Washington ? In an unprecedented move, the government is again allowing sales of a drug that was pulled off the market after causing seven deaths heeding the pleas of patients suffering from irritable bowel syndrome.

Lotronex is supposed to be prescribed only by certain doctors and to far fewer patients women only than when it was first sold. But the Food and Drug Administration didn’t order safety restrictions nearly as tough as its advisers recommended, and Lotronex returns with no guarantees against more deaths.

“We’re not anticipating with this program that the risk will go away,” acknowledged FDA gastrointestinal drugs chief Dr. Victor Raczkowski. “The goal … is to have the drug prescribed in patients for whom the benefits of the drug exceed those risks.”

That includes patients miserable from severe abdominal pain, diarrhea, and having to wear diapers to guard against bowel accidents who must have failed other therapies. They must understand Lotronex side effects could hospitalize them, lead to major intestinal surgery, even kill.

Patients who called Lotronex a miracle praised FDA’s decision, announced Friday.

“A catastrophic mistake was averted and individuals can now breathe a sigh of relief,” said Jeffrey Roberts of the IBS Self Help Group.

Roberts is pursuing a loophole, seeking a doctor who’ll prescribe Lotronex. The FDA cautions the drug hasn’t been proven safe or effective for men.