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Quick Hits: Unapproved Flu Meds, Birth Control Device Concerns & More

 

By Alanna McCatty

March 8, 2018

Quick Hits: Questions Over Accelerated Approval and Availability of Drugs Under Expanded Access

The FDA is advising consumers to take precautions when considering drugs that claim to prevent, treat or cure the flu because it may be an unapproved medication. This brutal flu season has sparked concerns regarding the possibility of consumers purchasing unapproved or fake flu medications that may be found online or in retail stores. The agency pinpointed that there are no legally marketed over-the-counter (OTC) drugs to prevent or cure the flu. However, there are legal OTC drugs that reduce fever and relieve muscle aches, congestion and other flu symptoms. According to the agency, fraudulent medications can cause serious injures and potentially lead to fatal outcomes. Posted March 2, 2018. Via FDA.

The FDA reaffirmed its commitment to the permanent birth control device Essure. However, the agency assured the public that they are taking concerns with the device very seriously. FDA Commissioner Scott Gottlieb mentioned a meeting he had with women who experienced significant medical problems that were caused by the birth control device. Gottlieb expressed his grave concern and detailed the steps that the FDA has and will be taking to ensure the safety of women who are using Essure. Posted March 7, 2018. Via FDA.

The FDA has approved a new kind of HIV treatment known as Trogarzo for those with limited treatment options. In order to assess the effectiveness of this treatment, researchers evaluated 40 patients with muiltidrug resistant HIV-1 who continued to have high levels of the virus, despite receiving numerous antiretroviral drugs. Once the patients received Trogarzo (ibalizumab-uiyk), a majority of them experienced a significant decrease in their HIV-RNA levels in just one week. After 24 weeks of Trogarzo, including other antiretroviral drugs, 43% of the participants achieved HIV suppression. Some of the side effects that were associated with Trogarzo were diarrhea, dizziness, nausea and rash. Severe side effects included rash and changes in the immune system. Posted March 6, 2018. Via FDA.

Alanna McCatty

Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.

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Last updated: March 8, 2018