October 25, 2014
The symptoms of vertigo include a sense of spinning or moving. These symptoms can be present even when someone is perfectly still. Movement of the head or body, like rolling over in bed, can escalate or worsen the symptoms.
The symptoms of vertigo are different from lightheadedness or a sense of fainting. Many people experience associated nausea or vomiting.
Physical examination often shows signs of abnormal eye movements, called nystagmus. Some patients experience imbalance in association with the vertigo. If imbalance lasts for more than a few days, or if the vertigo is accompanied by weakness or incoordination of one side of the body, the suspicion of stroke or other problem of the brain is much higher.
October 17, 2014
Following actions by the Food and Drug Administration (FDA), a Texas-based company has agreed to recall and destroy a dietary supplement linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants.
In addition to the recall of certain OxyElite Pro products, USPLabs assured FDA officials that it will destroy warehouse stocks of the supplement, with a retail value of about $22 million. FDA will oversee the destruction of the product.
“As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention (CDC),” said Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs. “Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace.”
FDA used new enforcement tools provided by the FDA Food Safety Modernization Act to act quickly in the face of a potential danger to public health.
The supplement was advertised as an aid to losing weight and building muscles. FDA warned the company on Oct. 11, 2013, that certain OxyElite Pro products and another supplement, VERSA-1, are considered adulterated because they contain a new dietary ingredient, aegeline, for which the company did not provide evidence of safety.
While FDA’s investigation is still ongoing, the agency continues to warn consumers to avoid using OxyElite Pro and VERSA-1.
Earlier this year, a stockpile of another formulation of OxyElite Pro was destroyed after being held through an FDA administrative detention order. A stimulant included in those products, DMAA, or dimethylamylamine, can cause high blood pressure and lead to heart attacks, seizures, psychiatric disorders and death.
After removing DMAA from its products, USPLabs substituted aegeline, among other ingredients, in certain OxyElite Pro products. Non-synthetic aegeline is an alkaloid extract from leaves of the Asian bael tree (Agele marmelos).
“Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law,” said Fabricant. “Losses to the company should also serve as a reminder that FDA’s laws and regulations serve a purpose and must be followed.”
On Sept. 13, 2013, FDA learned of a cluster of seven Hawaii residents with acute liver failure/non-viral hepatitis.
A joint investigation by the Hawaii Department of Health and CDC revealed that the patients all had consumed OxyElite Pro products. FDA meanwhile identified patients outside of Hawaii with similar liver dysfunction after using OxyElite Pro.
The FDA urged the public to avoid using products labeled as OxyElite Pro or VERSA-1 while the agency investigated further.
On Oct. 11, 2013, FDA warned the company that certain OxyElite Pro and VERSA-1 products were deemed adulterated and that failure to immediately cease distribution of both products could lead to enforcement actions. The FDA also outlined its findings of harm linked to OxyElite Pro.
As of the end of October 2013, there were 56 cases of acute liver failure or acute hepatitis linked to OxyPro Elite, 43 of them in Hawaii. The investigation continues.
October 1, 2014
The roots of the Interstate Travel Program at the Food and Drug Administration (FDA) can be traced back to long before the agency existed—to the presidency of John Adams.
Originally part of the Public Health Service, the program focused in the early days on the health of those traveling on Merchant Marine ships and was seen as instrumental in increasing the security of our young nation.
As the U.S. role in the world grew, so did the need for greater attention to the safety of travelers using both government-subsidized and privately owned transportation systems.
“During World War I and II there was nothing worse than sending 3,000 troops on a vessel and 400 of them show up well and the other 2,600 are sick,” says Matt Albright, a consumer safety officer at FDA.
Throughout the 1800s the program expanded as trains traveling across the U.S. were struck by yellow fever and small pox outbreaks. In the early 1900s, buses joined the ranks of interstate transportation and the program went airborne in the 1920s.
For the past 45 years the program has been under the purview of FDA, which has been working diligently to keep travelers healthy.
ITP is responsible for inspecting the food, water and waste-disposal systems in all commercial transport vehicles that travel from one state to another. However, its involvement begins long before the food and water are loaded aboard.
When the train, bus, ship or jet is being planned, ITP is involved from the beginning of the engineering process, including giving feedback on blueprints and designs.
With 20 years in the field conducting inspections and 10 more at FDA headquarters in College Park, Md., ITP manager Bruce Kummer knows that disease and infection can indeed be in the details.
“You don’t want your sewage discharge in front of the intake for water,” says Kummer, describing a basic design flaw. The team inspects for details that include making sure the fitting sizes are different for waste and water, so a worker couldn’t accidentally hook up the waste hose to the potable water intake. Safeguards like this—when implemented during construction – decrease the likelihood of errors that could endanger passengers’ health.
Another important aspect of the construction review process is limiting entrance and harborage areas for pests like rats, mice or cockroaches.
“You can’t fix deficiencies and structural integrity of a conveyance once it is in operation if it was built poorly,” says Albright. “You have to build it properly first.”
To ensure that the passenger conveyance is engineered and built in compliance with standards established by FDA, the ITP team inspects the prototype and addresses issues before mass production begins.
Kummer notes that FDA can withhold a Certificate of Sanitary Construction from a shipyard or other transport builder if there are major sanitary construction defects.
Throughout the transport vehicle’s construction and in the years that follow, FDA does spot checks and inspections as necessary. Larger companies, like Boeing, take advantage of a self-certification program in which FDA is provided with detailed reports on compliance with Agency regulations. FDA can – and has – entered facilities to perform audits to ensure that companies are complying with the construction guidelines.
Generally, FDA issues Warning Letters when deficiencies are discovered to give the company a short time to fix the problems while still operating its vehicle. If companies do not correct the problems, further regulatory steps may be taken and the transport vehicle can be taken out of service.
“Provisional” letters may be sent to operators of caterers, commissaries, watering points, and servicing areas if significant sanitary deficiencies are observed, giving the operators a limited amount of time to correct these items or risk losing their status as an FDA-approved facility. Transport companies are required under FDA regulations to use only approved facilities, which places more pressure on the servicing companies to clean up the deficiencies so they do not risk losing their approved status.
“I feel a lot of pride for my involvement in this work, in keeping travelers safe whether they’re traveling by land, sea or air,” Kummer says.