www.dailyrx.com - FDA Recalls and Alerts

Pfizer Announces Recall Of Birth Control

Staff — Wed, 01 Feb 2012 22:14:59 +0000

Pfizer Inc. announced that it has voluntarily recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic)for customers in the U.S. market.

Cephalon, Inc. Issues Voluntary Nationwide Recall of Treanda

Staff — Fri, 27 Jan 2012 22:19:57 +0000

Cephalon, Inc. is voluntarily recalling Treanda® (bendamustine HCL) for Injection 25mg/8mL; lot TB30111, expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.

Novartis Issues Voluntary Nationwide Recall of Certain Over-The-Counter Products

Staff — Thu, 12 Jan 2012 21:29:34 +0000

Novartis Consumer Health, Inc. (NCH) announced that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin and NoDoz products with expiry dates of December 20, 2014 or earlier as well as Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.

The Perfect Gift for Your Former BFF

Deanna Morey — Sun, 25 Dec 2011 23:46:11 +0000

One gift you might want to make sure is not on your list this season is the ShoulderFlex Massager. Though it might appear to be a relaxation-inducing gift, the FDA is warning to skip the dangerous device.

Blood Thinner Pradaxa May Lead to Bleeding

Deanna Morey — Thu, 08 Dec 2011 14:26:33 +0000

U.S. Food and Drug Administration officials are taking a second look at blood thinning drug Pradaxa (dabigatran etexilate mesylate) after reports of serious, potentially fatal, bleeding.

FDA Revokes Approval of Breast Cancer Drug

Staff — Fri, 18 Nov 2011 16:54:58 +0000

FDA Commissioner Margaret A. Hamburg, M.D., said she is revoking the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

Cholesterol Drug Trilipix May Not Lower Heart Risk

Deanna Morey — Thu, 10 Nov 2011 11:49:57 +0000

U.S. Food and Drug Administration officials have announced that cholesterol-lowering drug fenofibric acid (Trilipix) might not lower a patient's risk of having a heart attack or stroke.

FDA Focus on TNF Blockers

Laurie Stoneham — Tue, 08 Nov 2011 22:31:32 +0000

A class of drugs is now under suspicion of causing cancer in children, adolescents and young adults under the age of 30. These are called Tumor Necrosis Factor (TNF) blockers, and the U.S. Food and Drug Administration (FDA) recently released an update regarding its ongoing safety review of these drugs.

Osteoporosis Tool Approved

Lindsay Patterson — Sun, 06 Nov 2011 00:10:09 +0000

A diagnostic tool for early assessment of osteoporosis has gained FDA approval. The device, called Sunlight MiniOmni, is already used in Europe, Asia, and the Middle East.

Sepsis Drug Pulled

Deanna Morey — Tue, 25 Oct 2011 20:58:23 +0000

U.S. Food and Drug Administration officials announced that Eli Lily and Company have voluntarily pulled Xigris (drotrecogin alfa) from all markets because the medication failed to show increased survival for patients suffering from severe sepsis in a major study.

FDA Drug Safety Communication: Xigris

Staff — Tue, 25 Oct 2011 15:34:10 +0000

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)].

FDA Evaluating External Pacemakers

Deanna Morey — Tue, 18 Oct 2011 13:43:30 +0000

U.S. Food and Drug Administration officials are contemplating a proposal to lower the risk classification of external pacemakers from the highest risk category to labeling them a moderate risk.

Primatene Mist Being Pulled off Market

Laurie Stoneham — Thu, 29 Sep 2011 13:18:05 +0000

Next year, you will not be able to buy asthma inhalers without a prescription. A popular medication is being phased out because it contains chlorofluorocarbons (CFCs).

Abnormal Heart Rhythms Linked to Anti-Nausea Drug

Laurie Stoneham — Sat, 17 Sep 2011 10:30:05 +0000

A drug used to prevent nausea and vomiting associated with cancer chemotherapy, radiation and surgery has been linked to potentially fatal abnormal heart rhythms.

Oral Contraceptive Recall

Laurie Stoneham — Fri, 16 Sep 2011 19:33:59 +0000

Because of a packaging error, Qualitest Pharmaceuticals has voluntarily recalled multiple lots of eight brands of oral contraceptives. This is a nationwide recall.

Two Doses of HPV Vaccine Okay

Laurie Stoneham — Mon, 12 Sep 2011 20:02:05 +0000

There's been a lot of confusion around human papillomavirus (HPV) vaccination lately. The latest news actually simplifies the recommendations.

FDA Drug Safety Communication: Saphris

Staff — Thu, 01 Sep 2011 20:24:38 +0000

The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate).

FDA Drug Safety Communication: Reclast

Staff — Thu, 01 Sep 2011 19:40:07 +0000

The U.S. Food and Drug Administration (FDA) has approved an update to the drug label for Reclast (zoledronic acid) to better inform healthcare professionals and patients of the risk of kidney (renal) failure.

FDA Drug Safety Communication: Celexa

Staff — Thu, 25 Aug 2011 14:56:30 +0000

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day.

Ground Beef Recall

Stephanie Cheng — Wed, 17 Aug 2011 00:06:16 +0000

National Beef Packing Co. recalled ground beef products that have been distributed nationally due to E. coli contamination found in Ohio. Read on for details and safety preparation tips.

Outbreak Free America Continued

Stephanie Cheng — Sun, 14 Aug 2011 15:46:04 +0000

Food has never been safer with the new revisions from the Food Safety Modernization Act. With these revisions the Food and Drug Administration has the power to prevent foodborne outbreaks.

FDA: Unapproved Emergency Birth Control May Be Ineffective, Unsafe

Staff — Tue, 02 Aug 2011 14:33:16 +0000

The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital. These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy.

Evital has not been approved by the FDA for use in the United States.

This potentially ineffective and suspect counterfeit emergency birth control may also be in distribution in some Hispanic communities in the United States.

Label Warnings Updated for Chantix

Deanna Morey — Wed, 27 Jul 2011 12:46:04 +0000

U.S. Food and Drug Administration (FDA) officials have approved an updated drug label for smoking cessation medication varenicline (Chantix) with stronger warnings.

Foodborne Outbreak Potentially Associated With Papaya

Staff — Tue, 26 Jul 2011 17:30:01 +0000

The FDA is warning consumers not to eat papayas from Agromod Produce, Inc., a distributor in McAllen,Texas.

FDA Drug Safety Communication: TNF blockers

Staff — Tue, 26 Jul 2011 15:04:58 +0000

The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.

FDA Drug Safety Communication: Tysabri

Staff — Tue, 26 Jul 2011 14:50:50 +0000

The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) and Crohn's disease.

FDA Drug Safety Communication: Bisphosphonates and Esophageal Cancer

Staff — Thu, 21 Jul 2011 17:26:22 +0000

The U.S. Food and Drug Administration (FDA) is continuing to review data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus (esophageal cancer).

FDA Panel Green Lights Edwards Heart Valve

Deanna Morey — Thu, 21 Jul 2011 03:24:25 +0000

After a full day of debate a U.S. Food and Drug Administration panel approved the Edwards Lifesceinces' Sapien transcatheter heart valve system in a 9-0 vote. One member abstained from voting.

FDA Drug Safety Communication: Tamiflu

Staff — Tue, 12 Jul 2011 18:53:07 +0000

The U.S. Food and Drug Administration (FDA) is informing the public of important product safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension.

FDA approves Boostrix Vaccine

Staff — Tue, 12 Jul 2011 18:26:49 +0000

The U.S. Food and Drug Administration today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.