Pfizer Inc (NYSE:PFE)’s Prempro recalled in Cleocin, Norpace wake
Just last week Pfizer Inc (NYSE:PFE) recalled numerous lots of three of its drugs. This included Prempro, the hormone-replacement therapy that was recalled due to quality problems. A treatment for heart-rhythm disorders, Norpace and Cleocin, the antibiotic were the other drugs that had been recalled.
The company voluntarily recalled five different lots of Prempro from various pharmacies post routine testing. There were indications that the products from those lots might not meet potency specifications. Theoretically, substandard potency can change the intended effect of any drug. MacKay Jimeson, a Pfizer spokesperson said that using the recalled drugs is not likely to result in any adverse health consequences. However, PFE has taken this action as a precautionary measure. This recall involves a very small amount of tablets as the affected lots had a June-end expiry date. Most pharmacists tend to remove stock from the shelves six months prior to the expiration date and it has already been returned to the company.
What is a drug recall?
In a drug recall, the company that has manufactured the prescription or OTC takes the product off the shelves. In some cases, the U.S. FDA requests that the drug be recalled, while in other cases the manufacturer initiates it. In either case, the FDA plays an important role in the process.
What Is the FDA’s Role in drugs monitoring?
The Food Drug Administration is responsible for ensuring that products such as vaccines, drugs as well as medical devices are effective and safe. All new drugs are evaluated by its Center for Drug Evaluation and Research, to make sure that they work the way they should and also that their health-benefits outweigh any known risks. The Center is not really in charge of testing the drugs. That is the manufacturer’s job. The new drug is tested on animals as well as on humans. The results of the study are then sent by the manufacturer to the center. The study reports are then reviewed by the experts at the center. They decide whether a particular drug is effective safe, and of a good quality.
Once the FDA approves a drug and it is put on the market. It is the manufacturer’s duty to review as well as report any dug-linked problems that crop up. The problems can be reported by consumers directly to the FDA via the MedWatch program.