FDA Places Restrictions on Accutane

The FDA is placing restrictions on accutane:

WASHINGTON - The thousands of Americans who take the acne drug Accutane — and people who prescribe and dispense it — must enroll in a national registry, part of a major government program to tighten access to the medicine that causes birth defects.

The Food and Drug Administration enacted unprecedented curbs Friday in trying to keep Accutane and its generic competitors on the market while ensuring that women who use the risky pills don’t get pregnant. Critics see it as the drug’s last chance, after two decades of safety warnings and other restrictions failed to end Accutane-damaged pregnancies.

Accutane first hit the market in 1982. Since then, well over 2,000 pregnancies have occurred among users. “The vast majority ended in abortion or miscarriage, but the FDA counts more than 160 babies born with drug-caused defects.”

Under the program, every patient — men and women — must enroll in the iPLEDGE computerized registry starting Dec. 31 to receive Accutane or generic versions of the drug isotretinoin.

Doctors must register, too, if they wish to continue prescribing the pills. Drugstores and wholesalers also must register in order for the pills’ manufacturers to ship them any supplies.

The registry opens early, on Aug. 22nd, so people have plenty of time to learn how it will work. ” On that date, patients may enroll at http://www.ipledgeprogram.com or by phone at 1-866-495-0654.” For federal accutane info, click here.

FDA’s MedWatch

If you’re at all concerned about Vioxx, Bextra, Celebrex, Accutane, or Zyprexa, you may want to bookmark the FDA’s MedWatch page, which is “your Internet gateway for timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration.”

MedWatch is “The FDA Safety Information and Adverse Event Reporting Program,” and it contains a wealth of information and updates on adverse reactions to various medications, devices, and so forth.

For instance, today the front page includes recently updated info on counterfeit drugs coming from Mexico, external defibrillators, and meds like Zometa, Aredia and Natrecor.

Study says Accutane doesn’t cause depression

A Reuters article about Accutane was one of the top stories on Yahoo! today. The article mentioned a study that found the popular acne-fighting drug, which has been “linked to birth defects and is being monitored for ties to suicide, did not cause depression in a group of adolescents.”

Here’s an excerpt:

“The use of isotretinoin (generic version of Accutane) in the treatment of moderate-severe acne in adolescents did not increase depressive symptoms. On the contrary, our study shows that treatment of acne improves depressive symptoms,” wrote study author Dr. Christina Chia of Saint Louis University Health Sciences Center in St. Louis.

She echoed previous arguments by the drug’s manufacturer and some other researchers that acne itself could be a cause of “significant psychological stress.”

The U.S. Food and Drug Administration is monitoring the drug to determine if it causes depression and suicide. The agency also ordered creation of a registry to ensure pregnant women, or women who may become pregnant, do not take it because of a risk of birth defects.

Accutane was one of five drugs cited by veteran FDA scientist David Graham at a congressional hearing last year as approved drugs that ought to receive closer scrutiny.

The controversy over Accutane grew out of a wrongful death lawsuit involving a young pilot who was taking the drug and crashed his small plane into a building in Tampa, Florida, in 2002.