Recalls and warnings
A warning and labeling changes related to accidental overdoses of morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL). Serious adverse events and deaths have resulted from accidental overdoses, caused in most cases by products being ordered in milligrams (mg) but mistakenly interchanged for milliliters (mL). The stronger concentration was recently approved under the FDA's unapproved drugs program and the product will now be more clearly labeled to differentiate it from 20 mg/5 mL morphine sulfate.
A recall of one lot (#312566) of 250 mg metronidazole tablets due to the presence of underweight tablets, which could cause patients to not receive the prescribed dose and infections to worsen or recur.
A contraindication added to the label of dolasetron mesylate (Anzemet) noting that the injection form of the drug should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) because it can increase the risk of developing torsade de pointes. The injection may still be used for the prevention and treatment of postoperative nausea and vomiting because the lower doses are less likely to affect the electrical activity of the heart. Dolasetron mesylate tablets may still be used to prevent CINV although a stronger warning about abnormal heart rhythms is being added to the packaging of the tablets.
A recall of more than 300 lots of Abbott glucose test strips (marketed as Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima) because they may provide falsely low results.
A recall of one lot of atorvastatin calcium (Lipitor) 40 mg tablets due to one customer report of an uncharacteristic odor.
Several recalls of intravenous drugs related to potential for particulates:
- dexamethasone sodium phosphate’ injection, 4 mg/mL (30 mL multiple dose vial),
- sodium bicarbonate’ injection, 7.5% and 8.4%, (50 mL single dose vials), and
- acetylcysteine’ injection (Acetadote), 200mg/mL (30 mL single dose vials).
A class I recall of the NanoCross .014” OTW PTA dilatation catheter due to potential for cracking or breaking during use, which can result in the inability to inflate or deflate the balloon, leading to separation of catheter components and potential embolization catheter fragments.
A class I recall of the AngioSculpt percutaneous transluminal angioplasty scoring balloon catheter 0.018” OTW because of a design defect which can cause unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element.
A recall of albuterol sulfate inhalation solution 0.083% (3 mL unit dose vials) because the 2.5 mg/3 mL single use vials are incorrectly embossed with the concentration of 0.5 mg/3 mL and therefore, represents a potential significant health hazard. If clinicians read the incorrect concentration and upwardly adjust the volume, a range of adverse health effects are possible.
A limit on the amount of acetaminophen permitted in prescription combination products to no more than 325 mg in each tablet or capsule. The change will be phased in over three years, and the FDA also is requiring manufacturers to update labels of combination medications to warn of the potential risk for severe liver injury.
A new warning on dronedarone (Multaq) about cases of severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication. Clinicians should consider periodic hepatic serum enzymes for patients taking the drug, especially during the first six months of treatment. Patients should be warned about the signs and symptoms of hepatic injury or toxicity.
A complete U.S. market withdrawal of propoxyphene (Darvon and Darvocet) based on new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. Physicians should stop prescribing and dispensing propoxyphene-containing products, tell patients currently taking the drugs to discontinue use and discuss alternative pain management strategies.
A Class I recall of the Penumbra System Reperfusion Catheter 032 due to a manufacturing error which led to mid-shaft joint failures in some catheters. The company is advising customers to discontinue use of the product.
An expanded recall of Triton Pole Mount Infusion Pumps because the pump door open alarm does not always work to alert the user that the pump door is open. The condition has been found on 40% of pumps tested and could result in a free flow perfusion, potentially causing serious injury or death.
A recall of Advanced Bionics' HiRes 90K cochlear implant device in response to two confirmed instances in which patients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device and had to have the device removed.
A voluntary recall of all product lots of Children's Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors and all product lots of Junior Strength Motrin Caplets, 24 count, based on a manufacturer's review that found insufficiencies in the manufacturing process.
A recall of three Tylenol Cold Multi-Symptom liquid products in order to update the labeling and list alcohol as an ingredient on the front of the product packaging.
A recall of several cold decongestant medications (Refenesen Expectorant, Select Brand Mucus Relief Expectorant, QC Medifin Expectorant, and Leader Cough Tabs Expectorant) because they were mislabeled as containing only 200 mg of guaifenesin when they actually contain acetaminophen 325 mg, phenylephrine 5 mg and chlorpheniramine maleate 2 mg.
A recall of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews and Rolaids Multi-Symptom plus Anti-Gas Softchews following consumer reports of foreign materials in the product, including metal and wood particles.
A warning on benzonatate (Tessalon) that the drug is attractive to children and that accidental ingestion by children under the age of 10 years can result in death from overdose. Overdose with benzonatate in children less than 2 years of age has been reported following accidental ingestion of as few as 1 or 2 capsules. Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of the reach of children.
An expanded approval of the human papillomavirus (HPV) vaccine Gardasil to prevent anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people ages 9 through 26 years. In a randomized, controlled trial of men who self-identified as having sex with men, Gardasil was shown to be 78% effective in the prevention of HPV 16- and 18-related anal intraepithelial neoplasia.
Fentanyl transmucosal tablets (Abstral) to manage breakthrough pain for adults with cancer. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where they dissolve and are absorbed. The drug was approved under a Risk Evaluation and Mitigation Strategy program, intended to minimize the risk of misuse, abuse, addiction and overdose. Common adverse reactions in a trial of the drug include nausea, constipation, drowsiness and headache. Serious adverse events, including deaths, have been reported in patients with other immediate-release transmucosal fentanyl products. The deaths occurred as a result of improper patient selection and/or improper dosing.
A new indication for denosumab (new brand name: Xgeva) to help prevent skeletal-related events (SREs), including bone fracture and bone pain requiring radiation, in patients with cancer that has metastasized and damaged the bone.
A new FDA website, lists all recent approvals, both of novel drugs and new generics.
A safety review is underway of recombinant human growth hormone after results from a study conducted in France found that persons with idiopathic growth hormone deficiency and idiopathic or gestational short stature who were treated with the hormone during childhood and followed over a long period of time were at a small increased risk of death when compared to individuals in the general population of France. The FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.
The FDA is recommending that the breast cancer indication be removed from the label for bevacizumab (Avastin) based on a review of clinical trial data. From the results of four clinical studies of the drug in women with breast cancer, the agency concluded that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.
The FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems. Most of the reports have been related to pre-filled needleless glass syringes that contain adenosine, and the problem probably often occurs when an attempt is made to connect the syringe to some pin-activated needleless IV access systems. The syringe may cause the pin to break, thus clogging the syringe or damaging the IV tubing and/or the needleless connector and requiring reestablishment of a new intravenous access. These failures can cause a delay in administration of medication, which could potentially result in serious harm to patients. The FDA has also received reports of problems related to certain pre-filled needleless glass syringes containing amiodarone. Health care organizations currently using glass prefilled syringes should consider stocking adenosine supplied in vials or pre-filled plastic syringes as a backup measure, the FDA advised.