Medical Device Safety and Recalls: Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication

Medical Device Safety and Recalls: Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication

A safety communication has been posted titled, “Lubricious Coating Separation from Intravascular Medical Devices

The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes.

This communication contains important information physicians should consider to reduce the potential of adverse events. Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers should be aware of potential problems and consider certain actions prior to use.

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Drug Information Update- FDA approves new pill to treat certain patients with non-small cell lung cancer

Drug Information Update- FDA approves new pill to treat certain patients with non-small cell lung cancer
FDA Division of Drug Information: Know the Moment It Happens

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.

Today, the U.S. Food and Drug Administration granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.

Today, the FDA also approved the first companion diagnostic test (cobas EGFR Mutation Test v2) to detect the type of EGFR resistance mutation that Tagrisso is known to target. The newly approved version (v2) of the test adds the T790M mutation to the clinically relevant mutations detected by the original cobas EGFR Mutation Test (v1).

The most common side effects of Tagrisso are diarrhea, skin and nail conditions such as dry skin, rash and infection or redness around the fingernails. Tagrisso may cause serious side effects, including inflammation of the lungs and injury to the heart. It also may cause harm to a developing fetus.

The FDA granted Astra Zeneca breakthrough therapy designation, priority review and orphan drug designation for Tagrisso. Breakthrough therapy designation is granted for a drug that is intended to treat a serious condition when, at the time an application is submitted, preliminary clinical evidence indicates that a drug may demonstrate substantial improvement over available therapies. Priority review
designation is granted to drug applications that show a significant improvement in safety or effectiveness in the treatment of a serious condition. Orphan drug designation
provides incentives such as tax credits, user fee waivers, and eligibility for market exclusivity to assist and encourage the development of drugs for rare diseases.

Tagrisso was approved under the agency’s accelerated approval program which allows the approval of a drug to treat a serious or
life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.

For more information please visit: Tagrisso

Medical Device Safety and Recalls: Hamilton Recalls G5 Ventilator Because of Ventilation and Alarm Failure

Medical Device Safety and Recalls: Hamilton Recalls G5 Ventilator Because of Ventilation and Alarm Failure

A recall has been issued for the G5 Ventilator. The ventilator may stop working, without sounding an alarm, when the device operator presses the oxygen enrichment key to attach the ventilator mask to the patient (suctioning maneuver).

This problem can occur during the following conditions:

* When pressing the oxygen enrichment key a second time within 50 milliseconds after the disconnection is detected, or,
* When disconnection is detected immediately before the oxygen enrichment period automatically ends, so that detection of disconnection and termination of O2-enrichment occur within 50 milliseconds of each other.

If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.

The firm has received a total of 1 report of device malfunction. No injuries or deaths were reported. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm471717.htm

Medical Device Safety and Recalls: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication

Medical Device Safety and Recalls: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication

Today, the FDA issued the Safety Communication, “FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods
to notify health care professionals about our concerns with the safety and effectiveness of all Custom Ultrasonics’ AER models. This communication provides recommended actions health care facilities should take if they use Custom Ultrasonics’ AERs because of the risk of transmission of infectious organisms to patients.

U.S. Food & Drug Administration (FDA) Clinical Pharmacology Corner Update: FDA Approves COTELLIC (Cobimetinib)

U.S. Food & Drug Administration (FDA) Clinical Pharmacology Corner Update: FDA Approves COTELLIC (Cobimetinib)

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*FDA Approves COTELLIC^® (Cobimetinib) for the Treatment of Patients with Unresectable or Metastatic Melanoma with a BRAF V600E or V600K Mutation, in Combination with Vemurafenib *

On November 10, 2015, the United States Food and Drug Administration (FDA) approved COTELLIC (Cobimetinib) in combination with vemurafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K Mutation. The approved recommended dosage of COTELLIC tablets is 60 mg orally once daily with or without food for the first 21 days of each 28 day cycle until disease progression or unacceptable toxicity. The dosage of COTELLIC may be reduced to 40 mg or 20 mg once daily for adverse reactions. Clinically relevant QT prolongation has been reported with vemurafenib, further QTc prolongation was not observed when cobimetinib 60 mg daily was co-administered with vemurafenib. Monitor ECG and electrolytes before initiating treatment and routinely during treatment with cobimetinib, when administered with vemurafenib.

_Mechanism of Action (MOA), General Pharmacokinetics (PK) and Pharmacodynamics (PD) of Cobimetinib_

* /MOA:/ Cobimetinib reversibly inhibits mitogen-activated protein kinase (MAPK)/extracellular signal regulated kinase 1 (MEK1) and MEK2. * /Dose proportionality:/ Exhibited dose-proportional increases in systemic exposure over the dose range of 3.5 to 100 mg (i.e., 0.06 to 1.7 times the approved recommended dosage).
* /Accumulation:/ Mean of 2.4-fold at the approved recommended dosage. * /Absorption:/ The absolute bioavailability of COTELLIC was 46% in healthy subjects. The Tmax was 2.4 hours (range:1 to 24 hours) in cancer patients.
* /Plasma protein binding:/ Approximately 95%.
* /Terminal half-life (mean):/ Approximately 44 hours (range: 23 to 70 hours) in cancer patients.
* /Metabolism:/ Primarily metabolized by CYP3A and glucuronidated by UGT2B7.
* /Excretion:/ Approximately 76% of the total recovered radio-labeled cobimetinib dose was eliminated in the feces (with 6.6% as unchanged drug) and 17.8% was eliminated in the urine (with 1.6% as unchanged drug).

