The FDA posts recall of erectile dysfunction and antidepressant drugs



The Food and Drug Administration has posted a voluntary recall issued by AvKARE, a Tennessee-based pharmaceutical and infection control company. The issue? AvKARE discovered that two of their generic medications had a packaging mix-up. Those medications are sildenafil, which is used to treat erectile dysfunction, and trazodone, an antidepressant.

The two medications were inadvertently packaged together during the bottling phase of production at an unnamed third-party bottling facility. Needless to say, any medication switch can be dangerous. The fear with this one is especially geared toward people thinking they are taking the antidepressant, while actually taking sildenafil, the active ingredient in the brand-name Viagra. As the FDA makes clear:

Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues. For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

Yet the unintentional intake of trazodone while a person thinks they are taking sildenafil can also cause problems, including “somnolence/sedation, dizziness, constipation, and blurred vision. These adverse events may be more concerning in elderly patients due to a subsequent increased risk for falls and driving impairment,” the FDA says.

The affected lots of medicines involved in the mix-up include:

  • 100 mg tablets of sildenafil with a lot number of 36884, and an expiration date of 03/2022.
  • 100 mg tablets of trazodone hydrochloride with a lot number of 36783 and an expiration date of 06/2022.

AvKARE says consumers with questions regarding the recall can contact the company at 1-855-361-3993 Monday-Friday (8 a.m.-4 p.m. CST). They also note that consumers should contact their doctor immediately if they experience adverse symptoms from taking the mixed-up products.

We’ve reached out to AvKARE to ask for additional comment on the matter.





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High blood pressure can be treated without causing erectile dysfunction, shows study



Men with untreated high blood pressure have poorer penile blood flow than those with normal blood pressure, according to research presented today at ESC Congress 2020. The differences disappeared with blood pressure medication.

The results provide reassurance to men concerned about the effects of blood pressure-lowering medications.

Hypertension (high blood pressure) affects more than one billion people worldwide and is the leading cause of premature death.2 A healthy lifestyle is advised, including salt restriction, alcohol moderation, exercise, weight control, and smoking cessation.

Most patients also require drug treatment, which is linked to reduced risks of death, stroke, and heart disease – but around half of patients do not take their pills. Sexual dysfunction is one reason why patients stop medication.

Men with hypertension are almost twice as likely to have impaired penile blood flow and erectile dysfunction compared to men with normal blood pressure, increasing their risk of heart disease and death.

High blood pressure damages artery walls, causing them to harden and narrow, and reducing blood flow to the penis. Erectile dysfunction is an early warning sign of damaged blood vessels.

However, previous studies have shown that erectile dysfunction is more common in treated, than untreated, men with high blood pressure. And certain antihypertensive drugs – notably diuretics and beta blockers – have been linked with deterioration in sexual function.

This study examined the association between blood pressure level and penile blood flow, and whether blood pressure-lowering medication had an effect on the relationship.

The study included 356 men with erectile dysfunction and no history of diabetes or cardiovascular disease who attended a clinic between 2006 and 2019.

The cohort was divided into three categories according to blood pressure: normal, high-normal, and hypertension. A total of 164 (46%) patients were being treated with antihypertensive medications.

All patients underwent a penile colour Doppler ultrasound which is the standard method for evaluating penile blood vessels and erectile dysfunction.

The method involves injecting a drug into the base of the penis to open the blood vessels then measuring blood flow. Penile blood flow is considered impaired when the velocity is lower than 25 cm/s.

Among men not receiving antihypertensive medication, penile blood flow velocity progressively decreased with rising blood pressure – i.e. blood flow was fastest in those with normal blood pressure, slower in those with high-normal blood pressure, and slowest in those with hypertension.

In contrast, among men taking antihypertension therapy, there was no difference in penile blood flow velocity between the three blood pressure categories.

The progressive decrease in penile blood flow velocity across the three blood pressure categories in men not taking antihypertensive medication indicates significant structural changes in the penile blood vessels from longstanding hypertension.”

Charalambos Vlachopoulos, Study Author and Professor, National and Kapodistrian University of Athens

“The blood flow differences across the three blood pressure categories disappeared with treatment, suggesting a medication effect.”

An additional analysis compared treated and untreated men within each blood pressure group. In the hypertension category, treated and untreated patients had similar penile blood flow velocities. However, in the high-normal category, treated men had worse penile blood flow than untreated men. Similarly, in the normal blood pressure category, treated men had worse penile blood flow than untreated men.

Professor Vlachopoulos said: “These results imply that hypertensive patients already have significant structural damage in the penile arteries and adding antihypertensive drugs does not further reduce penile blood flow. But in men with normal or high-normal blood pressure, the penile arteries have minimal structural damage and medications could have a negative impact on penile blood flow.”

He urged men with concerns about sexual dysfunction to discuss it with their doctor. “For men with as yet untreated hypertension, older medications (beta blockers and diuretics) are not ideal and should be used only if absolutely indicated,” he said.

Professor Vlachopoulos noted that changing hypertensive medications in men with erectile dysfunction must be handled with caution. He said: “First, if a co-existing disease dictates using a specific drug category (for example, beta blockers for coronary artery disease and heart failure, diuretics for heart failure), then switching is not advocated.

Alternatives might be considered if patients are at risk of stopping lifesaving therapy because of the detrimental impact of erectile dysfunction on their life.”

“Second, switching to another drug class does not guarantee either the restoration or improvement of erectile function. This has to be carefully explained to patients in advance to avoid unreasonable expectations,” he said.

Professor Vlachopoulos concluded: “Our study shows that high blood pressure can be treated without causing erectile dysfunction. Patients and doctors need to have open discussions to find the best treatment option.”



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