Professional Documents
Culture Documents
MRX Clinical Alert-April 2020
MRX Clinical Alert-April 2020
CLINICAL
ALERT
YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS
EDITORIAL STAFF
DEPUTY EDITORS
Jessica Czechowski
PharmD
DRUG RECENT
INFORMATION PIPELINE
Lara Frick FDA
PharmD, BCPS, BCPP
HIGHLIGHTS NEWS
APPROVALS
Leslie Pittman
PharmD
2 | APRIL 2020
TRENDING TOPICS continued Word count: 742
For induction of remission, AGA suggests against The FDA is addressing potential supply chain issues,
thiopurine monotherapy (conditional; very low), but including disruptions of critical drugs and medical
this is suggested over no treatment for maintaining devices. According to the FDA as of February 27,
remission (conditional; low). Methotrexate monotherapy 2020, there is an unnamed drug shortage directly
is not suggested for induction or for maintenance of impacted by COVID-19, however, this drug has
remission (conditional; low). The combination of a alternatives. Moreover, they have identified about
TNF-alpha antagonist, vedolizumab, or ustekinumab 20 other unnamed, non-critical drugs, that are not
is suggested with a thiopurine or methotrexate over in shortage but sourced from China. The FDA is
biologic monotherapy or thiopurine monotherapy working with manufacturers to mitigate shortages
(conditional; low). Notably, early use of biologics with and continues to monitor the supply chain.
or without immunomodulator therapy is suggested over
gradual step up to these agents following failure of For more information on COVID-19, visit the Magellan
5-aminosalicylates (5-ASA) (conditional; very low). For Rx Coronavirus (COVID-19) Update webpage. For the
patients who achieve remission with biologic agents most current information, visit the FDA, the Centers
and/or immunomodulators or tofacitinib, the panel for Disease Control and Prevention (CDC), and the
suggests against continuing 5-ASA for induction and World Health Organization (WHO). State and local
maintenance of remission (conditional; very low). health departments also provide valuable information
regarding management in local communities.
3 | APRIL 2020
BEHAVIORAL HEALTH
CORNER
FDA DRUG SAFETY COMMUNICATION:
stronger warning is warranted. In addition to the boxed
MONTELUKAST (SINGULAIR®) warning, the FDA is requiring a new patient Medication
The FDA has recommended a boxed warning be added Guide providing details on these risks.
to the prescribing information for montelukast due to
the potential for serious behavior and mood-related The FDA has previously provided communications
changes, including the potential for suicidal ideation or regarding the mental health side effects with montelukast
behavior. Montelukast is a leukotriene receptor antagonist in 2008 and 2009. Data from the FDA’s Sentinel System
indicated for prevention and chronic treatment of asthma in and from the FDA’s Adverse Event Reporting System
patients ≥ 12 months of age, acute prevention of exercise- (FAERS) database was utilized to assess the risk for
induced bronchoconstriction (EIB) in patients ≥ 5 years these events. This data, in conjunction with published
of age, relief of symptoms of seasonal allergic rhinitis observational and animal studies and an outside panel
in patients ≥ 2 years of age, and relief of symptoms of of experts, was used to further evaluate the potential
perennial allergic rhinitis in patients ≥ 6 months of age. for these side effects. Overall, new data regarding these
risks are minimal; however, the reports received by the
Product labeling for all montelukast products already FDA for these events are ongoing. Furthermore, there are
included a warning regarding the potential for alternative agents for managing the conditions for which
neuropsychiatric events, as these have been reported montelukast is used. As a result, the FDA reassessed
in adult, adolescent, and pediatric patients. A number of the benefits versus risks of the drug and concluded a
post-marketing adverse events are described, including boxed warning was necessary. Notably, the agency is
agitation, aggressive behavior, anxious feelings, depression, recommending montelukast only be used for allergic
disorientation, changes in attention, dream abnormalities, rhinitis when other allergy medications are not tolerated
stuttering, hallucinations, insomnia, memory impairment, or do not provide adequate symptom control. In asthma
and suicidal ideation/behavior. Although product labeling patients, prescribers should evaluate the benefits versus
detailed these serious side effects and alerted patients risks of montelukast prior to prescribing.
and prescribers of these risks, the FDA has determined a
4 | APRIL 2020
BIOSIMILAR
CORNER
FDA LAUNCHES SEARCHABLE PURPLE BOOK FDA AND FTC ISSUE STATEMENT
The FDA has announced the launch of the first phase of SUPPORTING BIOSIMILAR ADOPTION
the new Purple Book searchable database. The Purple The FDA and Federal Trade Commission (FTC) have issued
Book is a reference source for information regarding a joint statement on efforts and steps that are going to
FDA-approved biological products, including which be taken to prevent anti-competitive business practices
products have received biosimilar and/or interchangeable for biologic products. Biosimilar and interchangeable
designations. The new searchable database will eventually products have the potential to substantially decrease
replace the current portable document format (PDF) lists healthcare costs; however, certain anti-competitive
for identifying FDA-approved biologic and biosimilar practices may be contributing to their slow adoption.
products. The new digital format of the Purple Book will
enhance accessibility and transparency. The FDA and FTC have established 4 goals to support
biosimilar adoption. The agencies will collaborate on
A Federal Register notice along with a public comment the following: 1) enhance biologic product competition,
open docket will be used to determine the next phases including the FDA’s development of educational
of the Purple Book’s development. The PDF lists will materials for consumers and prescribers regarding
continue to be available until the searchable database biosimilars; 2) ensure biosimilar developers have access
is complete. The initial database version currently to samples of the reference product for conducting tests
includes all approved biosimilar products and their assessing biosimilarity and/or interchangeability; 3)
related reference products. Once complete, the searchable mitigate false or misleading claims regarding biologics,
database will contain all licensed biological products, including biosimilars; and 4) evaluate patent settlement
including biological products transitioned from a new arrangements between reference product and biosimilar
drug application (NDA) to a biologics license application manufacturers for anticompetitive practices and antitrust
(BLA) as required by the Biologics Price Competition and violations.
