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.”

Evidence of Danger

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.

Rare Acetaminophen Risk

September 8, 2014

Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).

Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin. If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.

Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous prescription and non-prescription medicines. Tylenol is one brand name of the pain reliever sold over the counter, but acetaminophen is also available as a generic under various names. It is also used in combination with other medicines, including opioids for pain and medicines to treat colds, coughs, allergy, headaches and trouble sleeping.

“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction. “However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”

Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions. Advil and Motrin are among the common brand names that include ibuprofen as an active ingredient. Aleve and Midol Extended Relief are among the best-known brand names that include naproxen as an active ingredient.

FDA is requiring that a warning about these skin reactions be added to the labels of all prescription medicines containing acetaminophen. FDA will work with manufacturers to get the warnings added to the labels of over-the-counter (OTC) medicines containing acetaminophen.

On OTC medicines, the word “acetaminophen” appears on the front of the package and on the Drug Facts label’s “active ingredients” section. On prescription medications, the label may spell out the ingredient or use a shortened version such as “APAP,” “acet,” “acetamin” or “acetaminoph.”

 

Double Dosage of Acetaminophen

September 18, 2013

You have flu symptoms, so you’ve been getting some relief for the past two days by taking a cough and flu medicine every few hours. Late in the day, you have a headache and you think about grabbing a couple of acetaminophen tablets to treat the pain.

Stop right there.

What you may not realize is that more than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever. Taken carefully and correctly, these medicines can be safe and effective. But taking too much acetaminophen can lead to severe liver damage.

Acetaminophen is a common medication for relieving mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches and to reduce fever. It is also used in combination medicines, which have more than one active ingredient to treat more than one symptom.

The National Institutes of Health (NIH) says that Americans catch one billion colds per year and as many as 20% of Americans get the flu. Moreover, 7 in 10 Americans use OTC medicines to treat cold, cough and flu symptoms.

Fathia Gibril, M.D., M.HSc., a supervisory medical officer at the Food and Drug Administration (FDA), explains that consumers looking for relief from a cold or the flu may not know that acetaminophen comes in combination with many other medications used to treat those symptoms. “So if you’re taking more than one medicine at a time,” she says, “you may be putting yourself at risk for liver damage.”

Symptoms of acetaminophen overdose may take many days to appear, and even when they become apparent, they may mimic flu or cold symptoms. The current maximum recommended adult dose of acetaminophen is 4,000 milligrams per day, To avoid exceeding that dose:

  • don’t take more than one OTC product containing acetaminophen,
  • don’t take a prescription and an OTC product containing acetaminophen, and
  • don’t exceed the recommended dose on any product containing acetaminophen.

“When you’re at the store deciding which product to buy, check the ‘Drug Facts’ label of OTC cold, cough and flu products before using two or more products at the same time,” Gibril says. If you’re still not sure which to buy, ask the pharmacist for advice.

Medicines are powerful. They can cure disease, relieve symptoms, and help you stay healthy. But they can also do a lot of damage if taken incorrectly, when not needed, when prescribed inappropriately, or in case of medicine overdose.

The Food and Drug Administration (FDA) believes that many medication-related risks can be prevented if everyone committed to the safe use of medicines works together. Acting on that belief, the agency launched the Safe Use Initiative in November 2009 to foster collaborations within the health care community that will help prevent medication errors, misuse, and abuse.

Studies estimate that up to 50 percent of harm from medication use could be prevented. According to the Institute of Medicine, this would translate into about 1.5 million preventable incidents each year.

The goal of the Safe Use Initiative is to

  • identify specific, preventable harm related to medication use
  • develop methods (interventions or strategies) to reduce harm
  • identify ways to measure the success of these interventions

Tens of millions of people in the U.S. take prescription or over-the-counter (non-prescription) medicines each year, says Karen Weiss, M.D., director of the Safe Use Initiative. “If we can reduce injury that occurs because people are not prescribing or taking medications optimally, we can improve their individual health and the health of the public.”

When flu season arrives this fall, a liquid form of Tamiflu—the most widely used anti-viral flu medication—will be available in a new, lower concentration to reduce the possibility of medication errors.

The change applies to the oral suspension form of Tamiflu and not the capsule. Oral suspension is a powder form of the prescription medication that a pharmacist mixes with water to make a liquid treatment easier to take by children or adults who are unable to swallow a Tamiflu capsule.

Tamiflu is FDA-approved to treat adults and children older than 1 year who have had influenza symptoms for two days or less. Tamiflu stops the virus from spreading in the body and can help shorten the duration of such symptoms as a stuffy or runny nose, sore throat, cough and muscle aches.

Because there are no quality issues with the 12 mg/mL concentration Tamiflu, it will remain on the market until supplies run out and can be used until its expiration date.

With both dose concentrations being available during the flu season this fall, Kendall Marcus, safety deputy in FDA’s Division of Antiviral Products, cautions that pharmacists and physicians will have to be particularly careful in prescribing and dispensing the medication.

After the next flu season, only the 6 mg/mL concentration will be available.

Marcus says consumers need to know the following:

  • You could receive either the 6 mg/mL or the 12 mg/mL version at your local pharmacy during the next flu season. If you have any questions about how to use the product safely, speak to your pharmacist or other health care provider.
  • If you have taken oral suspension Tamiflu in the past, the container and label will look different.
  • The new oral dosing device is different and the volume (mL) of your dose may differ from past prescriptions.
  • If you have any problems with the medication, report them to your health care provider and to FDA’s MedWatch program.

Marcus notes that pediatric strength Tamiflu capsules (30 mg and 45 mg) have not changed and are still available for children who can swallow capsules. Another option for parents is to open the capsule and mix its contents with a flavored food, like chocolate syrup.