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Abbott says new data shows rapid COVID-19 test used at White House is highly accurate

By Manojna Maddipatla and Carl O’Donnell

(Reuters) – Abbott Laboratories on Wednesday released early data from a study on the accuracy of its ID NOW COVID-19 test, which is used in the White House, that could help alleviate concerns the diagnostic frequently fails to detect the virus.

Interim data from Abbott’s 1,003-participant study shows that its test, which can deliver results in under 15 minutes, correctly identified positive COVID-19 cases 95% of the time when used within seven days of symptom onset.

The U.S. Food and Drug Administration issued an emergency use authorization for the test in March, but said in May that early data suggested it could sometimes fail to detect the virus in sick patients. Abbott said it would conduct multiple studies of the test in a variety of healthcare settings.

U.S. President Donald Trump, his wife Melania and several members of the White House staff have contracted COVID-19, raising questions about whether Abbott’s test was reliable enough to be used as the White House’s daily screening tool.

A study conducted by Cleveland Clinic in April showed the test detected the virus in around 85% of cases, lower than many other COVID-19 tests. Other studies, including one by New York University, raised similar concerns.

The FDA said it had received 302 “adverse event” reports as of Sept. 30, including numerous accounts of false negatives – results showing people were not infected when they actually were.

Rapid tests such as Abbott’s are generally less accurate than molecular diagnostic tests, which are the industry gold standard but must be sent to a laboratory to produce results, a process that often takes several days.

Rapid tests are also seen as essential tools to help schools and businesses reopen and stay open.

The latest results confirm the data submitted to the FDA in March that won emergency use authorization for the test, Abbott said. (https://refini.tv/2GLCVA4)

Abbott said it has so far shipped more than 12 million ID NOW tests to all 50 states.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Saumyadeb Chakrabarty and Bill Berkrot)

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Popular anti-anxiety medications may be highly addictive, FDA says

The U.S. Food and Drug Administration said last month it will now require makers of benzodiazepines to outline the risks of abuse, addiction, physical dependence and withdrawal on the drugs’ labels.



text, letter: Xanax.


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Xanax.

Benzodiazepines, or “benzos,” which include brand name drugs like Xanax, Ativan, Klonopin, Librium and Valium, are used for the treatment of anxiety, insomnia, seizures, social phobia and panic disorder.

These prescription drugs have been around for decades but now there’s growing evidence that benzodiazepines have a high potential for abuse and addiction.

“If monitored carefully, they have a great effect and can be very helpful to many patients who take them as prescribed,” Dr. Bechoy Abdelmalak, a psychiatrist working in a chemical dependency clinic in New York City, told ABC News.



a book sitting on top of a table: Xanax.


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Xanax.

The medications, however, can be addictive and there is a thriving black market for these pills.

“Benzodiazepines will not be the next big epidemic. They have been a ‘silent’ epidemic for decades, intensifying consequences from the current opioid epidemic,” according to Dr. Harshal Kirane, medical director of Wellbridge Addiction Treatment and Research.

The first benzodiazepine, Librium, was approved in 1960, but the FDA only recently issued a warning about the risk of abuse.

MORE: Public health crises collide: Substance abuse linked to COVID-19 susceptibility

“We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence,” FDA Commissioner Stephen M. Hahn said on Sept. 23 when the new warnings were announced.

The FDA issued previous warnings in August 2016 but those warnings only mentioned the adverse effects, including death, from combining these class of drugs with opioids or cough medicines.

So what prompted this recent change in the FDA?

Based on adverse cases reported to the FDA Adverse Event Reporting System database, the FDA found that benzodiazepines are commonly prescribed in the U.S. for periods longer than recommended and frequently abused and misused.



Xanax.


© Bsip/Universal Images Group via Getty Images
Xanax.

The FDA also found that these drugs may be abused with alcohol, opioids or other illicit drugs, increasing the risk of serious or even fatal health problems.

“When you start taking these drugs, the response is very positive so it becomes hard for patients to discontinue them,” Abdelmalak said. “So patients often take them for many years and, with chronic use, the risk of side effects increases, especially in the elderly.”

The FDA also concluded, based on its review, that some users have had serious withdrawal symptoms, such as seizures, after these drugs were suddenly stopped or the dose was decreased too quickly.

“They are becoming more popular as street drugs,” John Brownstein, an epidemiologist at Boston Children’s Hospital, told ABC News. “They are being mentioned more on television, in movies, and music and therefore more attention is being paid to their abuse