Food And Drug Administration Drug Safety Research Articles

A cross- sectional study to assess medication safety, knowledge, attitude, and practices regarding nutrition and medication among pregnant women

Objective: To assess pregnant women's knowledge, attitude, and practice regarding nutrition and medication usage, analyse the prescribing pattern, and categorize them based on the Food and Drug Administration (FDA) guidelines. Methods: A cross-sectional study was conducted with 264 pregnant women in the obstetrics and gynaecology department of a tertiary care hospital from October 2022 to August 2023. A knowledge, attitude, and practice (KAP) questionnaire was prepared in English language by the researchers and validated by an expert panel consisting of 12 members. The validated questionnaire was then translated into regional languages, Kannada and Malayalam. The reliability of the questionnaire was assessed with test-retest method with a representative sample population of 30 subjects (10 subjects for each language). The subjects' knowledge, attitude, and practice were evaluated using the validated KAP questionnaire. The safety of the medication was assessed using the FDA drug safety classification for pregnancy. Results: The mean scores for nutritional and medication usage knowledge, attitude, and practice were 4.14±1.15, 4.50±1.09, and 3.00±1.47, respectively. Among 30 prescribed medications, 3 belong to category A (no risk in human studies), 8 belong to category B (no risk in animal studies), 18 belong to category C (risk cannot be ruled out) and 1 drug is not classified. A significant association was observed between medication knowledge and practice (r=0.159, P=0.010). Conclusions: Most of the study population knows the need to maintain good dietary and medication practices during pregnancy. Counselling pregnant women regarding diet and medication usage is crucial in maternal care.

Risk of Poor Neonatal Adaptation Syndrome Among Infants Exposed to Second-Generation Atypical Antipsychotics Compared to Antidepressants: Results From the National Pregnancy Registry for Psychiatric Medications.

Objective: While poor neonatal adaptation syndrome (PNAS) has been particularly well described among infants exposed to antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), this is not the case for second-generation antipsychotics (SGAs). In 2011, the US Food and Drug Administration (FDA) issued a drug safety warning regarding fetal antipsychotic exposure and risk for PNAS and extrapyramidal symptoms (EPS). The primary objective of this study was to examine the risk for PNAS among infants exposed to SGAs compared to SSRI/SNRI-exposed infants, leveraging the prospective, longitudinal design of the National Pregnancy Registry for Psychiatric Medications (NPRPM). Methods: The NPRPM is a prospective pharmacovigilance program in which pregnant women, aged 18–45 years, are enrolled and followed prospectively. Medical records were systematically reviewed and data abstracted using a checklist of PNAS and EPS symptoms specifically outlined in the FDA drug safety warning. The two study groups included infants exposed to an SGA during pregnancy and infants exposed to an SSRI/SNRI during pregnancy. The primary outcome was the presence of at least one or more PNAS symptoms during the first month of life. Other neonatal outcomes following exposure to the medication of interest, including preterm birth, neonatal intensive care unit (NICU) admission, rates of EPS, and whether infants were discharged home with their mothers, are also reported. Results: Of the 2,145 women enrolled in this study as of December 16, 2020, a total of 373 women and their infants (n = 384) were eligible for inclusion (n = 193 SGA-exposed infants and 191 SSRI/SNRI-exposed infants). Among SGA-exposed infants, 32.6% (63/193) experienced at least 1 PNAS sign compared to 34.6% of infants (66/191) in the SSRI/SNRI-exposed group. The majority of infants in each group showed no symptoms of PNAS. No differences were observed between the two groups with respect to rates of preterm birth, NICU admission, prevalence of EPS, and timing of infants being discharged home with their mothers. Conclusions: PNAS symptomatology was comparable among infants exposed prenatally to an SGA or to an SSRI/SNRI. These preliminary findings provide an estimated risk of PNAS among infants exposed to SGAs of roughly 30%. Interestingly, these findings are also consistent with estimates in the literature of PNAS in SSRI/SNRI-exposed infants, suggesting a possible common pathway underlying this phenomenon. Trial Registration: ClinicalTrials.gov identifier: NCT01246765

