A Call to Arms!

FDA Approval – SalivaDirect

The Food and Drug Administration on Saturday authorized emergency use of a new and inexpensive saliva test for Covid-19 that could greatly expand testing capacity.

The new test, which is called SalivaDirect and was developed by researchers at the Yale School of Public Health, allows saliva samples to be collected in any sterile container. It is a much less invasive process than the nasal swabs currently used to test for the virus that causes Covid-19, but one that has so far yielded highly sensitive and similar results. The test also avoids a key step that has caused shortages of chemical reagents used in other tests.

The research team validated SalivaDirect in part by testing NBA players, coaches, and staff, and Yale said the test is now being studied in asymptomatic people through the program with the NBA and its players union.

FDA clears saliva test for Covid-19, opening door to wider testing

Get tested and wear a mask.

EfVgeCLWsAQSVXt

To understand why this is a potential game changer this article on rapid screening tests.

First, frequent testing catches the vast majority of cases. Someone who is infected but gets a false-negative and slips through the cracks is likely to be caught the next time they’re tested. For a test that misses 20% of positive cases, the chance of an infected person getting two false negatives in a row may be as low as 4%. It’s like bailing a boat with a leaky bucket: You just have to bail more quickly to get the job done.

Second, most people who get false-negative results are unlikely to be contagious. Antigen-based screening tests are good at detecting the high virus levels needed to be contagious. By design, screening tests sacrifice accuracy where it matters least to achieve low costs, speed and ease of use.

AND I learned that the SalivaDirect test was funded by the NBA.

“My goal is not to test athletes,” Grubaugh said. “That’s not my target population. My target population is everybody. There were concerns about partnering with the NBA when all these other people need testing. But the simple answer ended up being the NBA was going to do all this testing anyway, so why not partner with them and try to create something for everyone?”

The NBA, Yale and the players’ association do not intend to take royalties from any use of the testing method, Grubaugh and others said. The NBA and union contributed more than $500,000 combined to fund the Yale work, sources told ESPN.

Saliva-based coronavirus test funded by NBA, NBPA gets emergency authorization from FDA

FDA Adds New Warnings to All Testosterone Product Labels

Testosterone and other AAS, which have a schedule III classification by the Controlled Substances Act, may be abused by adults and adolescents, including athletes and body builders.

“Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system,” the FDA notes.

Reported serious adverse outcomes include myocardial infarction, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. People abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia, the agency says.

Source: FDA Adds New Warnings to All Testosterone Product Labels

Source: Safety Alerts for Human Medical Products > Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement – Risks Associated With Abuse and Dependence

It is interesting you no longer see those Low-T commercials on television any more.  Really?  Just another clever marketing campaign to create a disease that doesn’t exist along with a convenient drug based solution.  What side effects?

Read this book.  Now.

Source: Bill Moyers Journal . Profile . Melody Petersen | PBS

FDA Approves Bupropion/Naltrexone Contrave for Obesity

FDA Approves Bupropion/Naltrexone Contrave for Obesity.

If I’m understanding this correctly we now have an anti-depressant combined with a drug originally approved for treating opioid, then alcohol addiction, approved by the FDA to treat obesity.

This will be interesting.

UPDATE

Obesity drugs have side effects. The reason it’s taken three years for the FDA to approve NB32/Contrave is that obesity drugs have serious side effects. So serious, in fact, that several major diet drugs have been yanked from the market, making doctors, regulators and yes, investors shy away. Cardiovascular disease and mood problems are just two of the potentially serious side effects associated with Qsymia and Belviq. Older drugs Xenical  and Alli carry a risk of permanent liver and kidney damage.  And those weight loss supplements you buy over the counter? Some are deadly.

via Contrave: Is This The Weight Loss Drug We’ve Been Waiting For?.

Like I said, this will be interesting.

Safety Alerts – Pradaxa dabigatran – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

Safety Alerts for Human Medical Products > Pradaxa dabigatran: Drug Safety Communication – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin.

ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.

Safety Alerts – Eszopiclone Containing Sleep Aids Can Cause Next-Day Impairment

Safety Alerts for Human Medical Products > Eszopiclone Containing Sleep Aids: Drug Safety Communication – Can Cause Next-Day Impairment.

A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware they were impaired.  The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day. 

Safety Alerts for Human Medical Products > Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage

Safety Alerts for Human Medical Products > Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage.

ISSUE: FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.