Teleflex Medical, Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube

A recall has been issued for the Teleflex Medical, Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube.  Teleflex Medical has received customer complaints about the endobroncial tube’s double swivel connector which may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress. This can lead to the need to re-intubate the patient, patient injury or death.

Source: FDA.gov

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Elite Biomedical Solutions Recall

A recall has been issued for the Elite Biomedical Solutions, Alaris Medley Large Volume Pump (LVP) Frame Membrane.  Elite Biomedical Solutions discovered that the use of this part can result in over or under infusion of fluids to the patient with the potential to cause patient injury or death.

For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm460079.htm

Source: FDA.gov

CDISC Training and Support

CDISC Training
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union.  For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

Designing Web Applications for Older Health Consumers

Designing Web Applications for Older Health Consumers – Easier Said Than Done

Consumers older than 65 may have difficulty using Web applications to identify providers that meet their needs, according to an AHRQ-funded study. Researchers created a Web application that enabled Rhode Island consumers to compare home health agencies based on information such as services offered and health outcomes. They conducted usability testing of the Web application using two focus groups, totaling 14 older consumers looking for information about home health agencies and six hospital case managers. Investigators noted that while Web applications are a cost-effective way to disseminate information, it is important to ensure that people with low literacy, low health literacy and low computer proficiency can access, understand and use these applications. Although the researchers based their initial design on best practices, user testing showed that they overestimated the extent to which older adults were familiar with using computer applications. Researchers subsequently adopted simpler navigation and additional user prompts. The study and abstract were published in the May 15 issue of the journal eGEMS (Generating Evidence & Methods to improve patient outcomes).

source: AHRQ.gov

CareFusion Alaris Syringe Pump Recall

A recall has been issued for the CareFusion Alaris Syringe Pump. An error in the syringe pump triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the error code 351.6740, the syringe pump does not respond to key presses until the product is detached and reattached to the PC unit used to program, monitor and provide power to the syringe pump. Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.

CareFusion has received 108 reports of the issue occurring. There have been no reports of permanent injury or death.

Source: FDA.gov

Insulet Corporation Issues Voluntary Recall of OmniPod Insulin Management System

On July 8, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet’s current manufacturing standards.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Source: FDA.org

FDA approved eltrombopag (Promacta for oral suspension, Novartis)

FDA approved eltrombopag (Promacta for oral suspension, Novartis) for the treatment of thrombocytopenia in pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.   August 24, 2015. 

Source: More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm459467.htm

FDA Announcement: Edurant (rilpivirine) product labeling

On August 26, 2015 the Edurant (rilpivirine) product labeling was updated to include the use of rilpivirine in combination with other antiretroviral agents for the treatment of HIV-1 infection to include treatment-naïve pediatric patients from 12 to less than 18 years of age with HIV-1 RNA less than or equal to 100,00 copies/mL. The summary of the changes are provided below. In addition to the addition of the adolescent data to the label, changes were made the Warnings and Precautions with respect to Depressive Disorders and updates to the adrenal function subsection in section 6 Adverse Reactions.

Section 2: DOSAGE AND ADMINISTRATION was updated as follows:

The recommended dosage of EDURANT in patients 12 years of age and older and weighing at least 35 kg is one 25 mg tablet once daily taken orally with a meal. EDURANT is not recommended for patients less than 12 years of age.

Section 5 Warnings and Precautions was updated as follows:

5.3 Depressive Disorders

The adverse reaction depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) has been reported with EDURANT. Patients with severe depressive symptoms should seek immediate medical evaluation to assess the possibility that the symptoms are related to EDURANT, and if so, to determine whether the risks of continued therapy outweigh the benefits.

During the Phase 3 trials in adults (N = 1368) through 96 weeks, the incidence of depressive disorders (regardless of causality, severity) reported among EDURANT (n = 686) or efavirenz (n = 682) was 9% and 8%, respectively. Most events were mild or moderate in severity. The incidence of Grade 3 and 4 depressive disorders (regardless of causality) was 1% for both EDURANT and efavirenz. The incidence of discontinuation due to depressive disorders among EDURANT or efavirenz was 1% in each arm. Suicidal ideation was reported in 4 subjects in each arm while suicide attempt was reported in 2 subjects in the EDURANT arm.