218 Online Social Listening Surveillance for Earlier Insights About Loperamide Abuse/Misuse, 2015-2021

Loperamide (LOP) is a safe, effective antidiarrheal medication available over-the-counter (OTC) for over 30 years with a maximum dose of 8 mg/day for adults. Intentional LOP abuse/misuse (ingesting 70-200 mg/day to self-treat opioid withdrawal symptoms or achieve euphoria) was first reported in online forums in 2005. Following a 2016 US Food and Drug Administration (FDA) Drug Safety Communication on the potential risk of cardiovascular adverse events with high doses of LOP, the OTC industry initiated a communications campaign (www.LoperamideSafety.org) to educate health professionals, including emergency medicine specialists, about LOP abuse/misuse awareness and prevention. Retrospective surveillance (eg, FDA Adverse Event Reporting System database and National Poison Data System) has traditionally been employed to track reports of drug abuse/misuse. We utilized modern online social listening technology to observe and analyze comments/conversations (posts) about LOP abuse/misuse on various websites and online social media platforms to gain earlier insight into potential LOP abuse/misuse. Utilizing the software tools Crimson Hexagon and Synthesio, we scanned thousands of publicly accessible user posts in online blogs, forums, and social networks – including major platforms such as Twitter, Facebook, YouTube, Reddit, and Forums – from January 2015 to March 2021 to observe posts about LOP abuse/misuse. Listening consisted of keyword-based scrapes of user-generated content using search terms including loperamide, Imodium, overdose, OD, get high, getting high, withdrawal, and related terms/phrases. Findings were analyzed and reported quarterly. From January 2015 to March 2021, there were 27,213 user posts regarding LOP abuse/misuse among all observed online platforms. Annual post volume peaked in 2016 before declining in 2019/2020, consistent with the pattern of annual intentional exposure cases reported by the American Association of Poison Control Centers. Over 2015-2021, there was an average of 390 posts per month. Since May 2018, Reddit contained the majority of posts (70%), followed by Twitter (18%), YouTube (6%), Forums (4%), Facebook (<1%), and other sites (<1%). Reddit and Forums accounted for an increasing percentage of posts over time with a decrease for all other platforms. Posts primarily addressed the use of high-dose LOP for easing withdrawal symptoms (73%) or seeking euphoria (17%). Posts about risks and dangers of misuse/abuse were 16% of Reddit posts from Q2 2020 to Q1 2021, with a peak of 22% in Q2 2020. Spikes in posts coincided with key events, including journal article publications regarding effects of high doses (2,499 posts in May 2016 and 830 posts in January 2017) and FDA Drug Safety Communications regarding abuse/misuse of LOP (650 posts in June 2016 and 1,400 posts in January 2018). Post volume also appeared to increase in relation to US COVID-19 infection rates in 2020/2021 slightly. Online chatter about LOP abuse/misuse rose from 2015 to a peak in 2016 before declining in 2019/2020, consistent with the pattern of reported annual intentional exposure cases. While not a substitute for epidemiological surveillance, online social media listening is a useful adjunct surveillance strategy for earlier insight into potential LOP abuse/misuse by observing and analyzing online comments/conversations, sentiments and contexts.

Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk.

In 2018, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding fluoroquinolone-associated aortic aneurysm. This quasi-experimental study assessed antibiotic prescribing for 198 patients hospitalized with diabetic foot infection. Following the warning, median inpatient fluoroquinolone days of therapy (DOT) decreased from 3 to 0 days (P < 0.001), corresponding to increased beta-lactam DOT and outpatient parenteral antimicrobial therapy enrollment. FDA communications may influence antibiotic selection and transitions of care, representing opportunities for antimicrobial stewardship.

Concomitant drugs associated with increased mortality for MDMA users reported in a drug safety surveillance database

3,4-Methylenedioxymethamphetamine (MDMA) is currently being evaluated by the Food and Drug Administration (FDA) for the treatment of post-traumatic stress disorder (PTSD). If MDMA is FDA-approved it will be important to understand what medications may pose a risk of drug–drug interactions. The goal of this study was to evaluate the risks due to MDMA ingestion alone or in combination with other common medications and drugs of abuse using the FDA drug safety surveillance data. To date, nearly one thousand reports of MDMA use have been reported to the FDA. The majority of these reports include covariates such as co-ingested substances and demographic parameters. Univariate and multivariate logistic regression was employed to uncover the contributing factors to the reported risk of death among MDMA users. Several drug classes (MDMA metabolites or analogs, anesthetics, muscle relaxants, amphetamines and stimulants, benzodiazepines, ethanol, opioids), four antidepressants (bupropion, sertraline, venlafaxine and citalopram) and olanzapine demonstrated increased odds ratios for the reported risk of death. Future drug–drug interaction clinical trials should evaluate if any of the other drug–drug interactions described in our results actually pose a risk of morbidity or mortality in controlled medical settings.

