Search results for "FDA update"
Recalls for oral docusate sodium, INR monitoring system
This column reviews a recall of an oral liquid docusate sodium solution because of contamination and of an international normalized ratio monitoring system because it may provide significantly lower results than another method.
https://immattersacp.org/archives/2016/09/fda.htm
1 Sep 2016
New safety labels added to entire class of fluoroquinolones
Oral and injectable fluoroquinolones are associated with side effects involving tendons, muscles, joints, nerves, and the central nervous system, an FDA safety review found. These side effects may occur hours to weeks after use and can be permanent.
https://immattersacp.org/weekly/archives/2016/08/02/5.htm
2 Aug 2016
Warning on an antipsychotic; generic rosuvastatin approval
This update covers a warning that aripiprazole may be associated with compulsive or uncontrollable urges, as well as approval of the first generic version of rosuvastatin tablets.
https://immattersacp.org/archives/2016/07/fda.htm
1 Jul 2016
New safety notice issued for alosetron hydrochloride (Lotronex)
Clinicians are advised to evaluate patients with signs of ischemic colitis (e.g., rectal bleeding, bloody diarrhea, new or worsening abdominal pain), discontinue the drug immediately if signs of ischemic colitis occur, and counsel patients to discontinue the drug immediately if they develop constipation or symptoms of ischemic colitis.
https://immattersacp.org/weekly/archives/2016/06/14/6.htm
14 Jun 2016
Warning on an antipsychotic; generic rosuvastatin approval
This update covers new warnings on the entire class of opioids and approval of the first leadless pacemaker approved to treat heart rhythm disorders.
https://immattersacp.org/archives/2016/06/fda.htm
1 Jun 2016
Updated warning issued on risks of fluoroquinolones
Fluoroquinolone use for sinusitis, bronchitis, and uncomplicated urinary tract infections should be reserved for patients who do not have alternative treatment options, according to an FDA safety communication.
https://immattersacp.org/weekly/archives/2016/05/24/5.htm
24 May 2016
Approval for cancer drug; proposed ban for gloves
This update covers approval of Crizotinib (Xalkori) to treat people with metastatic non-small-cell lung cancer whose tumors have an ROS-1 gene alteration.
https://immattersacp.org/archives/2016/05/fda.htm
1 May 2016
Recall of glucose test strips; approval for hepatitis C drug
This update covers a class I recall of blood glucose test strips which might cause clinicians to overlook hypoglycemia.
https://immattersacp.org/archives/2016/04/fda.htm
1 Apr 2016
New opioid warnings, powdered glove ban
The FDA announced plans to add new warnings to opioids and to ban powdered medical gloves last week.
https://immattersacp.org/weekly/archives/2016/03/29/6.htm
29 Mar 2016
Warning about different doses for 2 forms of posaconazole
This update covers a warning that differences in dosing regimens between the 2 oral formulations of posaconazole (Noxafil) have resulted in dosing errors.
https://immattersacp.org/archives/2016/03/fda.htm
1 Mar 2016