FDA Related Information

FDA, i.e. Food and Drug Administration is the United States federal regulatory agency in the Department of Health and Human Services. “Protecting Public Health” is the main motto of this agency. In order to achieve its mission, the agency has to ensure that food, cosmetics, and nutritional supplements are safe to consume, the drugs and the new medical equipments released, get FDA approval first and are properly labeled prior to their marketing and being available for commercial consumption.

Baycol is a bad cholesterol lowering drug. It got its approval from FDA in 1997. As per FDA approval it was a good medicine that blocked a specific enzyme responsible for the synthesis of cholesterol, thereby lowering bad cholesterol.

However after the release of the medicine, continual problems were being reported related to its usage. So finally FDA had to look into the matter and on August 8, 2001, FDA announced the withdrawal of Baycol by its manufacturer, in USA Today newspaper. The reason for this worldwide withdrawal was that the drug had rhabdomyolysis as its fatal side effect. FDA was in complete agreement with Baycol’s manufacturers and supported their decision of calling off the medicine. Before FDA concluded this decision, it had also received reports of some 31 deaths which were the result of the complications caused due to consumption of Baycol. The cause of all these 31 deaths was rhabdomyolysis, which in easier terms can be called muscle degeneration. In this disease the muscle cells after breaking down release myoglobin, which is a muscle fiber content, into the blood stream. When the kidneys filter out myoglobin out of the body, it further breaks into compounds that stress the passages of kidneys that result in its failure. Many deaths were also due to fatal rhabdomyolysis which was reported amongst patients who were either elderly, or used baycol with gemfibrozil or any other cholesterol lowering drug. Baycol, had many more non serious side effects like headache, rashes, giddiness, bloating of stomach or abdomen, heartburn, gas, constipation or diarrhea. Peripheral Neuropathy was another serious side effect of the medicine, in which the patient kept loosing the sensations in hands and feet. Though no deaths were reported due to peripheral neuropathy, as a side effect of the drug, still it was another dangerous one.

FDA declared the withdrawal of the medicine in a reporting type of press release rather than as an announcement of action being taken by FDA. It was a serious conce
that after the release of the medicine in 1997, the patients suffered from some of the most dangerous side effects before its complete wipe out in 2001. In other words, it took four years and almost 31 deaths to understand that Baycol was not a patient friendly drug.

FDA had initially as well marked baycol in category X of medicine. Medicines belonging to category X are unfit for pregnant ladies, ladies planning pregnancy and nursing mothers. Baycol has known to cause birth defects if consumed by pregnant ladies and has also been to nursing babies if passed through breast milk.

In case you are still taking baycol, stop it at once and consult with your practitioner. Or if any of your loved ones has suffered in any form due to baycol medicine then a specialized litigation atto
ey should be consulted to understand the compensation terms and conditions.