228. Fluoroquinolone Prescribing for Diabetic Foot Infections following an FDA Drug Safety Communication for Aortic Aneurysm Risk

BackgroundFluoroquinolones were commonly prescribed for hospitalized patients with diabetic foot infection (DFI) at our institution, included in 69% of empiric antibiotic regimens from 2011–2014. On December 20, 2018, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding the risk of aortic aneurysm with fluoroquinolones. The objective of this study was to assess the impact of the FDA Communication on antibiotic prescribing for DFI.MethodsThis was a single-center quasi-experimental study of hospitalized patients initiated on antibiotics for DFI before (February-December 2018) and after (February-December 2019) the 2018 FDA Communication. Patients with concomitant infections or documented beta-lactam or fluoroquinolone allergies were excluded. The primary outcome was inpatient days of fluoroquinolone therapy. Secondary outcomes included days of beta-lactam therapy and Outpatient Parenteral Antibiotic Therapy (OPAT) enrollment. Variables were compared using the Pearson’s chi square, Fisher’s exact, and Mann Whitney U tests, as appropriate. A logistic regression was performed to identify predictors for inpatient receipt of fluoroquinolones.ResultsA total of 198 patients were included. Baseline characteristics were similar between groups (Table 1). After the FDA Communication, the median duration of inpatient fluoroquinolones decreased from 3 [0–5.5] to 0 [0–1] days (p< 0.001). The duration of antipseudomonal beta-lactams increased from 0 [0–2] to 2 [0–6] days (p< 0.001). OPAT enrollment increased from 16.5% to 29.7% (p=0.028), with a corresponding increase in peripherally inserted central catheter placement (15.5% to 25.7%, p=0.074). There was no difference in outpatient fluoroquinolone prescribing over time. Incidence of re-infection, readmission for DFI, and antibiotic adverse events were similar between groups (Table 2).Table 1 Table 2 ConclusionInpatient fluoroquinolone prescribing for DFI decreased significantly following the 2018 FDA Communication, followed by an increase in antipseudomonal beta-lactam use and OPAT enrollment. FDA statements can influence institutional antibiotic prescribing and transitions of care decisions, representing an opportunity for education by Antimicrobial Stewardship programs.Disclosures All Authors: No reported disclosures

Pediatric anesthesiologists' attitudes about neurotoxicity and the FDA drug safety communication.

The 2016 Food and Drug Administration (FDA) Drug Safety Communication states that brain development in children under 3 years old may be affected by "repeated or lengthy use of general anesthetic and sedation drugs" and advises healthcare providers to "discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing of surgery or procedures requiring anesthetic and sedation drugs." This preliminary study's aims were to explore 1) pediatric anesthesiologists' attitudes regarding the FDA statement, 2) the statement's impact on informed consent practices, and 3) whether institutional policies pertaining to disclosure of neurotoxicity risk exist.

Association of eszopiclone, zaleplon, or zolpidem with complex sleep behaviors resulting in serious injuries, including death.

