Archives for April 2015

FDA approves first generic Abilify to treat mental illnesses

The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.

 

Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

Medical Mass Murder Case

It was just another colorless trade show, one of thousands held each year in hotels across the United States. But it was there, at an Embassy Suites in Franklin, Tennessee, that the simple handoff of a business card proved to be the first link in a two-year chain of events that led to the horrific, tortuous deaths of the first victims in a mass killing that trailed from New England to Tennessee, from Michigan to North Carolina.

Injectable Products by Mylan: Recall – Presence of Particulate Matter

including certain lots of:

  • Gemcitabine for Injection
  • Carboplatin Injection
  • Methotrexate Injection
  • Cytarabine Injection

 

AUDIENCE: Pharmacy, Oncology, Rheumatology

ISSUE: Mylan N.V. is conducting a voluntary nationwide recall to the hospital/user level of select lots of injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples.

Blue Bell Creameries Voluntarily Expands Recall to Include All of its Products Due to Possible Health Risk

April 20, 2015 – BRENHAM, TX – Blue Bell Ice Cream of Brenham, Texas, is voluntarily recalling all of its products currently on the market made at all of its facilities including ice cream, frozen yogurt, sherbet and frozen snacks because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Pet Owner Alert: Compounded Flurbiprofen Pain Creams Can Kill, Sicken Cats

The FDA’s Center for Veterinary Medicine released a warningthis afternoon to veterinarians, pet owners, healthcare providers, and pharmacists that pain creams containing flurbiprofen have sickened five cats across three households, with three of the cats dying. The cats suffered kidney and intestinal damage consistent with poisoning by a non-steroidal anti-inflammatory agent (NSAID), the drug class shared by flurbiprofen with the more common oral pain reliever, ibuprofen.

Teixobactin: A New Class of Antibiotic

A new antibiotic has been discovered: Teixobactin. This in itself represents a significant breakthrough since it is the first new type of antibiotic to be discovered since the late 1980s. The discovery carries more significance especially in the era of antibiotic crisis, in which a rising number of microbial strains are evolving resistance to common antibiotic (and in the case of a narrower but more potent range, “multi-drug resistant” which infers resistance to more than one type of antibiotic.) Though we welcome the new antibiotic, their discovery reports are addressed in much of the popular media (and, unfortunately, in some of the scientific press) are always tainted by hyperbole. (And, unfortunately, in some of the scientific press) is tainted with hyperbole.

Baxter Initiates Voluntary Recall of Select Lots of IV Solutions Due to the Potential Presence of Particulate Matter

Baxter International Inc. announced today it is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. In high-risk patients this may lead to serious adverse health consequences.

FDA Cannot Find Conclusive Evidence Zyprexa Injection Killed Patients

After an investigation, the US Food and Drug Administration has stated that they are still unsure whether the long-acting, injectable antipsychotic drug Zyprexa Relprevv (olanzapine pamoate) killed two people who died within several days of receiving the injection, according to an FDA press release.