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Weekly News Round Up - September 7, 2011

Saphris (asenapine): Serious Allergic Reactions Prompt Label Revision

FDA updates Saphris antipsychotic prescription label to reflect reports of serious Type I hypersensitivity (allergic) reactions Read more...

Allergic drug reactions can range from a mild rash to anaphylaxis that may disrupt breathing. Saphris (asenapine), an atypical antipsychotic medication used for schizophrenia and bipolar disorder in adults has been associated with 52 cases of Type I hypersensitivity as determined from the FDA’s Adverse Event Reporting System (AERS). Some hypersensitivity cases have occurred after the first Saphris dose. Patients that are prescribed Saphris should ask their healthcare providers how to recognize the Saphris allergic reaction symptoms, which may include difficulty breathing, face, tongue or throat swelling, wheezing, lightheadedness, and itching. Patients should seek emergency treatment if they develop these reactions. Patients with a known allergy to Saphris should not use the medication.

FDA Drug Safety Communication: Reclast (zoledronic acid) Use in Kidney Impairment

Reclast contraindicated in patients with creatinine clearance less than 35 mL/min or with evidence of acute renal impairment Read more...

New instructions for prescribing Reclast in patients with kidney impairment are being provided by the manufacturer of Reclast (zoledronic acid) and the FDA. Reclast should not be used in patients with a creatinine clearance less than 35 mL/min or evidence of acute renal impairment. Healthcare providers should screen patients to identify those at risk for kidney impairment prior to each Reclast administration, and should monitor kidney function once treatment has started. Risk factors for acute renal impairment include: underlying renal impairment, concomitant use of nephrotoxic or diuretic drugs, advanced age, and severe dehydration before or after Reclast administration.

Vaccine Rates Increasing for US “Tweens” Despite Fears of Adverse Reactions

New study suggests more 11- and 12-year-olds are getting recommended vaccines, but there is still room for improvement Read more...

Luckily, parents still make many decisions for adolescents, especially ‘tweens’ that hover between 11 and 12 years old. And it appears more parents are in favor of vaccination for their adolescents. After a whirlwind of younger childhood vaccines, it is at this age that vaccine administration ramps up again: tetanus-diphtheria (Td) and/or tetanus/diphtheria/whooping cough (Tdap), meningococcal vaccine, and human papillomavirus (HPV) for girls are due to be given between 11 and 12 years of age. Data analyzed from the 2009 National Immunization Survey - Teen Telephone Interview suggests that vaccine rates for this age group are increasing, but still fall short of goals set by the Healthy People 2020 campaign. Additionally, to ease fears even more, the Institute of Medicine recently reported that vaccines are typically safe with rare serious adverse events.

Popular NSAID Painkillers May Lead to Increased Risk of Miscarriage

NSAID use in first 20 weeks of pregnancy shown to lead to more than 2-fold increased risk for miscarriage Read more...

NSAIDs (nonsteroidal anti-inflammatory drugs), common pain relievers used for their anti-inflammatory action, have long had a warning against use (contraindication) in the 3rd trimester of pregnancy. NSAID use in early pregnancy has not had such a warning. A recent study suggests that use of NSAIDs in the first 20 weeks of pregnancy may double or even triple the risk of miscarriage. Diclofenac, ibuprofen and naproxen were associated with the highest risk. If needed, acetaminophen is a safe headache and pain relief alternative to NSAIDs for use in pregnancy.

Updated Boxed Warning for Tumor Necrosis Factor-alpha (TNFα) Inhibitors

Boxed warnings for entire TNFα inhibitor class highlight increased risk for Legionella and Listeria bacterial infections Read more…

The FDA has announced label changes to the boxed warnings for tumor necrosis factor-alpha (TNFα) inhibitors to include the added risk of Legionella and Listeria bacterial infections. TNFα blockers are a biologic class that suppress the immune system, and are used to treat diseases such as Crohn’s disease, rheumatoid arthritis and psoriasis. Serious and sometimes fatal infections are a known risk with TNFα blocker use due to the decreased ability to fight an infection. Other warnings have been updated to reflect consistent information about serious infection risk and associated pathogens. Agents in this class include: Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab).

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