To identify and analyze postmarketing cases of complex sleep behaviors (CSBs) resulting in serious injuries, including death, associated with eszopiclone, zaleplon, or zolpidem (Z-drugs). Retrospective analysis of the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 16 December 1992 through 27 February 2018 and medical literature using PubMed and EMBASE. We used random sampling and descriptive statistics. We identified 66 cases that met inclusion and exclusion criteria, four of which were identified in the medical literature. Twenty cases reported death and 46 cases reported serious injuries in association with CSBs occurring after the use of a Z-drug. Fatal cases described events, such as carbon monoxide poisoning, drowning, falls, hypothermia, motor vehicle collisions, and apparent completed suicide. Nonfatal cases resulting in serious injuries described events, such as accidental overdoses, falls, gunshot wounds, hypothermia, third-degree burns, and self-injuries or suicide attempts. Twenty-two cases reported a previous episode of a CSB while taking a Z-drug prior to the event reported in this case series. The FAERS and medical literature cases support the need for increased awareness of the consequences that may occur because of CSBs associated with the use of Z-drugs. Therefore, to protect public health, regulatory actions were taken, including adding a Boxed Warning, a Contraindication in patients who have experienced a prior episode of a CSB with a Z-drug, and updating the existing Warnings and Precautions. An FDA Drug Safety Communication was also disseminated to alert healthcare professionals and the public of this potential risk.

US Food and Drug Administration Safety Advisories and Reporting to theAdverse Event Reporting System (FAERS).

The US Food and Drug Administration (FDA) and other major regulators regularly issue safety advisories about licensed drugs with new adverse effects that have been documented through observational studies, clinical trials, and spontaneously reported adverse drug events. To assess the possible effects of a representative group of FDA Drug Safety Communications on the reporting of the specific adverse effect featured in the advisory on new cases reported to the FDA Adverse Event Reporting System (FAERS). We examined 16 FDA Drug Safety Communications issued from 2010 to 2015 that had not previously been the focus of advisories from regulators in the UK, Canada, or Australia. We compared the reports of the adverse effect in the 8 calendar quarters preceding the advisory and in the 4 quarters following. We measured change in reporting frequency by calculating the event reporting odds ratio (ROR) for the post-warning compared to the pre-warning periods. We defined a credible association of the advisory with increased reporting as a ROR ≥ 2.0 and p value of < 0.05 by Fisher's Exact Test. We found statistically significant increased reporting for 4/16 advisories with RORs that ranged from 3.9 to 40.6. Three advisories had smaller but still statistically significant increases that were less than the ROR ≥ 2.0 threshold. For 7 advisories, we found no statistically significant changes in reporting. No consistent pattern or effect was found on spontaneous reporting following these safety advisories. After results were available, we observed that some cases with the largest reporting increase also involved substantial numbers of legal claims. Changes in adverse event reporting following a warning need to be evaluated on a case-by-case basis.

Changes in emergency department visits for zolpidem‐attributed adverse drug reactions after FDA Drug Safety Communications

To identify possible changes in U.S. emergency department (ED) visits from zolpidem-attributed adverse drug reactions (ADRs) after 2013 Food and Drug Administration (FDA) Drug Safety Communications (DSCs), which notified the public about FDA's new dosing recommendations for zolpidem. We estimated the occurrence of ED visits from zolpidem-attributed ADRs using nationally representative, public health surveillance of medication harms (National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project, 2010-2017). We estimated the number of zolpidem prescriptions using IQVIA National Prescription Audit, 2010-2017. We calculated rates of ED visits for zolpidem-attributed ADRs per 10 000 dispensed zolpidem prescriptions and identified time trends and potential inflection points using joinpoint regression. For comparison, we repeated these analyses for sedating antidepressants commonly used to treat disordered sleep (trazodone, doxepin, and mirtazapine). The best-fit regression model for rates of ED visits for zolpidem-attributed ADRs by 6-month intervals identified a single inflection point in the second half of 2014 (P = .024) with a 6.7% biannual decrease from 2010 to 2014 ([-13.1%, 0.3%], P = .059) and a 13.9% biannual increase from the second half of 2014 through 2017 ([-1.1%, 31.3%], P = .068). No change or inflection points were identified for rates of ED visits for sedating antidepressant-attributed ADRs. While there was a nominal decline in the rate of ED visits for ADRs in the time period before and for 18 months after FDA's 2013 zolpidem DSCs, the decrease was not sustained, and thus questions remain concerning the long-term impact of the zolpidem DSCs on ADRs.

