Health Highlights: July 13, 2018
Fake FDA Warning Letters Being Sent to Consumers Jury Awards $4.62 Billion in Johnson & Johnson Talcum Powder Lawsuit Heart Disease in Dogs May be Linked to Certain Pet Foods: FDA FDA Creates Task Force to Tackle Drug Shortages
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Fake FDA Warning Letters Being Sent to Consumers
Criminals are sending fake U.S. Food and Drug Administration warning letters to people who tried to buy medicines online or over the phone, the FDA says.
The agency does not typically send warning letters to individuals, and this appears to be an extortion scam.
"While warning letters are a common compliance tool used by the FDA, we typically send them directly to companies and individuals involved in the manufacturing or distribution of FDA-regulated products," FDA Commissioner Dr. Scott Gottlieb said in news release.
"Consumers who aren't involved in manufacturing or distributing FDA regulated products should be on alert that if you get an FDA warning letter, it's probably fake, and probably a scam," he warned.
"We know the confusion and concern that these fake warning letters may cause and want to assure consumers that we generally don't take action against individuals for purchasing a medicine online, though we regularly take action against the owners and operators of illegal websites," Gottlieb said.
"With that said, as a public health agency, we must remind consumers of the dangers of purchasing medicines from illegal online pharmacies. These risks range from receiving unapproved and potentially counterfeit medicines to unknowingly making themselves targets to scams like these," he added.
"Many of these illegal websites appear legitimate, and it can be hard to tell the difference between a legally operating online pharmacy and a rogue website. We understand the temptation to buy online, and there are ways to do it safely, including only buying from U.S.-licensed pharmacies that require a prescription," Gottlieb said.
These fake warning letters claim to be from the FDA or the FDA and the Federal Trade Commission and say that the FDA has identified drug violations based on a review of the person's parcels and social media accounts.
The letters also warn recipients that "we are still investigating the root of this delivery & necessary legal steps will be taken if we found [sic] out any suspicious activity on your end."
Consumers who believe they've received a fake warning letter should email the FDA's Internet Pharmacy Task Force with as much information about the letter and it's packaging, the agency said.
Jury Awards $4.62 Billion in Johnson & Johnson Talcum Powder Lawsuit
A jury says Johnson & Johnson must pay $4.62 billion to 22 women who allege they developed ovarian cancer after using the company's Baby Powder and Shower to Shower brand talcum powder as part of their daily feminine hygiene routine.
The St. Louis jury announced their decision Thursday after weeks of hearing testimony and eight hours of deliberation. The award includes $550 million in compensatory damages and $4.14 billion in punitive damages, CNN reported.
It's the largest such verdict against the company, which plans to file an appeal.
"Every verdict against Johnson & Johnson in this court that has gone through the appeals process has been reversed and the multiple errors present in this trial were worse than those in the prior trials which have been reversed," the company said.
Johnson & Johnson faces thousands of similar lawsuits nationwide. Favorable verdicts have been awarded to plaintiffs in five of the cases, but those cases are in various stages of appeal, CNN reported.
Heart Disease in Dogs May be Linked to Certain Pet Foods: FDA
A possible link between heart disease in dogs and certain pet foods is being investigated by the U.S. Food and Drug Administration.
"We are concerned about reports of canine heart disease, known as dilated cardiomyopathy (DCM), in dogs that ate certain pet foods containing peas, lentils, other legumes or potatoes as their main ingredients. These reports are highly unusual as they are occurring in breeds not typically genetically prone to the disease," Martine Hartogensis, deputy director of the FDA's Center for Veterinary Medicine's Office of Surveillance and Compliance, said in an agency news release.
"The FDA is investigating the potential link between DCM and these foods. We encourage pet owners and veterinarians to report DCM cases in dogs who are not predisposed to the disease," Hartogensis said.
Large dogs such as Great Danes, Newfoundlands, Irish Wolfhounds, Saint Bernards and Doberman Pinschers have a genetic risk for canine DCM, a disease of the heart muscle that often leads to congestive heart failure. The disease is less common in small and medium breed dogs, except American and English Cocker Spaniels.
The FDA said it's concerned about recently reported cases of DCM in Golden and Labrador Retrievers, a Whippet, a Shih Tzu, a Bulldog, Miniature Schnauzers, and mixed breeds.
Early reports suggest that for periods ranging from months to years, these dogs' main source of nutrition were foods with peas, lentils, other legume seeds or potatoes as their main ingredients, the FDA said.
FDA Creates Task Force to Tackle Drug Shortages
A new task force to help deal with drug shortages in the United States was announced Thursday by the Food and Drug Administration.
The task force will expand upon the work of a group created by the Food and Drug Administration Safety and Innovation Act of 2012, which gave the agency new powers to address drug shortages.
They included expanding requirements that drug makers notify the FDA of a permanent discontinuation or temporary interruption in manufacturing that could result in a shortage of prescription drugs for serious illnesses.
"Being notified of these issues has been critically important. It has allowed the FDA to work with manufacturers to address and prevent hundreds of shortages in the past few years," FDA Commissioner Dr. Scott Gottlieb said in a statement.
"However, challenges around drug shortages persist. We must work to find new and creative ways to tackle the issue," he added.
The new task force, led by Keagan Lenihan, the FDA's associate commissioner for strategic initiatives, will "delve more deeply into the reasons why some shortages remain a persistent challenge. The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages," Gottlieb said.
Along with senior FDA officials, the task force will also include officials from the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, which provide or pay for prescription medicine for millions of Americans.
Several work groups will be formed to examine various aspects of drug shortages, including assessing the FDA's current powers and evaluating reimbursement policies of CMS and other payors that could be make it difficult for companies to manufacture certain drugs profitably.
"I also want the task force to explore possible incentives to encourage expansion of manufacturing capacity and enhanced quality," Gottlieb said.