A new safety labelling change for hydrochlorothiazide (HCTZ) drug was approved by United States Food and Drug Administration (US-FDA).

Hydrochlorothiazide is loop diuretic (acts on kidneys by eliminating excess fluids) used in the treatment of high blood pressure and oedema associated with the congestive heart failure.

A new safety information identified through routine pharmacovigilance (PV) activities of Hydrochlorothiazide which included a small increased risk of basal cell skin carcinoma or squamous cell skin cancer (non-melanoma skin cancer) associated with the use hydrochlorothiazide.

A regulatory action would be triggered whenever there is a new and significant safety information emerging from the usage of medicinal product(s) from the public (either through systematic data collection or from spontaneous sources). The type of regulatory action (drug recall, withdrawal, suspension, product label updates, etc.,) depends on the type, strength of evidence, and impact of safety concern on the patient safety and overall public health.

Safety Update to Product Label:

US-FDA provided approval to marketing authorization holder (MAH) for the inclusion this new safety information in the below mentioned sections-

Adverse Reactions

Post marketing Experience: Inclusion of ‘increased risk of non-melanoma skin cancer associated with HCTZ.’

Patient Counseling Information: Inclusion of instructions to patients ‘to protect their skin from the sun and undergo regular skin cancer screenings.’

The overall risk for non-melanoma skin cancer increases as individuals age and as they spend more time in the sun. The increased risk of developing non-melanoma skin cancer while taking Hydrochlorothiazide, a drug associated with photosensitivity (increased sensitivity to sunlight), is small.  

As per the FDA’s Sentinel Initiative study, the increased risk for squamous cell carcinoma in patients treated with hydrochlorothiazide was approximately one additional case per 16,000 patients per year. It was reported that the non-melanoma skin cancer treatment is typically local and successful, with very low rates of death.

Important information to health care professionals:

• Disseminate this new safety information to patients and patient care providers.
• Provide advice about protection of skin from sun exposure as risk minimizing measure.

Important information to patients/patient care providers:

• Be aware of this new safety update for hydrochlorothiazide
• Should continue hydrochlorothiazide and do not discontinue/stop this medicine unless advised from your health care provider, as the risk of uncontrolled hypertension could be severe and life-threatening.
• Implement the below risk minimizing measures.

1. Protect your skin from sun exposure by applying broad spectrum sunscreens (sun protection factor value of at least 15).
2. Regular reapplication of sunscreen and limiting time in the sun.
3. Use protective clothing, sunglasses and broad-brimmed hats are other ways to avoid sun exposure.

Voluntary ADR reporting

Health care professionals and consumers are advised to report any new or already known or suspicious adverse experiences or reactions or quality issues with the use of medicinal products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and voluntarily submit the report Online.
• Regular Mail or Fax: Download form FDA’s MedWatch zone, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800- FDA-0178.