Rhabdomyolysis News and Research

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Rhabdomyolysis (often shortened to simply "rhabdo") is the rapid breakdown (''lysis'') of skeletal muscle (''rhabdomyo'') due to injury to muscle tissue.

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

MSD announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.

3 Sep 2010

Lots of water breaks prevent dehydration in kids

Scorching heat has taken its toll across the country this summer with record temperatures and heat indexes reaching well above 100 degrees. Add kids playing outside and outdoor summer activities in full swing to the dangerous heat you've got a hazardous combination.

20 Jul 2010

BBD reports analyze effectiveness and safety of statin use

A series of new reports from Consumer Reports Best Buy Drugs (BBD) caution that the benefits of statin use by children and some women may not outweigh the risks. Drugs to lower cholesterol - including statins - are the most commonly prescribed drugs in the U.S. and garnered more than $14 billion in sales last year.

29 Jun 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

Experts address fundamental questions related to renal failure in ICU

Despite the fact that recent medical advances have allowed healthcare professionals to stabilize patients who would have otherwise died, many stabilized patients later develop organ system failure. In fact, acute renal failure is one of the biggest threats to critically ill patients: forty percent of patients with this condition die.

14 May 2010

Optivia Biotechnology launches OptiDDI Suite for assessing transporter-related DDIs

Optivia Biotechnology Inc., a leading provider of in vitro transporter assay services, today announced the launch of the OptiDDITM Suite, a novel assay panel that assesses the most clinically significant transporter-related drug-drug interactions (DDIs), as identified by the International Transporter Consortium (ITC) in its report "Membrane Transporters in Drug Development" (Nature Reviews-Drug Discovery, March 2010).

12 May 2010

High dose of Zocor could lead to muscle injury, warns FDA

The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg.

20 Mar 2010

Winners of NMSIS scholarship award

Two winners have been selected for the Promising New Investigators Travel Scholarship Awards given annually by the Neuroleptic Malignant Syndrome Information Service (NMSIS).

10 Mar 2010

Paracetamol reduces damage caused to kidneys following severe muscle injury

The commonly-used painkiller Paracetamol can protect against kidney failure after severe muscle injury, according to research at the University of Essex.

4 Feb 2010

Seroquel XR supplemental NDA recommended for approval

The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for Seroquel XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).

9 Apr 2009

FDA approves Symbyax for treatment-resistant depression

The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax (olanzapine and fluoxetine HCl capsules), Eli Lilly and Company has announced.

23 Mar 2009

Taser study finds serious injuries rare after Taser use

An emergency medicine researcher at Wake Forest University Baptist Medical Center has just published the first large, independent study of injuries from conducted electrical weapon (CEW) or Taser use, finding that serious injuries occurred in fewer than 1 percent of 1,201 Taser uses by law enforcement officers.

19 Jan 2009

Lilly receives complete response letter for Olanzapine LAI for treatment of schizophrenia

Eli Lilly and Company has announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults.

7 Jan 2009

Do statins cause muscle problems?

A Michigan State University researcher is studying whether the most popular class of cholesterol-lowering drugs may cause muscle problems in users.

11 Nov 2008

Crestor (rosuvastatin calcium) shown to significantly reduce major cardiovascular events

New data from the JUPITER study demonstrated that Crestor (rosuvastatin calcium) 20 mg significantly reduced major cardiovascular (CV) events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by a dramatic 44% compared to placebo (p<0.001) among men and women with elevated hsCRP but low to normal cholesterol levels.

10 Nov 2008

Sedative propofol could be fatal

Patients treated for their prolonged seizures with the sedative propofol may be at high risk for complications and even death. New research presented at CHEST 2008, the 74th annual international scientific assembly of the American College of Chest Physicians (ACCP), shows that the use of propofol as an antiepileptic agent in patients with refractory status epilepticus (RSE), prolonged seizures that do not respond to initial treatment, was associated with significant mortality and morbidity.

28 Oct 2008

AstraZeneca submits sNDA for SEROQUEL XR for treatment of major depressive disorder

AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once- daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.

1 Mar 2008

Lilly knocked back by FDA on Zyprexa for schizophrenia treatment

Eli Lilly and Company has received a not approvable letter from the U.S. Food and Drug Administration for Zyprexa long-acting injection (olanzapine LAI) for the treatment and maintenance treatment of schizophrenia in adults, the company announced.

28 Feb 2008

AstraZeneca submits sNDAs for SEROQUEL XR for bipolar symptoms

AstraZeneca has announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.

3 Jan 2008