During the Phase 2 trial in pediatric subjects 12 to less than 18 years of age (N = 36) receiving EDURANT through 48 weeks, the incidence of depressive disorders (regardless of causality, severity) was 19.4% (7/36). Most events were mild or moderate in severity. The incidence of Grade 3 and 4 depressive disorders (regardless of causality) was 5.6% (2/36). None of the subjects discontinued due to depressive disorders. Suicidal ideation and suicide attempt were reported in 1 subject.

Section 6: ADVERSE REACTIONS – Adults was revised as follows

Adrenal Function

In the pooled Phase 3 trials, at Week 96, there was an overall mean change from baseline in basal cortisol of -0.69 (-1.12, 0.27) micrograms/dL in the EDURANT group and of -0.02 (-0.48, 0.44) micrograms/dL in the efavirenz group.

In the EDURANT group, 43/588 (7.3%) of subjects with a normal 250 micrograms ACTH stimulation test at baseline developed an abnormal 250 micrograms ACTH stimulation test (peak cortisol level < 18.1 micrograms/dL) during the trial compared to 18/561 (3.2%) in the efavirenz group. Of the subjects who developed an abnormal 250 micrograms ACTH stimulation test during the trial, fourteen subjects in the EDURANT group and nine subjects in the efavirenz group had an abnormal 250 micrograms ACTH stimulation test at Week 96. Overall, there were no serious adverse events, deaths, or treatment discontinuations that could clearly be attributed to adrenal insufficiency. The clinical significance of the higher abnormal rate of 250 micrograms ACTH stimulation tests in the EDURANT group is not known.

Section 6.2: Clinical Trials Experience: Pediatric Patients was added as follows.

The safety assessment is based on the Week 48 analysis of the single-arm, open-label, Phase 2 trial, TMC278 C213, in which 36 antiretroviral treatment naïve HIV 1 infected patients 12 to less than 18 years of age and weighing at least 32 kg received EDURANT (25 mg once daily) in combination with other antiretroviral agents [see Clinical Studies (14.2)]. The median duration of exposure was 63.5 weeks. There were no patients who discontinued treatment due to ADRs. No new ADRs were identified compared to those seen in adults.

ADRs were reported in nineteen pediatric subjects (52.8%). Most ADRs were Grade 1 or 2. The most common ADRs reported in at least 2 subjects (regardless of severity) include headache (19.4%), depression (19.4%), somnolence (13.9%), nausea (11.1%), dizziness (8.3%), abdominal pain (8.3), vomiting (5.6%) and rash (5.6%).

Observed laboratory abnormalities were comparable to those in adults.

Adrenal Function

In trial TMC278 C213, at Week 48, the overall mean change from baseline in basal cortisol showed an increase of 1.59 (0.24, 2.93) micrograms/dL.

Six of 30 (20%) subjects with a normal 250 micrograms ACTH stimulation test at baseline developed an abnormal 250 micrograms ACTH stimulation test (peak cortisol level < 18.1 micrograms/dL) during the trial. Three of these subjects had an abnormal 250 micrograms ACTH stimulation test at Week 48. Overall, there were no serious adverse events, deaths, or treatment discontinuations that could clearly be attributed to adrenal insufficiency. The clinical significance of the abnormal 250 micrograms ACTH stimulation tests is not known.

Section 12 Clinical Pharmacology was updated to include the adolescent pharmacokinetic data

Section 14 Clinical Studies section was added as follows:

14.2 Treatment-Naïve Pediatric Subjects (12 to less than 18 years of age)

The pharmacokinetics, safety, tolerability and efficacy of EDURANT 25 mg once daily, in combination with an investigator-selected background regimen (BR) containing two NRTIs, was evaluated in trial TMC278-C213, a single-arm, open-label Phase 2 trial in antiretroviral treatment-naïve HIV-1 infected pediatric subjects 12 to less than 18 years of age and weighing at least 32 kg. Thirty six (36) subjects were enrolled in the trial to complete at least 48 weeks of treatment. The 36 subjects had a median age of 14.5 years (range: 12 to 17 years), and were 55.6% female, 88.9% Black and 11.1% Asian.

