20 July, 2016 AHFS

The July update to the AHFS Patient Medication Information (PMI) database has been published. Highlights of the update include:

New PMI Monographs:

Uridine Triacetate (Vistogard^®)
- Uridine triacetate is used for the emergency treatment of children and adults who have either received too much of chemotherapy medications such as fluorouracil or capecitabine (Xeloda^®) or who develop certain severe or life-threatening toxicities within 4 days of receiving fluorouracil or capecitabine.
Midodrine (Orvaten^®, Proamatine^®, also available generically)
- Midodrine is used to treat orthostatic hypotension (sudden fall in blood pressure that occurs when a person assumes a standing position).
Selexipag (Uptravi^®)
- Selexipag is used in adults to treat pulmonary arterial hypertension (PAH; high blood pressure in the vessels that carry blood to the lungs) to slow down the worsening of symptoms and reduce the chance of being hospitalized for PAH.
Pimavanserin (Nuplazid^®)
- Pimavanserin is used to treat hallucinations and delusions in people with psychosis from Parkinson’s disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance).

FDA MedWatch Alerts – Monograph Revisions

6 July, 2016 AHFS

The July update to the AHFS Drug Information/Essentials database was published today. Highlights from this month’s update include:

Daclatasvir (Daklinza^®)
- Daclatasvir dihydrochloride is used in conjunction with sofosbuvir (with or without ribavirin) for the treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection in adults who are treatment-naive (previously untreated) or previously treated, including those with cirrhosis (compensated or decompensated), liver transplant recipients, and those with human immunodeficiency virus (HIV) coinfection
Ombitasvir, paritaprevir, and ritonavir (Technivie^®)
- The fixed combination of ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/ritonavir) is used in conjunction with ribavirin for the treatment of chronic hepatitis C virus (HCV) genotype 4 infection in treatment-naive (previously untreated) or previously treated adults without cirrhosis

Canagliflozin & Dapagliflozin
- FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
Aspirin
- The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach
Sumatriptan
- Sumatriptan iontophoretic transdermal system patch (Zecuity) manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the sumatriptan iontophoretic transdermal system patch
Loperamide
- FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death

22 June, 2016 AHFS

The June update to the AHFS Patient Medication Information (PMI) database has been published. Highlights of the update include:

Cobicistat (Tybost^®)
- Cobicistat is used to increase the amounts of atazanavir (Reyataz^®) or darunavir (Prezista^®) in your blood when these medications are used to treat human immunodeficiency virus (HIV) in adults.
Venetoclax (Venclexta^®)
- Venetoclax is used to treat certain patients with chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) who have already been treated with at least one other chemotherapy medication.
Brivaracetam & Brivaracetam Injection (Briviact^®)
- Brivaracetam is used is used along with other medications to control partial onset seizures (seizures that involve only one part of the brain) in people who are 16 years of age or older.
Ixekizumab Injection (Taltz^®)
- Ixekizumab injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in people whose psoriasis is too severe to be treated by topical medications alone.
Defibrotide Injection (Defitelio^®)
- Defibrotide injection is used to treat adults and children with hepatic veno-occlusive disease (VOD; blocked blood vessels inside the liver, also known as sinusoidal obstruction syndrome), who have kidney or lung problems after receiving a hematopoietic stem-cell transplant (HSCT; procedure in which certain blood cells are removed from the body and then returned to the body).

Aspirin
- The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach.
Loperamide
- FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death.
Ketoconazole
- FDA is warning healthcare professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections.
Canagliflozin & Dapagliflozin
- FDA has strengthened the existing warning about the risk of acute kidney injury.