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FDA: Labeling Update, Blood Donation Ban, and New Drugs

Labeling Update

The FDA has published a final rule that redefines how information about the risks of using certain prescription medications and biological products during pregnancy and breastfeeding are to be presented.1

The new method replaces the letter-based categorization system with 3 subsections—labeled Pregnancy, Lactation, and Females and Males of Reproductive Potential—that must include a summary of the real world risk of using the medications for these categories and the data supporting the summary.

Both the pregnancy and lactation sections will include the subheadings of risk summary, clinical considerations, and data, which break the information down even further.

The rule goes into effect on June 30, 2015 and will require all new product labels to make use of the new format immediately, while older products will be changed over time.
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Blood Donation Ban

An FDA advisory panel has suggested lifting the ban on blood donations from men who have sex with men. The ban was originally installed in the 1980s during the AIDS epidemic, but the recommended reversal is in response to improved methods for testing blood for HIV.2

Should the ban be lifted when the FDA issues national blood bank guidelines in the near future, it would allow these men to donate blood only if they had not had sex with men in the past year.  This precaution allows for the time it can take for HIV to appear in tests.

Blincyto: Acute Lymphoblastic Leukemia

The FDA has approved Lincyto (blinatumomab) to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), a rare form of acute lymphoblastic leukemia.3

In B-cell ALL, bone marrow produces too many B-cell lymphoblasts—a type of white blood cell. Blincyto causes the body’s T-cells to attack and destroy leukemia cells by connecting the CD19 protein and CD3 protein. It is intended for use in patients with relapsed or refractory disease.

In a study of 185 adults with B-cell ALL treated with the drug for 4 weeks via infusion, 32% of participants showed complete remission after 6.7 months.

Blincyto carries a boxed warning of possible low blood pressure and difficulty breathing associated with treatment, as well as possible difficulty thinking and other neurological effects.

The most common side effects include fever, headache, swelling, nausea, fatigue, and tremor.

Priftin: Latent Tuberculosis

The FDA has approved Pritin (rifapentine) tablets to be used in combination with isoniazid for the treatment of latent tuberculosis infection in patients at high risk for disease progression.4

The drug’s approval is based on results of the PREVENT TB study, comparing 12 weeks of once-daily Priftin plus isoniazid with 9 months of self-administered daily isoniazid. Tuberculosis fully-developed in 5 of the 3074 participants taking Priftin and in 10 of those taking only isoniazid.

Several adverse events are possible while taking Priftin, including liver injury, relapse of cavitary pulmonary lesions, red-orange discoloration of body tissue, and Clostridium difficile-associated diarrhea.

Common side effects include anemia, lymphopenia, arthralgia, headache, vomiting, rash, pruritis, and anorexia.

—Michael Potts

References:

  1. FDA. FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products [press release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm. Accessed December 4, 2014.
  2. Wall Street Journal. Panel advises FDA to lift ban on gay men giving blood. http://online.wsj.com/articles/fda-panel-advises-lifting-ban-on-gay-men-giving-blood-1417560946. Accessed December 4, 2014.
  3. FDA. FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia [press release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425549.htm. Accessed December 4, 2014.
  4. Sanofi. Sanofi receives FDA approval of Priftin (rifapentine) tablets for the treatment of latent tuberculosis infection [press release]. www.news.sanofi.us/index.php?s=33507&item=136875. Accessed December 4, 2014.