Saturday, May 25, 2013

Migraine Medication Labeling Changes

By Teri Robert, Health Guide Wednesday, January 20, 2010

Do you ever wonder if you have the most current information about your Migraine and headache medications? It can be difficult to keep up with the changes made to the labeling of medications.


Fortunately, the FDA's MedWatch program makes it easier to keep up. Each month, they publish a list of all updates and changes to medication labeling. In December, there were changes to the labeling for some of the medications we may take for our Migraines and headaches.


Below is a list of all medications that had labeling changes last month. I've included all of them in case you take medications for other conditions. To find the details of the labeling changes for any of the medications, just click on the name of the medication. There's also a key to what the various columns mean. The most serious changes will be the "BW," boxed warning changes.


The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE, PCI=PATIENT COUNSELING INFORMATION



DRUG NAME SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI
/MG
Arixtra (fondaparinux sodium) injection X          
Fragmin (dalteparin sodium) injection X          
Innohep (tinzaparin sodium) injection X          
Lovenox (enoxaparin sodium) injection X          
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI
/MG
Actonel (risedronate sodium) tablets   X X X    
Amlodipine besylate/ Benazepril hydrochloride capsule   X   X    
Didronel (etidronate disodium) tablets   X X X    
Innopran XL (propranolol hydrochloride) extended release capsules   X   X    
Ortho Evra (norelgestromin and ethinyl estradiol) transdermal system   X   X X PPI
Spiriva HandiHaler (tiotropium bromide) inhalation powder   X X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI
/MG
Arranon (nelarabine) injection     X X X  
Bicillin L-A (penicillin G benzathine) and Bicillin CR (penicillin G benzathine and penicillin G procaine) injectable suspensions     X X    
Daytrana (methylphenidate) transdermal system     X   X MG
Janumet (sitagliptin/metformin HCl) tablets 

*pancreatitis

    X X X PCI
Januvia (sitagliptin) tablets

*pancreatitis

    X X X PCI
Lexiscan (regadenoson) injection     X X X  
Seroquel (quetiapine fumarate) tablets     X X    
Seroquel XR (quetiapine fumarate) Extended-Release tablets     X X    
Topamax (topiramate) tablets and sprinkle capsules     X X    
Velcade (bortezomib) for injection     X X    
Verelan PM (verapamil hydrochloride) Extended-Release capsules     X X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI
/MG
Famvir (famciclovir) tablets       X    
Flomax (tamsulosin hydrochloride) capsules       X    
Qualaquin (quinine sulfate) capsules       X    
Zyvox (linezolid) tablets, IV injection, and oral suspension       X X  
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI
/MG
Invanz (ertapenem) injection         X  
Zestril (lisinopril) tablets         X  
Ziac (bisoprolol fumarate and hydrochlorothiazide) tablets         X  


By Teri Robert, Health Guide— Last Modified: 09/04/10, First Published: 01/20/10