Promethazine belongs to a category of medications referred to as sedating antihistamines. These initially received approval to be marketed in 1951 and have been used to treat a broad range of pediatric health conditions such as nausea and allergies. The most common uses for this medication include:
- Allergic reactions
The medication is promoted under the brand name Phenergan and other generic types of products. There are three primary forms in which this medication can come – elixir, syrup and tablet.
A doctor’s prescription is required in order to obtain promethazine. Where there may be some advantages for using promethazine for pediatric patients, it is unfortunately also being linked to a broad range of adverse reactions. The drug’s label was updated in 2000 to include health risks and warnings associated with children. In 2004 the medication received a black box warning which is the most severe pharmaceutical label associated with the dangerous impacts of its IV push administration.
Basics of Promethazine
When certain children are exposed to allergens like dust or pollen, their body may release the chemical histamine causing symptoms like coughing, sneezing, skin rashes or watery eyes. Promethazine blocks these histamines and minimizes or eliminates some allergy symptoms.
While it might minimize the impact of reactions and symptoms it does not eliminate the cause of the histamine. The dosage of promethazine prescribed and the frequency of the dosage will depend on the type of the treatment and the child’s health condition.
Serious Side Effects of Promethazine
Some young adults may experience serious side effects while taking this medication. While the majority of these side effects are mild and will only last for a short period of time, others can lead to serious complications that warrant medical attention.
One of the most serious risks connected with a child taking promethazine is pediatric respiratory problems. Respiratory depression in children can even be fatal. This is one of the primary reasons why promethazine products now include a black box warning and should never be given to any children younger than the age of two.
Any parent who is considering promethazine for their child should exercise caution before administering this even if the child is older. Some of the other serious side effects associated with this medication include:
- Stiff muscles
- Irregular heartbeat
- Difficult breathing
- Yellowing of the eyes and skin
- Uncontrollable movements
- Swelling of the feet, other parts of the body or hands
Children ages 16 and under face the highest risk of serious health complications associated with promethazine. Make sure to consult with your physician before taking a prescription for this medication and filling it.
As a number of health complications arose associated with this medication, the FDA required that manufacturers of this medication update the product labels. If your child has been negatively affected by this drug with serious medical conditions, you may be entitled to recover compensation after speaking with a defective drug attorney. Do not wait to get the help that you need from a lawyer.
A major lawsuit in 2009 was the first big legal action that exposed the manufacturer to litigation. This lawsuit named the drug manufacturer as liable for serious side effects associated with tissue necrosis. The lawsuit argued that the company had not gone far enough to warn consumers and physicians about the severe side effects linked to tissue necrosis if they took Promethazine.
The patient involved in that particular suit had to have her arm amputated as a result of tissue necrosis. Initially, the parent company of the manufacturer argued that since they had placed a general warning on the box as requested by the FDA that they should not be held liable for a patient who suffered tissue necrosis after using the medication. After an initial settlement amount for the plaintiff, the manufacturer appealed the results. Ultimately, the case made its way to the Supreme Court, in which the court determined that the company should have intensified the warning about tissue necrosis and the original settlement was upheld.
Our law firm is currently investigating claims from victims who have suffered serious medical conditions after taking Promethazine. If this applies to you, contact our firm today.