|
|
BY OUR PHARMA CORRESPONDENT
6 August, 2005: A flurry of recalls and drug safety warnings in the recent months by the U S Food and Drug Administration have left considerable confusion and scare among the drug users, reports say.
So far this year, the agency has issued its most serious alert - black box warnings – five times as many to drug labels as it did a year ago. In the first half of 2005, the agency placed black-box warnings on the labels of 45 drugs compared to just 9 during a similar period last year.
The FDA has also issued 11 public health advisories about drug risks compared with five in all of last year and two in 2003.
Experts aver the new hyperactivism by the FDA as a response to fierce recent criticism that the agency has failed to protect the public against drug dangers, has upset some doctors and drug makers. They say the warnings are scaring patients and reducing sales.
Earlier, the agency hesitated issuing disturbing warnings about drugs unless studies proved that a risk was certain as they felt that issuing warnings about suspected problems would cause undue alarm and lead patients to stop taking needed therapies.
However, controversies involving antidepressants and suicide risk and the withdrawal of the pain pill Vioxx have put the agency on the more cautious mode.
Now, instead of waiting for proof, the agency has promised to issue public health alerts about drug risks even when problems are only suspected. And over the last year, it has demanded that pharmaceutical companies add tough warnings for drugs as diverse as the antidepressant Zoloft, because it might lead a small number of teenagers to become suicidal, and the popular pain pill Advil, because it might in rare cases cause heart attacks.
Recently, the agency issued a news release about the recall of 206,000 intravenous pumps made by Baxter International, a first for such a recall. In the past, the FDA had asked companies to publicize such recalls. The agency recently created a Drug Safety Oversight Board that will likely encourage more such communiqués.
In each case, the agency has acted with little or no evidence that the risks are real. But it has demanded that warnings be placed on them anyway. In many cases, patients have stopped taking the medicines in the wake of the warnings.
But public warnings issued by the agency garner far more attention and create more alarm than those made by drug makers, experts.
However, the agency officials maintain that they are simply trying to do a better job of communicating drug risks directly to doctors, pharmacists and patients after years of letting drug makers do most of the talking. Dr Lester Crawford, commissioner of the Food and Drug Administration has said that the agency can no longer wait until risk information is proved but must communicate its uncertainty to the public.
Drug firms say the agency is also taking more time to review new drug applications. For drugs approved in the first half of 2005, the average time from application to approval was 29 months, compared with an average of 16 months for drugs approved in the first half of 2004. And the FDA is more often asking that drug makers study the safety of their medicines after they are approved. BY OUR PHARMA CORRESPONDENT
|
