Promethazine HCl News

Promethazine hydrochloride is an antihistamine that helps with allergy symptoms, hives, and other medical conditions. In limited cases, healthcare professionals also prescribe the drug for sedation.

Studies have also shown that this medication can help treat motion sickness. Researchers have also found that patients with severe pain enjoy relief if they take promethazine with meperidine, an opioid pain medication.

Promethazine is a first-generation antihistamine with anticholinergic properties. You can take this medication orally, intramuscularly, or using rectal suppositories.

Rhone-Poulenc initially marketed the drug, but Sanofi acquired the company and now markets Promethazine HCl. Sanofi sells the drug under the brand name Phenergan. The Food and Drug Administration approved the drug in 1952. It has been on the U.S. market ever since.

Here, we’ll discuss recent research, news, and Promethazine lawsuits. We will also briefly explain what to do if you or a loved one become sick after using Promethazine HCl.

Side Effects of Promethazine

As with most prescription drugs, Promethazine has adverse side effects. Many of these are minor. But some can be life-threatening. Some patients should avoid taking this medication because of these potential health risks.

Common side effects of Promethazine include:

• Dizziness
• Shortness of breath
• Nausea
• Vomiting
• Headache
• Drowsiness
• Sleepwalking
• Dry mouth
• Blurred vision
• Constipation

If any of these adverse effects persist, contact your healthcare provider. Generally, these adverse events pass after a few days. Other, more persistent side effects can be life-threatening.

According to the FDA, the serious side effects of Promethazine include:

• Seizures
• Hypotension (severe low blood pressure)
• Neuroleptic malignant syndrome (NMS)
• Serotonin syndrome
• Central nervous system (CNS) depression
• Severe respiratory depression
• Bone marrow depression
• Kidney disease

These side effects are so severe the FDA ordered the drug manufacturer to include black box warnings.

Who Should Avoid Taking Promethazine HCL

Certain patients should avoid the use of Promethazine HCl. Your doctor may suggest an over-the-counter remedy instead. For example, if you’re taking tricyclic antidepressants, you should avoid Promethazine.

You should also avoid taking this medication if you have an allergic reaction. There are plenty of other antihistamines that can help with your symptoms.

Some of the other patients who should avoid this drug include:

• People taking monoamine oxidase inhibitors (MAOIs)
• Patients who take antidepressants (SSRIs)
• People with a seizure disorder
• Children under the age of 12
• Older adults
• Patients suffering from severe asthma
• People with a brain tumor
• Patients taking codeine

You should also avoid this drug if you take muscle relaxers or diuretics. The FDA fact sheet for this medication specifically indicates these contraindications. People with a lower body weight may be at an increased risk of a life-threatening reaction from taking Promethazine.

February 2022: Florida Pharmacist Indicted on Promethazine Scheme

Over the last several years, the DEA and FDA have pursued several pharmacists for illegal sales of Promethazine. One case involved pharmacist Adam Runsdorf of Boca Raton, Florida. The government charged Runsdorf and nine other defendants with the illicit manufacture and sale of counterfeit Promethazine HCl cough syrup.

Runsdorf is the owner of Woodfield Pharmaceutical LLC. His company manufactured the counterfeit drugs in Houston, Texas.

May 2023: FDA Study on Patients Taking Promethazine and Flonase

In May 2023, the FDA published the results of a clinical study. It found a potential adverse drug interaction between Promethazine and Flonase. The study found that females who took the two drugs in combination suffered from pneumonia. It also found that men who took both drugs experienced severe pain.

May 2023: Akorn Pharmaceuticals Voluntary Recalls Generic Promethazine HCL

In May 2023, Akorn Pharmaceuticals issued a voluntary recall of two generic versions of Promethazine HCl. These included Promethazine HCl oral solution and the company’s Promethazine HCl with codeine phosphate oral solution.

The company recalled more than 70 generic medications. The drugmaker didn’t provide specific reasons for why they issued the recall.

December 2023: FDA Requires Drugmaker to Update Warnings and Instructions for Promethazine

On December 27, 2023, the FDA ordered Sanofi to change its labeling instructions for injectable Promethazine products. The new label requirements were for the company’s intravenous version of the drug.

According to the new label instructions, healthcare professionals must dilute the drug before administering the injection. The FDA said this would reduce the risks of irritation and tissue damage.

January 2024: Illegal Prescriptions for Promethazine Cough Syrup

In January, a federal judge sentenced a pharmacist to three years in federal prison. Zaman Alshafey was buying Promethazine cough syrup from distributors and selling it to illegal drug dealers for huge profits.

The FDA and Department of Justice confirmed that Alshafey purchased more than $2.5 million of the drug. He earned more than $9 million in profits from selling the drug illegally.

When you take Promethazine cough syrup in large doses, it can get you high. The street name used by drug users and dealers is "green drink" or "purple drink."

The FDA and federal judge warned that pharmacists can only sell prescription drugs for the purposes on the drug’s label.

What To Do if You Become Sick After Taking Promethazine

If you or your loved one become sick after taking Promethazine or any other prescription medication, seek immediate medical care. Then, you should contact an experienced product liability lawyer. They can explain your legal options.

Depending on the facts of your case, you may have a valid legal claim. Most personal injury lawyers offer a free initial consultation. Visit FindLaw.com’s attorney directory to find a lawyer near you.