Medical Device Safety: Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA Safety Communication

A safety communication has been issued due to a problem with the quality of mammograms at Boston Diagnostic Imaging in Orlando, Florida. The FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms. ThisContinue reading “Medical Device Safety: Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA Safety Communication”

Medical Device Safety and Recalls: Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst

A recall has been issued for Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit. The company received reports that when the OxyTote is mishandled or dropped, the oxygen cylinder may ignite causing an internal flash fire and the canister to burst. The firm has received a total of 2 reports of incidents in which the deviceContinue reading “Medical Device Safety and Recalls: Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst”

Blue Square Market Issues Update to Voluntary Nationwide Recall

Blue Square Market Issues Update to Voluntary Nationwide Recall of Kaboom Action Strips and Lida Daidaihua Due to the Presence of Undeclared Sulfoaildenafil, Sibutramine and Phenolphthalein Blue Square Market Inc. of North Huntingdon, PA, is recalling “Kaboom Actions Strip 12 Pack” and LiDa DaiDaiHua to the user level after FDA analysis revealed the products containContinue reading “Blue Square Market Issues Update to Voluntary Nationwide Recall”

Tivicay (dolutegravir) and Triumeq (abacavir/dolutegravir/lamivudine) product labeling was update

The Tivicay (dolutegravir) and Triumeq (abacavir/dolutegravir/lamivudine) product labeling was updated with drug-drug interaction information. Section 7 Drug Interactions was updated to include a statement that in vitro, dolutegravir was not a substrate of OATP1B1 or OATP1B3. Additionally, the following information was added to section 7. If TIVICAY is used with carbamazepine adjust dose of TIVICAYContinue reading “Tivicay (dolutegravir) and Triumeq (abacavir/dolutegravir/lamivudine) product labeling was update”

FDA approves first drug treatment for sexual desire disorder

FDA approves first drug treatment for sexual desire disorder The U.S. Food and Drug Administration has approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women. HSDD is characterized by low sexual desireContinue reading “FDA approves first drug treatment for sexual desire disorder”

CDRH Industry: Medical Device Export Certificates: Revised FDA Fees

CDRH Industry: Medical Device Export Certificates: Revised FDA Fees Today the FDA issued a Federal Register (FR) Notice announcing revised fees for medical device export certificates that will go into effect on September 1, 2015. This is the first time the FDA has changed the fees for these certificates since the start of the exportContinue reading “CDRH Industry: Medical Device Export Certificates: Revised FDA Fees”

Medical Device Safety and Recalls: Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs

Today the FDA issued a safety communication regarding serious adverse events with Implantable Left Ventricular Assist Devices (LVADs). To date, there are two implantable LVADs approved by the FDA: The HeartMate II Left Ventricular Assist System manufactured by Thoratec Corporation, and the HeartWare Ventricular Assist System HVAD manufactured by HeartWare, Inc. The FDA is aware ofContinue reading “Medical Device Safety and Recalls: Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs”

New FDA Drug Safety Communication on Gilenya (fingolimod)

The U.S. Food and Drug Administration is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with anContinue reading “New FDA Drug Safety Communication on Gilenya (fingolimod)”