Safety Alerts & Recalls

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FDA Asks Manufacturer to Stop Sales of Its Leukemia Drug Iclusig (Ponatinib)
At the request of the Food and Drug Administration (FDA), the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) has agreed to stop advertising and selling Iclusig because of safety concerns. Iclusig is associated with the risk of life-threatening blood clots and severe narrowing of blood vessels which can cause serious outcomes like heart attack or stroke. The FDA will continue to evaluate Iclusig to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks. At this time, patients and healthcare professionals should follow the FDA’s new recommendations for the drug, which include: --- Patients currently taking Iclusig who are not responding to the drug should stop treatment and discuss alternative treatment options with their healthcare professional. --- Patients who are currently taking Iclusig and who are responding to the drug and whose healthcare professional determines that the potential benefits outweigh the risks can still receive Iclusig through either an Investigational New Drug (IND) application or expanded access registry program while FDA’s safety investigation continues. The FDA will work with the manufacturer on a plan to quickly switch these patients to a program that will allow them access to Iclusig. For more information, please visit:
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FDA Works to Put Tighter Controls on Hydrocodone Combination Pain Killers
The Food and Drug Administration (FDA) has announced they will submit a formal recommendation to the U.S. Department of Health and Human Services (HHS) to change the controls on hydrocodone combination products to Schedule II. Hydrocodone is a pain medicine available in combination with acetaminophen or ibuprofen and is sold by its generic name and brand names Lortab, Co-Gesic, Zydone, Norco, Vicoden, and Vicoprofen. A Schedule II classification places hydrocodone combination products in the same classification as opioids like oxycodone (Oxycontin) and imposes new restrictions on how they are prescribed and used. Hydrocodone combination products are currently a Schedule III, the third-highest level on a five-stage scale that takes into account the potential for addiction. While there are millions of American patients experiencing an acute medical need or living with chronic pain who benefit from appropriately prescribed opioids, there is increasing concern about the abuse and misuse of opioid products, especially hydrocodone. Accordingly, the FDA has been working to determine how to balance the need to ensure continued access to patients who rely on these medicines for pain relief while addressing the ongoing concerns about abuse and misuse. The recommendation from the FDA to reclassify hydrocodone combination products as Schedule II comes after a thorough analysis of scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which the FDA collected input from patients, healthcare providers, outside experts, and other government entities. For more information, please visit:
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Date Published Title Drug Source
2013-11-01 FDA Asks Manufacturer to Stop Sales of Its Leukemia Drug Iclusig (Ponatinib) Ponatinib FDA
2013-10-25 FDA Works to Put Tighter Controls on Hydrocodone Combination Pain Killers Hydrocodone FDA
2013-10-25 FDA To Complete Phase-Out of Chlorofluorocarbon Inhalers Including Combivent Inhalation Aerosol and Maxair Autohaler. Maxair FDA
2013-10-18 Nephron Pharmaceuticals Announces Recall of Albuterol Sulfate Inhalation Solution, 0.083% Albuterol FDA
2013-10-14 FDA Warns of Increased Reports of Serious Blood Clots with Iclusig (Ponatinib) Ponatinib FDA
2013-09-30 New Boxed Warning for Anti-Cancer Drugs Arzerra (Ofatumumab) and Rituxan (Rituximab) Rituximab FDA
2013-09-30 Combo-Medicine Juvisync Production Discontinued Sitagliptin and Simvastatin FDA
2013-09-30 FDA Warns: Do Not Use Budesonide Nasal Irrigation from The Compounding Shop Budesonide Inhalation FDA
2013-09-30 FDA Adds New Boxed Warning, Warns of Increased Risk of Death with Tygacil (Tigecycline) Tigecycline FDA
2013-09-25 Changes to Duragesic (Fentanyl) Packaging to Reduce Risk of Accidental Exposure Fentanyl FDA
2013-08-30 Consumers Warned Not to Purchased Ortiga, an Unapproved Product Diclofenac FDA
2013-08-29 FDA Investigating Report of Progressive Multifocal Leukoencephalopathy (PML) in Patient Taking Gilenya (Fingolimod) Fingolimod FDA
2013-08-19 FDA Strengthens Neuropathy Warnings for Fluoroquinolone Class of Antibiotics Gemifloxacin FDA
2013-08-05 FDA Warns of Rare But Serious Skin Reaction with Acetaminophen FDA
2013-08-05 FDA Warns: Purity First’s Expands Recall and Now Includes Healthy Life Chemistry B-50, Vitamin C and Multi-Mineral Vitamin B Complex FDA
2013-07-30 Nova Diabetes Care Recalls of Several Lots of Nova Max Glucose Test Strips Tolazamide Manufacturer
2013-07-29 FDA Strengthens Warnings for Antimalarial Drug Mefloquine For Serious Psychiatric and Nerve Side Effects Mefloquine FDA
2013-07-29 FDA Warns: Healthy Life Chemistry By Purity First B-50 Contains Possibly Harmful Anabolic Steroids Vitamin B Complex FDA
2013-07-29 FDA Places Strict Limits on Oral Ketoconazole (Nizoral) Use Ketoconazole FDA
2013-07-08 Sandoz Announces Voluntary Recall of One Lot of Estarylla Ethinylestradiol with Norgestimate FDA