Question

Answer these questions about the article below.

Ways in which their event could have been avoided?

How the FDA should have handled the drug's availability on the market.

Media responses to the medication incident.

Follow up studies on individuals affected by the disaster.

In 2001, the cholesterol medication Baycol (cerivastatin) that was manufactured by the German drug company Bayer and first released in the US in 1998, was recalled due to findings that it could cause a potentially fatal condition called Rhabdomyolysis (Angelmar, 2006). Rhabdomyolysis happens when there is injury to skeletal muscles that cause toxic cellular materials to be released into the blood which can lead to kidney failure (De Guzman, 2018).

There were 31 people in the United States and 21 in other counties, who developed rhabdomyolysis and died from kidney failure as a result of taking Baycol (Furber, & Pitt, 2001). Thousands of people who were among the millions who took Baycol during it's time on the market, filed lawsuits against the company (Angelmar, 2006).

As part of its marketing campaign Bayer claimed that, “With Baycol you

get premium power, not premium price” (Angelmar, 2006, p4). Bayer was using this concept to promote Baycol in an attempt to compete with other popular statins at that time, by offering something more effective but at a more affordable cost.   

Baycol belongs to a group of medicines called statins. Statins are known to cause muscle pain as a side effect and taking certain medications along with them increases the likelihood of experiencing this problem (Angelmar, 2006). These side effects are more common with higher doses of statins and Baycol was originally only available with the highest dose of 0.4 mg (Angelmar, 2006). At 0.4mg Baycol wasn't shown to be as effective as its competitors, so even with the increased risk of side effects, Bayer made Baycol in a 0.8mg strength (Angelmar, 2006). Had they focused on making their lower dose version more effective instead of making a higher does that had the potential for serious risks, they may have been able to avoid some of the deaths that occurred. There were concerns about the occurrences of Rhpbdomyolysis even at the 0.4mg dose, but Bayer still applied for and received FDA approval for the 0.8mg dose. The FDA should have been more cautious or required additional testing and research before allowing the higher dose of Baycol to be released to the public.   

As a result of the deaths caused by Baycol, questions were raised about the safety of all statins and negative attention was drawn to the pharmaceutical industry as a whole. The media focused heavily on how Bayer chose to inform investors of the recall first while also timing the withdrawal based on stock prices, instead of focusing on patient safety (Angelmar, 2006).

I wasn't able to find an follow up stories regarding the recall of Baycol

Answer 1

There are many ways to avoid the events and safety handling of availabilities of drugs in market.

. The pharmaceutical industries should strictly ban Thier campaign because they are not talking about the safety measures of their drugs they are only promoting their medicine by providing low price .

. The testing of baycol in laboratory should be increased at some higher level some more level of testing needed

. A notice should be issued by the pharmaceutical industry regarding the baycol in public that baycol should only taken under Dr prescription and listing all the side effects of baycol

. A notice agiven to all Dr that diagnosed some allergy tests while prescribing baycol to the patient and some regular tests of kidney should be written by the doctor while the patient is taking the baycol and if patient's having effects on their kidney then strictly stop consupticon of medicine.

. The FDA dissapproved their 0.8 mg production of baycol and notice them to increase the safety measures and modify their drug as soon as possible .

. The availability of baycol drug in the market is handled by giving the drug only to the patient having the Dr prescription paper with allergy test reports .

. The pharmaceutical industry should organise a conference with media and talk about incident of the drug baycol and inform media about all the action and activities that they are taking against baycol and inform media to take the drug only under Dr prescription with all the tests prescribed by doctor.

. After the 2001 the number of deaths by rhabdomyolysis increase to 52-80 and there are 385 non fatal cases of rhabdomyolysis and then FDA took decision to withdraw the baycol drug from market.