Latest on the cyclospora outbreak; first oral PCSK9 inhibitor approved; AHA update: how much coffee is heart-safe? — Morning Medical Update

Cyclospora cases climb as FDA reaffirms lettuce source

Michigan cases pass 6,000 as the FDA holds to Taylor Farms lettuce, days after a positive test proved a false alarm.

Michigan, the hardest-hit state, reported 6,148 cyclosporiasis cases as of July 20, up more than 1,100 in three days, with 102 hospitalizations and no deaths. National counts run lower and lag behind because the U.S. Centers for Disease Control and Prevention (CDC) tallies only laboratory-confirmed cases: as of July 13 it had confirmed 1,645 across 34 states, with 141 hospitalizations, and was reviewing roughly 5,100 more reports. Counting confirmed and probable cases together, the CDC puts the nationwide total at nearly 7,000 since May 1.

The FDA said its traceback investigation continues to point to shredded iceberg lettuce from Taylor Farms de Mexico, grown in central Mexico and served at Taco Bell locations in Indiana, Kentucky, Michigan, Ohio and West Virginia. The agency walked back a July 18 report that a lettuce sample had tested positive, saying laboratory experts re-reviewed the result and judged it a false positive; as of July 19 no product sample had tested positive. Taylor Farms, which recalled iceberg lettuce from central Mexico on July 17, said the FDA had acknowledged a mistake and that no product test has confirmed the parasite.

The CDC urges physicians to consider cyclosporiasis in patients with prolonged or relapsing diarrhea, to treat confirmed cases with trimethoprim-sulfamethoxazole and to report them to local health departments; the parasitic infection spreads through food or water contaminated with feces and can cause watery diarrhea lasting weeks. Former FDA Commissioner Scott Gottlieb said the retracted test did not weaken the case against the lettuce, which entered the supply chain weeks before the sampled product.

FDA approves first oral PCSK9 inhibitor

Merck's once-daily Lipfendra lowers LDL as much as injectable PCSK9 drugs, at a lower list price.

The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, as an adjunct to diet and exercise to lower LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. Made by Merck, the once-daily 20-mg tablet is a macrocyclic peptide that blocks PCSK9, the same target as the injectable antibodies evolocumab and alirocumab. In the phase 3 CORALreef trials, it lowered LDL by a placebo-adjusted 56% to 59%, reductions Merck said matched the injectables.

Merck set a list price of $315 for a 30-day supply, below the roughly $500 to $600 monthly list prices of injectable PCSK9 inhibitors, which reach only about 1% of eligible patients, and said primary care physicians can prescribe it.

The approval lands as cholesterol treatment widens: a University of Pittsburgh analysis in JAMA found that updated 2026 guidelines make about 87.5 million U.S. adults, or 56.6% of those ages 30 to 79, eligible for statins — an increase of 21.5 million.

Side effects were similar to placebo in the trials, and an outcomes study is underway to determine whether the LDL reduction lowers rates of heart attacks and strokes, as it has for the injectable drugs. Lipfendra will be available within a few weeks, Merck said.

How much coffee is heart-safe?

Up to five cups a day, the American Heart Association says, but energy drinks are another matter.

Most adults can safely consume up to 400 mg of caffeine a day, about five 8-ounce cups of coffee, without raising cardiovascular risk, and moderate coffee intake is associated with lower rates of type 2 diabetes, heart disease, stroke, heart failure and some arrhythmias, according to a new American Heart Association (AHA) scientific statement in Circulation. The authors stressed that most of the evidence is observational, making it hard to separate caffeine's effects from other compounds in coffee, and that individual responses vary with genetics, age and habitual intake.

The picture is different for energy drinks and concentrated energy shots, which can carry three to four times more caffeine per ounce than brewed coffee and have been linked to high blood pressure and irregular heart rhythms, even in healthy adults under 30.

Adding sugar, cream or flavored syrups may cancel out coffee's potential benefits, the statement notes, and unfiltered coffee such as espresso and French press contains cafestol, a compound that can raise LDL cholesterol.

The AHA said more randomized trials are needed.