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Popular Weight-Loss Drugs Like Wegovy May Raise Risk of Complications Under Anesthesia
Patients who take blockbuster drugs like Wegovy or Ozempic for weight loss may face life-threatening complications if they need surgery or other procedures that require empty stomachs for anesthesia. This summer’s guidance to halt the medication for up to a week may not go far enough, either.
Some anesthesiologists in the U.S. and Canada say they’ve seen growing numbers of patients on weight-loss drugs who inhaled food and liquid into their lungs while sedated because their stomachs were still full — even after following standard instructions to stop eating for six to eight hours in advance.
The drugs can slow digestion so much that it puts patients at increased risk for the problem, called pulmonary aspiration, which can cause dangerous lung damage, infections and even death, said Dr. Ion Hobai, an anesthesiologist at Massachusetts General Hospital in Boston.
“This is such a serious sort of potential complication that everybody who takes this drug should know about it,” said Hobai, who was among the first to flag the issue.
It’s not clear how many patients taking the anti-obesity drugs may be affected by the issue. But because the consequences can be so dire, Hobai and a group of colleagues decided to speak out. Writing in the Canadian Journal of Anesthesia, they called for the drug to be stopped for even longer — about three weeks before sedation.
New COVID Strain Arrives as Vaccine Makers Gear Up
As summer vacations wind down and people return to work and school, a new strain of COVID-19 is boosting cases yet again. The latest version, which some are calling Eris, is now a “variant of interest” at the World Health Organization, having been reported in at least 51 countries since early August, including China, the U.S., Korea, Japan, and Canada.
The good news is WHO called the public health risk from the new variant low at a global level. Eris makes up about 17% of the COVID cases in the U.S., according to estimates from the Centers for Disease Control and Prevention. COVID-19 hospitalizations are rising but at low levels. COVID stopped being a federal public health emergency in May.
Pfizer PFE +0.99% (ticker: PFE), Moderna MRNA –3.10% (mRNA), and NovavaxNVAX –1.63% (NVAX) are getting ready to roll out updated COVID-19 vaccines this fall that will target recent strains, though not specifically the most recently identified Eris. They are all descendants of the same strain, however.
Vaccine makers expect to be ready when respiratory vaccine demand picks up this fall in anticipation of winter flu season. Pfizer CEO Albert Bourla told investors in August that they expect to make their updated COVID vaccine commercially available in September, after securing the needed regulatory approvals this month.
They aren’t so sure about demand, however. “Obviously, the severity of disease and people’s desire for treatment also will be factors,” Bourla told investors.
Pfizer, Scripps Sue to Block Copy of ‘Most Expensive’ Heart Drug
Pfizer Inc. and the Scripps Research Institute allege in a new lawsuit that a copy of Vyndamax proposed by Dexcel Pharma Technologies Ltd. infringes three patents for the blockbuster heart drug, an increasingly important source of Pfizer’s revenue.
Pfizer and Scripps “together own all substantial rights” to the patents, according to a complaint filed Thursday in the U.S. District Court for the District of Delaware. Two were assigned to Scripps and one to Pfizer.
Vyndamax is used to reduce the risk of death and hospitalization from a rare heart condition called transthyretin amyloid cardiomyopathy, or ATTR-CM. The disease is caused by a buildup of proteins in the heart.
The drug has an annual wholesale cost of more than $240,000, Bloomberg Intelligence analyst Marc Engelsgjerd wrote in a note last October. In the wake of its May 2019 approval by the U.S. Food and Drug Administration, researchers critical of its cost — then $225,000 a year — called Vyndamax “the most expensive cardiac medication in history” and said older adults were struggling to afford it.
FDA Delays Decision on Valneva’s Chikungunya Vaccine
The Food and Drug Administration has delayed by three months its decision on what could be the first vaccine available in the U.S. for chikungunya virus. In an announcement Monday, French vaccine maker Valneva said the FDA extended an evaluation of its shot to the end of November. The regulator was expected to decide whether to grant the vaccine an “accelerated” approval by August 31.
However, according to Valneva, the agency needs more time to come to terms with the company on the design of a post-marketing trial first. Such a study is required for drugs that receive accelerated approval and is meant to provide further information about a treatment’s purported benefits, risks and best uses.
The FDA hasn’t asked Valneva to submit any new data before approval, the company said.
The news represents the latest setback for Valneva, which has seen its shares plummet from more than $60 in 2021 to less than $14 apiece. The company and partner Pfizer recently pushed back their development timeline for an experimental Lyme disease shot. Valneva also struggled with a COVID-19 shot that has faced multiple hurdles in Europe.
Scrutiny Over Drug Costs Shifts to Pharmacy Benefit Managers
The pharmaceutical industry has taken most of the heat in Congress and the public’s mind for high drug prices. But increasingly, scrutiny is shifting to a different part of the supply chain: pharmacy benefit managers.
Why it matters: PBMs may not resonate with the average person the way big drugmakers like Pfizer do, but they play an important role in determining how much people wind up paying for medicines.
PBMs negotiate prices with drug companies and also help insurers decide which drugs are covered for a patient.
Amylyx ALS Drug Sales Tick Higher After Fast U.S. Launch
The use of Amylyx Pharmaceuticals’ recently approved ALS drug Relyvrio continues to grow in the U.S., where it was launched last fall.
Approximately 3,800 people with ALS, or amyotrophic lateral sclerosis, were taking Relyvrio at the end of June, Amylyx said in a conference call held Thursday to discuss the company’s second-quarter earnings. That’s a step up from the estimated 3,000 patients who were on treatment as of March 31.
The drug’s launch has gone better than the company and analysts on Wall Street had expected. Sales during the first quarter widely beat forecasts and, in the second quarter, did so again, with Amylyx reporting $98 million in sales of Relyvrio in the U.S. and Canada. Analysts were predicting around $91 million.
FDA staff had raised a number of concerns with Amylyx’s data and an advisory committee initially voted against the drug, before supporting it in a second meeting.