Innovation Act of 2009 (BPCI Act).
5 | APRIL 2020
DRUG INFORMATION
HIGHLIGHTS
• F
or the week ending March 28, 2020, the CDC reported • T he FDA has approved prescription to over-the-counter
that laboratory-confirmed influenza has continued to (OTC) switches for 1 topical product and 2 ophthalmic
decrease sharply and is now considered to be low; products. Diclofenac sodium topical gel, 1% (Voltaren®
however, influenza-like illness (ILI) activity is still elevated. Gel) will now be available OTC as Voltaren Arthritis
The proportion of patients utilizing healthcare may be Pain starting in Spring 2020. It is approved for the
impacted by the COVID-19 pandemic. Puerto Rico and temporary relief of arthritis pain. Two OTC formulations
22 states reported widespread influenza activity, and of olopatadine hydrochloride have also received FDA
the remaining areas reported regional, local, or sporadic approval: Pataday® Twice Daily Relief (0.1%; formerly
influenza activity. Nationwide, influenza A(H1N1)pdm09 Patanol Rx version) and Pataday® Once Daily Relief
is the predominant virus. No widespread shortages of (0.2%; formerly Pataday Rx version). The Pataday
antivirals used to treat influenza have been reported. products are approved for the temporary relief of itchy
eyes due to various allergens. The prescription versions
• Brand Epipen®, Epipen Jr®, and authorized generic (AG) of all 3 products will be discontinued.
versions of the epinephrine auto-injectors may have
improper injection that could delay or prevent emergency • T aro has issued a voluntary recall of 2 lots of phenytoin
treatment. The device may activate prematurely if the oral suspension, USP in the strength of 125 mg/5 mL
blue safety release is raised or is removed using a in 237 mL bottles. Product from these lots may not
sideway force. The carrier tube rim of some devices may resuspend properly upon being shaken, which is a
be deformed preventing ease of device removal from the required step in the administration process. Failure of
tube. Additionally, user errors may impede proper and the drug to properly resuspend could potentially lead
timely delivery of the medication. Pharmacists should to over- or under-dosing of the anti-seizure medication.
inspect the product before dispensing to ensure the
blue safety release is not raised and that the device can • A
merican Health Packaging (AHP) has issued a voluntary
be easily removed from the carrier tube. Patients should recall of 11 lots of ranitidine tablets, USP 150 mg
perform a similar inspection and periodically review the supplied as 100-count unit-dose blister packs due to
instructions for use prior to needing the medication. the potential for N-nitrosodimethylamine (NDMA) levels
Patients may obtain replacement of affected product higher than allowed by the FDA. This is an extension
at no additional cost by contacting Mylan Customer of the recall by Amneal that included impacted lots
Relations. which were repackaged by AHP.
• T he FDA is reporting shortages of epinephrine auto- • Hikma (formerly known as West-Ward) is voluntarily
injectors. Mylan Specialty is reporting manufacturing extending its previously announced recall of certain
delays of Epipen 0.3 mg, Epipen Jr 0.15 mg, and AG lots of the non-steroidal anti-inflammatory drug (NSAID)
versions. Supplies will vary among pharmacies. Teva ketorolac tromethamine injection USP 30 mg/mL,
is experiencing sporadic supply interruptions of their 1 mL fill/2 mL vials to the medical facility and retail
generic epinephrine 0.3 mg and 0.15 mg auto-injectors. levels. The recall is due to the presence of small visible
Supply of both strengths of Impax’s generic version particulate matter of a gelatinous/oily nature that
are on allocation due to manufacturing delays. All appear black in some lots and have the potential to
strengths of Kaleo’s Auvi-Q® and Adamis’s Symjepi® cause particulate deposition in the lung, pulmonary
are available. microemboli, and acute respiratory distress. No adverse
events have been reported to date.
6 | APRIL 2020
PIPELINE
NEWS
UPCOMING PRESCRIPTION DRUG/BIOSIMILAR USER FEE ACT (PDUFA/BsUFA) DATES
DRUG NAME FORMULATION ANTICIPATED
PROPOSED CLINICAL USE
MANUFACTURER THERAPEUTIC CLASS FDA APPROVAL
7 | APRIL 2020
RECENT FDA
APPROVALS
DRUG NAME
DESCRIPTION
MANUFACTURER
New Drugs
8 | APRIL 2020
RECENT FDA APPROVALS continued
DRUG NAME
DESCRIPTION
MANUFACTURER
9 | APRIL 2020
RECENT FDA APPROVALS continued
DRUG NAME
DESCRIPTION
MANUFACTURER
Expanded Indications
10 | APRIL 2020
RECENT FDA APPROVALS continued
DRUG NAME
DESCRIPTION
MANUFACTURER
References:
ashp.org cdc.gov fda.gov gastro.org