chloride)
Onglyza (saxagliptin)
Amturnide (aliskiren/amlodipine/hydrochlorothiazide)
Combivir (lamivudine/zidovudine)
Emtriva (emtricitabine)
Epivir (lamivudine)
Epzicom (abacavir sulfate and lamivudine)
Isentress (raltegravir potassium)
Lioresal Intrathecal (baclofen injection)
Methotrexate Sodium for Injection
Retrovir (zidovudine)
Tekamlo (aliskiren/amlodipine)
Toviaz (fesoterodine fumarate)
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
Trizivir (abacavir sulfate, lamivudine, and zidovudine)
Twynsta (telmisartan/amlodipine)
VFEND (voriconazole)
Videx (didanosine)
Videx EC (didanosine, USP)
Vimovo (naproxen/esomeprazole magnesium)
Viread (tenofovir disoproxil fumarate)
Zerit (stavudine)
Ziagen (abacavir sulfate)
Zyflo CR (zileuton)
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