Periodically, via the MedWatch Service, the U.S. Food and Drug Administration (FDA) provides an update of changes to medicines. Most of these are the result of information provided by the manufacturer, although some can arise as a result of FDA findings.
The current list of affected products is:
Actimmune (Interferon gamma-1b)
Adcetris (brentuximab vedotin)
Botox (onabotulinumtoxin A)
Copegus (ribavirin) Tablets
Daytrana (methylphenidate transdermal system)
Geodon (ziprasidone hydrochloride) Oral Suspension
Geodon (ziprasidone mesylate) Injection
Geodon (ziprasidone) Capsules
Gilenya (fingolimod) Capsules
Glyxambi (linagliptin and empagliflozin)
Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride)
Implanon (etonogestrel implant)
Janumet (sitagliptin and metformin)
Janumet XR (sitagliptin and metformin extended release)
Januvia (sitagliptin)
Jentadueto (linagliptin and metformin)
Kazano (alogliptin and metformin)
Kombiglyze XR (saxagliptin and metformin extended release)
Lotensin HCT (benazepril hydrochloride/hydrochlorothiazide) Tablets
Mircera (methoxy polyethylene glycol-epoetin beta)
Myrbetriq (mirabegron) Extended-release Tablets
Nesina (alogliptin)
Nexplanon (etonogestrel implants)
Onglyza (saxagliptin)
Oseni (alogliptin and pioglitazone)
Prestalia (perindopril arginine/amlodipine besylate) Tablets
Prinivil (lisinopril) Tablets
Sovaldi (sofosbuvir) Tablets
Sprycel (dasatinib) Tablets
Tegretol (carbamazepine) Tablets, Chewable Tablets, Oral Suspension, and Tegretol-XR (carbamazepine extended-release) Tablets
Thalomid (thalidomide) Capsules
Tivicay (dolutegravir) Tablets
Tradjenta (linagliptin)
Triumeq (abacavir/dolutegravir/lamivudine)
Vaseretic (enalapril maleate/hydrochlorothiazide) Tablets
Vasotec (enalapril maleate) Tablets
Xenical (orlistat) Capsules
Xtandi (enzalutamide) Capsules
Zelboraf (vemurafenib) Tablets
Zestoretic (lisinopril/hydrochlorothiazide) Tablets
Zestril (lisinopril) Tablets
Looking into some of these in more detail, with Zelboraf (generic name vemurafenib) tablets, these are designed for the treatment of late-stage melanoma (skin cancer.) With these there have been occasional reactions when patients are also treated with radiation. An advice note has been provided to healthcare professionals.
Myrbetriq (generic name mirabegron) is used to treat over-active bladders, with symptoms of
frequent or urgent urination and urinary incontinence. Angioedema of the face, lips, tongue, and/or larynx has been reported in some instances when the tablets have been taken. Angioedema is the swelling of the deeper layers of the skin, caused by a build-up of fluid.
Finally, Gilenya (fingolimod). This is used to treat relapsing forms of multiple sclerosis (MS) in adults, in the form of a once-a-day pill. In relation to taking the medication, cases of progressive multifocal leukoencephalopathy (PML) have been reported with some patients. PML is an opportunistic viral infection of the brain. It is caused by the JC virus, which is normally present and kept under control by the immune system.
For further details and information about other medicines, refer to the FDA MedWatch report.
