ALERT: Widely used pills recalled for deadly flaw, FDA yet to act

(NaturalHealth365)  An alert has been issued cautioning consumers against using a popular potassium chloride pill.  The pills were recalled after a potentially fatal flaw was discovered.  However, the Food and Drug Administration (FDA) has yet to act.

This lack of immediate oversight raises serious concerns about the regulatory framework to protect public health.  With millions of lives potentially at risk, the issue demands urgent attention.

Potentially deadly flaw in commonly used pills all consumers should know about

Official records reveal that Glenmark Pharmaceuticals issued over half a dozen recalls for its potassium chloride pills.  The pills fail to properly dissolve when contacting moisture, such as saliva and other water, in the human body.  This failure to dissolve has the potential to lead to pain, hospitalization, and death.

The shocking twist is that the FDA has dragged its feet on investigating the Glenmark Pharmaceuticals drug factory’s flawed operations.  To date, there has been no government inspection of the drug factory.  The FDA is aware that the pills have the potential to cause deadly potassium spikes, yet it refuses to take meaningful action.

The pills were produced at a single factory in India.  If our federal government were the watchdog it claims to be, it would have prevented Glenmark Pharmaceuticals from shipping pills produced at the Mumbai factory to the rest of the United States.

Why the potassium chloride pills have the potential to kill healthy people

There is a widespread misconception that potassium chloride is entirely safe simply because it has been on the market for decades.  The drug is frequently prescribed to address issues with muscle and nerve function and is particularly valued for its benefits to heart health.

While potassium chloride pills are effective for individuals with low potassium levels, they can pose significant risks under certain conditions.  Excessive amounts of the drug can have lethal consequences.

High doses of potassium chloride can result in complete heart failure, a risk that cannot be ignored.  This danger is so pronounced that potassium chloride is a key component in lethal injections used for executions in several states.  This reality highlights just how deadly the drug can be when misused or improperly formulated.

Is a recall of the drug enough?

The danger of Glenmark Pharmaceuticals’ potassium chloride pills became apparent in May when the Indian drugmaker recalled nearly 47 million capsules.  The extended-release medication’s failure to dissolve prompted the FDA to issue its own recall of the defective product.

Shockingly, the FDA was already aware of manufacturing issues at Glenmark Pharmaceuticals’ facilities at the time of the recall.  Over the previous eight months, the Mumbai-based drugmaker had been responsible for four separate recalls.  In the months following, two more recalls were issued, each citing the same critical flaw: the pills’ inability to dissolve properly.

While recalls play a crucial role in protecting consumers, they are far from sufficient in addressing systemic issues.  The FDA has failed to prevent Glenmark from continuing to distribute potentially dangerous pills to the American market.

Even more troubling is the agency’s failure to thoroughly investigate the root cause of the problem.  Despite the glaring risks, the FDA has not conducted an on-site inspection of Glenmark’s Mumbai facility since its last review – more than four years ago.  This glaring oversight raises serious concerns about the FDA’s capacity to enforce meaningful accountability and ensure the safety of imported drugs.

Glenmark Pharmaceuticals: A case study in corporate negligence

It seems we have drifted too far toward a laissez-faire economy, where corporate greed often goes unchecked.  Within a single year, Glenmark Pharmaceuticals issued seven recalls for medications that failed to dissolve as intended, yet no significant government action has been taken to address the underlying issues.

Glenmark’s public relations team has acknowledged three deaths and several hospitalizations linked to their defective products.  FDA records corroborate these reports, confirming the dangers of potassium chloride pills.  However, the FDA appears reluctant to formally attribute these deaths and hospitalizations to the drug, allowing Glenmark’s pursuit of profit to continue virtually unimpeded.

The time has come for a comprehensive overhaul of the FDA.  The agency currently lacks the resources and authority to effectively oversee the manufacturing, distribution, and recall of generic medications produced in factories outside the United States.  If the FDA were fulfilling its intended role, it would immediately take decisive action against Glenmark.

Sources for this article include:

IPDpharma.com
Childrenshealthdefense.org

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