FDA Drug Alerts
FDA approves first implantable drug to treat opioid addiction
The Washington Post (5/26, McGinley) reports in “To Your Health” that the Food and Drug Administration “on Thursday approved the first implantable drug to deliver long-lasting medication to people addicted to opioids.” The implant, known as Probuphine, “administers the anti-addiction drug buprenorphine in a continuous dose for six…
CDC Health Advisory: Increases in Fentanyl Drug Confiscations
Increases in Fentanyl Drug Confiscations and Fentanyl-related Overdose Fatalities Summary The Centers for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA) are investigating recent increases in fentanyl-related unintentional overdose fatalities in multiple states across the U.S. The purpose of this HAN advisory is to: (1)…
1st drug in the world manufactured by 3-D printing wins FDA approval
In a world first, the US Food and Drug Administration has given the go-ahead for a 3D-printed pill to be produced: a dissolvable tablet that treats seizures.” Aprecia Pharmaceuticals announced on Monday that the FDA approved Spritam (levetiracetam), a tablet “manufactured through a layered process via 3-D printing”…
Hydrocodone Reclassification: What physicians need to know
Recently, the Drug Enforcement Administration (DEA) issued a final rule rescheduling hydrocodone combination products (HCPs) into Controlled Substance Schedule II, effective October 6, 2014. Rescheduling issues directly related to Arkansas: Under Arkansas law, physician assistants and advance practice registered nurses are not authorized to write prescriptions for…
Hydrocodone Drugs Moving to Schedule II Oct 6
The U.S. Drug Enforcement Administration (DEA) published a final rule Aug. 22 that changes the controlled substance scheduling of hydrocodone combination products (HCP) from Schedule III to Schedule II. The change is scheduled to take effect Oct. 6. The new rules include these requirements: HCP prescriptions issued on or…
New restrictions on hydrocodone to take effect
Article below from USA Today Online. Read more at federalregister.gov. WASHINGTON (AP) — The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S. The new rules mean that drugs…
New Information On Acetaminophen
FDA Acetaminophen Limits in Combination Products Effective January 14, 2014, it will become unlawful to purchase or sell any narcotic/acetaminophen combination products that contain greater than 325mg of acetaminophen. This ban on high dosage acetaminophen in prescription combination products was first passed by the FDA in January 2011. …
FDA Warns Oral Anti-Fungal May Cause Adrenal, Liver Problems
The Wall Street Journal (7/27, Burton, Subscription Publication, 2.29M) reported that the US Food and Drug Administration announced Friday that it was limiting the use of Johnson & Johnson's oral, anti-fungal therapy, Nizoral (ketoconazole). Although the product is available as a topical, including as a cream and a…
FDA Drug Alert Issued
An important FDA-approved Drug Alert for INVIRASE affecting Cardiology, Infectious Disease, Internal Medicine, Pediatrics, Nurse Practitioners, and Pharmacies was published on February 28, 2013. This PDR® Drug Alert was delivered electronically to all Arkansas Medical Society members within this specialty who are registered with PDR® Network. To ensure…
FDA Drug Alert Issued for Xeljanz
An important FDA-approved Drug Alert for XELJANZ affecting Rheumatologists, Infectious Disease, Family Medicine/General Practice, Internal Medicine and Emergency Medicine physicians was published on November 20, 2012. This PDR® Drug Alert was delivered electronically to all Arkansas Medical Society members within these specialties who are registered with PDR® Network. View…
FDA-approved Drug Alert Issued
An important FDA-approved Drug Alert for BONIVA affecting Family Medicine/General Practitioners, Internal Medicine, Endocrinology, Diabetes & Metabolism and Obstetrics & Gynecology was published on October 1, 2012. This PDR® Drug Alert was delivered electronically to all Arkansas Medical Society members within these specialties who are registered with PDR®…