Our Maryland-based prescription drug error attorneys have been following the U.S. Food and Drug Administration’s recent announcement, ordering the makers of around 500 prescription cold, cough and allergy medications to take the drugs off the pharmacy shelves, as they have not been proven to be safe and effective.
According to the FDA, the prescription drugs in question have not been linked to any major problems or drug-related injuries, but the FDA is still concerned that the medical problems associated with the drugs could be seriously under reported.
The agency claims that the drugs have not been evaluated by the FDA, and taking them may be more of a risk to the consumer than taking over-the-counter (OTC) medications to treat the same symptoms, that have been approved. The FDA also claimed that the action is necessary to protect consumers from any health and safety risks posed by these unapproved drugs, as the agency does not know how they are made, whether they are effective, or what is in them.
One of the problems that the agency found was with time-release drugs, which are reportedly hard to manufacture, and can release too slowly or not at all if quality controls in the manufacturing of the drug are inadequate. The FDA also made a move against unapproved products that contain drug combinations that could be considered dangerous, like combining two antihistamines, which could react in oversedation.