Varenicline and Nicotine Replacement Use Associated With US Food and Drug Administration Drug Safety Communications

Drug safety communications released by the US Food and Drug Administration (FDA) are often based on limited evidence on safety signals after approval. Varenicline may serve as a relevant case study because it was the target of several FDA communications in 2008 and 2009; ultimately, the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) dismissed safety concerns on increased suicidal thoughts and aggressive and erratic behavior on December 16, 2016. To examine the association between FDA drug safety communications and the use of varenicline. Retrospective, longitudinal, cross-sectional study of Veterans Health Administration (VHA) outpatient data from October 1, 2001, through December 31, 2018, and Medicaid drug state use data from July 1, 2006, through September 30, 2018, on varenicline prescribing. Prescribing records for varenicline and nicotine replacement therapy (NRT) in the VHA were extracted, and the number of unique varenicline and NRT users in the VHA per quarter was measured. An interrupted time series analysis was performed to describe the association between FDA safety warnings and the use of varenicline and NRT. To test the generalizability of the findings, similar analyses were conducted using the number of prescriptions reimbursed for varenicline by Medicaid every quarter in 2006-2018. After its addition to the VHA national drug formulary in January 2007, varenicline use presented a steady increase, reaching a peak of 32 581 quarterly unique users in the first quarter of 2008. Within 12 months of the February 1, 2008, public health advisory, quarterly varenicline use in VHA patients decreased by 68.7% (from 32 581 to 10 182 patients; P < .001 for slope change), and NRT use increased by 32.1% (from 55 728 to 73 629 patients; P < .001 for slope change). In Medicaid prescriptions, varenicline use decreased by 38.0% (from 109 308 to 67 761 prescriptions; P < .001 for slope change) within 12 months of the 2008 public health advisory. Twelve months after the publication of the EAGLES trial, which showed no significant increase in psychiatric/behavioral effects with varenicline relative to NRT, use of varenicline increased by 42.7% in VHA patients (from 9251 to 13 199 patients; P = .01 for slope change) and by 26.0% in Medicaid prescriptions (112 063 to 141 122; P = .26 for slope change ). With use of varenicline as a case study, early communications from the FDA and VHA followed by a labeling change appeared to be associated with a considerable decrease in drug use, which may have been associated with negative public health consequences.

Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.

Because clinical trials conducted for US Food and Drug Administration (FDA) approval occur in carefully monitored settings and often have strict inclusion criteria for participation, new information about drug safety is commonly discovered once a medication is FDA approved and used by larger numbers of patients. The FDA issues Drug Safety Communications when new information arises about the safety of marketed drugs that may change decision making by healthcare providers and patients. Since their inception, over 250 Drug Safety Communications have been issued alerting consumers and prescribers in the USA about safety risks related to prescription and over-the-counter medications. Researchers at the Brigham and Women's Hospital in Boston in conjunction with officials from the FDA undertook a multi-modal study of the content, dissemination, and uptake of FDA messaging, focusing on two 2013 Drug Safety Communications related to zolpidem (Ambien; Sanofi, Paris, France). Traditional and social media analyses note incomplete dissemination of key DSC messages. Surveys of patients and interviews of physicians and patients suggest important limitations in patient-provider communication that have hindered sharing of safety information with patients. Finally, pharmacoepidemiologic analyses of zolpidem dispensing patterns after the Drug Safety Communications were released suggest possible opportunities for enhancing uptake of new safety knowledge that may lead to changes in clinical practice, where appropriate.

Annals for Educators - 5 February 2019.

Annals for Educators - 5 February 2019.

Anesthesia Exposure in Children: Practitioners Respond to the 2016 FDA Drug Safety Communication.

In December 2016, the US Food and Drug Administration (FDA) issued a drug safety warning stating that 11 commonly used anesthetic and sedative medications had potential neurotoxic effects when used in children under the age of 3 years and in pregnant women during the third trimester. A panel presentation at the sixth biennial Pediatric Anesthesia Neurodevelopmental Assessment (PANDA) symposium addressed the FDA announcement in a session entitled "Anesthesia Exposure in Children During Surgical and Non-Surgical Procedures: How Do We Respond to the 2016 FDA Drug Safety Communication?" Panelists included representatives from pediatric anesthesiology, obstetrics, pediatric surgery, and several pediatric surgical subspecialties. Each panelist was asked to address the following questions: How has the FDA labelling change affected your clinical practice including patient discussions, timing, and frequency of procedures? Has your professional society provided any guidelines for this discussion? Has there been any discussion of this topic at your national meetings? The panelists provided important perspectives specific to each specialty, which generated a lively discussion and a detailed response from the Deputy Director of the Division of Anesthesia and Addiction of the FDA describing the FDA procedures that led to this drug safety warning.

