- 10 FDA Drug Warnings Pharmacists Should Know (pharmacytimes.com)
Summer was a busy season for FDA drug warnings...Now that fall is in full gear, pharmacists should get familiarized with the drug safety communications sent out this past summer...Here are the FDA’s medication safety alerts since June, starting with the most recent:
- Ceftazidime and avibactam (Avycaz) - drug strength
- Tramadol (Ultram, Ultram ER, Conzip) – pediatric use
- Clozapine (Clozaril) – neutropenia management , REMS Program
- Ingenol mebutate (Picato) - adverse reactions
- Dipeptidyl peptidase-4 (DPP-4) inhibitors - joint pain warning
- Fingolimod (Gilenya) - progressive multifocal leukoencephalopathy
- Gadolinium-based contrast agents for magnetic resonance imaging - brain deposits
- Vortioxetine (Brintellix) and ticagrelor (Brilinta) – name confusion
- Codeine-containing cough-and-cold medications – pediatric use, respiratory conditions
- Methylphenidate transdermal system (Daytrana patch) - permanent skin discoloration
- Naloxone Nasal Spray Seeks FDA Nod (pharmacytimes.com)
FDA is considering approval for an intranasal formulation of the opioid overdose antidote naloxone (Narcan). Naloxone has been the standard of emergency treatment for opioid overdose …only injectable formulations of naloxone are currently approved for use…FDA has granted priority review to Adapt Pharma’s naloxone...nasal spray, which was previously given a fast track designation…
- Sun Pharma recalls more than 216,000 bottles after label leaches chemical (fiercepharmamanufacturing.com)
According to the most recent FDA Enforcement Report, Mutual Pharmaceutical, a division of Sun Pharmaceutical, is recalling 187,106 bottles of felodipine extended-release blood pressure tablets and 29,660 bottles of the antidepressant imipramine because the varnish is leaching benzophenone… during long-term stability testing, it found trace amounts of benzophenone in the drugs, which it said is unlikely to cause any adverse effects.
- Medjacking: The newest healthcare risk? (healthcareitnews.com)Report: Healthcare more susceptible to privacy attacks than other industries (fiercehealthit.com)
If you're looking for trends in cyber-crime, it's best to follow the money…Healthcare information is being exposed in more places every day, creating new risks for patients, providers, payers, and other organizations…medical devices…are already being hacked, a trend that is alarming hospitals and other healthcare organizations…these devices are being hacked to unlock portals into larger medical systems and steal protected health information… economics of cyber-crime,..stolen medical identities can bring in many times the price of a stolen credit card number.
- Bill would allow Minnesotans to buy Rx drugs from Canada (kare11.com)
Minnesotans could get their prescription drugs from Canada by 2017 if a state representative has his way…State Representative Joe Atkins plans to introduce a bill next legislative session that would make it legal for Minnesotans to buy…prescription drugs from Canada through their local pharmacies…"Right now – we're turning Americans into criminals. We've got Minnesotans driving up to Canada to buy these drugs at much lower prices.".. His bill would require the commissioner of the Minnesota Department of Human Services to establish the program where local pharmacies could sign up, as well as creating a web site for ordering prescriptions.
- Israel’s MediWound signs $112 million deal in U.S. for burn treatment (reuters.com)
Israel-based MediWound has signed a five-year, $112 million contract with the U.S. authority that handles public health medical emergencies to further develop and buy the company's drug treatment for severe burns (NexoBrid,bromelain)…Investment group Clal Biotechnology, which has a 45 percent stake in MediWound, said in a statement that the deal with the Biomedical Advanced Research and Development Authority would raise preparedness for mass-casualty incidents.
- World’s largest reinsurer ready to insure against FDA actions (fiercepharmamanufacturing.com)
Munich Re to offer coverage for plants closed for regulatory issues…If a pharma plant closes because of an explosion or a natural disaster, well there is business interruption insurance for that. But if it closes to deal with issues after the FDA issues a Form 483 or a warning letter, then the drugmaker is on the hook for all of the costs. Now a couple of insurance companies say they will offer something to soften such blows…Munich Re, the world's largest reinsurer, says it will insure drugmakers against regulatory actions by the "FDA and its international counterparts" that could cause them to suspend manufacturing...
- Why Partnerships are Key to the Science of Patient Input (blogs.fda.gov)
We recently announced…Patient Engagement Advisory Committee …The Committee will provide advice to the FDA Commissioner on…issues relating to medical devices, the regulation of devices, and their use by patients…PEAC will bring patients, patient advocacy groups, and experts together for a broader discussion of important patient-related issues, to increase integration of patient perspectives into the regulatory process, and to help drive more patient-centric medical device innovation, development, evaluation, and access.
- Pharmacists Shouldn’t Use TPA Abbreviations (pharmacytimes.com)
…abbreviations "TPA" and "t-PA" are causing medication mix-ups between alteplase (Activase) and tenecteplase (TNKase)….This confusion is a significant contributing factor to wrong drug errors between Activase and TNKase, according to the FDA and Institute for Safe Medication Practices… To avoid this, ISMP recommends removing the abbreviations from all standardized order sets, electronic order entry screens, and treatment protocols, and referring to the medications by their brand names, generic names, or both in all verbal and written communication.
- Amgen’s leukemia drug gets conditional European approval (reuters.com)
European health regulators…conditionally approved Amgen Inc's rare blood cancer drug, Blincyto (blinatumomab), which is one of the world's most expensive cancer treatments…Food and Drug Administration in December approved Blincyto for acute lymphoblastic leukemia, which has few treatment options once a patient has relapsed…Blincyto is a so-called bispecific antibody, an emerging class of drugs that could prove more potent than conventional antibodies,…