DURHAM, N.C. (BP)–The Food and Drug Administration recently required that all anti-depressants be labeled with the strongest possible warning, informing patients that symptoms of depression may worsen and that there is an increased risk of suicidal ideation that may accompany the use of anti-depressants in children and adolescents.
No similar study has been conducted to determine whether equal risk is present for adults, but it seems sensible to assume that it is. According to the FDA, studies indicate that patients taking anti-depressants (SSRIs) are twice as likely to experience suicidal tendencies as those taking placebos.
Ironic, that a drug promoted as a treatment for depression has been shown to double the risk of suicidal thinking and behavior. Yet, strangely, there has been no mention of this in the flurry of commercial advertisements which continue to appear, with alarming frequency, on televisions across America. News-watchers are bombarded nightly with such direct-marketing blips. Evidently, the marketing departments of some pharmaceutical companies have discovered big business in interrupting news broadcasts laden with the daily details of war and crime with direct marketing of mood-altering drugs to the general public. After all, depressing news is fertile soil for the companies that profit from the sale of these expensive drugs.
In a recent warning letter issued to the manufacturers of one of the more popular of these drugs, the FDA has written:
“The TV ad is false or misleading because it contains a representation or suggestion, not approved or permitted for use in the labeling, that [the drug] is useful in a broader range of conditions or patients, and is safer than has been demonstrated by substantial evidence or substantial clinical experience in violation of the Federal Food, Drug, and Cosmetic Act (ACT) (21 U.S.C. 352 (n)) and FDA implementing regulations (21 CFR 202.1 (e)(6)(i)). This ad is concerning from a public health perspective because it broadens the use of [the drug] … while also minimizing the risks associated with the drug.”
In the same correspondence, the FDA demands that the manufacturer “immediately cease the dissemination of promotional materials for [the drug].”
While we applaud the FDA for canceling this particular advertisement, we also realize that this action will do little to affect the drug’s sales or to halt its procession into the medicine cabinets of millions of fresh customers. The pill in question generated nearly $3 billion in the United States alone last year, according to one pharmaceutical manufacturer. Also, according to the same report, Americans spent a whopping $16 billion last year on anti-depressants.
It seems that the liabilities presented by these miracle pills are acceptable to those who are prescribed them. According to the Drug Abuse Warning Network, a division of the U.S. Department of Health and Human Services, 43 percent of emergency department episodes mentioning drugs are attributable to legal medications, referred to in the annual DAWN report as “other drugs.” As high as this percentage is, it is notable that not all cases involving prescription or over-the-counter (OTC) drugs are reportable to DAWN, but that DAWN receives only reports of emergency room episodes involving the non-medical use of legal drugs. Accordingly, the actual numbers for emergency room episodes involving legal drugs could be substantially more disturbing.
North America accounts for 75 percent of worldwide anti-depressant sales. Ironically, the evidence indicates that, of all of the countries in the world, citizens of these United States have the least to be depressed about. But, as long as the public demands relief from the pressures of comfortable living, and as long as there exist manufactories of new disorders and stronger potions, there will continue to be a legal drug problem in America.
We want to remind readers that abruptly discontinuing medications can be harmful. Anyone taking a prescription drug who desires to quit should not stop taking medications immediately. This can cause severe depressive episodes as well as a host of other unpleasant withdrawal symptoms. Withdrawal is best accomplished slowly and under the supervision of a physician.
Ted Stone and Philip Barber are Southern Baptist speakers and writers on the subject of drug abuse. Contact them through Ted Stone Ministries, P.O. Box 1397, Durham, N.C. 27702, or at (919) 477-1581.