Med Check

Back to table of contents Previous article Next article Med CheckFull AccessMed CheckNick ZagorskiNick ZagorskiSearch for more papers by this authorPublished Online:15 Dec 2017https://doi.org/10.1176/appi.pn.2017.12b53FDA Fast Tracks Alzheimer’s MedicationAlzheon Inc.’s oral anti-amyloid medication ALZ-801, a prodrug formulation of the compound tramiprosate, has been granted fast-track status by the Food and Drug Administration (FDA).Tramiprosate—which was designed to break down amyloid aggregates—failed in a previous clinical trial, but investigators found data to suggest the prodrug version could work in patients with the APOE4 risk gene. Alzheon is initiating a new phase 3 study of ALZ-801 that will specifically enroll participants who are homozygous for the risk gene and have a diagnosis of mild Alzheimer’s.FDA Committees Recommend Approval of Buprenorphine InjectableThe FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted 17-3 in favor of approving of CAM2038, a buprenorphine injection for the treatment of adults with opioid use disorder (OUD).CAM2038, developed by Braeburn Pharmaceuticals, is available in both weekly and monthly formulations. The drug is intended to be administered by health care professionals to ensure proper delivery of medication, while also minimizing risks of diversion, misuse, and accidental pediatric exposure.The committee’s recommendation was based on the results of seven clinical trials, including a phase 3 efficacy study and a long-term safety study. CAM2038 was given a priority review designation by the FDA in September.FDA Approves Implant For Sleep ApneaThe FDA in October approved an implantable neurostimulation device to treat moderate-to-severe central sleep apnea. Central sleep apnea occurs when the brain fails to send signals to the diaphragm to breathe. The resulting loss of sleep quality can lead to a range of physical and behavioral complications. The device, called the Remedē System, is an implanted nerve stimulator that sends electrical currents to the phrenic nerve to stimulate the diaphragm and restore normal breathing. The Remedē System, manufactured by Respicardia, is implanted under the skin of the upper chest. The approval was based on a clinical trial of 141 patients. After six months, more than half of the patients implanted with the active Remedē System saw at least a 50 percent reduction in their apnea hypopnea index, which measures the severity and frequency of sleep apnea, compared with only 11 percent of patients in the control group.Alkermes Submits NDA For Long-Acting Injectable InitiatorAlkermes has submitted a New Drug Application to the FDA for its novel injectable compound Aripiprazole Lauroxil NanoCrystal Dispersion. The product was designed to provide extended-release aripiprazole in a formulation that enables faster dissolution and leads to more rapid achievement of therapeutic levels of aripiprazole.If approved, administration of this product in conjunction with a single oral dose of 30 mg aripiprazole could replace the need for three weeks of concominant oral aripiprazole following the first injection of the extended-release formulation of aripiprazole, according to the company.“Patients with schizophrenia are particularly vulnerable to nonadherence and relapse when transitioning from inpatient care to outpatient settings,” said Alkermes’ Executive Vice President of Research and Development Elliot Ehrich, M.D., in a press release. “The ability to initiate long-acting treatment with Aristada on Day 1 without the need to continue oral supplementation during this critical transition period may be a useful and welcomed option for the clinical community.” ■ ISSUES NewArchived

Accelerated approval of drugs: ethics versus efficacy.

To analyse the post-marketing status of molecules approved through the expedited review process in the last quintile. This observational study was carried out between January 2016 and June 2016. The details of the time taken to approve drugs were collected from the official website of United States Food and Drug Administration (FDA). The average time taken to review drugs and take a decision following the review were ascertained from the FDA's annual release of novel drugs from 2011 to 2015. Information on adverse drug reactions noted after approval was gathered from the FDA Drug Safety Communication and FDA Adverse Event Reporting System (FAERS). In the last five years, 166 products were approved by expedited review. Of these, 45 (27.1%) did not meet the stringent criteria framed for expedited review. Reports of serious adverse event alerts were submitted for 79 (47.5%) of the 166 molecules. Fourteen (8.4%) drugs were associated with inducing severe autoimmune disorders. It can be observed that a lower average time of review is positively correlated with a greater number of adverse events (p<0.05). Thirty-seven (45.7%) of the molecules failed to be of any benefit in the treatment scenario. Drug approval by accelerated review should be stringent. Beneficence and non-maleficence are applicable to the global population, and should apply equally to subjects involved in trials. Approving drugs on the basis of trivial evidence is non-scientific and absolutely unethical, since it can lead to clinical failure and produce serious adverse events.

