FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen

Thursday, 29 Jul 2010 15:42:13 GMT

[07-29-2010] The U.S. Food and Drug Administration (FDA) is reviewing reports of adverse effects from Evamist in children who may have been unintentionally exposed to the drug through skin contact with women using this product.

Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

Thursday, 29 Jul 2010 14:41:10 GMT

Reports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product.

FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin)

Thursday, 29 Jul 2010 12:41:44 GMT

FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin)

Safety Announcement

Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

Thursday, 29 Jul 2010 11:43:50 GMT
Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin.

Federal Register: Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification; Reopening...

Wednesday, 28 Jul 2010 11:41:10 GMT
The FDA is reopening until 9/7/2010, the comment period for the proposed rule published in the Federal Register of April 5, 2010 (75 FR 17093). The document proposed to amend certain neurological and physical medicine device regulations to establish...

Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening o...

Wednesday, 28 Jul 2010 11:41:04 GMT
The FDA is reopening until 9/7/2010, the comment period for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine...

FluLaval

Tuesday, 27 Jul 2010 23:41:30 GMT

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Vaccines, Blood & Biologics

FluMist

Tuesday, 27 Jul 2010 20:41:38 GMT

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Vaccines, Blood & Biologics

Fluzone and Fluzone High-Dose

Tuesday, 27 Jul 2010 20:41:30 GMT

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Vaccines, Blood & Biologics

Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient

Thursday, 22 Jul 2010 16:41:17 GMT
Product contains sibutramine; may increase blood pressure/pulse rate with risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, stroke.

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

Thursday, 22 Jul 2010 16:41:11 GMT
Recall due to balloon inflation assembly that may not hold air

FDA Statement on Avandia TIDE Trial

Wednesday, 21 Jul 2010 15:41:44 GMT

FDA Statement on Avandia TIDE Trial
The U.S. Food and Drug Administration today informed GlaxoSmithKline (GSK), the manufacturer of the diabetes drug Avandia (rosiglitazone), that the postmarketing trial known as TIDE (Thiazolidinedione Intervention With Vitamin D Evalu

CONSTELLATION Vision System: Recall

Tuesday, 20 Jul 2010 16:41:52 GMT
Software and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems.

Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient

Tuesday, 20 Jul 2010 10:41:41 GMT
Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil.

Slim- 30 Herb Supplement: Undeclared Drug Ingredient

Monday, 19 Jul 2010 11:41:27 GMT
Product found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning

Friday, 16 Jul 2010 15:41:26 GMT
Certain inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

Medical Device Recall: Cobe Spectra Apheresis System Disposable Tubing Sets

Friday, 16 Jul 2010 10:41:32 GMT
Reports of leaks at the return luer connection on two (2) lots of COBE Spectra White Blood Cell disposable tubing sets. WBC Set, Spectra, Functionally closed WBC Set, Spectra.

Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk

Thursday, 15 Jul 2010 14:41:28 GMT
A recently published study suggested use of ARBs may be associated with a small increased risk of cancer.

Federal Register: Town Hall Discussion With the Director of the Center for Devices and Radiological Health and Other Senior Center Management

Wednesday, 14 Jul 2010 09:41:53 GMT
The purpose of this meeting is to present the CDRH Fiscal Year (FY) 2010 Priorities. In addition, FDA is interested in engaging in discussions about issues that are of importance to the medical device industry.

Coumadin 1 mg Tablet Blister Packs: Recall

Wednesday, 14 Jul 2010 09:41:45 GMT
Some tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient.

Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

Tuesday, 13 Jul 2010 15:41:13 GMT
Warning highlights the risk of severe liver injury and how this risk may be reduced.

Procleix Ultrio Assay

Tuesday, 13 Jul 2010 14:41:16 GMT

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FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)

Tuesday, 13 Jul 2010 14:41:11 GMT
[07-13-2010] The U.S. Food and Drug Administration (FDA) is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) – a drug used to treat rheumatoid arthritis - to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced.

Federal Register: Oversight of Laboratory Developed Tests; Public Meeting; Change of Meeting Location

Tuesday, 13 Jul 2010 09:42:00 GMT
The public meeting will be held at The Marriott Inn & Conference Center, University of Maryland University College, 3501 University Blvd. E, Hyattsville, MD 20783.

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products

Tuesday, 13 Jul 2010 09:41:53 GMT
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

Friday, 09 Jul 2010 13:42:35 GMT
Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products.

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products

Friday, 09 Jul 2010 09:42:08 GMT
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.

Que She Herbal Supplement: Undeclared Drug Ingredients

Thursday, 08 Jul 2010 16:43:37 GMT
Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions.

Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions

Thursday, 08 Jul 2010 14:42:37 GMT
New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.

FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)

Thursday, 08 Jul 2010 10:42:55 GMT
[07-08-2010] Due to continued reports of serious side effects in patients using Qualaquin "off-label" (a non-FDA-approved use) for night time leg cramps, the U.S. Food and Drug Administration (FDA) has approved a risk management plan to warn against the use of this drug for such unapproved uses.

Bioscience Technology Online - Regulatory News

FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen

Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin)

FDA Drug Safety Communication: Eosinophilic pneumonia associated with the use of Cubicin (daptomycin)

Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

Federal Register: Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification; Reopening...

Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening o...

FluLaval

FluMist

Fluzone and Fluzone High-Dose

Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

FDA Statement on Avandia TIDE Trial

FDA Statement on Avandia TIDE Trial

CONSTELLATION Vision System: Recall

Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient

Slim- 30 Herb Supplement: Undeclared Drug Ingredient

Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning

Medical Device Recall: Cobe Spectra Apheresis System Disposable Tubing Sets

Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk

Federal Register: Town Hall Discussion With the Director of the Center for Devices and Radiological Health and Other Senior Center Management

Coumadin 1 mg Tablet Blister Packs: Recall

Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

Procleix Ultrio Assay

FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)

Federal Register: Oversight of Laboratory Developed Tests; Public Meeting; Change of Meeting Location

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products

Que She Herbal Supplement: Undeclared Drug Ingredients

Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions

FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate)