Medmonitor

The FDA issued a Federal Register notice that assessed the safety and effectiveness of certain naloxone hydrochloride products for nonprescription use, hoping to make the opioid overdose reversal agent more accessible to the public. The preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products. The FDA is continuing to collect data, such as product-specific data on non-prescription user interface design, including packaging and labeling. The notice requests comments from the public on whether there is data to support safe and effective nonprescription use of higher dose naloxone products and on potential consequences of a switch from prescription to nonprescription status.

Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg – fixed combination tablets indicated to lower blood pressure and treat hypertension – due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. The lot numbers impacted are QE2021005-A and QE2021010-A. The tablets are pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with “D” on the scored side and “19”on other side, supplied in 90’s HDPE bottle.

Golden State Medical Supply, Incorporated initiated a voluntary recall of Clopidogrel 75mg Tablets (lot# GS046745) and Atenolol 25mg Tablets (lot #GS046745) due to a label mix-up. Atenolol is indicated for the treatment of hypertension, to lower blood pressure, while Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems. Patients who suddenly stop taking atenolol are at increased risk for ischemic hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta antagonism. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen.

Vi-Jon, LLC has issued a nationwide voluntary recall for all lots of magnesium citrate saline laxative oral solution lemon flavor, 10 FL Oz (296 mL) due to microbial testing that identified the presence of gluconacetobacter liquefaciens. This microbe can be lead to invasive infections in immunocompromised patients, which can cause serious adverse health consequences. Constipation is a common side effect of opioid use, and as opioids are used in workers’ comp for the treatment of pain, it is possible that injured worker claimants may have purchased these over-the-counter products, which were previously available in stores such as Publix, Kroger, Rite Aid, Walgreens, and other independent stores.

The FDA granted Emergency Use Authorization (EUA) to the Novavax COVID-19, Adjuvanted vaccine for individuals aged 18 and older. This vaccine is administered in two primary doses given three weeks apart. The vaccine was assessed in an ongoing randomized, blinded, placebo-controlled study involving 17,200 people. Overall, the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19. This vaccine utilizes a different technology than other COVID-19 vaccines, and was recently endorsed by the Centers for Disease Control and Prevention.

Bryant Ranch Prepack Inc. is voluntarily recalling one lot of morphine sulfate 30 mg Extended-Release tablets and one lot of morphine sulfate 60 mg Extended-Release tablets, as the labels for these two products were mixed-up. Morphine sulfate is an opioid product for the management of severe pain. Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death. Patients prescribed the 60 mg dose who receive the 30 mg dose may experience withdrawal and untreated pain if the dose given is too low.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 in favor of recommending an Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine for individuals aged 18 and older. Phase 3 clinical trials with 30,000 people saw an efficacy rate of 90.4%. This vaccine requires two doses, delivered at least 21 days apart.

The FDA has limited the authorized use of the Johnson & Johnson/Janssen COVID-19 Vaccine to individuals for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals who elect to receive the Johnson & Johnson/Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine. The FDA has determined that the Johnson & Johnson/Janssen COVID-19 vaccine comes with the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration.

The FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. These products are marketed as treatments for arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. These medications are sold on various websites and in some retail stores, making them easily accessible to injured workers who may purchase them to help manage pain. Certain Artri and Ortiga products contained undeclared dexamethasone, diclofenac sodium, and methocarbamol, all which come with safety risks when not used appropriately. Furthermore, these drugs can interact with an individual’s overall drug regimen, leading to additional safety concerns, including drug-drug or drug-disease interactions.

The FDA authorized a second booster dose of either the Pfizer or Moderna COVID-19 vaccines for individuals aged 50 and older at least four months after their first booster dose, and for immunocompromised individuals at least four months after their first booster dose. Immunocompromised individuals include those who have undergone solid organ transplants or those living with conditions considered to have an equivalent level of immunocompromise.

Sandoz Inc. issued a recall of 13 lots of Orphenadrine Citrate 100 mg Extended Release (ER) tablets to the consumer level due to the presence of a nitrosamine impurity. Orphenadrine is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. Nitrosamines are substances with carcinogenic properties – which could cause cancer.

The FDA issued an emergency use authorization (EUA) for bebtelovimab, a monoclonal antibody, for the treatment of mild-to-moderate COVID-19 that retains activity against the omicron variant in patients weighing at least 88 pounds who are at high risk of progression to severe COVID-19. This drug is not authorized for hospitalized patients or patients who require oxygen therapy. Bebtelovimab is not a substitute for vaccination.

The CDC announced proposed draft updates to the Clinical Practice Guideline for Prescribing Opioids. This draft notice is available to the public and can be commented on until April 11, 2022. The CDC’s opioid guidelines have shaped opioid prescribing policies over the last few years. Changes to these guidelines could impact prescribing behaviors, especially as several states across the country base their treatment guidelines on the CDC’s regulations.

The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. Dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues. Buprenorphine is used to treat pain as well as to help individuals with opioid use disorder (OUD) reduce opioid use. A new warning for dental problems will be added to drug labels.

The FDA issued an emergency use authorization for molnupiravir for the treatment of mild-to-moderate COVID-19 who are at high risk of progression to severe COVID-19, including hospitalization and death, and for whom alternative COVID-19 treatments are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. Molnupiravir is not a substitute for vaccination.

The FDA issued an emergency use authorization (EUA) for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in patients who are high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is only available via prescription and should be initiated as soon as possible after diagnosis and within five days of symptom onset. Paxlovid is not a substitute for vaccination.

The FDA issued an emergency use authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis of COVID-19. This product is only authorized for individuals not currently infected with COVID-19 who were recently exposed to infected individuals. Furthermore, this authorization requires that patients either have moderate-to-severely compromised immune systems or a history of severe adverse reactions to a COVID-19 vaccine. Evusheld is not a substitute for vaccination.

Teligent Pharma issued a recall for two lots of Lidocaine HCl topical solution USP 4% 50ml due to super potency. Lidocaine is used as a local anesthetic, but an increased lidocaine dose could lead to systemic toxicity depending on the duration of treatment and the specific patient. This can result in central nervous system reactions such as hypotension and cardiovascular collapse, along with severe morbidity and even death.

Gilead Sciences Inc issued a recall of two lots of Veklury (remdesivir) injections due to the presence of glass particulates. Remdesivir is indicated for the treatment of severe COVID-19 that requires hospitalization. The administration of an injectable product containing glass particulates may result in local irritation or swelling. If the particulates reach the blood vessels it can travel to various organs and block vessels in the heart, lungs, or brain, which can cause stroke and death. The lots impacted at 2141001-1A and 2141002-1A.

The FDA issued emergency use authorizations for all currently available COVID-19 vaccines – Pfizer, Moderna, Johnson & Johnson – allowing all adults aged 18 and older to receive a booster dose. Individuals must complete their initial vaccine series prior to receiving a booster dose, with those who received either the Pfizer or Moderna vaccine required to wait six months after completion of vaccination, and those who received the Johnson & Johnson vaccine to wait two months after completion of vaccination.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-inc-issues-voluntary-nationwide-recall-levetiracetam-injection-usp-due-lack

Sagent Pharmaceuticals issued a recall for four lots of Levetiracetam Injection, USP due to a lack of sterility assurance. Levetiracetam is used for the treatment of certain types of seizures. Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening. Lot numbers recalled include BOG85VB, BOK88VA, BOK89VA, and B1G194A.

The FDA has expanded the emergency use authorizations (EUAs) for the Moderna and Johnson & Johnson COVID-19 vaccines to allow for the use of a single booster dose among certain populations. The Moderna vaccine may now be administered at least six months after completion of the primary vaccine series to individuals 65 years of age and older, individuals 18-64 years of age at high risk of severe COVID-19, and individuals 18-64 years of age with frequent institutional or occupational exposure to COVID-19. The Johnson & Johnson vaccine may be administered at least two months after completion of the single-dose primary regimen to any individual aged 18 or older. Furthermore, the FDA clarified that after finishing an initial vaccination regimen, individuals may mix and match which vaccine they use for a booster dose.

Bryant Ranch Prepack is recalling one lot of methocarbamol 500mg tablets, as the bottles labeled as 500mg tablets in fact contain 750mg tablets, and excessive dosing could result in central nervous system depression, which can cause nausea, sedation, fainting, falls, seizures, coma, and death. Methocarbamol, along with rest, physical therapies, and other measures, is used for the relief of discomfort associated with acute, painful, musculoskeletal conditions.

Teligent Pharma is recalling five lots of Lidocaine HCl topical solution 4%, 50mL after uncovered super potency. Use of super potent products can result in higher than intended doses of medication. Lidocaine hydrochloride works as a local anesthetic that can relieve pain. An increased lidocaine dose can lead to the development of local anesthetic systemic toxicity, which can cause a number of central nervous system reactions, including death.

The FDA updated the emergency use authorization (EUA) for the combined administration of bamlanivimab and etesevimab – two monoclonal antibodies – to include emergency use as a post-exposure prophylaxis (prevention) for COVID-19 patients aged 12 or older who are at high risk of progression to severe COVID-19. These drugs can only be administered as a prophylaxis for COVID-19 if patients are not fully vaccinated or are not expected to mount an adequate immune response to complete COVID-19 vaccination, including for example, immunocompromised patients. Post-exposure prophylaxis is not a substitute for vaccination against COVID-19.

