08 | 20 | 2007 Posted By Regan Zambri & Long

54 Prescription Drugs Get Safety Label Updates

Safety labels on fifty-four prescription drugs have recently undergone changes that may merit your attention, according to the U.S. Food and Drug Administration (FDA).  Flagged as part of the agency's Safety Information and Adverse Event Reporting Program, the latest labeling changes could alert many patients to health hazards or dangerous situations before they become critical.  The following drugs made changes to the "contraindications" or "warnings" sections of their labeling:

  • "Enjuvia (synthetic conjugated estrogens, B) Tablets
  • Fentora (fentanyl buccal tablet)
  • Ativan (lorazepam) Tablets
  • Femara (letrozole tablets)
  • Invirase (saquinavir mesylate) Capsules and Tablets
  • Advicor (niacin extended-release/lovastatin tablets)
  • Baraclude (entecavir) Tablets and Oral Solution
  • Exjade (deferasirox) Tablets for Oral Suspension
  • Levitra (vardenafil HCl) Tablets
  • Minocin (minocycline hydrochloride) Pellet-Filled Capsules
  • Sarafem (fluoxetine hydrochloride tablets)
  • Zerit (stavudine) Capsules and Zerit (stavudine) for Oral Solution
  • Zyvox (linezolid) Injection and Tablets and Zyvox (Iinezolid) for Oral Suspension"
These drugs had modifications to patient information labeling on the medication guide or patient package insert:
  • "Enjuvia (synthetic conjugated estrogens, B) Tablets
  • Fentora (fentanyl buccal tablet)
  • Invirase (saquinavir mesylate) Capsules and Tablets
  • Baraclude (entecavir) Tablets and Oral Solution
  • Levitra (vardenafil HCl) Tablets
  • Zerit (stavudine) Capsules and Zerit (stavudine) for Oral Solution
  • Actonel (risedronate sodium tablets)
  • Apidra (insulin glulisine [rDNA origin] injection)
  • Aranesp (darbepoetin alfa) for Injection
  • Focalin (dexmethylphenidate hydrochloride) Tablets
  • Focalin XR (dexmethylphenidate hydrochloride) Extended- Release Capsules
  • Fortamet (metformin hydrochloride) Extended-Release Tablets
  • Lantus (insulin glargine [rDNA origin] injection)
  • Ritalin hydrochloride (methylphenidate hydrochloride tablets, USP)
  • Ritalin-SR (methylphenidate hydrochloride, USP sustained-release tablets)
  • Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
  • Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules Strattera (atomoxetine HCl) Capsules
  • Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets
  • Solagé (mequinol 2%, tretinoin 0.01%) Topical Solution
  • EC-Naprosyn (naproxen delayed-release tablets), Naprosyn (naproxen tablets), Anaprox/Anaprox DS (naproxen sodium tablets), and Naprosyn (naproxen suspension)
  • NicoDerm CQ (nicotine transdermal system)"
If you have questions about the safety of a medication you are taking, contact your physician immediately. 

Previously on the D.C. Metro Area Medical Malpractice Blog, we have posted articles related to:

If you or a family member believes that you have a case involving medications or medical error, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.  If you would like to receive our complimentary electronic newsletter, please click here.