May 22, 2019 by John Fernandez and Tanya Racoobian
Roundup: FDA to Target High-Risk, Homeopathic ‘Remedies’; Flu Shots Now OK for Those with Egg Allergies
The U.S. Food and Drug Administration is proposing tougher enforcement against so-called homeopathic drugs, which are “remedies” sold over-the-counter and often marketed as a cure or a way to combat chronic or serious conditions or illnesses, including cancers, heart disease and opioid addictions.
The FDA says it’s new approach will help the agency “better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits.”
Prescription and nonprescription drug products labeled as homeopathic, sometimes referred to as “alternative medicine,” have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988. The agency will target products that pose the biggest safety risks, including those marketed for children or for serious diseases.
In recent years, there’s has been a significant increase in products on the market labeled as homeopathic or natural remedies. The FDA’s new enforcement approach is outlined in a draft guidance that will be open for public input for 90 days. Over a year ago, the FDA cracked own on homeopathic teething tablets and gels containing belladonna which were linked to 400 injuries and the deaths of 10 children. An FDA lab review later confirmed that some of the products “contained elevated and inconsistent levels of belladonna,” a toxic substance, the agency said.
“In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,” said FDA Commissioner Scott Gottlieb, M.D.
The commissioner added that the agency respects that some individuals want to use alternative treatments. But the FDA has “a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm,” he added.
The FDA says it intends to focus its enforcement on:
- Products with reported safety concerns;
- Products that contain or claim to contain ingredients associated with potentially significant safety concerns;
- Products for routes of administration other than oral and topical;
- Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
- Products for vulnerable populations; and
- Products that do not meet standards of quality, strength or purity as required under the law.
Flu Shots: No Precautions Needed for People With Egg Allergies
For years, people with an egg allergy have needed to take certain precautions when getting a flu shot, or avoid them alltogether, because most influenza vaccines are grown in eggs and contain a tiny amount of egg protein.
But now a leading U.S. allergists’ group says the flu shot is safe for those with egg allergies. Doctors don’t need to question patients about egg allergies before giving the vaccine, according to updated guidelines from the American College of Allergy, Asthma and Immunology (ACAAI ). The ACAAI is an organization of more than 6,000 allergists-immunologists and allied health professionals
“The overwhelming evidence since 2011 has shown that a flu shot poses no greater risk to those with egg allergy than those without,” says allergist Matthew Greenhawt, MD, chair of the ACAAI Food Allergy Committee and lead author of the practice parameter.
Dozens of studies have involved thousands of patients with egg allergy who have received a flu shot without allergic reactions – including hundreds with life-threatening egg allergy. The influenza vaccine does not contain enough egg protein to cause an allergic reaction, even in patients with severe egg allergy
The updated guidelines ares consistent with recommendations from the U.S. Centers for Disease Control and Prevention and the American Academy of Pediatrics.
California’s Warning on Cellphone Radiation Stirs Debate
The California Department of Public Health has issued guidelines to help people “decrease their exposure to the radio frequency energy emitted from cell phones.” But the state’s new guidelines — which has made national headlines — might suggest that using a cell phone carries far more risk than scientific evidence suggests, say critics of the new guidelines.
California health officials somewhat concede that point in their statement on the new guidelines. “Although the scientific community has not reached a consensus on the risks of cell phone use, research suggests long-term, high use may impact human health,” says the California Department of Public Health (CDPH).
The department said the information was intended to help people who are concerned about health risks, particularly to kids and young adults.
“Children’s brains develop through the teenage years and may be more affected by cell phone use,” said CDPH director and State Public Health Officer Dr. Karen Smith. “Parents should consider reducing the time their children use cell phones and encourage them to turn the devices off at night.”
The new CDPH guidance includes steps both adults and children could take to reduce exposure to radio frequency energy from cell phones. That includes:
- Keeping the phone away from the body.
- Reducing cell phone use when the signal is weak.
- Reducing the use of cell phones to stream audio or video, or to download or upload large files.
- Keeping the phone away from the bed at night.
- Removing headsets when not on a call.
- Avoiding products that claim to block radio frequency energy. These products may actually increase your exposure.