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article imageDrug safety warnings

By Tim Sandle     Jul 20, 2014 in Health
Washington - The U.S. Food and Drug Administration (FDA) has updated its list of drug safety warnings and errors to labels and information leaflets.
Looking through the list (detailed below), the stand out concern relates to Sporanox (Itraconazole) Capsules. This is a medicine which is used in certain types of fungal infections. Based on clinical trial data, the drug has a link to cardiac disorders, including cardiac failure, left ventricular failure, and tachycardia.
Another warning relates to Alsuma (sumatriptan) injection. This is an anti-migraine drug. The safety warning suggests that overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache).
According to the FDA, the following drugs, distributed around the U.S., had modifications to the boxed warnings, contradictions, warnings and precautions sections:
Alsuma (sumatriptan)
Androderm (testosterone)
AndroGel (testosterone) gel
Avalide (irbesartan and hydrochlorothiazide)
Aveed (testosterone undecanoate)
Axiron (testosterone)
Benicar (olmesartan medoxomil)
Benicar HCT (olmesartan medoxomil-hydrochlorothiazide)
Caverject (alprostadil for injection)
Caverject Impulse Dual Chamber System (alprostadil for injection)
Cerebyx (Fosphenytoin Sodium Injection)
Cleocin Phosphate (Clindamycin injection, USP) and (clindamycin injection in 5 percent dextrose)
Cleocin HCL (clindamycin hydrochloride)
Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate)
Comtan (entacapone)
Delatestryl (testosterone enanthate)
Ella (ulipristal acetate)
Fortesta (testosterone) gel
Gazyva (obinutuzumab)
Herceptin (trastuzumab)
Hycamtin (topotecan)
Jetrea (ocriplasmin)
Lupron Depot (leuprolide acetate)
Nutropin AQ (somatropin [rDNA origin])
Prolia (denosumab)
Ravicti (glycerol phenylbutyrate)
Saizen (somatropin [rDNA origin])
Serostim (somatropin [rDNA origin] for injection)
Sporanox (itraconazole)
Striant (testosterone)
Sutent (sunitinib malate)
Symlin (pramlintide acetate)
Testim (testosterone)
Testosterone gel
Tev-Tropin (somatropin [rDNA origin])
Thalomid (thalidomide)
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide)
Trileptal (oxcarbazepine)
Votrient (pazopanib)
Xgeva (denosumab)
Zestril (lisinopril)
Concerned consumers and patients should contact the FDA. For earlier warnings, Digital Journal has also provided a list of drug safety issues collated by FDA during May 2014.
The information comes via the FDA Medwatch service. MedWatch is the Food and Drug Administration’s reporting system for an adverse event or sentinel event, founded in 1993. This system of voluntary reporting allows such information to be shared with the medical community or the general public. The system includes publicly available databases and online analysis tools for professionals.
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