FDA Warns Reglan Side Effects Can Be Permanent

Gastrointestinal disorders are becoming increasing diagnosed, so the demand for medications to treat these disorders is high. Since no permanent, effective cures for the effects of gastrointestinal disorders have been developed, patients often seek a long-term treatment. One of the medications that has been used widely in this way is Reglan (Metoclopramide).

What is in Reglan That Makes it Dangerous

Various gastrointestinal medications have emerged over the years to treat gastric disorders. All of the ones that have been extensively used tend to contain an antiemetic, such as metoclopramide. These antiemetics are meant to treat nausea and/or excessive vomiting. It also increases the movement of stomach muscles and helps with the intestine emptying process. However, recently the FDA has come out publicly and stated that the prolonged use of any product containing metoclopramide can cause serious (often permanent) side effects for consumers.

Effects and Symptoms

Since there is presently no known permanent cure for serious gastrointestinal distress, it is not surprising that many patients seek out treatments to provide long-term relief. According to package insert dosage instructions, Reglan was only intended to be taken for up to three months. People who have taken this drug for longer than the three–month prescribed period have sometimes developed a seriously debilitating condition known as tardive dyskinesia. Recently, the FDA has issued a public health warning to both patients and physicians with the intention of avoiding additional instances of this devastating disorder. Symptoms of tardive dyskinesia include the following:

• Repetitive and involuntary movements of the face
• Excessive blinking and erratic eye movements
• Involuntary protrusions of the tongue
• Lip smacking
• Constant grimacing
• Difficulty moving the fingers

No treatment is currently available to treat tardive dyskinesia symptoms. Many of these side effects are irreversible and permanent.

FDA Issues Black Box Warning

To date, the FDA has taken two important steps to increase public awareness of these potentially severe side effects. The first of these is the issuance of a black box warning. This warning appears on the package inserts for prescription drugs alerting consumers of possible deleterious side effects that may occur when using the medication.

The second FDA action is the requirement of REMS, a risk evaluation and mitigation strategy. This investigation determines if the risks associated with a drug are worth the benefits that patients may experience.

Precautions You Can Take

If you or someone you care about has taken a product with the brand name Reglan or Metoclopramide in its name, there may be danger of incurring permanent and very serious side effects.

If you find that you or a loved one is currently experiencing any symptoms of tardive dyskinesia, you should take steps that will enable you to receive help now. Fill out our case review to arrange for your complimentary consultation today.

By filling out this free consultation form, you are NOT forming an attorney-client relationship. You can only retain an attorney by entering into a fee agreement. By submitting this form you are not entering into a fee agreement. This form is just a request for legal advice. Any information that you will receive in response to the above question is general information and you will NOT be charged for the response to this e-mail question. THIS IS AN ADVERTISEMENT, www.reglanhealth.com is not a Lawyer referral service. We are a marketing group that provide your information to attorneys across the country on a non-exclusive basis. Not available in all states, including FL.