New York, NY - The Food and Drug Administration has demanded that all pharmaceutical companies change their warning labels on a huge swathe of painkillers to warn consumers about possible stomach and heart problems the drugs may cause. The FDA's edict covers both prescription and OTC (over-the-counter) drugs.

Companies were given six months to make the changes. "We've received the letter, we're reviewing it, and we'll be working closely with the FDA to finalize the label," Pfizer spokeswoman Mariann Caprino said.

The FDA called for the stronger cautions after Pfizer suspended sales of its Bextra painkiller, which was linked to cardiovascular and skin disorders. The agency will monitor how companies phrase and display the advisories, said Kathleen Quinn, an FDA spokeswoman. "This is an ongoing process and we will be in contact with the companies," she said.

The drugs covered by the warning are all in the non-steroidal anti-inflammatory drug class, or NSAIDS. Those drugs include ibuprofen, ketoprofen, or naproxen. OTC brands using ibuprofen include Advil, Genpril, Haltran, Motrin, Menadol, Midol, Nuprin, and Rufen.

Labels on OTC medications must also inform consumers about increased heart and bleeding risk, as well as possible allergic reactions, the FDA said. The word "NSAID" must be displayed prominently on the label in color contrast or bold type, the agency said.

Prescription NSAIDs, most notably Celebrex, will require a "black box" warning, the FDA's most severe, regarding the increased risk of heart disease and gastrointestinal bleeding. The labels must also include a description of the early symptoms of Stevens - Johnson syndrome, a rare skin condition that can be triggered by use of painkillers, the FDA said.

The warnings come on the heals of those the FDA demanded earlier for Cox-2 pain inhibitors Bextra (Pfizer), Vioxx (Merck) and Celebrex (also Pfizer). Those warnings covered possible cardiac problems in some patients. As a result of studies and the warnings, Bextra was later withdrawn from the market, and Vioxx is currently the subject of a hundreds of lawsuits.

Celebrex and Bextra generated $4.59 billion in worldwide sales for New York-based Pfizer in 2004, while Merck's Vioxx had $2.5 billion a year in sales before the recall.

Aspirin and acetaminophen, despite being regarded by doctors as the roughest pain relievers on patients' stomachs, were absent from the new warning list. Pharma execs have long joked that if aspirin were presented to the FDA today it would not gain approval.

It is yet to be seen whether the news will cause another rash of lawsuits against pharma companies who make NSAIDs, because the stomach side effects have long been known in the industry. The absence of acetaminophen in the new warning opens up the possibility that some marketers-such as Tylenol (Johnson & Johnson) or Bayer's Aspirin-will now be able to advertise the fact that they do not contain chemicals cited by the FDA.