The FDA officially approved the Pfizer-BioNTech COVID-19 vaccine in late August. This is the first FDA-approved vaccine for the prevention of COVID-19 and potentially serious outcomes including hospitalization and death. Prior to this approval, COVID-19 vaccines had only received emergency use authorization (EUAs) – declarations that circumstances exist to justify the emergency use of drugs that have not been FDA-approved, particularly when no effective alternatives are available. Full FDA approval means that a drug has undergone the FDA’s full standard process for reviewing the quality, safety, and effectiveness of medical products. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

The White House announced plans to make COVID-19 boosters available for all adults starting the week of September 20th. Boosters could only be administered eight months after an individual’s second dose of the Pfizer or Moderna vaccine. In essence, during the initial start of booster administration, only healthcare workers, nursing home residents, and other early receivers of the vaccine would be eligible. The White House’s decision coincides with recommendations from the Department of Health and Human Services (HHS) and the CDC. 

The FDA amended the emergency use authorization (EUA) for both the Pfizer and Moderna COVID-19 vaccines to allow for an additional dose in certain immunocompromised individuals, specifically organ transplant recipients, or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. According to the CDC, emerging data suggest some people with moderately to severely compromised immune systems do not always build the same level of immunity compared to people who are not immunocompromised. People who are immunocompromised in a manner similar to those who have undergone solid organ transplantation have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19, and the administration of a third vaccine dose may increase protection in this population.

The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in patients weighing at least 40 kilograms (about 88 pounds) with COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

Hospira voluntarily recalled lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection and lot EG8933 of 1% Lidocaine HCl Injection, due to mislabeling whereby a portion of each lot was incorrectly labeled as the other product. Both drugs are indicated for the production of local or regional anesthesia. Using lidocaine 1% instead of bupivacaine 0.5% drug instead could lead to underdose and inadequate pain management, while use of bupivacaine 0.5% instead of lidocaine 1% could lead to overdose, which could cause seizures, respiratory abnormalities, and heart problems.

As of early March, three COVID-19 vaccines received emergency use authorization (EUAs) from the FDA. In
December, the Pfizer/BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine received EUAs, and in late
February the Johnson & Johnson/Janssen COVID-19 vaccine received an EUA. Both the Pfizer/BioNTech and Moderna vaccines require two separate doses, while the Johnson & Johnson/Janssen vaccine requires only a single dose. EUAs are not an FDA approval; EUAs are authorizations for non-FDA-approved drugs when no other effective alternatives are available, and the benefits appear to outweigh the risk.

In April, the FDA and the CDC announced that six women experienced rare and severe blood clots after receiving the Johnson & Johnson COVID-19 vaccine. As of April 12, 2021, more than 6.8 million doses of this specific vaccine have been administered, making the occurrence of these blood clots rare. The CDC and FDA reviewed these cases, recommending a pause in the use of this vaccine, but following a safety review, the FDA and CDC determined that the use of the Johnson & Johnson COVID-19 vaccine should be resumed. Current data shows that the vaccine’s known and potential benefits outweigh risks and that the chance of these blood clots occurring is very low.

In November of 2020, the FDA issued an emergency use authorization (EUA) for bamlanivimab, an investigational monoclonal antibody designed to block the coronavirus’ attachment and entry into human cells, for the treatment of mild-to-moderate COVID-19. However, in April of 2021, the FDA revoked that EUA. Based on ongoing analysis of emerging scientific data, viral variants of COVID-19 were found to be resistant to bamlanivimab, and with no testing technologies available to allow healthcare providers to test individual patients for COVID-19 variants, the potential benefits of using the drug no longer outweighed the risks.

An FDA safety review found the potential for increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine).These studies began when the FDA received reports of abnormal electrocardiographic (ECG) findings among individuals taking this medication. In some cases, problems including chest pain, loss of consciousness, and cardiac arrest occurred. The FDA is currently evaluating whether other medicines in the same drug class have similar effects on the heart.

The FDA alerted clinical laboratory staff and healthcare providers that genetic variants of COVID-19 may lead to false negative results in certain diagnostic tests. This alert applies to all molecular COVID-19 tests, though the FDA continues to monitor the effect of different variants on molecular tests. Negative test results should be considered in combination with clinical observations, patient history, and epidemiological information. Retesting may be considered when patients display symptoms but test negative.

The FDA alerted the public that preliminary results from a safety clinical trial found an increased risk of serious heart related problems and cancer with Xeljanz (tofacitinib) and Xeljanz XR. These drugs are indicated for the treatment of rheumatoid arthritis, which may develop in workers’ comp populations due to cumulative or acute trauma, or when a pre-existing inflammatory joint disease is made worse by an occupational injury.