FDA issues Box Warning to Reglan
FDA, the U.S Food and Drug Administration agency within the Department of Health and Human Services, is mainly responsible for safeguarding the public health by keeping a stringent check on all the safety measures related to drugs, biological products, medical devices, etc.
In the FDA News dated Feb 26, 2009, it is clearly mentioned that FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs. The Agency categorically states that prolonged use of this medicine to treat gastrointestinal problems can in turn cause impairments which are incurable. The agency has told all the manufacturers that the drug should carry this warning with all its labels. Tardive dyskinesia, a disease which causes involuntary, uncontrollable and repetitive movement of muscles is one of the major side- effects linked with this drug. In some cases it has been reported that even after discontinuing the medicine the side effects prevailed.
As per the FDA news, the Makers of the medicine have to implement REMS i.e. Risk Evaluation and Mitigation Strategy, to ensure that all the risks are discussed in the medication guide provided to the patients, thereby assuring latter’s complete safety from any undesirable complications.
Janet Woodcock, M.D., director of the FDA’s Centre for Drug and Evaluation Research is of the opinion that the patients and the health care professionals should become well versed with all the possible side effects, both major and minor, of the drug to make judicious decisions about the treatment. In all medical scenarios, which require prolonged use of this medicine, the benefit should outweigh the risk, and then only the course of this drug should be decided, because as earlier stated that even after discontinuing the medicine the side effects may stay.
The Black Box Warning on the product labeling is mainly to make the consumer aware of the risk of tardive dyskinesia with intensive metoclopramide treatment. It states the warning in the following manner:
Tardive dyskinesia basically affects the receptors of the brain that control movements. Hence patients suffering from this disease often experience uncontrollable movements of certain muscles and continuously lose their ability to stay motionless. Continuous and repetitive movements of mouth, tongue and jaw, uncontrollable movements of arms, legs, fingers and toes, facial grimacing, lip smacking, puffing of the cheeks, swaying motions of hips or trunks are some of the common symptoms of tardive dyskinesia. Though metoclopramide has been used to stimulate lactation in women, however at the same time, nursing mothers should check with their doctors before taking this preparation, as it has proved to be unsafe for nursing babies in some cases. For pediatric patients as well, this drug is safe only as far as small bowel intubation is to be facilitated, unless otherwise is not stated.
For drugs like metoclopramide, which can cause uncommon but fatal symptoms like Neuroleptic Malignant Syndrome, medical advice must be taken before consuming the drug, as the side effects can be severe and irreparable.