Report Adverse Reactions to Medical Products

By reporting adverse reactions to drugs, biologics such as vaccines, and medical devices such as heart valves or sutures, you can help improve understanding of how people with alpha-gal syndrome may react to medical products.

Medwatch

MedWatch is the FDA’s medical product safety reporting program for health professionals, patients and consumers.

You can report an adverse reaction to a medical product via the Medwatch website. Access it via the button below. 

How to report a suspected reaction to a drug, biologic, or medical device

Reporting suspected reactions helps federal agencies identify possible safety problems affecting people with alpha-gal syndrome.

If you are experiencing a reaction now, seek emergency medical care first. Reporting can be completed after you are safe.

Where should you report it?

Use FDA MedWatch to report a serious or medically important reaction involving:

• Prescription or over-the-counter drugs
• Biologic products
• Blood products or transfusions
• Human cells or tissues
• Medical devices and implants
• Combination products, such as prefilled syringes or drug-coated devices

Patients can submit a report through the MedWatch online portal or use consumer Form FDA 3500B. A healthcare professional can submit Form FDA 3500, but clinicians generally are not required to make voluntary reports. If your clinician does not submit one, you can report the reaction yourself.

Reactions following vaccines should be reported to the Vaccine Adverse Event Reporting System, or VAERS, instead of MedWatch.

You do not have to prove what caused the reaction

Report the event if you reasonably suspect that a medical product, ingredient, or device material may have contributed to it. FDA does not require you to prove that the product caused the reaction.

Be clear about what is known and what remains uncertain. Do not identify a particular ingredient or material as the cause unless that information has been confirmed.

How to prepare a strong report

1. Ask a healthcare professional to help

If possible, ask your allergist, emergency physician, pharmacist, or other treating clinician to help complete the report or provide information from your medical record.

A report supported by clinical records is easier for FDA to evaluate. However, you can—and should—file the report yourself if a healthcare professional does not submit it.

2. Clearly identify alpha-gal syndrome

Write “alpha-gal syndrome” in both:

• The medical history or allergy section
• The description of the reaction

Do not describe the condition only as a “food allergy” or say simply that you are “allergic.” Spelling out the diagnosis helps federal safety reviewers recognize reports that may be connected to alpha-gal syndrome.

3. Identify the exact product

Provide as much identifying information as you can find.

For a drug or biologic, include:

• Brand and generic names
• Manufacturer, labeler, or compounding pharmacy
• Strength and dose
• How it was given, such as by mouth, injection, or intravenous infusion
• National Drug Code, or NDC
• Lot number and expiration date
• Whether it was compounded, generic, or a biosimilar

For a medical device, implant, or surgical material, include:

• Brand and type of device
• Manufacturer
• Model or catalog number
• Lot and serial numbers
• Unique Device Identifier, or UDI
• Implantation and removal dates, when applicable

For a human tissue product, include the product name and unique tracking number.

Copy identification numbers exactly as they appear on the packaging or label. A pharmacy, hospital, surgical facility, or medical office may be able to provide information that does not appear in your patient records.

4. Describe the timeline

Explain what happened in chronological order. Include:

• The date and time the product was administered or the device was used
• The dose and route of administration
• How much time passed before symptoms began
• The order in which symptoms appeared
• Blood pressure, oxygen level, or other objective findings, if available
• Treatment received, including epinephrine
• Emergency care, hospitalization, or other outcomes
• The clinician’s diagnosis or assessment
• Relevant test results, such as alpha-gal–specific IgE or tryptase, if obtained
• Other drugs, biologics, devices, foods, or possible exposures around the same time

If you do not know an exact time or date, provide your best estimate and identify it as an estimate.

5. Explain the possible connection to alpha-gal syndrome

You may adapt the following language:

The patient has physician-diagnosed alpha-gal syndrome, an IgE-mediated allergy involving galactose-alpha-1,3-galactose. After receiving [exact product] by [route] on [date and time], the patient developed [symptoms] after approximately [amount of time]. An alpha-gal–related reaction to the product or a mammalian-derived ingredient or material is suspected. The presence of alpha-gal in the product is [confirmed/not confirmed/unknown].

If the responsible ingredient or material is unknown, you may add:

The specific ingredient or device material responsible for this reaction is unknown. A mammalian-derived excipient, processing material, or device component is suspected, but its source and alpha-gal content have not been disclosed or confirmed.

6. Report inadequate labeling when it contributed to the problem

If incomplete ingredient or material information prevented you or your healthcare team from evaluating the product’s risk, explain that in the report.

You may identify this as a product or labeling concern. When a suspected product problem may have contributed to an adverse reaction, FDA instructs reporters to select both “adverse event” and “product problem.”

Describe the missing information precisely. For example:

The product information available to the patient and treating clinicians did not identify the source of [ingredient or material]. This prevented an informed assessment of its suitability for a patient with alpha-gal syndrome.

Take two additional steps

Notify the manufacturer

Contact the manufacturer’s medical-information, pharmacovigilance, or product-safety department. Ask the company to open an adverse-event case and provide you with its case number.

If you already submitted a MedWatch report, give the company your FDA report reference number. Manufacturers have federal reporting responsibilities for certain adverse events and medical-device problems.

Notify the healthcare facility

If the exposure occurred in a hospital, infusion center, surgery center, nursing facility, or other healthcare setting, contact its patient-safety or risk-management office.

Ask the facility to review the event and determine whether it must submit its own report. Certain facilities have mandatory reporting obligations for serious injuries or deaths involving medical devices.

Save your records

Keep copies of:

• Your completed report and narrative
• The submission acknowledgement or identification number
• Manufacturer and facility case numbers
• Product packaging, labels, receipts, and photographs
• NDC, lot, serial, tracking, or UDI numbers
• Emergency department and hospitalization records
• Medication-administration records
• Operative or procedure notes
• Laboratory results and discharge summaries
• Correspondence from the manufacturer, facility, FDA, or VAERS

If you obtain additional information later, submit it as follow-up information under the original case number whenever possible. Do not create an unrelated new report for the same event. If a clinician, manufacturer, or facility submits another report, ask that it cross-reference the earlier case as involving the same patient and event.

Reporting vaccine reactions

Anyone can submit a report to VAERS, even when it is uncertain whether the vaccine caused the event. If you provide contact information, VAERS will issue a confirmation or identification number. Save that number so you can provide records or other follow-up information later.

The most important step

Make sure a detailed report reaches FDA or VAERS directly. Reports to the manufacturer and healthcare facility provide additional reporting pathways, but patients should not assume that someone else has notified the federal government.

Submitting a report documents a suspected association. It does not prove that the product caused the reaction. Collectively, however, complete and accurate reports can help federal agencies detect patterns and investigate possible risks to people with alpha-gal syndrome.

For additional guidance, see the FDA instructions for completing Form 3500 and the VAERS frequently asked questions.

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