Health Highlights: July 26, 2019
New Warnings About Blood Clot, Death Risk in Patients Taking Tofacitinib for Ulcerative Colitis: FDA Juul Electronic Cigarettes Never Meant for Teens, Company Co-Founder Says First U.S. Trial Using CRISPR Within the Body Is Set to Begin
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
New Warnings About Blood Clot, Death Risk in Patients Taking Tofacitinib for Ulcerative Colitis: FDA
New warnings about an increased risk of blood clots and of death among ulcerative colitis patients taking the 10 mg twice daily dose of the drug Xeljanz, Xeljanz XR (tofacitinib) have been issued by the U.S. Food and Drug Administration.
The agency also said that the approved use of tofacitinib for ulcerative colitis will be restricted to certain patients who don't respond to, or who have severe side effects with, certain other medicines.
The changes, including adding the FDA's most prominent Boxed Warning, were made after the agency reviewed interim data from an ongoing clinical trial assessing the safety of 5 mg and 10 mg twice daily doses of tofacitinib in patients with rheumatoid arthritis.
That data showed an increased risk of blood clots and of death in patients treated with the 10 mg twice daily dose, compared with tofacitinib 5 mg twice daily or a TNF blocker, according to the FDA.
The agency first approved tofacitinib in 2012 to treat adult patients with rheumatoid arthritis who did not respond well to the medicine methotrexate. The approved dose for those patients is 5 mg twice a day.
In 2018, the FDA approved the drug to treat ulcerative colitis, a chronic, inflammatory disease affecting the colon.
The FDA said patients should stop taking tofacitinib and seek immediate emergency medical attention if they develop any unusual symptoms, including those that may signal a blood clot such as: sudden shortness of breath; chest pain that worsens with breathing; dwelling of a leg or arm; leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm.
Other patients should not stop taking tofacitinib without first talking to their health care provider, the FDA said.
Juul Electronic Cigarettes Never Meant for Teens, Company Co-Founder Says
Juul developed its electronic cigarette for adult smokers who want to stop and never intended it to be adopted by underage teenagers, company co-founder James Monsees told a U.S. House subcommittee on Thursday.
He said "combating underage use" is the company's highest priority, the Associated Press reported.
There is an "epidemic" of electronic cigarette use among American teens, even though federal law forbids the sale of the devices to those under 18.
Juul has been under increasing scrutiny for its role in the problem, but this is the first time the company has been called before Congress, the AP reported.
Two hearings were convened this week by House Democrats, who last month launched an investigation into Juul's marketing, technology and business practices.
At Thursday's hearing, Democrats grilled Monsees about early Juul ads and marketing that they contend led to widespread teen use of electronic cigarettes.
"We must trace the origins that led to this epidemic," said Rep. Raja Krishnamoorthi of Illinois, chairs of the economic subcommittee of the House Committee on Oversight and Reform.
First U.S. Trial Using CRISPR Within the Body Is Set to Begin
In a U.S. first, a clinical trial to begin this fall will use the inside-the-body gene-editing technique CRISPR to try to cure illness. Doctors hope to use the cutting-edge technique to cure a type of inherited form of blindness called Leber congenital amaurosis.
Even though they have normal eyes, patients with this type of blindness lack a gene that turns light into signals to the brain that enable sight, the Associated Press reported.
Using a tool that cuts or "edits" DNA in a specific spot, researchers will attempt to give child and adult patients a healthy version of the gene they lack. The trial will include 18 people across the United States and will be conducted by two companies, Editas Medicine and Allergan.
Leber congenital amaurosis is the most common cause of inherited childhood blindness, occurring in about 2 to 3 of every 100,000 births.
The only other trial to use gene editing inside the body was to treat metabolic diseases. That was done by a company called Sangamo Therapeutics, the AP reported.