FDA issues 3 new medication guides

March 29, 2011

FDA recently released new medication guides and made revisions to a number of others. The following is a synopsis of FDA's actions.

FDA recently released new medication guides and made revisions to a number of others. The following is a synopsis of FDA's actions:

New medication guides:

Belimumab (Benlysta)

Benlysta, which contains belimumab, is a prescription medicine used to treat adults with active systemic lupus erythematosus (SLE or lupus) who are receiving other lupus medicines.

Benlysta can cause serious side effects, some of which may cause death. Patients should tell a healthcare provider right away if they have infections or symptoms of infections, heart problems, or mental health problems when receiving Benlysta.

Carbamazepine (Tegretol, Tegretol-XR)

Tegretol is a prescription medicine used to treat:

  • Certain types of seizures (partial, tonic-clonic, mixed)

  • Certain types of nerve pain (trigeminal and glossopharyngeal neuralgia)

Patients should not suddenly stop taking Tegretol without first talking to a healthcare provider. Tegretol may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when patients begin taking the drug within the first 4 months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If a patient is of Asian descent, there may be a need for a genetic blood test before the patient begins taking Tegretol to see whether the patient faces a higher risk for serious skin reactions with this medicine.

Tegretol may cause rare but serious blood problems. Symptoms may include fever, sore throat, or other infections that come and go or do not go away; easy bruising; red or purple spots; bleeding gums or nose bleeds; and severe fatigue or weakness.

As do other antiepileptic drugs, Tegretol may cause suicidal thoughts or actions in a very small number of people (approximately 1 in 500).

Oxcarbazepine (Trileptal)
Trileptal is a prescription medicine used:

  • Alone or with other medicines to treat partial seizures in adults

  • Alone to treat partial seizures in children 4 years and older

  • With other medicines to treat partial seizures in children 2 years and older

Patients should not stop taking Trileptal without first talking to a healthcare provider, as serious problems may result. Trileptal can cause serious side effects, including low blood sodium, symptoms of which include nausea, tiredness, lack of energy, headache, confusion, and more frequent or more severe seizures.

Similar symptoms that are not related to low sodium may occur from use of Trileptal. Patients should inform a healthcare provider if they have any of these side effects.

Trileptal may also cause allergic reactions or serious problems, which may affect organs and other body parts such as the liver or blood cells. Many people who are allergic to carbamazepine are also allergic to Trileptal.

As do other antiepileptic drugs, Trileptal may cause suicidal thoughts or actions in a very small number of people (approximately 1 in 500).

Updated medication guides

  • Aripiprazole (Abilify) [2011 version]

  • Testosterone (Androgel) [2011 version]

  • Moxifloxacin (Avelox) [2011 version]

  • Rufinamide (Banzel) [2011 version]

  • Diclofenac (Cataflam) [2011 version]

  • Ciprofloxacin (Cipro) [2011 version]

  • Icodextrin (Extraneal) [2010 version]

  • Gemifloxacin (Factive) [2011 version]

  • Ofloxacin (Floxin) [2011 version]

  • Adalimumab (Humira) [2011 version]

  • Lopinavir and Ritonavir (Kaletra) [2011 version]

  • Ambrisentan (Letairis) [2011 version]

  • Levofloxacin (Levaquin) [2011 version)

  • Gabapentin (Neurontin) [2011 version]

  • Norfloxacin (Noroxin) [2011 version]

  • Peginterferon alfa-2a (Pegasys) [2011 version]

  • Dabigatran etexilate mesylate (Pradaxa) [2011 version]

  • Desvenlafaxine succinate (Pristiq) [2011 version]

  • Eltrombopag (Promacta) [2011 version]

  • Ciprofloxacin hydrochloride (Proquin XR) [2011 version]

  • Zoledronic acid (Reclast) [2011 version]

  • Infliximab (Remicade) [2011 version]

  • Atomoxetine hydrochloride (Strattera) [2011 version]

  • Topiramate (Topamax) [2011 version]

  • Diclofenac sodium (Voltaren) [2011 version]

For complete information, visit FDA's Medication Guides page on the web at http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm