U.S. warns Forest Labs on hypertension drug ad

WASHINGTON (Reuters) - U.S. health regulators have warned Forest Laboratories Inc for promoting its hypertension drug Bystolic to doctors without properly noting the medication's risk, according to a letter released on Monday.

An 8-page advertisement, which ran in various medical journals, also implied that the drug is better than rival products even though there is no substantial evidence to prove such claims, the U.S. Food and Drug Administration said in the letter.

"Although the journal ad does include important safety information on its second page, it omits and minimizes certain risks," wrote Thomas Abrams, head of the FDA's Division of Drug Marketing, Advertising and Communications.

Forest's ad specifically left off a warning about the drug's use in patients with congestive heart failure, the letter dated August 28 said.

The drugmaker's Senior Vice President for Finance and Chief Financial Officer Frank Perier said the ad had been running in a variety of professional medical journals since January but was no longer in use.

He added the company was taking the FDA's warning seriously and planned to respond to the agency's request for company comment by September 12.

The FDA letter said the New York-based drug maker's ad also made claims that the beta-blocker works better for patients who are obese, diabetic or have poor metabolism, even though clinical trials were not designed to show such an effect.

Bystolic, approved in December 2007, has been linked to a number of serious risks such as cardiac failure and chest pain, according to the letter. It is also not supposed to be used in a variety of patients, including those with various heart problems.

The FDA sends dozens of similar warning letters each year; most are resolved without further action, although the FDA can impose fines or other penalties.

The letter was released on the FDA website Monday here

Shares of Forest Laboratories closed 7 cents higher at $30.26 in regular trading Monday on the New York Stock Exchange.

(Reporting by Susan Heavey, editing by Gerald E. McCormick and Tim Dobbyn)