Depression and chronic pain relief drug, Duloxetine, recalled after failing tests

The drug Duloxetine, more commonly known as its brand name Cymbalta, is generally used to treat depression, anxiety, and chronic pain. It’s an active ‘serotonin-norepinephrine reuptake inhibitor’, providing pain relief for patients with diabetes or sufferers from chronic or widespread pain.

The drug is commonly prescribed to people with arthritis and fibromyalgia. However, select batches of the Torrent Dutor Gastro-resistant Capsules have been recalled by the Medicines and Healthcare products Regulatory Agency (MHRA) because “out of specification results for dissolution were obtained during routine stability testing”.

Manufacturer Torrent Pharma (UK) Ltd are recalling their Dutor Gastro-resistant Hard Capsules in 20, 30, 40 and 60mg tablets. The tablets are not to be brushed, chewed, broken or opened as the medication is designed to be swallowed to allow slow release of the contents, but this latest Class 3 recall was initiated amidst concerns that the tablet’s physical integrity may be compromised.

Those who take the recalled batches of Duloxetine are urged to contact their GP to seek alternative medication. However, Duloxetine has also been under scrutiny for being associated with withdrawal complications, including higher suicide risks, serotonin syndrome, abnormal bleeding, birth defects and even death.

The importance of safe drug manufacturing

The production of medical drugs is no small task as patients rely on them to improve their health and mitigate pain and suffering for all sorts of ailments. Drug manufacturers have a huge responsibility to ensure the products they make are effective whilst remaining safe. Prescribed drugs are usually carefully and expertly tested out to ensure they’re safe for use.

As such, any problems with the integrity of the medication could lead to the drug being incorrectly administered, which can in turn cause problems for patients.

Vulnerable patients at risk

Particularly potent drugs can significantly alleviate pain, but when used in the wrong way, they can cause serious harm to health. The most common patients who take Duloxetine are people who suffer chronic and widespread pain, and those who suffer from depression and anxiety; as such, we are talking about very vulnerable people indeed.

Tablets that cannot withstand routine stability testing can cause problems for the patient.

Claiming compensation

If you take prescribed medication and suffer side effects you were not reasonably warned about, you may be eligible to recover compensation for the harm you suffer. Sometimes, your doctor may not even be able to warn you about the adverse risks when the manufacturer do not supply such information, or where they haven’t supplied such information because of a manufacturing error.

Medical drug manufacturers like Eli Lilly who make the branded version of Duloxetine (known as Cymbalta) must ensure extensive testing is carried out before the drug is distributed. Any adverse effects must be disclosed and shared with their distributors, medical health providers and the patients. If the adverse risks the drugs carry outweigh the benefits of taking the drug, it should not be made available and pulled off the shelves.

Whether the problems are caused by a failure to warn you, or by a medical manufacturing defect, you may be eligible for compensation.