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Latest Adverse effect Stories

2014-05-01 08:34:23

FRAMINGHAM, Mass., May 1, 2014 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR), today issued a voluntary Urgent Medical Device Correction related to all HeartWare(®) Ventricular Assist System batteries, product codes 1650 and 1650-DE. In letters to clinicians and patients, the company reports an observed increase in complaints related to earlier-than-expected battery depletion and routine battery handling. HeartWare is providing information to assist patients and clinicians in...

2014-04-24 20:23:05

FRAMINGHAM, Mass., April 24, 2014 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR) today announced issuance of a clinician and patient reminder concerning the Urgent Medical Device Correction distributed to all of its clinical sites by the company in December 2013. The device correction discussed eight complaints that the locking mechanism of the driveline connector of the HeartWare(®) Ventricular Assist System had failed to engage and instructed clinicians to inspect patient...

2014-04-08 08:31:42

New submission based on positive Phase 3 data from the RESONATE(TM) trial RARITAN, N.J., April 8, 2014 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA(TM) (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE(TM) study in relapsed or refractory chronic...

2014-03-17 16:28:56

PLEASANTON, Calif., March 17, 2014 /PRNewswire/ -- On March 4, 2014, Thoratec Corporation initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II(®) LVAS Pocket System Controller (the "Pocket Controller"). The following information is provided as a reinforcement of the initial release. Failure to completely connect the driveline during the process of exchanging Pocket System Controllers has resulted in serious...

2014-03-14 12:28:50

LEXINGTON, Massachusetts, March 14, 2014 /PRNewswire/ -- Shire Pharmaceuticals announced today the initiation of a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV due to the presence of visible particulate matter, identified as stainless steel and barium sulfate. The particulate matter was found in a small number of vials in the three packaged lots of VPRIV. A Shire investigation identified the particulate matter root cause as the third...

2014-03-13 17:18:53

Investigators call on drug regulators to provide clear evidence to patients on claims of drug side effects At a time when the wider prescription of statins is under renewed public scrutiny, a substantial analysis of placebo-controlled randomised trials of statins has found that only a small minority of side effects reported by those taking the cholesterol-lowering drugs are actually attributable to them. Almost all the side effects reported in these trials "occurred anyway when patients...

2014-03-10 23:01:48

With Pradaxa Lawsuit Mounting, A Recently Published Study Indicates The FDA Received More Complaints About The Blood Thinner Pradaxa Than Any Other Prescription Drug Over A Two Year Period Columbus, OH (PRWEB) March 10, 2014 As Pradaxa Lawsuits continue to be filed (MDL 2385), lawyers at Wright & Schulte LLC are reviewing the findings of a recently released study found the blood thinner Pradaxa to be the most complained about prescription drug in the United States. This Pradaxa study...

2014-03-04 16:26:01

PLEASANTON, Calif., March 4, 2014 /PRNewswire/ -- On March 4, 2014, Thoratec Corporation initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II(®) LVAS Pocket System Controller (the "Pocket Controller"). This safety advisory is being issued because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller. These...

2014-03-03 23:01:27

Scott A. Norton, MD, MPH, chief of dermatology at Children’s National Health System, and two medical students working with him identified improper sales of antibiotics without prescriptions in neighborhood grocery stores in the Washington, DC, area. Washington, DC (PRWEB) March 03, 2014 Scott A. Norton, MD, MPH, chief of dermatology at Children’s National Health System, and two medical students working with him identified improper sales of antibiotics without prescriptions in...

2014-02-27 12:27:13

bioCSL Inc. initiates 2014-15 season pre-booking for AFLURIA® (Influenza Vaccine) KING OF PRUSSIA, Pa., Feb. 27, 2014 /PRNewswire/ -- CSL Biotherapies Inc. announced today it has changed its name to bioCSL Inc., effective February 21, 2014. This change is pursuant to the Australian, New Zealand and German renaming of the company, which occurred one year ago. In September 2013, bioCSL was the first United States supplier to complete its 2013-14 seasonal influenza vaccine delivery...


Word of the Day
endocarp
  • The hard inner (usually woody) layer of the pericarp of some fruits (as peaches or plums or cherries or olives) that contains the seed.
This word comes from the Greek 'endon,' in, within, plus the Greek 'karpos', fruit.
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