In the efficacy analysis, most subjects (75%; 28/36) had baseline HIV RNA <100,000 copies/mL.  For these 28 subjects the median baseline plasma HIV-1 RNA was 44,250 (range: 2,060-92,600 copies/mL) and the median baseline CD4+ cell count was 445.5 cells/mm3 (range: 123 to 983 cells/mm3).

Among the subjects who had baseline HIV RNA ≤ 100,000, the proportion with HIV 1 RNA <50 copies/mL at Week 48 was 79% (22/28), versus 50.0% (4/8) in those with >100,000 copies/mL. The proportion of virologic failures among subjects with a baseline viral load ≤100,000 copies/mL was 21.4% (6/28), versus 37.5% (3/8) in those with >100,000 copies/mL. At Week 48, the mean increase in CD4+ cell count from baseline was 201.2 cells/mm3.

You can view the complete label at drugs@fda or dailymed.

Source: FDA.org

FDA warns health care professionals not to use compounded or repackaged drugs stored in Becton-Dickinson (BD)

FDA warns health care professionals not to use compounded or repackaged drugs stored in Becton-Dickinson (BD) 3 milliliter (ml) and 5 ml syringes unless there is no suitable alternative available.

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


FDA is alerting health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3 milliliter (ml) and 5ml syringes manufactured by Becton-Dickinson (BD) unless there is no suitable alternative available. Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe.

If you have been using products packaged in these syringes, be aware that using a substitute product may require a dosage adjustment in case the patient has been receiving a subpotent product, or adverse consequences could occur.

BD’s 10ml, 20ml and 30ml syringes may also contain the same rubber stopper. The company is alerting their customers not to use these syringes as a closed container system for compounded and repackaged drugs.

FDA has cleared these syringes as medical devices for general purpose fluid aspiration and injection only.  These syringes were not cleared for use as a closed container storage system for drug products, and the suitability of these syringes for that purpose has not been established.  This issue may extend to other general use syringes made by other manufacturers that were not cleared for the purpose of closed-container storage usage.

FDA has received several reports of compounded and repackaged drugs, such as fentanyl, morphine, methadone and atropine, losing potency when stored in BD 3ml and 5ml general purpose syringes. It is possible that this chemical reaction may affect other compounded and repackaged drugs stored in syringes not FDA cleared for closed-container storage.

Hospital and pharmacy staff should check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored in general purpose BD 3ml and 5ml syringes.  These syringes are marked with the BD logo at the base of the syringe.

At this time, FDA does not have information on how long drugs can be stored in these syringes before degrading. There is no information to suggest that there is a problem with potency or drug degradation when medication is administered promptly after the syringes are filled.

This warning does not extend to products approved by FDA for marketing as pre-filled syringes, because as part of the approval process, FDA has determined that these products have been shown to maintain stability in the syringe container through the expiration date on the product.

On July 30, 2015, the Institute for Safe Medication Practices (ISMP) issued a Special Alert regarding this problem.  See http://www.ismp.org/newsletters/acutecare/articles/loss-of-drug-potency.aspx

The FDA is continuing to investigate this issue and will provide more information when it is available.

FDA asks health care professionals and patients to report any adverse reactions to the FDA’s MedWatch program:

Source: FDA.gov

New Alzheimer’s, prevention, and caregiving studies enrolling volunteers

 

Interested in participating in Alzheimer’s and related research? Volunteers are needed for the following clinical trials and studies recently added to the National Institute on Aging (NIA) listing. To find out more, click on a trial name below. Contact the study coordinator for your area to learn about participating.

Learn more about volunteering for clinical trials and studies.

Drugs

Cognitive Training/Tests

Caregivers

Registries

  • Alzheimer’s Prevention Registry (nationwide)—get information and updates about participating in future Alzheimer’s prevention trials.
  • Brain Health Registry (nationwide)—sign up for an online study of brain health and learn about possible research-study opportunities.

Major Studies Still Recruiting

Get more information about these and other Alzheimer’s clinical trials. Or, call the ADEAR Center at 1-800-438-4380 (toll-free) or email adear@nia.nih.gov.

Help us spread the word about Alzheimer’s and related clinical trials!