By NORM ALSTER, INVESTOR'S BUSINESS DAILY Posted 03/21/2011 06:10 PM ET

The FDA has caused drugs like Midrin to be pulled from the market, affecting roughly 30 million Americans who suffer from migraines. Newscom View Enlarged Image

Roughly 30 million Americans suffer from painful and often disabling migraine headaches.

But for reasons that have baffled doctors and patients, Midrin and chemically identical meds like Epidrin have disappeared.

Midrin was the first drug that ever worked for Nancy (last name withheld), who previously suffered from crushing headaches that would have her vomiting and bed-ridden for days.

"I've been using it for five years," said the Buffalo, N.Y., resident. "It stops the migraine."

The Food and Drug Administration has been pulling many drugs that were sold before laws in 1962 required testing for efficacy (safety tests have been mandated since 1938). This month it pulled 500 prescription cold, cough and allergy remedies off the market.

But the FDA, in a written reply to IBD queries, denies pulling Midrin-type drugs. It did seize products from a maker that didn't meet current manufacturing standards. Also, Excellium Pharmaceutical halted Epidrin production this year. But the FDA says it wasn't involved, and that the move was a "business decision."

But that's not how Lou Dretchen, Excellium's head of sales and marketing, sees it. The FDA, he says, is squeezing firms selling untested drugs, or DESIs (for Drug Efficacy Study Implementation). The firms face long delays with applications for other drugs.

The FDA "made it difficult for manufacturers of prescription products looking for new drug approvals to get approvals unless they cancel manufacturing of any DESI products," Dretchen said.

Indirect Pressure

Regulators have ways of getting products off the market without explicitly pulling them.

"The FDA has advised us that any Rx product that does not have FDA approval cannot be legally marketed," said Larry Lapila, senior vice president at Breckenridge Pharmaceutical, which once distributed the Migrazone version of Midrin.

The FDA, Dretchen says, has also made it difficult to import one of Epidrin's ingredients.

Compounding pharmacists mix ingredients to formulate meds like Midrin and Epidrin. Several confirmed that the meds' sedative, dichloralphenazone, has been impossible to source. "No one can get it," said a New England compounding pharmacist.

The FDA questions drugs that have not gone through formal testing. But the Midrin drugs have had the real-world test of more than five decades of wide use.

Doctors who've prescribed the drugs say they work with few side effects. For some patients they may be the only safe option.

"I think they were safe. I don't think there's any question they were effective," said Dr. Jack Klapper, head of the Colorado Neuro & Headache Center. The drugs were especially useful for patients with heart conditions who can't take newer migraine medications, Klapper says.

Dr. Seymour Diamond says he's treated "at least 10 to 15 thousand" patients with Midrin drugs.

"In 40 years, I have not seen any severe adverse reactions," said the founder of the Diamond Headache Center in Chicago.

"They worked well for a select group of patients," Diamond said, notably children and adolescents and older patients with heart disease or high blood pressure.

He dismisses claims that two newer classes of drugs are better.

"If I saw a patient over 60, I wouldn't use ergotamines or triptans," Diamond said.

The newer drugs also cost $16 or more vs. 25-50 cents for Epidrin capsules, Dretchen notes.

"People are really upset," said Teri Robert, of MyMigraineConnection.com. "Some people say Midrin is the only drug that's ever worked for them."

In Buffalo, Nancy tried triptans but had unwelcome side effects. "I'm pretty disgusted since there aren't any more drugs available to abort a migraine. It doesn't seem fair to have a drug taken away when it works for so many."