FDA AERS Alerts
FDa Drug Changes
Feb 17, 2012 02:13PM
Feb 16, 2012 05:20AM
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tafamidis meglumine, the company’s investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).
Feb 14, 2012 09:08AM
Merck's Eye Medication Zioptan Approved
Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved Zioptan (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution.
Jan 31, 2012 12:50PM
FDA Approved New Type 2 Diabetes Drug
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin.
Jan 30, 2012 03:36PM
Bydureon Approved for Type Two Diabetes
Some diabetes drugs have to be taken multiple times a day. For many patients, it can be hard to stay on such a strict schedule. Now, patients have the option of a once-weekly drug for type 2 diabetes.
Jan 30, 2012 11:18AM
FDA Approves Advanced Basal Cell Cancer Drug
Roche announced that Erivedge (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for adults with a type of skin cancer, called basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.
Jan 03, 2012 10:04AM
Prevnar 13 Approved for New Age Category
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults. Prevnar 13 is indicated for adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes contained in the vaccine.
Dec 24, 2011 07:36PM
Helping Kids Awaiting Heart Transplant
U.S. Food and Drug Administration officials have given the green light to a device designed to support weakened hearts in children with heart failure who are awaiting a transplant.
Dec 21, 2011 05:11PM
FDA Approves Combo Hypertension Treatment
U.S. Food and Drug Administration officials have approved new combination hypertension drug Edarbyclor, which combines azilsartan medoxomil and chlorthalidone.
Nov 19, 2011 01:37AM
Erwinaze Approved to Treat Leukemia
The U.S. Food and Drug Administration has approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
Nov 12, 2011 05:51PM
First Cord Blood Product Gets FDA Stamp of Approval
For the first time, U.S. Food and Drug Administration officials have given the green light to an umbilical cord blood product that could be used in stem cell transplants for patients with blood cancer and metabolic or immune disorders.
The quarterly watch list consists of 9 medications that treat conditions ranging from arthritis to schizophrenia. The agency is studying them to determine whether they are causally linked to the possible risks reported through AERS from October 1, 2010, through December 31, 2010. If a link is established, the FDA then would consider some form of regulatory action, such as revising the drug's label information, requiring a Risk Evaluation and Mitigation Strategy (REMS), or gathering more data to better characterize the risk.
The FDA cautions that a drug's appearance on the watch list does not mean the agency has determined that the drug actually poses the health risk in question. Accordingly, physicians should not stop prescribing these drugs, nor should patients stop taking them.
Since the last quarter of 2010, 1 drug on the current list — an antiarrhythmic agent called dronedarone (Multaq, Sanofi-Aventis) — has prompted increased FDA vigilance. In February, the agency alerted clinicians to cases of rare but severe liver injury, including 2 cases of acute liver failure, in patients treated with dronedarone. The agency also added information about the potential risk of liver injury to the drug's label.
| Product Name: Active Ingredient (Trade) or Product Class |
Potential Signal of a Serious Rick/New Safety Information |
| Asenapine maleate (Saphris, Merck & Co) |
Hypersensitivity |
| Dronedarone HCl (Multaq, Sanofi-Aventis) | Liver failure |
| Fenofibrate products (several brand names) | Paradoxical decrease in HDL cholesterol |
| Golimumab (Simponi, Centocor Ortho Biotech) | Hypersensitivity reactions and anaphylaxis |
| Ibuprofen lysine (Neoprofen, Lundbeck) | Serious skin reactions (in pediatric patients) |
| Morphine sulfate; naltrexone HCl (Embeda, King Pharmaceuticals) | Withdrawal symptoms (not associated with misuse) |
| Oxycodone HCl controlled-release tablets (Oxycontin, new formulation, Purdue Pharma) | Choking and gastrointestinal obstruction |
| Regadenoson (Lexiscan, Astellas Pharma US) | QT prolongation |
| Sevelamer HCl (Renagel, Genzyme) | Choking (esophageal obstruction) |
|
|
 |
 |
Privacy Policy Site Policies About Contact Us Pharmacy Affiliate Pharmacist Contributors Medical Advisory Board