_Drug Interaction Potential_

* Avoid strong or moderate CYP3A inhibitors. If concurrent short term (14 days or less) use of moderate CYP3A inhibitors including certain antibiotics (e.g., erythromycin, ciprofloxacin) is unavoidable for patients who are taking COTELLIC 60 mg, reduce COTELLIC dose to 20 mg. After discontinuation of a moderate CYP3A inhibitor, resume COTELLIC at the previous dose. Use an alternative to a strong or moderate CYP3A inhibitor in patients who are taking a reduced dose of COTELLIC (40 or 20 mg daily). Coadministration of the strong CYP3A inhibitor itraconazole increased cobimetinib AUC by 6.7-fold and Cmax by 3.2-fold.
* Avoid strong or moderate CYP3A inducers. Cobimetinib exposures are estimated to decrease by 83% when coadministered with a strong CYP3A inducer and by 73% when coadministered with a moderate CYP3A inducer. * Cobimetinib is a substrate of efflux transporter P-glycoprotein (P-gp) in vitro. Drugs that inhibit P-gp may increase cobimetinib concentrations; however, the clinical relevance of this finding is unknown.
* Clinically relevant pharmacokinetic interactions were not observed following coadministration of COTELLIC with the following medications: vemurafenib, midazolam (sensitive CYP3A substrate), dextromethorphan (sensitive CYP2D6 substrate), or rabeprazole (proton pump inhibitor).

_Use in Specific Populations_

The following population characteristics were not associated with a clinically significant effect on the pharmacokinetics of cobimetinib: sex, age (19 to 88 years), race/ethnicity, mild to moderate renal impairment (creatinine clearance [CLcr] 30 to 89 mL/min), and mild hepatic impairment (total bilirubin ≤ upper limit of normal [ULN] and AST > ULN or total bilirubin > ULN but ≤ 1.5 × ULN and any AST). The effect of moderate to severe hepatic impairment (total bilirubin > 1.5 to 3 × ULN and any AST), severe renal impairment or end-stage renal disease with or without hemodialysis (CLcr less than 29 mL/min) on cobimetinib exposure (i.e., AUC and Cmax) is unknown.

_Safety and Efficacy_

Clinical effectiveness and safety of cobimetinib were demonstrated at the approved recommended dosage in a multicenter, randomized (1:1), double-blinded, placebo-controlled trial in patients with previously untreated, BRAF V600 mutation-positive, unresectable or metastatic, melanoma. The median progression-free survival (PFS) was 12.3 months in patients treated with cobimetinib and vemurafenib compared with 7.2 months in those receiving vemurafenib as a single agent [hazard ratio: 0.56 (0.45, 0.70, p < 0.001)].

The most common adverse reactions were diarrhea, photosensitivity reaction, nausea, and vomiting. Advise patients to avoid sun exposure. Monitor for severe skin rashes and interrupt, reduce, or discontinue COTELLIC if required.

Daratumumab injection

Daratumumab injection
The U.S. Food and Drug Administration granted accelerated approval to daratumumab injection (DARZALEX, Janssen Biotech, Inc.), administered as a single agent for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. November 16, 2015. More Information:
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm472904.htm

Recent Device Approvals: cobas® HCV Test

Recent Device Approvals: cobas® HCV Test

The FDA has recently approved the cobas® HCV Test to be marketed. The cobas® HCV is a laboratory test used to measure the
amount of hepatitis C virus (HCV) RNA (ribonucleic acid) in a patient’s blood. Viral RNA is genetic material from HCV.

Hepatitis C is a liver infection caused by HCV. Hepatitis C is transmitted when blood or another body fluid from a person infected with the Hepatitis C virus enters the body of someone who is not infected. This can happen through sharing needles, syringes, or other
drug-injection equipment, from mother to baby at birth, and less commonly, through sexual contact. Approximately 75% – 85% of people who become infected with hepatitis C develop chronic infection. Chronic Hepatitis C can lead to serious health issues, like cirrhosis or liver cancer.

The results from the cobas® HCV must be interpreted within the context of all other relevant clinical and laboratory findings.

Drug Information Update – FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose

Drug Information Update – FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose
FDA Division of Drug Information: Know the Moment It Happens

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.

Yesterday the U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose. Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illegal drug heroin.

Drug overdose deaths, driven largely by prescription drug overdoses, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade. When someone overdoses on an opioid, it can be difficult to awaken the person, and breathing may become shallow or stop – leading to death if there is no medical intervention. If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.

The use of Narcan nasal spray in patients who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

For more information, please visit: Narcan

Drug Information Update – FDA approves new oral medication to treat multiple myeloma

Drug Information Update – FDA approves new oral medication to treat multiple myeloma
FDA Division of Drug Information: Know the Moment It Happens

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.

Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy.

Multiple myeloma is a form of blood cancer that occurs in
infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. The disease may result in a weakened immune system and cause other bone or kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year.

The most common side effects of Ninlaro are diarrhea, constipation, low blood platelet count (thrombocytopenia), peripheral neuropathy (numbness and pain from nerve damage, usually in the hands and feet), nausea, peripheral edema (fluid under the skin causing swelling), vomiting and back pain.

For more information, please visit: Ninlaro

Ixazomib

Ixazomib

FDA approved ixazomib (NINLARO, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome
inhibitor. November 20, 2015. More Information:
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm473804.htm