Unintentional administration of insulin instead of influenza vaccine: a case study and review of reports to US vaccine and drug safety monitoring systems

There have been isolated case reports of medication product mix-ups involving insulin unintentionally given to patients when the intent was to administer vaccines. Information on how and why these types of errors occur is limited. To describe incidents of unintentional administration of insulin instead of influenza vaccine and identify possible causes for errors. We describe a 2014 investigation of an apparent mix-up where a cluster of five adult patients unintentionally received insulin instead of influenza vaccine. We also searched Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) vaccine and drug safety monitoring databases from January 2005 to April 2015 in order to identify other incidents. We classified cases as either ‘highly suggestive’ or ‘suggestive’ of insulin and influenza vaccine mix-ups. Investigation of the primary cluster incident revealed deviations from recommended practices for storage, handling, preparation, and administration of drugs and vaccines; the five cases were classified as highly suggestive of insulin and influenza vaccine mix-ups. Our search of CDC and FDA vaccine and drug safety monitoring databases identified an additional two highly suggestive and 15 suggestive cases, for a total of 22 cases (7 highly suggestive and 15 suggestive) during the 10-year study period. Insulin and vaccine mix-ups have the potential to cause serious harm to patients, and are preventable with proper training and application of standards. Our investigation indicated that improper storage—including inadequate segregation of insulin and influenza vaccine products in clearly labeled containers or bins—lack of standardized procedures for confirming the contents of vials, and decreased vigilance in preparation and administration likely contributed to the primary cluster incident.

Medication Safety

Medication Safety

Impact of the U.S. Food and Drug Administration's Safety-Related Announcements on the Use of Bisphosphonates After Hip Fracture.

The U.S. Food and Drug Administration (FDA) issued several announcements related to potential risk of bisphosphonates including osteonecrosis of the jaw (2005), atrial fibrillation (2007), and atypical femur fracture (2010). We aimed to evaluate the impact of three FDA drug safety announcements on the use of bisphosphonates in patients with hip fracture using claims data from a U.S. commercial health plan (2004-2013). We calculated the proportion of patients in each quarter who received a bisphosphonate or other osteoporosis medication in the 6 months following hospitalization for hip fracture. Segmented logistic regression models examined the time trends. Among 22,598 patients with hip fracture, use of bisphosphonate decreased from 15% in 2004 to 3% in the last quarter of 2013. Prior to the 2007 announcement, there was a 4% increase in the odds of bisphosphonate use every quarter (OR 1.04; 95% CI, 1.02 to 1.07). After the 2007 announcement, there was a 4% decrease in the odds of bisphosphonate use (OR 0.96; 95% CI, 0.93 to 0.99) every quarter. The announcement in 2007 was associated with a significant decline in the rate of change of bisphosphonate uses over time (p < 0.001), but no impact on other osteoporosis medication use (p = 0.2). After the 2010 announcement, the odds of bisphosphonate use continued to decrease by 4% (OR 0.96; 95% CI, 0.94 to 0.98) each quarter and the odds of other osteoporosis medication use remained stable over time (OR 0.99; 95% CI, 0.96 to 1.02). The FDA safety announcement related to atrial fibrillation in 2007 was significantly associated with a decrease in bisphosphonate use among patients with hip fracture. © 2016 American Society for Bone and Mineral Research.

Parkinson's Drug Doesn't Increase Cardiovascular Risk

* The Food and Drug Administration (FDA) has determined that drugs containing entacapone, used in the management of Parkinson's disease symptoms, does not increase the risk of cardiovascular events. * This announcement reverses an older FDA Drug Safety Communication in which the agency expressed concerns over possible cardiovascular events associated with use of the drug.